Annual technical report: 2013 : department of reproductive health and research, including UNDP/UNFPA/WHO/World Bank Special Programme of Research Training in Human Reproduction (HRP)
Publication date: 2013
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Contents Abbreviations 1 Introduction 5 Human Reproduction 11 Improving Maternal and Perinatal Health 55 Adolescents and at-risk Populations 83 Research capacity-strengthening 101 Biostatistics and Data Management 109 Research Project Review and Ethics 117 Advocacy and communications 121 Abbreviations 1 AGH Adolescent and at-risk Populations (team) ALIRH Latin American Association of Reproductive Health Researchers AMR antimicrobial resistance ANM auxiliary nurse midwife BOLD Better Outcomes in Labour Difficulty (project) C4-GEP Comprehensive cervical cancer control: a guide to essential practice CDC Centers for Disease Control and Prevention CEPEP Centre for Population Studies (Asunción, Paraguay) CIDES Centre for Research and Development in Sciences (La Paz, Bolivia) CIN cervical intra-epithelial neoplasia CIRE Continuous Identification of Research Evidence CREP Centro Rosarino de Estudios Perinatales (Uruguay) CRF case report form D&C dilatation and curettage DECIDE Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence (project) DHS Demographic and Health Surveys ECHO Evidence for Contraceptive options and HIV Outcome ECSA-HC East, Central and Southern African Health Community ELSI ethical, legal and social implications EMTCT elimination of mother-to-child transmission FCHV female community health volunteer FP2020 London Summit on Family Planning initiative GAP Gender and Rights Advisory Panel Gentle Assisted Pushing (project) GASP Gonococcal Antimicrobial Surveillance Programme GCP Good Clinical Practice GFMER Geneva Foundation for Medical Education and Research GRADE Grading of Recommendations Assessment, Development and Evaluation GREAT Guideline‐driven, Research priorities, Evidence synthesis, Application of evidence, and Transfer of knowledge ((Network) H4+ UNFPA, UNICEF, WHO, World Bank, UNAIDS, UN Women HDI Human Development Index HPV human papilloma virus HRP UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction HRX Human Reproduction (team) Abbreviations Annual Technical Report 20132 HSV herpes simplex virus IARC International Agency for Research on Cancer IAWG inter-agency working group IBP Implementing Best Practices Initiative ICD International Classification of Diseases ICPD International Conference on Population and Development IHP International Health Partnership IM intramuscular IMPT Initiative for Multipurpose Technologies IPTp intermittent preventive treatment in pregnancy IT information technology IUD intrauterine device IVB Immunization, Vaccines and Biologicals (team) IVF in vitro fertilization IVR Initiative for Vaccines Research JTF James Tudor Foundation LID Long-term Institutional Development (grant) MDG Millennium Development Goal MEC Medical eligibility criteria for contraceptive use mHealth mobile health MiP malaria in pregnancy MMR maternal mortality ratio MPA Maternal and Perinatal Health and Preventing Unsafe Abortion (team) MPT multipurpose prevention technology MR menstrual regulation MSM men who have sex with men mTERG WHO mHealth Technical and Evidence Review Group MVA manual vacuum aspiration NGO nongovernmental organization NIH National Institutes of Health (USA) NSAID non-steroidal anti-inflammatory drug NSWP OHCHR Global Network of Sex Work Projects UN Office of the High Commissioner for Human Rights PATH PCC Program for Appropriate Technology in Health Policy and Coordination Committee PCR polymerase chain reaction PICOT Population, Indicator/Intervention, Comparator, Outcome, Time RCT randomized controlled trial RHL WHO Reproductive Health Library RHR Department of Reproductive Health and Research RMNCH reproductive, maternal, newborn and child health RP2 Research Project Review Panel Abbreviations 3 SELMA Simplified, Effective, Labor-Monitoring Assistant SERG Scientific and Ethics Review Group SIS Statistics and Informatics Services SP sulfadoxine–pyrimethamine SPR Selected practice recommendations for contraceptive use SRH sexual and reproductive health STAG Scientific and Technical Advisory Group STEPMAG Simplified Treatment for Eclampsia Prevention using Magnesium sulphate (trial) STI sexually transmitted infection TAG Topic Advisory Group TFV tenofovir TFV ISC Tenofovir Gel Implementation Steering Committee THRIVE Technologies for Health Registries, Information, and Vital Events (consortium) TRC Technical Resource Team UK United Kingdom of Great Britain and Northern Ireland UNAIDS Joint United Nations Programme on HIV/AIDS UNDP United Nations Development Programme UNFPA United Nations Population Fund UNICEF United Nations Children’s Fund US United States USA United States of America USAID United States Agency for International Development VIA visual inspection with acetic acid WAHO West Africa Health Organization WHO World Health Organization WHO MCS WHO multicountry survey on maternal and newborn health Annual Technical Report 20134 Introduction 5 Introduction “… We must do more for the teenage girl facing an unwanted pregnancy; for the married woman who has found she is infected with the HIV virus; and for the mother who faces complications in childbirth…”. This impassioned and urgent call in September 2010 by the United Nations Secretary-General launched the Global Strategy for Women’s and Children’s Health and underscores the importance of WHO’s and HRP’s work in sexual and reproductive health. The UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) is the main instrument within the United Nations for sexual and reproductive health research, bringing together policy-makers, scientists, health-care providers, clinicians and community representatives to identify and address priorities for research to improve sexual and reproductive health. HRP is a cosponsored Special Programme executed by WHO, which is part of the WHO Department of Reproductive Health and Research (RHR), based in the WHO cluster on Family, Women’s and Children’s Health (FWC). For RHR and HRP, the year 2013 represented a critical year of transition, marked by the appointment of a new Director and senior leadership team; the implementation of a programme of strategic planning and restructuring; and the completion of a five-year independent External Evaluation. This report describes these changes, whilst at the same time summarizes HRP’s record of achievement in 2013 on the generation of new knowledge, synthesis of research evidence, strengthening of research and technical capacity, development of guidelines, and strengthening of research and policy dialogue on sexual and reproductive health and rights. Strategic planning and restructuring In February 2013, a functional review of RHR was carried out which aimed to (i) review and revise the Department’s priority functions and areas of work and ensure that these are relevant for, and aligned with, its overall strategic direction; (ii) rationalise the current structure of the Department, to make it more coherent and efficient in terms of its functional organisation; (iii) to redefine focus and clarity of HRP, and (iv) examine working practices and identify areas for improved and coordinated working across the Department, within WHO as a whole, and within the global sexual and reproductive health and rights community. The overall result of the review was a more focused programme, which is better aligned with changing global context and needs. The review concluded that while the work should continue in all key areas of sexual and reproductive health, including maternal and perinatal health, family planning, prevention of unsafe abortion, controlling sexually transmitted infections, gender and human rights related to sexual and reproductive health, and adolescent sexual and reproductive health, certain aspects should be further prioritized. Specifically, the review recommended that family planning, maternal and perinatal health and adolescent sexual and reproductive health should be prioritized, with a focus on research (biomedical, clinical, health systems, epidemiological and implementation research), guidelines, norms and standards, and monitoring and evaluation. At the same time, in view Annual Technical Report 20136 of enhanced resources provided at the regional and country levels to technical support to countries, the functional review recommended a reduction in the relative contribution to this work, with a corresponding reduction in staffing. The present report of 2013 achievements has been structured under the new priority headings, which are also reflected the new structure of the department, shown in Figure 1 below. Figure 1. Organizational chart. Department of Reproductive Health and Research Department of Reproduc�ve Health and Research (RHR), including UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduc�on (HRP) Marleen Temmerman, Director � Global strategies, frameworks and ini�a�ves (ICPD, MDGs, H4+) � Partnerships and global advocacy � Oversight and coordina�on of research, research capacity building, work with WHO Regional and Country oﬃces and WHO collabora�ng centres � Biosta�s�cs and data management � Programme Management, HRP Trust Fund, HRP direct administra�ve support Reproduc�ve tract and sexually transmi�ed Human Reproduc�on (HRX) Coordinator (Vacant) � Contracep�on / Family planning � infec�ons � Infer�lity � Women’s health based Risk Popula�ons prac�ces Adolescents and at - (AGH) Lale Say, Coordinator � Adolescent sexual and reproduc�ve health � Gender and sexual violence � Harmful � Sexual and reproduc�ve health in emergencies, conﬂict, and humanitarian crises, and of other at risk popula�ons Maternal and Perinatal Health and Preven�ng Unsafe Abor�on (MPA) Me�n Gülmezoglu , Coordinator � Maternal and perinatal health � Preven�on of unsafe abor�on � Pre concep�on / pre pregnancy HRP External Evaluation, 2008-2013 HRP is subject to periodic independent external evaluation, commissioned by its Policy and Coordination Committee (PCC), most recently in 2013 (2). This evaluation, covering the period 2008–2013, was requested by the World Bank at the 71st meeting of the standing committee in June 2011. At this meeting, the cosponsors agreed on draft terms of reference, elaborating an approach that would review the comparative advantage of HRP and its impact in improving outcomes and influencing evidence-based changes in sexual and reproductive health policies and programmes, as well as carrying out a number of case-studies cutting across all thematic areas. The results, which were presented at PCC in June 2013, concluded that: “The HRP team in Geneva, though relatively small, is highly impressive in its capacity to identify and coordinate a large network of investigators, collaborators and experts, from academic and research institutions all over the world, capable of addressing and developing long-term solutions to global SRH challenges. In the period 2008–2012, the Programme continued to produce many important global public goods in the area of SRH. This was largely due to three factors: the dedication and excellence of its staff; the leadership and determination of its Introduction 7 directors in making the necessary decisions to ensure that HRP continued to move forward; and its fundamentally sound governance and technical oversight systems. By helping to lead and guide global developments in SRH, and then adapting to the changing environment, HRP continues to demonstrate that its business model is robust, and that its work remains highly relevant to the needs of programme countries” (2)” Structure of this report In the chapters that follow, HRP’s achievements in 2013 are highlighted. They are structured under the new priority headings, which also reflect the new structure of the department, namely human reproduction, maternal and perinatal health, and adolescent and at risk populations. In addition, the department carries out a number of cross-cutting activities that underpin the work of all three thematic teams, relating to international partnerships, gender, rights and advocacy for sexual and reproductive health. These are described below. ICPD Beyond 2014: redefining the global agenda on sexual and reproductive health – WHO’s role and strategy Progress While significant progress has been made in many of the diverse goals of the ICPD Programme of Action, preliminary results from the Global Survey demonstrate that profound disparities persist. In this context, in 2013 RHR led an intra-organizational task team to identify priority topics to address, and developed a package of eight evidence briefs focusing on the core neglected topics of the Programme of Action for use by advocates and policy-makers at the Commission of Population and Development in 2014. Planned activities To improve sexual and reproductive health globally, and thus to reduce inequality, there is a need to link the ICPD efforts with the Millennium Development Goals (MDGs). To advance health in the neglected topics of both agendas, there is a need to reach out to policy-makers, technical experts, and the communities affected. WHO headquarters, in collaboration with the Regional Office for Africa, will convene a regional workshop in spring 2014 that brings together countries with success in improving outcomes on a priority health topic, and countries committed to progress. This consultation will serve as an opportunity to facilitate south-to-south exchange of best practices learnt. Lessons from these case examples will be distilled into suggested action items for community advocates on priority health topics, and published as a cohesive document. WHO will prepare a toolkit that combines the ICPD evidence briefs, relevant WHO technical guidelines, and the lessons from the case-studies. This toolkit will serve as an advocacy resource for countries as they engage in the work of the ICPD Programme of Action and the MDGs. Annual Technical Report 20138 High level advocacy for sexual and reproductive health Progress RHR and HRP outputs were widely disseminated, and high-level advocacy for sexual and reproductive health was carried out at 36 different conferences, symposia and high-level international meetings (please refer to list in Annex 3). One of the major events in 2013 was the Women Deliver Conference in Kuala Lumpur. This conference is one of the largest gatherings to date of government leaders, policy-makers, health-care professionals, researchers, nongovernmental organization representatives, corporate leaders, and global media outlets, focusing exclusively on women’s health and empowerment, bringing together over 4500 participants from 149 countries. RHR participated in concurrent sessions, including high-level plenaries, skills-building workshops, and a ministerial and parliamentarian forum; also, among other key presentations to share the latest updates on sexual, reproductive and women’s health, RHR launched two new reports, the Investment case for eliminating mother-to-child transmission of syphilis. Promoting better maternal and child health and stronger health systems, and Comprehensive cervical cancer prevention and control – a healthier future for girls and women. In 2013, RHR also engaged in another important global initiative, FP2020. Launched at the 2012 London Summit on Family Planning, FP2020 aims at expanding access to family planning information, services, and supplying contraception to an additional 120 million women and girls in the world’s poorest countries by 2020. RHR has actively contributed to the FP2020 initiative, chairing the Performance, Monitoring and Accountability Working Group, together with the Population Council. In November 2013, FP2020 launched its first progress report, Partnership in Action 2012–2013, at the International Conference on Family Planning in Addis Ababa. The report details successes and progress made since the 2012 London Summit on Family Planning, highlighting commitments, accountability, innovation, collaboration and ways to measure FP2020’s progress. In the lead up to the 20th anniversary of the International Conference on Population and Development (ICPD) Programme of Action, RHR and WHO has supported the work of UNFPA in reviewing progress and identifying remaining gaps in the implementation of the Programme. Within WHO, HRP led an intra- organizational task team to develop eight evidence summaries on neglected priority areas for use by policy-makers and advocates at the advocacy events, including at the Commission on Population and Development. RHR has also been working with the Inter-Parliamentary Union (IPU) and other thematic and regional parliamentarian such as the European Parliament and the Pan Africa Parliament to advocate for the uptake of sexual and reproductive health issues. In particular, in 2013, the Director of RHR has been appointed as WHO focal point for IPU and other parliamentarian activities. In 2013, RHR supported IPU in the draft of a resolution on demographic trends and natural constraints, and the Pan African Parliament in the finalization and endorsement of a resolution on gender-based violence, including recommendations on legislation to address child marriage. Introduction 9 Planned activities For 2014, RHR plans to continue to advocate for improved sexual and reproductive health and rights at conferences, symposia and high level international meetings, such as at the 13th Congress of the European Society of Contraception and Reproductive Health, which will take place in Lisbon from 28 to 31 May, 2014, at the Third Global Symposium on Health Systems Research which will be held in Cape Town, South Africa, from 30 September to 3 October 2014. United Nations H4+ joint support to countries advancing Millennium Development Goals 4 and 5 H4+ (UNFPA, UNICEF, WHO, World Bank, UNAIDS, UN Women) works with countries to support the implementation of commitments to the United Nations Secretary-General’s strategy on Every Woman, Every Child (46), to accelerate progress towards Millennium Development Goals (MDGs) 4 and 5. Action focuses on effective high-impact interventions in RMNCH, by strengthening the health systems and by improving equity in accessing quality services. Bilateral donors like the Swedish International Development Agency, the Canadian International Development Agency, and the French Muskoka Initiative have considered the partnership as a valuable platform to operationalize their support for the Every Woman Every Child strategy. HRP/RHR and other departments in the Family, Women’s and Children’s Health Cluster have contributed to the planning and implementation of these initiatives. Progress The 2013 H4+ report includes an assessment of the support provided by H4+ teams in 58 countries to help them reach their RMNCH goals (47). The partnership has become a “one-stop shop” for countries to access technical and financial support for the entire spectrum of RMNCH issues; 57% of countries have established their H4+ country teams, which have supported strategic activities, such as in preservice training curriculum development, training of trainers, and engaging community health workers in service delivery in countries like Benin, Côte d’Ivoire, Mali and Togo. Countries have also used evidence-based planning and costing tools, e.g. the OneHealth examples of achievements in Benin, Democratic Republic of the Congo, Niger, Sierra Leone and Togo. At least 12 country teams have mobilized additional resources to support the implementation of H4+ joint plans among international agencies and national partners. Planned activities � Develop a joint, rapid multi-stakeholder synthesis of the RMNCH landscape that brings together the various RMNCH-related plans, subplans and initiatives. � Strengthen country engagement to align and coordinate funding streams to support implementation of prioritized interventions, such as family planning, maternal health and adolescent SRH services. � Increase efforts to integrate RMNCH service with HIV and malaria prevention/ treatment, and support equitable access to quality services for all women and children, including those in deprived and hard-to-reach areas. Annual Technical Report 201310 Sexual and Reproductive Health and Human Rights Progress made During 2013, the Department continued to contribute to the work of United Nations Treaty Monitoring Bodies. This included ongoing support to the Committee on Economic, Social and Cultural Rights in the development of its draft general comment on the right to sexual and reproductive health. The Department also developed technical guidance on the application of a human- rights-based approach to the implementation of policies and programmes to reduce preventable maternal morbidity and mortality. This represented a significant contribution to the implementation work of the UN Office of the High Commissioner for Human Rights (OHCHR). The Department is working closely with OHCHR on the application of this guidance in four countries in southern Africa (Malawi, South Africa, Uganda, and the United Republic of Tanzania). The Department also disseminated Safe abortion: technical and policy guidance for health systems to UN treaty monitoring bodies. A successful meeting was organized for the UN Committee Against Torture and the recommendations of WHO are reflected in its recent concluding observations in relation to conscientious objection. During 2013, the Department worked on developing guidelines on ensuring human rights in the provision of contraceptive services and information and an analysis of existing quantitative indicators in relation to contraceptives based on human rights (see Human Reproduction chapter for further details). Also in 2013, the Sexual and Reproductive Health and Human Rights: a Tool for Examining Laws, Regulations and Policies and a WHO/joint UN agency statement on forced sterilization was finalised. Finally, the Department has been working on the integration of human rights into the WHO International Classification of Diseases (ICD 10) revision process in connection to sexuality issues which are currently classified under mental health. Proposals were developed that are currently being field tested in five low- and middle-income countries. Planned Activities Planned activities for the work on sexual and reproductive health and human rights include: development of a research agenda on sexual and reproductive health and human rights; integration of human rights in the key areas of work of the Department; contribution to the development and interpretation of human rights standards and developing guidance on the implementation of sexual and reproductive health standards based on a human rights-based approach. References 1. United Nations Secretary-General. Global Strategy for Women’s and Children’s Health. Geneva: The Partnership for Maternal, Newborn and Child Health, 2010 (http://www.who.int/pmnch/topics/maternal/201009_globalstrategy_ wch/en/, accessed 10 June 2013). 2. UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction. External evalu- ation 2008–2012. Geneva, World Health Organization, 2008 (http://www. who.int/entity/hrp/about_us/governance/intro_assessment.pdf, accessed 16 September 2013). Human Reproduction 11 Human Reproduction Summary Key objectives The workplan in the area of human reproduction is progressively expanding its focus on implementation into the areas of research, guidelines and partnership. Research studies planned at present are developed to address research priorities that have important programmatic implications. Currently, the available WHO guidance on human reproduction primarily addresses “what to do” in providing quality services. However, the Human Reproduction team has already started to collaborate with its partners to enhance this work by including evidence on “how to do it” – and to use this guidance to provide WHO recommendations for key interventions to expand high-quality services, as well as for how best to implement them in the field. Major achievements Research In line with the distinguished trajectory of the Programme in contraceptive research, HRP/RHR completed a multicountry study comparing the safety and effectiveness of two contraceptive implants. The results of the study, which will be published early 2014, will inform global implementation efforts such as the London Summit on Family Planning (FP2020) initiative and the United Nations Commission on Life Saving Commodities for Women and Children’s Health. In addition, the Programme invested in the protocol development and implementation plans of the International Contraceptive Choice Study (which will ensure a rights-based approach in ensuring quality family planning services offering a good method mix) and the ECHO (Evidence for Contraceptive options and HIV Outcome) trial (to determine the risk of HIV acquisition in women using hormonal contraception), which will be two of the most important international research efforts in the area of family planning in the next 4–5 years and will generate results with significant health-policy and programmatic implications. In the area of sexually transmitted infection (STI), the Programme secured funds and international support to start several new studies on evaluation and implementation of screening and diagnostic tests. Guidelines The Continuous Identification of Research Evidence (CIRE) system continues to work effectively to constantly update WHO guidance in contraceptive use, with ongoing preparations for the next revision in 2014. Work will also start on implementation of the guidance document on family planning and human rights recently submitted to peer review. The new WHO guidelines for screening and treatment of precancerous lesions for cervical cancer prevention was published and launched and received huge success. In addition, the Programme launched in 2013 the guide Programming strategies for postpartum family planning, to help programme planners and managers identify opportunities to offer family planning/contraception to postpartum women within existing health systems. The new sexuality counselling guidelines for health care were completed and Annual Technical Report 201312 the Programme secured funding and international technical support to start the processes of developing guidelines for the management of STIs, as well as guidelines for topical pre-exposure prophylaxis for woman-controlled HIV prevention; the sexual and reproductive health of women living with HIV; and the diagnosis, management and treatment of infertility/subfertility. Dissemination, advocacy and partnerships The team has participated in important international partnerships and supported global initiatives to support the increased interest in promoting reproductive health and contraception, such as the H4+ initiative (WHO, UNFPA, UNICEF, The World Bank, Joint United Nations Programme on HIV/AIDS [UNAIDS], UN Women joint country support for Millennium Development Goals [MDGs] 4 and 5); the Muskoka Initiative; Implementing Best Practices Initiative (IBP); Africa Build; Global Fund; United Nations Commission for Life Saving Commodities, where RHR led the Technical Resource Team for Emergency Contraception; and the Initiative for Multipurpose Prevention Technologies. Activities ranged from providing technical assistance to countries; disseminating key information in family planning, infertility, STIs, including HIV, and women’s health; supporting implementation of evidence-based guidelines and tools; and providing advocacy for policy development. The team actively participated in numerous conferences, including the International Conference for Family Planning (November, Addis Ababa), Women Deliver, the International Union against Sexually Transmitted Infections, and the European Society of Contraception and Reproductive Health (ESCRH), through high-level side events and plenary sessions, oral and poster presentations, and IBP workshops and panel sessions. Finally, WHO guidelines for (i) Ensuring human rights in the provision of contraceptive information and services and (ii) Responding to intimate partner violence and sexual violence against women were developed. 1. Introduction The Human Reproduction (HRX) team of the World Health Organization (WHO) Department of Reproductive Health and Research (RHR) carries out activities in: � research and development � norms, standards and tools � research capacity-building � monitoring and evaluation � dissemination, advocacy and partnerships. The team’s activities focus upon the following thematic areas within a consolidated and comprehensive approach to sexual and reproductive health (SRH): � family planning/contraception � sexually transmitted infections (STIs), including HIV/AIDS � women’s health, including cancers of the reproductive tract � infertility. The following areas of SRH, including bidirectional linkages between the areas, underlie some of the most critical global health challenges that need to be effectively addressed to improve health and foster socioeconomic development worldwide. Human Reproduction 13 � An estimated 222 million women in low- and middle-income countries would like to delay or stop childbearing but, because of lack of access and knowledge, are not using any method of contraception; improving access to contraception could reduce maternal mortality by 30% worldwide. � There are 499 million new infections of curable STIs (syphilis, gonorrhoea, chlamydia and trichomoniasis) each year and drug resistance, especially for gonorrhoea, is dangerously increasing, posing a major threat to STI control globally. � An estimated 1.4 million pregnant women are infected with syphilis each year and, as a result of insufficient testing, there are over 300 000 stillbirths or neonatal deaths per year. � HIV is now the leading cause of mortality of women of reproductive age, with an estimated 60% of people living with HIV being female; HIV-related maternal mortality rates in sub-Saharan Africa have increased and surpassed other causes. � One in every four couples in low- and middle-income countries have been found to be affected by infertility, and a 2012 WHO study estimated that levels and trends have not improved from 1990 to 2010 (1). � Cervical cancers are increasingly recognized as one of the major causes of mortality for women, in both low- and middle-income countries and high- income countries, and globally more women are dying from breast and cervical cancer than from maternal mortality. The team conducted an extensive prioritization exercise effort with internal and external partners, to answer important research questions and to address vital implementation challenges through the most cost-effective strategies. Building on the convening power and scientific/technical excellence of the United Nations Development Programme (UNDP)/United Nations Population Fund (UNFPA)/ United Nations Children’s Fund (UNICEF)/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), the team has established large international collaborative networks to generate innovative approaches to deal with the major unmet needs in SRH. To achieve this objective, the team is implementing a collaborative, science-driven approach, the key components of which are: 1. identification and conduction of priority research activities to strengthen the evidence base on priority needs; 2. development of normative guidance that addresses the needs; 3. identification of research gaps and elaboration of funding strategies to meet these gaps; 4. research synthesis and updating of the guidance in a timely fashion; 5. support for utilization of evidence in countries through systematic introduction of science-driven solutions to inform health policies. The HRX team’s plan of work shows how this approach translates into concrete and coordinated activities toward achieving the ultimate goal of improving SRH. Annual Technical Report 201314 2. Research and development Research and development in family planning/contraception 2.1 Global research priority setting in family planning In 2011–2012, the Department conducted a research priority-setting exercise, using the methodology of the Child Health and Nutrition Research Initiative to identify global research needs in contraceptive research and to guide investment in effective interventions to satisfy the large and currently unmet need for modern methods of family planning. Progress Through a global survey, experts on contraception were invited to identify and rank the research priorities that would address knowledge gaps on reducing the unmet need for family planning in the next decade, on the basis of five criteria: (i) being deliverable, affordable and sustainable; (ii) leading to a substantial reduction in the unmet need for contraceptives; (iii) being effective and efficient in improving health systems; (iv) being addressed in an ethical way; and (v) having an equitable effect on the target population. The overall scores were then ranked. The survey prioritized research on the following relevant issues: implementation of the health systems and policies relevant to family planning; integration of services – to address barriers to contraceptive use; and interventions targeted at underserved groups, such as adolescents. These observations will inform decision- makers, researchers and funding agencies in developing a clear and focused research approach to satisfying the global need for family planning and reaching the target set by the London Summit on Family Planning (FP2020) initiative. An article presenting the results of the survey was published in the Bulletin of the World Health Organization (2). Planned activities � Future activities will be related to planning research and alignment of study groups to the priorities stated. 2.2 ECHO (Evidence for Contraceptive options and HIV Outcome): research studies on the risk of HIV acquisition in women using hormonal contraception Historically, HRP has played a major role in assessing the safety of contraceptives, as it led the scientific efforts that contributed to decreasing concerns about links between contraceptive use and cancer and cardiovascular risk. Nowadays, the potential risk of HIV acquisition associated with the use of various hormonal contraceptives is the issue generating concerns within the international community. Recent published studies have suggested a possible increased risk of acquiring HIV among women using progestin-only hormonal contraceptives, most notably injectables. This concern has important health policy implications, as many of the countries most affected by HIV are also those with the fewest contraceptive options, and many rely heavily on the provision of injectable progestin-only contraception. Further complicating matters are the competing risks women must weigh in settings where foregoing family planning puts them at significant risk of maternal morbidity or mortality. Human Reproduction 15 Progress To address this knowledge gap, a multicentre randomized clinical trial to compare the rate of HIV acquisition between women using depot medroxyprogesterone acetate injectables, the copper-bearing intrauterine device (IUD), and another possible method (either norethisterone enantate injectable or a hormonal implant) in African settings is being planned. Women will be followed for one year, after randomization to one of the two or three methods, and will undergo HIV testing at 3, 6, 9 and 12 months after enrolment. Because the incidence of HIV at the study sites is unknown at this time, an adaptive study design will be pursued, to ensure that the number of seroconversions observed in the study is sufficient to distinguish a clinically meaningful difference. The study protocol has been approved by WHO’s scientific and ethics review boards. This protocol is being discussed with other international partners and experts, to consider harmonization with other research plans aimed at addressing similar research questions. Planned activities � The study will be conducted at clinics in East London, Cape Town and KwaZulu- Natal in South Africa, and in Mombasa, Kenya. 2.3 Expanding the choice of contraceptive methods through the International Contraceptive Choice Project Extensive prioritization efforts conducted by HRP, in collaboration with internal and external partners, indicated that the most pressing need in terms of research in family planning is to determine how to expand the use and choice of contraceptive methods in low-resource settings. In order to identify factors to facilitate expansion of the method mix and integration of provision of contraceptives into antenatal, safe abortion, post-abortion and post-partum services, to inform health policies at national level, the recently published cohort study, the Contraceptive Choice Project (3), will be used as a model for expansion and adaptation to low-income countries in Africa (International Choice project). The Contraceptive Choice Project, conducted in the city of St Louis, Missouri, United States of America (USA) has shown that use of long-acting contraceptive methods could be effectively promoted by acting on three dimensions: � appropriate information for providers and clients; � availability of methods free of charge; � reducing delay and unnecessary procedures/barriers in delivering the method. Importantly, Choice has shown that this approach resulted in increased uptake of contraceptives, fewer unintended pregnancies and reduced abortion rates. The Choice cohort study protocol will be adapted to include strategies for recruitment that are feasible in low-resource settings, focusing on post-abortion/ postpartum approaches in integration with reproductive maternal, neonatal and child health (RMNCH) services. There will be a need to look into strengthening health systems, capacity-building for local human resources, and community mobilization, as well as considering local policies as part of the adaptation process in low-income countries. Annual Technical Report 201316 Progress A series of consultative meetings has been convened by HRP with the University of North Carolina, FHI 360, and Washington University at St Louis, USA, to develop the project, which has received preliminary approval from the Bill and Melinda Gates Foundation, for a planning grant to be implemented in Zambia. Discussions with other potential funding agencies to expand the project to other countries are ongoing. The European CHOICE study looked at the important role of counselling in the uptake of various hormonal contraceptives. An application has been made to the European Union (EU) for adaptation of the International Contraceptive CHOICE Project in another site. 2.4 Multicentre randomized clinical trial of two implantable contraceptives for women: 2-rod levonorgestrel implant (Jadelle) and 1-rod etonorgestrel implant (Implanon) Progress HRP/RHR recently completed a multicentre, randomized clinical trial to assess the 3- and 5-year safety, effectiveness and acceptability of two hormonal contraceptive implants: 2-rod levonorgestrel implant (Jadelle) and 1-rod etonorgestrel implant (Implanon). The study was conducted in seven countries: Brazil, Chile, Dominican Republic, Hungary, Thailand, Turkey and Zimbabwe. A total of 2963 women have been randomized to one of the two implants (with 971 women on the TCu380A IUD enrolled in an age-matched cohort). An article presenting the baseline characteristics of the two study groups was published in Contraception in 2013 (4). A manuscript describing the 3-year follow-up of clients in the implant study is in preparation and will be submitted to a peer-reviewed journal by end of January 2014. Planned activities � The main paper on the 5-year analysis of the study will be submitted in 2014. 2.5 Study on sperm suppression using norethisterone ethantate and testosterone undecanoate Progress To expand contraceptive options for men, HRP/RHR initiated a phase II trial of a combined progestin (norethisterone ethantate) + androgen (testosterone undecanoate), as this product has been shown to determine sperm suppression. However, the high number of side-effects such as depression and emotional side efffects reported in the trial led to discontinuation of recruitment in 2012. While the early termination of the study will compromise the precision of a final estimate of the contraceptive failure rate of this regimen, other analyses linking the serum hormonal levels to the clinical effects are planned. The study participants have been followed up until the end of the recovery phase (when sperm levels are observed to return to normal levels). All study sites have completed follow-up of recruited subjects. Planned activities � Data cleaning and analysis are ongoing and the analysis of the serum hormone levels is expected to be completed in 2014. Human Reproduction 17 2.6 Pericoital oral contraceptive use of levonorgestrel 1.5 mg This is a study to provide a “proof of concept” for the use of a levonorgestrel oral contraceptive pill that can be taken 24 hours before or after sexual intercourse (pericoital use), up to six times a month. The study will provide preliminary data to justify a pivotal phase III study to establish efficacy and safety and to inform policies and programmes worldwide, as well as for regulatory purposes. Progress A total of 320 participants in four countries have been recruited, in a prospective, open-label, single-arm, multicentre study to evaluate whether oral levonorgestrel (1.5 mg), taken around the time of sexual intercourse, can offer an acceptable level of safety and contraceptive efficacy. Follow-up has been completed in Singapore and Thailand and is under way in Brazil and Hungary, to end in mid-2014. Planned activities � Analysis is expected to be completed in late 2014, with a technical report and scientific publications prepared. 2.7 Evaluation study of the feasibility, utility and effects of the use of family planning counselling tools at the community level The positive role of counselling tools in communicating high-quality and correct information to family planning clients is well established. However, counselling tools for use at the community level by health workers with limited education and training (6 weeks or less) have not been developed until recently. Therefore HRP/RHR, in collaboration with the Population Council, conducted an evaluation determining the relative utility and acceptability of three simplified counselling tools designed for community health workers – the WHO publication, A guide to family planning for community health workers and their clients (5), the Population Council Balanced Counseling Strategy tool (6), and a hybrid version with key features common between the two, as compared with the usual information material provided to community health workers in India. Progress The evaluation, conducted with 142 community health workers, has shown that in almost all cases (90% to 100%), there were no major variations between various counselling tool groups and the control group, and that community health workers were able to perform their counselling tasks appropriately and effectively when using the simplified tool, including facilitating choosing an appropriate method and providing it, if available. Planned activities � The full technical report and scientific publications will be prepared in 2014. � Discussions on how to improve the various counselling tools or the respective adaptation guides based on the study reports is planned for early 2014. Annual Technical Report 201318 2.8 Measuring the need for family planning among women attending HIV services: a comparison of data-collection methods There is an established need to identify more accurate methods for measuring the unmet need for family planning among persons living with HIV. Therefore, HRP/ RHR conducted a study to compare how the use of a simplified questionnaire adapted from Demographic and Health Survey (DHS) questions determined unmet needs when used by health-care providers during their interaction with the clients at the HIV clinic, or by external interviewers conducting exit interviews among women attending HIV care and treatment services. Progress Using a cross-sectional study design, 1186 women aged 15 to 49 years were interviewed only once, either during the provider contact or during the exit interview at selected HIV care and treatment facilities with large client loads in Kenya, Uganda and Zambia. Data collection took place between March 2012 and February 2013. The study showed that providers’ use of this brief tool in allocating family planning need status is statistically equivalent to the allocations made by external, non-clinical interviewers. This implies that the tool can be used to collect routine data on family planning need status, which may be aggregated at the facility level and higher up the health information system, in order to monitor progress in reducing unmet need for contraception among women living with HIV. Planned activities � The results of this study will be submitted for publication in 2014. 2.9 Reviewing and generating evidence on financing mechanisms for sexual and reproductive health services and commodities including family planning Progress Lack of access to affordable contraceptive services and commodities is contributing to unmet needs for family planning in many low- and middle- income countries. Evidence on the best mechanisms to provide these affordable services and commodities using financial schemes is limited. Therefore, HRP/ RHR is conducting a series of systematic reviews to identify the current gaps in knowledge and potential research topics in health-care financing in contraception. In addition, HRP/RHR is collaborating with Marie Stopes International and other organizations to implement and evaluate two projects that aim at reducing barriers to SRH services, including family planning, among women living in one of the poorest regions of the Philippines and in Pakistan. These evaluations will contribute to generating evidence on the effectiveness of reducing barriers to health services by using vouchers programmes, integrating supply and demand components of health, and increasing enrolment into social insurance schemes. Planned activities � The systematic reviews will be conducted in 2014. The projects in Pakistan and Philippines have begun in 2013, with the Pakistan project expected to be completed by 2014. Two manuscripts describing the baseline data and the research protocol of the Pakistan project have been finalized and submitted to peer-reviewed journals in 2013. Evaluation of the Philippine study site will be conducted after recovering from the effects of the typhoon. Human Reproduction 19 Sexually transmitted infections, including HIV/AIDS Recently, several studies have been initiated by HRP/RHR to advance knowledge on implementation of cervical cancer screening and human papilloma virus (HPV), dual HIV/syphilis testing, behaviour-change communication, and STI diagnostics. However, there are still gaps in the evidence required to ensure effective STI prevention and management. STI guideline management which will highlight the key gaps in STI research. These research gaps will be published with the guidelines and will support a future research agenda. 2.10 ESTAMPA: a multicentre study of cervical cancer screening and triage with HPV testing ESTAMPA is a multicentre screening study among 50 000 women in selected Latin American countries, to compare visual, cytological and molecular triage methods, or combinations of these methods, in terms of performance and cost effectiveness, among HPV-positive women participating in HPV-based screening programmes and a sub sample of HPR negative women. In each participating centre, at least 5000 women aged 30–49 years who are attending clinics for cervical screening will be invited to participate in the study. The combined number of histologically confirmed diagnoses of cervical intra-epithelial neoplasia CIN3+ (estimated n = 500) will be the outcome of primary interest for evaluation of the performance of the various triage modalities. The effectiveness and costs of each alternative strategy will be assessed under various scenarios of feasibility, cost and effectiveness. The study is a great opportunity to develop a model for organized screening intervention in the selected sites, and to define the target population, in order to evaluate factors associated with implementation – participation rates, follow-up completeness, psychosocial factors etc. WHO partners that are supporting this study include the International Agency for Research on Cancer (IARC), WHO headquarters, and the Pan American Health Organization, with the National Institutes of Health (NIH) of the USA. Progress Ten centres in six countries have initiated the study. Out of these, two centres in Colombia have started the recruitment (770 as of December 2013). All the other centres/countries are now ready to start between January and March 2014. Planned activities � Additional sites are planning to carry out the study: earlier planning phases include Chile, Costa Rica (two sites), Guatemala, Panama, Peru, Puerto Rico and Venezuela. These sites should be ready by September 2014. In February 2014, the Data Safety and Monitoring Board will meet to review data and progress. � To address issues specific to Africa with the introduction of HPV testing, and also of a visual inspection with acetic acid (VIA)-based algorithm, WHO and IARC are developing another joint protocol for a randomized cluster trial to evaluate different algorithms for cervical cancer screening in Africa. Algorithms currently considered as study arms include HPV test and treatment; VIA and treatment; HPV test followed by VIA and treatment; and HPV test followed by colposcopy and treatments. Potential participating countries are Cameroon, Malawi and the United Republic of Tanzania. The identification of study coordinators is ongoing and, at the end of February 2014, a principal investigator meeting will be held by WHO to review the study protocol. Annual Technical Report 201320 2.11 Implementation research on the introduction of HPV testing in the United Republic of Tanzania In 2005, WHO, with the Ministry of Health and Social Welfare in the United Republic of Tanzania and partners implemented a pilot programme of cervical cancer screening and treatment based on VIA and cryotherapy at the primary, district and regional levels of the health-care system. These demonstration sites and others identified by the Ministry of Health and Social Welfare are ideal as the basis for conducting operational research to introduce new rapid HPV DNA- based screening tests for cervical cancer (careHPV) to improve cervical cancer and prevention programmes at health facility level. The objective of the study is to assess the reproducibility, feasibility and acceptability of careHPV at each level of the health system and to determine whether it is able to perform as intended to improve the national cervical cancer-prevention programme based on screening with VIA. Progress In November 2013, a field visit is taking place to evaluate the capacity of the site for the research and plan the implementation of the study starting in 2014. Planned activities � In January 2014, the test kits will be shipped and training will start in the different sites and at the national level. The study will start at the end of February 2014, and the recruitment will last for 3 months. It is expected that the results will be available before the end of 2014. 2.12 Road map for development of STI vaccines Although progress has been made in the control of STIs, recent global estimates have found that nearly 500 million adults are infected, without counting viral infections. The limitations around existing approaches for prevention, screening, diagnosis and treatment of STI has motivated HRP/RHR and the Immunization, Vaccines and Biologicals (IVB)/Initiative for Vaccine Research (IVR) teams to revisit, in collaboration with partners, progress in STI vaccine development. During the last decades, significant advances in vaccine technology have resulted in the development and widespread use of two valuable STI vaccines, for hepatitis B and HPV. However, progress in vaccine development to prevent other critical STIs, i.e. gonorrhea, chlamydia, syphilis, trichomoniasis, and herpes simplex virus (HSV), has lagged behind. Progress A technical consultation to develop a STI vaccine road map was held in 2013. Several background papers were prepared for the technical consultation, and were accepted for publication in a special issue of Vaccine, co-edited by WHO/ RHR, WHO/IVR and NIH, addressing: (i) the pressing needs for STI vaccines and the theoretical impact; (ii) key immunological issues for the development of STI vaccines; (iii) the state of the art on the development of vaccines against HSV, Chlamydia trachomatis, Neisseria gonorrhoea, Trichomonas vaginalis and Treponema pallidum; (iv) the programmatic issues linked to the introductions of these vaccines, as well as barriers and challenges from the manufacturer perspective to development of such vaccines; and (v) the way forward to develop such vaccines and a call for action with the STI vaccine road map. The special issue of Vaccine will be published in January 2014. Human Reproduction 21 Planned activities WHO, the United States (US) Centers for Disease Control and Prevention (CDC) and NIH will organize a workshop during the meeting of the International Union against Sexually Transmitted Infections in Atlanta in 2014, to review progress and future plans for implementation of the road map. Three major issues will be discussed: � by HRP/RHR: the follow-up work with regard to all STI epidemiologic data, burden of diseases and impact of interventions, as per the road map; � by IVR: the target product profiles for each of these vaccines; � by NIH: the basic research needs for development of the vaccines. 2.13 Accelerating introduction of dual HIV/syphilis rapid diagnostic tests to eliminate mother-to-child transmission of HIV and syphilis Global and regional initiatives have been launched for dual elimination of mother- to-child transmission (EMTCT) of HIV and syphilis. One critical component of these initiatives is early detection and timely intervention with pregnant women infected with HIV and/or syphilis. Innovative strategies are needed to improve the number of pregnant women tested and treated, as coverage is currently inadequate. At least three manufacturers have developed dual HIV/syphilis rapid diagnostic tests, which hold potential to improve the coverage of syphilis and HIV testing, efficiency of services, and quality of laboratory testing. To date, there are no independent data on the laboratory performance, field performance, or operational implications of these dual HIV/syphilis rapid diagnostic tests. Progress WHO has worked with countries and other partners (PATH [Program for Appropriate Technology in Health], the London School of Hygiene and Tropical Medicine, University of Bristol, CDC, The Bill and Melinda Gates Foundation, etc.) to prepare a comprehensive package of studies to evaluate dual HIV/syphilis rapid diagnostic tests to provide data for future WHO recommendations on appropriate use of these tests. Laboratory evaluations in China and Nigeria have been approved by the Research Project Review Panel (RP2). Protocols for evaluation of field performance in Zambia and introduction studies of dual rapid diagnostic tests in China and Colombia have also been approved by RP2. Another introduction study protocol in Nigeria is being finalized. A mathematical modelling exercise has been initiated to evaluate the diagnostic and cost implications of using different syphilis-testing strategies. Planned activities � WHO prequalification of three dual rapid diagnostic tests is scheduled for early 2014. � The approved studies of new dual HIV/syphilis rapid diagnostic tests in China, Colombia, Nigeria and Zambia, and complete modelling exercises, will be initiated in 2014. � Data from studies and modelling exercises are to be prepared for review within the ongoing WHO STI guidelines process. Annual Technical Report 201322 2.14 Assessment of adverse outcomes of syphilis in pregnancy and the impact of timing of maternal treatment in Mozambique Antenatal syphilis screening and treatment has been shown to be a highly cost- effective intervention to reduce fetal and infant morbidity and mortality associated with maternal syphilis infection. However, it is unclear how early screening should be done, and what the impact on different adverse outcomes is. In addition, diagnosis of congenital syphilis is extremely difficult, even in settings with substantial laboratory capacity. Progress HRP/RHR support was provided to Mozambique National Health Institute and Health Alliance International, to conduct a retrospective cohort study of the effectiveness of syphilis treatment administered at different times during pregnancy, and the utility of polymerase chain reaction (PCR) in diagnosis of congenital syphilis. Enrolment of 16 812 women was finalized in March 2013. Preliminary analysis has been conducted, and final analysis is pending finalization of laboratory processing of specimens. Planned activities � Finalization of laboratory assessment is anticipated by January 2014, and final analysis and dissemination by June 2014. 2.15 Advancing STI control and prevention through new innovations for STI testing technology – integrated point- of-care tests for sexually transmitted infections Between 80% and 90% of the global burden of STIs occurs in low- and middle- income countries, where there is limited or no access to appropriate diagnostics. In such settings, syndromic management is used, which results in over diagnosis of STI among women with vaginal discharge for example, and under diagnosis of STI among symptomatic women and men. In both developed and developing countries, STI-related stigma and ostracism negatively affect health-seeking behaviours, therefore limiting opportunities for diagnosis. The absence of reliable, affordable and private diagnostic tests is therefore a major obstacle to effectively reducing the burden of STIs. This barrier could be overcome by developing reliable, low-cost, point-of-care tests, which could offer immediate results to patients, allowing them to receive immediate diagnosis and treatment while protecting their privacy. Therefore, HRP is developing a research project to contribute to ensuring universal access to high-quality STI testing through the development and implementation of low-cost point-of-care tests for STIs. Progress A systematic review of studies and a landscape analysis have been conducted to identify the most promising point-of care diagnostics tests for different STIs (syphilis; trichomoniasis; chlamydial, gonococcal and HPV infection). The results of the systematic review will be discussed at a meeting of experts to be held in March 2014. Human Reproduction 23 Planned activities � The systematic review and expert meeting will inform the development of a research proposal for a multicountry validation study of the most promising diagnostic tests to determine both analytical and operational performances in the field. 2.16 Advancing STI prevention through new evidence-based behaviour-change interventions Behaviour-change interventions have consistently been seen as an essential part of comprehensive STI/HIV prevention. Current understanding of prevention combines structural changes, such as access to commodities (condoms, information) and services (testing, treatment and care), within a human rights framework focusing on promoting relevant behaviour-change interventions, such as delay in sexual debut; consistent condom use; partner reduction strategy; STI/ HIV testing; and promotion of sexual well-being through increasing self-esteem, self-regulation and a positive attitude towards one’s own and other’s sexuality. Sexual behaviour is very much driven by local norms, traditions and culture; thus, behaviour interventions have to conform to local contexts. HRP/RHR will implement a research project to establish the validity of specific behaviour-change interventions that are proven in their effectiveness in high- income settings, to address the needs of low- and middle-income settings, especially on combination prevention strategy among key populations such as adolescents and young people. The goal of the project is to produce solid scientific evidence to promote the most up-to date and effective behaviour- change interventions to prevent STI/HIV in both key populations and the general population in low- and middle-income countries. Progress A systematic review of available techniques of brief behaviour-change interventions used for STI/HIV prevention was conducted in 2013. Planned activities � The results of the systematic review will inform the development of a multicountry study to validate the most promising identified techniques of brief behaviour-change interventions in both targeted populations and the general population. 2.17 SIALON II – multicounty integrated bio-behavioural survey, among men who have sex with men Additional efforts are needed to strengthen HIV/STI prevention, diagnosis and treatment in men who have sex with men (MSM). Data from 23 European countries show that the annual number of HIV cases in MSM increased by 86% between 2000 and 2006. To address this challenge, the European Commission is funding the integrated project SIALON II, which aims to implement innovative surveillance methodologies for hard-to-reach populations like MSM. These innovative surveillance methodologies are intended to be an effective tool in implementing ongoing and systematic behavioural surveillance in the participating countries. HRP/RHR actively participated in developing the conceptual framework of the project, which identifies which behaviours should be monitored and in which populations. This surveillance approach enables accurate monitoring of at-risk Annual Technical Report 201324 groups and understanding of whether and how the rates of HIV/STIs are changing over time, as well as measuring the impact of implemented prevention activities. Progress Formative research was carried out in order to identify specific conditions and methods for data collection among MSM, according to local contexts and for prevention-needs assessment in participating countries: Armenia, Belgium, Bulgaria, Germany, Italy, Lithuania, Moldova, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom of Great Britain and Northern Ireland (UK). The data collection has been completed in most of the study sites. Planned activities � The primary analysis of the data collected by the surveillance system will be carried out in 2014. The final analysis and development of series of articles are planned for the end of 2014. HIV Linkages 2.18 Temperature-recording vaginal ring device for accurate measurement of user adherence Vaginal rings are already marketed for various clinical indications, including contraception, hormone replacement therapy and luteal phase support, and are being actively developed as HIV microbicide and multipurpose prevention technology (MPT) products. To date, all microbicide clinical trials, including the CAPRISA-004 (Centre for the AIDS Programme of Research in South Africa), VOICE (Vaginal and Oral Interventions to Control the Epidemic) and FEM-PrEP (Pre- exposure Prophylaxis Trial for HIV Prevention among African Women) studies, have relied on self-reporting questionnaires as a measure of user adherence. However, the reliability and validity of these adherence data are questionable; participants are likely to report good adherence, given the expectation to comply with the study protocols. More objective, quantitative and accurate methods for assessing adherence are needed. Progress A study proposal was finalized with Queen’s University Belfast, Northern Ireland, UK to evaluate a temperature-recording device for vaginal rings, to improve measurement of user adherence. Preliminary experiments are ongoing at Queen’s University Belfast, to establish proof-of-concept in a non-clinical setting. A prototype ring design has been proposed to permit the programming and insertion of the nano-temperature device after manufacture and prior to the start of a trial. Planned activities � Initial development work to produce a prototype ring with a temperature device will be developed, and a phase I study planned to evaluate adherence with two different vaginal rings. � HRP/RHR will support as co-investigator and partly finance the 3-year project at the School of Pharmacy, Queen’s University Belfast, Northern Ireland, UK, to develop simple and inexpensive injectable-type MPT products, with the potential to provide simultaneous long-term hormonal contraception and antiretroviral-based protection against HIV infection. Two different Human Reproduction 25 formulation strategies will be assessed, involving reformulating Depo-Provera (medroxyprogesterone acetate) to include an antiretroviral agent, in which the polymer component precipitates to form a depot implant upon injection. 2.19 Evaluating national assessments on sexual and reproductive health/HIV linkages using the rapid assessment tool HRP/RHR, in collaboration with the International Planned Parenthood Federation (IPPF), UNFPA, the Joint United Nations Programme on HIV/AIDS (UNAIDS), the Global Network of People living with HIV (GNP+), the International Community of Women with HIV/AIDS (ICW) and Young Positives, developed the Rapid assessment tool for sexual and reproductive health and HIV linkages (8), to assess national bidirectional linkages between HIV/AIDS and SRH, identify gaps, and contribute to the development of country-specific action plans. This initiative was launched by HRP/RHR in 2008 with the initial implementation of the tool in Botswana. To date, over 48 countries have completed implementation of the assessment tool. HRP/ RHR is currently supporting countries and partners to share the process, findings, recommendations, and lessons learnt from this implementation. Progress In 2013, HRP/RHR co-convened the SRH/HIV Linkages Indicators Specialists Symposium, which led to the development of a draft SRH/HIV linkages indicator compendium. Pilot testing for the three new integration indicators is currently under way in Botswana, Lesotho, Namibia, Malawi, Swaziland, Zambia and Zimbabwe, in collaboration with the Joint UNFPA/UNAIDS regional project on linking SRH and rights and HIV in Southern Africa. In addition, following the implementation the Rapid Assessment Tool, 20 country case summaries have been finalized and are available in the SRH & HIV Linkages Resource Pack (9) (see Fig. 1). Fig. 1. Countries that have implemented the SRH/HIV Rapid Assessment Tool since 2008 Annual Technical Report 201326 Planned activities � The SRH/HIV linkages indicator compendium will be finalized. The review of key findings from the implementation of the rapid assessment tool in 25 countries, and the report of pilot testing of SRH/HIV indicators are expected to be completed in the last quarter of 2014. Infertility/subfertility 2.20 Development of a rapid assessment tool to assess existing health policy, systems and services for fertility care It is the choice of each individual and couple, within their own sense of conscience, to determine whether they intend pregnancy, and, if so, the size of their family unit and the timing of when to have a child or children. If fertility problems arise, interventions for the woman and man can be attempted, from simple fertility-awareness methods to more advanced methods associated with in vitro fertilization (IVF). Many of these problems can be avoided or addressed, through affordable interventions with timely help seeking. HRP/RHR wishes to support the operations and implementation research required to introduce affordable fertility interventions into health systems. Progress HRP/RHR convened a meeting in 2013 to scope the requirements for successful infertility care integration into existing health-care systems. A draft country rapid assessment tool to assess existing health policy, systems and services – which will facilitate the ability at country level for decision-makers to determine how, what and where to introduce various levels of fertility care – was developed. A research proposal, Plan with the end in mind: targeting the preconception period for a healthy pregnancy has been drafted and submitted for funding. It includes the development and adaptation of a fertility-awareness tool for community health workers. Planned activities � The rapid assessment tool for integration of infertility care into policy, systems and services will be field-tested. A second consultation with mobile health (mHealth) experts, to adapt the rapid assessment tool for use on tablets is planned for Spring 2014. Funding has been secured through a special grant from the Australian Institute for Innovation. 2.21 Research in infertility and subfertility for neglected and at-risk populations Better understanding of the prevalence of infertility/subfertility in all countries, trends over time, and also research to assess the prevalence of infertility/ subfertility in all individuals, including at-risk populations, such as HIV-positive individuals, has been limited. As HIV-positive individuals are living longer, healthier and more productive lives, with the advent of more affordable antiretroviral therapies, their reproduction needs increase. This is especially true within cultures where great emphasis is placed on childbearing. While engaging in sexual activity, HIV-serodiscordant couples knowingly risk HIV transmission to their uninfected partner in order to achieve pregnancy. This can be a contributing factor in the HIV epidemic, particularly in countries with a high HIV burden – and within settings Human Reproduction 27 where the integrity of pharmaceutical products and management of their usage, are less reliable. Although assisted reproductive services may be considered for HIV-serodiscordant couples, these innovative technologies are often dismissed in some settings, owing to barriers to access within health sectors in either high or low- and middle-income countries. Progress In collaboration with the WHO Department of Health Statistics and Information Systems, several papers have been published to present data on infertility prevalence and trends covering the analysis of fertility surveys in 190 United Nations Member States (10–14). A paper on the algorithm defining a specific measure for infertility was discussed; a paper on measuring the prevalence of infertility; and also several papers on trends to address needs for access to infertility care, owing to an unmet desire for a pregnancy, have been published and presented at two regional, as well as country and international, conferences in 2013. Research to measure the prevalence of infertility was conducted using DHS data in three high-burden HIV sub-Saharan African countries, published as an abstract and presented at the XXVII International Union for the Scientific Study of Population, Korea in August, 2013. Planned activities � The three recent WHO papers on prevalence data for infertility/subfertility (10, 12, 13), have contradicted some of the prevalence values and estimates that WHO had previously published in 1984 (15) and 2004 (16). Research is ongoing to utilize a statistical model that has been generated to reconcile the differences. A manuscript is in preparation. � The DHS research analysis had shown an extended time to pregnancy in HIV-positive women attempting pregnancy and not using any form of contraception. Additional research is under way using DHS data, modifying and extending this analysis to 11 high-burden HIV countries worldwide. In addition, a unique detailed community dataset from the United Republic of Tanzania is being cleaned to address similar information and assess trends over time. This work will result in multiple manuscripts for publication in a peer-reviewed journal in 2014 and 2015. � A research grant was written and supported through a competitive call to assist with a consultation and workshop to be conducted in December 2014, for the development of operations research protocols which include an ethical, legal and social implications (ELSI) dialogue, in the dedicated area of infertility/subfertility and at-risk populations. Following two-side consultations for protocol development at the European Society of Human Reproduction and Embryology and the American Society for Reproductive Medicine, the second research randomized controlled trial (RCT) proposal has been finalized, which addresses researching options of fertility/subfertility interventions for HIV-serodiscordant couples, entitled A child wish granted – addressing ZERO transmission to partner and child. These research protocols seek funding and will be submitted to competitive funding calls for this area of work in 2014 and 2015. Annual Technical Report 201328 3. Norms, standards and tools Family planning/contraception Effective dissemination of evidence through WHO guidelines is critical, to be sure that research results will inform the actions of governments and organizations committed to expanding contraceptive choices for women, especially in low- resource settings. 3.1 Continuous Identification of Research Evidence and the family planning guidelines – revision of the Medical eligibility criteria for contraceptive use and Selected practice recommendations for contraceptive use In partnership with the US CDC/WHO Collaborating Centre for Reproductive Health, HRP/RHR uses the Continuous Identification of Research Evidence (CIRE) system to assure that WHO’s global family planning guidance is created – and maintained – based upon the best available published evidence since 2002. The PubMed bibliographic database regularly searches for newly published evidence (in any language) relevant to the recommendations of Medical eligibility criteria for contraceptive use (MEC) (17) and Selected practice recommendations for contraceptive use (SPR) (18). Citations are uploaded and discussed for relevance and a systematic review is prepared (or updated) as needed and later submitted for expert peer review. Experts advise WHO on whether: (i) the current recommendations remain consistent with the body of evidence and no action is needed; (ii) the current recommendation is inconsistent with the body of evidence but the inconsistency is insufficient to warrant interim guidance; or (iii) the current recommendation is strongly inconsistent with the body of evidence and interim guidance should be issued. Progress The Guidelines Steering Group met in May 2013 to review the scoping questions for the guidelines. A guideline development group will convene in March 2014 to review evidence summarized within systematic reviews and Grading of Recommendations Assessment, Development and Evaluation (GRADE) system summary of finding tables to formulate recommendations. The guideline development group comprises an external, multidisciplinary, gender- and regionally balanced membership with a WHO Secretariat. Planned activities � Efforts to finalize the revisions of the MEC (17) and SPR (18) are targeted for late 2014. The revisions will be published on HRP/RHR’s website. Related counselling tools and job aids will be updated accordingly. � WHO has received requests from its Member States, as well as professional organizations, to offer information within the SPR in a more user-friendly, simplified format. A job aid (or tool) for health-care providers, tentatively titled “The Contraceptive Service Delivery Tool”, based upon the SPR guideline, will be prepared and field-tested for usability during Summer 2014. Tentatively, field- testing is planned in Bangladesh, Congo and Kenya. Human Reproduction 29 3.2 Programming strategies for postpartum family planning Following childbirth, women often lack the support they need to space and limit future pregnancies. By addressing the unique needs of these women, postpartum family planning can help improve maternal, neonatal and child health. Programming strategies for postpartum family planning (19) outlines the important elements of a postpartum family planning intervention, to help programme planners and managers identify opportunities to offer family planning to postpartum women within existing health systems. Progress A working group comprising experts in international family planning convened at WHO in September 2012 to prepare the document. Decision-making was through consensus and informed by a synthesis of the peer-reviewed and grey literature. The document was purposefully organized to offer a variety of approaches to support postpartum family planning programme development. Strategies can be applied towards comprehensive programming or to strengthen a single (or multiple) component(s) of a programme. Considerations for design include: examining the local context; applying a health-systems framework to identify needs, challenges and opportunities for strengthening services; and identifying opportunities for integration (i.e. antenatal, labour and delivery, postpartum and postnatal, infant health and immunization). Examples of programme models are offered throughout and supported by a summary of the evidence and country case-studies to guide programme design efforts. The final document was launched during the 3rd International Conference on Family Planning in Addis Ababa in November 2013, and is available on the WHO website (19). 3.3 Contraceptive services delivery in the OptimizeMNH guidance document on task shifting/sharing Progress The WHO OptimizeMNH guidance (20) contains evidence-based recommendations for the safe provision of key maternal and neonatal health interventions by different cadres of health workers. This document also summarizes the WHO recommendations on the cadres, ranging from lay health workers to mid- level providers that may be trained and supported to provide the following contraceptive methods safely: tubal ligation, vasectomy, IUD, implants and injectables, as well as promotional activities. The process of enabling additional cadres to provide a specific health intervention is referred to here as “task shifting” but is also widely known as “task sharing”. This guidance document, and its accompanying policy brief (21), were presented in a special side event at the International Conference on Family Planning in Addis Ababa. 3.4 Training Resource Package for Family Planning The Training Resource Package for Family Planning (TRP) (22) is a comprehensive set of up-to-date online training materials on family planning/contraception, based on WHO’s cornerstones for family planning guidance. It includes the components and tools needed to design, implement and evaluate training for both clinical and community-level providers, for pre-service and in-service training. Annual Technical Report 201330 Progress Nine modules (Benefits of Family Planning, Combined Oral Contraceptives, Male Condoms, Female Condoms, Contraceptive Implants, Family Planning Counseling, IUDs, Progestin-only Injectables, and WHO Family Planning Guidance and Job Aids) include PowerPoint presentations, lesson plans, evaluation tools and job aids, and are currently available online (22), with two more soon to be released. WHO/RHR and the Implementing Best Practices Initiative (IBP) have conducted dissemination activities during the East, Central and Southern African Health Community (ECSA-HC) Best Practices Forum, and the UNFPA regional meeting on Family Planning for five South-east Asian/Western Pacific countries, workshops in francophone Africa in October 2013, and at the International Conference on Family Planning in Addis Ababa in November 2013. All PowerPoint presentations of the modules and one facilitator manual have been translated into French. The remainder will be translated into French and Spanish in early 2014. Planned activities � RHR is currently completing the development of the new module on Emergency Contraception, as part of the workplan for the United Nations Commission on Life Saving Commodities. � Follow-up dissemination activities in either French or English will continue. An evaluation survey of all countries that have participated in dissemination activities will be conducted in 2014. 3.5 Ensuring human rights in the provision of contraceptive information and services: guidance and recommendations Progress A need for guidance, focused at the service-delivery level, on how to ensure that human rights are respected, protected and fulfilled was identified, and a needs scoping conducted. A guideline development committee was created, and spoke monthly by telephone. Systematic reviews of the literature were conducted. Two technical consultations were convened to develop the guidelines. The guidelines have been written and have received conditional clearance by the WHO Guidelines Review Committee. A need for indicators to monitor accountability to human rights in contraceptive programmes was also identified. A methodology was developed by a WHO-led advisory group, and draft quantitative indicators identified. A draft report has been written, and is being circulated for peer review. Planned activities � A launch for this guideline is planned in early 2014. Dissemination will also occur as part of the Department’s contributions to the ICPD Beyond 2014 agenda. � Publication of the report on indicators to ensure accountability in contraceptive programmes is also planned for early 2014. Furthermore, the group will continue to develop this body of work through adding policy and qualitative measures to the piece, and identifying where the creation of new indicators is needed. Human Reproduction 31 Sexually transmitted infections, including HIV/AIDS 3.6 Guidelines for the prevention, management and control of sexually transmitted infections The Guidelines for the management of sexually transmitted infections (23) are being updated to provide evidence-based guidance and assist Member States to develop standardized guidelines. A stepwise approach is being proposed, owing to the numerous issues that need to be addressed for various STIs, the cost implication, and the methodological challenges required by the WHO Guideline Review Committee. Phase I will address important STI issues, namely treatment of major STIs, syndromic management, and syphilis screening. Phase II will focus on prevention. As new information becomes available, phase III will address other STIs and phase IV will focus on STI screening. Progress HRP/RHR initiated activities to update the 2003 WHO Guidelines for the management of sexually transmitted infections (23) based on the new WHO handbook for guideline development (24) approved by the WHO Guideline Review Committee. A STI Guideline Steering Committee meeting was organized in September 2013, to define the scope of the guideline. The first STI Guideline Development Group meeting was convened in December 2013, with the scoping document submitted it to the Guideline Review Committee for approval. HRP/RHR also developed the STI and SRH section of the operational tool Implementing comprehensive HIV/STI programmes with sex workers: practical approaches from collaborative interventions (25). Planned activities � Systematic reviews and modelling studies will be completed for the guidelines review meetings for phase I in 2014. Phase II will be initiated next year. � HRP/RHR will continue to work with the WHO HIV department to develop the comprehensive guidelines on HIV and STIs among key populations. Women’s health, including reproductive tract cancers 3.7 Development of WHO normative guidance on topical pre- exposure prophylaxis HRP/RHR has been involved in the development and evaluation of microbicides for STI and HIV prevention. The guideline development process is being started, while the late-stage clinical studies to confirm the safety and effectiveness of 1% tenofovir (TFV) gel and the dapivirine ring are under way, in anticipation of successful results. While the first licensure decisions are not expected before 2016, the guidance is being planned and developed in advance, so that the WHO recommendations can be issued soon after licensure. WHO normative guidance is critical to accelerating expansion of a new product in countries and facilitates the use of public funds to support country programmes. The development of the WHO normative guidance on topical pre-exposure prophylaxis will be closely coordinated with other guidance on the strategic use of antiretroviral drugs for treatment and prevention, as well as SRH, gender-based violence, and adolescent HIV testing and counselling. Annual Technical Report 201332 Progress The Department maintained and updated the inventory of ongoing research related to the regulatory process on TFV gel, continuing the liaison with the TFV Development Group and the TFV Regulatory Group, supported the European Medicines Agency in application of the Article 58 process to involve developing country regulators in the review of registration dossiers, and participated in European Medicines Agency consultative meetings on technologies for HIV prevention. The Guidelines Steering Committee meetings for the TFV gel were convened in June and November 2013. Extensive discussions have taken place with partners in the HIV Department and the International Partnership for Microbicides, to ensure that the guidance on topical pre-exposure prophylaxis and the planning, design and implementation of the introductory and demonstration studies can be built upon experience with developing similar projects for the delivery of oral pre-exposure prophylaxis. Planned activities � A stakeholder consultation on topical microbicides and Guidelines Development Group meetings is planned for March 2014 in South Africa. The criteria for prioritization and mapping of countries for pre-licensure pre- introductory studies’ consideration for TFV gel and/or the dapivirine ring will be completed. 3.8 Reproductive health commodities in essential medicines HRP/RHR has continued to work in collaboration with UNFPA and the Reproductive Health Supplies Coalition on activities aimed at improving access to and quality of reproductive health essential medicines and commodities. This includes conducting the review process to develop and publish technical guidance that defines the quality-assurance processes, specifications, testing procedures and requirements for prequalification and procurement processes for male latex condoms, female condoms and the copper-bearing intrauterine device (TCu380A IUD). Progress A technical review meeting in September 2013 of 10 technical experts addressed the updating and development of the WHO/UNFPA specifications, prequalification scheme and procurement process for male latex condoms, female condoms and copper-bearing IUD. Initiating this technical review process required a consultation to revise the advisory note on the bulk procurement of personal lubricants for male and female condoms. In addition, a technical consultative process with key stakeholders was started, to guide incorporating the United Nations Policy on Green Procurement, which requires that environmental performance considerations be embedded into the decision-making process, in the same manner as price, performance, quality and availability, for the manufacturing, prequalification and procurement process for contraceptives. Planned activities � A technical consultation will review and finalize the update of the specification, prequalification and guidance on procurement for the three commodities. This revision will include the implementation and monitoring of practical approaches that enhance the eco-production of these devices. Human Reproduction 33 � Efforts to support the eco-production of products will undertake relevant technical and cost–benefit analysis to make these less restricting and allow possible use of biodegradable materials in packaging. � A technical consultation to review the evidence and formulate guidance on the bulk procurement of personal lubricants will be planned with partners. 3.9 Development of a core set of sexual health indicators In 2010, WHO convened an expert consultation on sexual health, to make recommendations on strategic directions for work in this area. One specific recommendation of the consultation was to develop, operationalize and promote sexual health indicators, in order to strengthen monitoring and evaluation of sexual health-related activities at national level. Since the establishment of the WHO International Advisory Group on Sexual Health Indicators in July 2011, a working version of the Core set of sexual health indicators has been developed. The proposed indicators cover the following areas of sexual health: healthy sexuality, sexual well-being, sexual dysfunction, sexual vulnerability, sexual violence, harmful practices, and adolescent sexual health. The document recommends 15 outcome/ impact and determinants indicators as well as a National Commitments and Policy Instrument tool to assess the policy context and environment. Progress Some outcome survey-based indicators have been integrated into ongoing surveys and studies in 2013, including the Integrated Bio-behavioral Surveys among injecting drug users in Russia and in Spain; and the multisite (in 21 EU, Eastern European countries) Integrated Bio-Behavioural Surveys on sexual behaviour. Some of these have also been included in the SIALON II study. The above surveys should assess the validity and feasibility of the indicators in these various settings. The working version of the document was reviewed in WHO regional offices and by the main technical partners, and will be available in electronic format by the end of 2013. Planned activities � Results of the previously mentioned surveys will be monitored to assess how these indicators were used and what results were obtained, for possible revision, if needed. � HRP/RHR will explore other opportunities to pilot the core set of sexual health indicators into other population groups and in various settings. 3.10 Sexuality counselling guidelines for health-care providers In 2010, WHO convened an expert consultation on sexual health, to make recommendations on sexuality counselling guidelines for health-care providers, to be used for incorporating counselling into primary health-care services and in SRH services. The ultimate goal of this initiative is to ensure access to SRH services for all, and promotion of sexual health. The development of this guideline followed the WHO Guidelines Review Committee’s standards (24) and was initiated in 2012. Annual Technical Report 201334 Progress The main scoping topics included the effectiveness of brief sexuality counselling applied to adolescents and adults, compared to usual standard of care, in addressing various sexual health-related concerns, including preventing HIV/ STIs, unplanned pregnancy and abortion, or sexual violence, and promoting sexual well-being, and the identification of which elements of programmes (such as sensitization training) for primary health-care providers increase knowledge and skills on sexuality counselling/communication. Systematic reviews on these various questions were prepared to inform the committee. The guidelines have been drafted and are undergoing review. Planned activities � The final version of the sexuality counselling guideline for health-care providers will be made available in the first quarter of 2014. � This process will help to initiate development of a training module on sexual health/sexuality for WHO staff. 3.11 Development of WHO normative guidance on the sexual and reproductive health of women living with HIV The SRH of women living with HIV/AIDS is fundamental to their well-being and that of their partners and children. The 2006 guidelines on Sexual and reproductive health of women living with HIV/AIDS: guidelines on care, treatment and support for women living with HIV/AIDS and their children in resource-constrained settings (26) address their specific SRH needs and contain recommendations for counselling, antiretroviral therapy, care and other interventions. Since then, there have been new developments in treatment and on the relationship between HIV and SRH, including contraception, which would have to be updated in this document. Progress The steering committee meeting to discuss the plans to revise the document was held in September 2013. Key PICOT (Population, Indicator/Intervention, Comparator, Outcome, Time) scoping questions were identified, and a mapping document was prepared to compile other relevant WHO recommendations, documents and publications, and to identify other existing sources of evidence for potential topics to be covered in the updates. Planned activities � In the interests of ensuring that the priority issues of women living with HIV are addressed through the guidelines, and to ensure broad-based support for, and engagement with, the product, an e-consultation with women living with HIV will be conducted in the first two quarters of 2014. This will be followed by a meeting of the Guideline Development Group in quarters 2 and 3 of 2014. 3.12 Updating cervical cancer guidelines for the Comprehensive cervical cancer control: a guide to essential practice Comprehensive cervical cancer control: a guide to essential practice (C4-GEP) (27) was first published in 2006 by RHR and the Department of Chronic Diseases and Health Promotion of WHO, and other partners, to provide a single, easy-to-use Human Reproduction 35 publication that puts together existing experience and evidence-based knowledge for the prevention and treatment of cervical cancer. Since then, new evidence and guidelines are available in preparation for the next edition of the CC4-GEP. Progress A number of documents have been published this year, in order to provide the background information and evidence to update C4-GEP. � Monitoring national cervical cancer prevention and control programmes: quality control and quality assurance for visual inspection with acetic acid (VIA)-based programmes (28): this guide outlines quality-control and quality-assurance considerations, to support introduction or scale-up of VIA as a screening test for cervical cancer, within the context of national comprehensive cervical cancer prevention and control programmes. The guide proposes a framework for quality control and quality assurance, including a core set of indicators, and provides examples for how the indicators can be set, measured and used to strengthen programme implementation. � Comprehensive cervical cancer prevention and control – a healthier future for girls and women: WHO guidance note (29): this WHO guidance note advocates for a comprehensive approach to cervical cancer prevention and control and is aimed at senior policy-makers and programme managers. It describes the need to deliver effective interventions across the female life-course, from childhood through to adulthood. These include community education, social mobilization, HPV vaccination, screening, treatment and palliative care. � WHO guidelines for screening and treatment of precancerous lesions for cervical cancer prevention (30): this guideline provides recommendations for strategies for a screen-and-treat programme. It builds upon the existing WHO guidelines: Use of cryotherapy for cervical intraepithelial neoplasia (published in 2011) (31) and on the new WHO guidelines for treatment of cervical intraepithelial neoplasia 2–3 and glandular adenocarcinoma in situ (forthcoming). � WHO guidelines for treatment of cervical intraepithelial neoplasia 2–3 and glandular adenocarcinoma in situ: cryotherapy, large loop excision of the transformation zone (LEEP/LLETZ), and cold knife conization (CKC) (forthcoming): this guideline builds upon the WHO guidelines: Use of cryotherapy for cervical intraepithelial neoplasia (31) published in 2011, and provides recommendations for the use of cryotherapy versus loop electrosurgical excision procedure (LEEP) versus cold knife conization (CKC) for the treatment of histologically confirmed CIN2+, and additional recommendations for the treatment of histologically confirmed adenocarcinoma in situ. Planned activities � The new edition of the C4-GEP will be finalized, compiling the document described above. The comprehensive guide will published, translated and disseminated in 2014. Implementation plans are already being prepared, in collaboration with WHO regional offices. Annual Technical Report 201336 4. Infertility/subfertility 4.1 Development of comprehensive evidence-based guidelines for the diagnosis, management and treatment of infertility and subfertility Within the mandate of provision of reproductive health care, are the newly prioritized areas of diagnosis of infertility or an inability to become pregnant or maintain a pregnancy; and service interventions for subfertility – fertility care for desired pregnancy, awareness, support and management. Therefore HRP/RHR has started new activities in this area of work, to develop evidence-based guidelines and to update and expand the guidance provided within existing publications: the WHO Manual for the standardized investigation and diagnosis of the infertile couple (1993) (32); and the WHO Manual for the standardized investigation, diagnosis and management of the infertile male (1999) (32), as well as the WHO laboratory manual for the examination and processing of human semen (2010) (33). Progress Initial steps for the development of new and updated comprehensive infertility/ subfertility care guidelines require a significant amount of research through systematic reviews in multiple topics. A Guidelines Development Group scoped the field into 26 areas, which covered all aspects of comprehensive fertility care for males and females. Through a global prioritization process in 2013, PICOT questions were developed and systematic reviews commissioned in the following: male (including semen) subfertility diagnosis and management, female subfertility diagnosis and management, controlled ovarian stimulation, intrauterine insemination (IUI), IVF–ICSI (intracytoplasmic sperm injection), polycystic ovary syndrome, endometriosis and provision of reproductive medicine interventions to HIV-positive and HIV-discordant couples desiring pregnancy. In 2013, there have been three Guideline Development Group subgroup consultations held as side meetings during two regional and international congresses. Planned activities � In the next year, WHO will complete the systematic reviews and modelling studies to inform the recommendations on the comprehensive guidelines. Additional side meetings/consultations will be held during 2014, with regional congresses in July and October. The main Guideline Development Group and Expert Group meeting will be held in November 2014, to assess the evidence, make recommendations and identify research gaps. A draft set of guidelines will be submitted in late 2014 or early 2015 for Guidelines Review Committee approval. The next set of priority topics from the 26 scoped areas will be addressed in late 2014. Human Reproduction 37 5. Monitoring and evaluation Sexually transmitted infections, including HIV/AIDS 5.1 Antimicrobial resistance to N. gonorrhoeae Antimicrobial resistance (AMR) to N. gonorrhoea is increasingly acquiring the dimension of a major public health problem globally, with fewer antibiotics available to treat the infection. In 2012, 36 countries reported increasing the minimum inhibitory concentration to third-generation extended spectrum cephalosporins, with 10 countries reporting treatment failure. HRP/RHR works to expand the Gonococcal Antimicrobial Surveillance Programme (GASP) and implement the Global action plan to control the spread and impact of antimicrobial resistance in Neisseria gonorrhoeae (35). Progress More countries now report to GASP, from 50 in 2011 to 67 in 2012. Annual mapping of patterns of gonococcal AMR are available on the HRP/RHR website (36) (see Fig. 2). WHO reference panel strains are regularly updated to ensure availability of valid, comparable data on gonococcal AMR and to standardize definition of resistance to cephalosporins in N. gonorrhoeae. HRP/RHR continues to coordinate the regional GASP network through regular meetings and teleconferences. The Institute Pasteur in Cote d’Ivoire and the Medical Microbiology Department of University of Nairobi, Kenya were selected as subregional reference centres to support GASP-in-Africa, with training conducted on monitoring of gonococcal AMR. Work was initiated with the Prince of Wales Laboratory, WHO Collaborating Centre for STIs to support China and the Philippines in developing enhanced surveillance systems for PCR molecular typing in 2014. Laboratory capacity-building for gonorrhoea diagnosis and AMR monitoring was done in eight countries in the WHO Region of the Americas, 19 Pacific Island countries, two countries in the WHO South-East Asia Region, three countries in the WHO African Region, and five countries in the WHO European Region. Programmes to integrate strengthening of STI surveillance and GASP were carried out in Indonesia and Zimbabwe. An online training module on gonococcal antimicrobial surveillance, and an operational tool on surveillance, were developed for dissemination starting in 2014. A supplement on gonococcal AMR was published in the BMJ journal Sexually Transmitted Infections, in December 2013 (37). Planned activities � HRP/RHR will support GASP-in-Africa to expand countries conducting AMR monitoring, to integrate GASP into overall STI surveillance. In addition, HRP/ RHR will organize global and regional GASP network meetings, to review progress and facilitate implementation of the global action plan (35). Human Reproduction 39 Fig. 3. Road map for strengthening STI surveillance Source: Baseline report on global sexually transmitted infection surveillance 2012. Geneva: World Health Organization; 2013 (38). Planned activities � Release a 2014 global STI surveillance report using data collected through the HIV Global AIDS Response Progress Reporting System, and case-studies from pilot exercises � Publish peer-reviewed manuscripts on the 2012 global burden of syphilis in pregnancy and associated adverse outcomes, 2012 global burden of curable STI, 2012 global burden of HSV2, and lessons learnt from the eight-country STI- strengthening exercises. � Work with regional offices to establish national centres of excellence for STI surveillance. � Work with global partners to identify modelling strategies for incorporating routine STI surveillance into global estimation processes. 5.3 Monitoring progress in elimination of mother-to-child transmission of HIV and syphilis EMTCT of HIV and syphilis has been endorsed as a dual initiative in the Americas, Asia Pacific, and Africa, and targets have been set for 2015 and beyond. However, it is critical to have criteria and processes for how to validate that EMTCT has occurred, as well as credible systems to collect data at a global level to assess progress toward EMTCT of HIV and syphilis. Progress WHO worked jointly with UNAIDS, UNFPA and UNICEF to finalize guidance on criteria and processes for validation of EMTCT of HIV and syphilis, intended to help countries improve monitoring, harmonize standards, and celebrate successful country efforts. Tables and maps of data on syphilis testing and seropositivity in pregnancy, collected through the Global AIDS Response Progress Reporting System were made publicly available through the Global Health Observatory Data Repository (39), to encourage use of the data (see Fig. 4). Annual Technical Report 201340 Fig. 4. Percentage of antenatal care attendees positive for syphilis (latest available data since 2005) Source: Global Health Observatory Data Repository (39). Global estimates of syphilis in pregnancy and associated adverse outcomes were published in PLOS Medicine (40), as well as an accompanying meta-analysis of expected adverse outcomes in the Bulletin of the World Health Organization (41) in 2013. Estimates for 2012 have been drafted and methodological improvements reviewed and approved by external technical advisers in November 2013. Planned activities � Convene the first global EMTCT of HIV and syphilis validation committee in June 2014, and review evidence for validation of elimination for at least one country. � Publish a summary of global progress in EMTCT in the 2014 WHO global STI report, and finalize global estimates of syphilis in pregnancy and associated adverse outcomes for 2012. � Work with PATH to finalize the investment case for dual EMTCT of HIV and syphilis in India, Nigeria and Zambia. 6. Dissemination, advocacy and partnerships Family planning/contraception 6.1 RHR contributions to the United Nations Commission on Life Saving Commodities for Women and Children’s Health Under the auspices of the United Nations Secretary-General’s Every Woman Every Child initiative, the Commission on Life-Saving Commodities for Women and Children was established to advocate at the highest levels for the increased availability, affordability and accessibility of essential but underutilized commodities, including contraceptives. Within the Commission, RHR leads the Technical Resource Team (TRT) for Emergency Contraception and participates in the TRTs for the Female Condom and for Hormonal Implants. Human Reproduction 41 Progress A review of the literature on best practices for increasing access to emergency contraception identified mostly studies on knowledge, attitudes and practices of providers and of users, on service provision, and on policy governance. This review will inform the development of operational research proposals on improving access to emergency contraception. This work started in 2013 with a workshop on technical assistance on emergency contraception programmes and on operation research methodology, organized by the International Consortium on Emergency Contraception for representatives of five African countries (Ethiopia, Malawi, Nigeria, Senegal and Uganda) that requested support from the Commission to expand access to emergency contraception. In addition, a module on emergency contraception for the WHO/USAID/UNFPA Family Planning Training Resource Package was developed and is being prepared for field-testing. For female condoms, HRP conducted the desk review of completed surveys on knowledge, attittudes and practices of female condom users and non-users in various countries with different levels of use of the female condom. Planned activities � A report on the review of the literature on best practices for increasing access to emergency contraception will be prepared for journal publication. � The operations research proposals will be reviewed and approved for funding for implementation in 2014. � An adaptation of the Family Planning Training Resource Package on Emergency Contraception for pharmacists will be developed and disseminated. � Development and field-testing of an assessment-monitoring tool and a step- by-step guide for introduction at country level of new types of female condom. 6.2 French Muskoka grant in support of reproductive, maternal and child health HRP/RHR is implementing the French Muskoka grant to strengthen family planning services in francophone Africa. The grant is implemented by HRP/RHR, in collaboration with the WHO Maternal Newborn Child and Adolescent Health Department and three other United Nations agencies. Progress In its second year, the initiative has supported six francophone countries (Cote d’Ivoire, Democratic Republic of the Congo, Guinea, Mali, Senegal and Togo) in the adaptation and dissemination of RHR norms and guidelines, especially the WHO publication, A guide for family planning for community health workers and their clients (5) and the Family Planning Training Resource Package (22). All countries also conducted a situation analysis on RMNCH services and various capacity-building workshops for family planning service providers, with emphasis on long-acting methods. In Guinea, 1000 new users of long-acting methods of contraception were reported. National strategic plans were also developed and disseminated in Cote d’Ivoire and Guinea. Annual Technical Report 201342 Planned activities � In the forthcoming third year of the grant, the focus will be on high-impact interventions in RMNCH, such as scaling up community-based services, making available a wider range of contraceptive methods in clinics, and ensuring informed choice for family planning. The initiative will be expanded to two new countries (Benin and Niger). 6.3 Activities of the Implementing Best Practices Initiative Since 1999, the IBP Initiative has worked at the global, regional and country levels to foster collaboration, reduce duplication, and harmonize approaches among several organizations implementing family planning programmes, to support the identification, implementation and scaling up of effective technical and managerial practices to improve reproductive health. Progress Partnership and knowledge management Last year, Futures Group, Plan International, Population Media Center, Hesperian Health Guides, and the West Africa Health Organization (WAHO) joined the IBP Consortium, which now has 41 partners. In 2013 IBP started implementing its current 5-year strategy and its accompanying results framework. The objectives of the strategy are to increase the scale-up of effective practices in reproductive health, strengthen the ability and commitment of IBP partners to actively work towards expected results, support sustained collaboration at the country level, and enhance knowledge sharing. IBP partners and the larger reproductive health community keep connected through the Knowledge Gateway, which is a reliable, consistent knowledge- management platform with over 350 000 users worldwide, of which 30 000 focus on reproductive health/family planning, through discussion groups or “communities of practice”. In 2013, new communities were created, including one on “Systematic approaches for scale-up of best practices in family planning/ reproductive health”, hosted by the Evidence2Action project, and another by the Alliance for Reproductive Maternal and Child Health on “Family planning research priorities for donors”, in December, 2012. In addition, IBP established task teams addressing specific activities in the plan of action. The Fostering Change task team has worked with K4Health to finalize the newly updated online Fostering Change tool. The Monitoring and Evaluation task team has finalized a matrix of indicators, in order to evaluate the IBP strategy. The High Impact Practices task team has been created to focus on the dissemination and implementation of high-impact practices. A task team was created to address sharing effective practices in the Latin America and Caribbean region. Promoting fostering change for scale-up of effective reproductive health practices in countries and with regional bodies The IBP publication, A guide for fostering change to scale up effective health services (42) was designed to reinforce the synergy between using proven change- management practices and the introduction, adaptation, use and scale-up of clinical or programme practices, such as in the activities described next. IBP has supported the ECSA-HC to co-facilitate a workshop in fostering change for scaling up effective practices in Harare, Zimbabwe, for five Member States, Human Reproduction 43 building on successful local experience, which developed a programme to offer nursing students peer-provided reproductive health services in their dormitories. IBP partners also assisted in organizing and implementing the ECSA 7th Best Practices Forum in the United Republic of Tanzania in August 2013, with pre- conference workshops on family planning technical updates, population, health and environment, SRH and persons with disabilities, and SRH and adolescents. A new IBP member, WAHO, worked with IBP and ECSA-HC to initiate a process for holding its own Best Practices Forum for the Economic Community of West African States, now being planned for next year. Finally, Zambia, IBP’s first focus country, began activities in October with requested support for documentation of best practices in family planning, to identify practices in the implementation and scale-up of their new 8-year family planning strategy. IBP hosted 28 sessions at the International Conference on Family Planning in Addis Ababa. The main track of eight interactive sessions focused on overcoming obstacles to scale-up, and on using a systematic approach to scale-up, using practical, tested programmatic tools and approaches. IBP partners also organized smaller workshops to share tools and resources and allowed targeted discussions on implementation of evidence-based practices, expanding on discussions from the IBP main track, and on how to engage at national and regional levels. IBP partners widely distributed the document, From Kampala to Dakar and on to Addis (43), to capture the lessons learnt from actual implementation of effective practices at the country level, presented during the IBP interactive sessions in the International Conference on Family Planning in Dakar in 2011. Planned activities � IBP partners will continue to work with ECSA to plan their 2014 Best Practices Conference and to follow up countries on their scale-up activities. The IBP secretariat and partners will continue to work with WAHO to plan and document their first Best Practices Forum in Reproductive Health for the end of 2014. � Activities will continue with Zambia as an IBP focus country. Validation and dissemination of the document on best practices in family planning will be conducted in early 2014. Another focus country may be identified during 2014. In addition, the IBP main secretariat and partners will follow up regional family planning tools workshops, by supporting countries that have requested technical assistance in documentation and scale-up of effective practices. 6.4 The Africa Build EU project: building a research and education infrastructure for Africa Africa Build is a coordination action involving eight partners, aiming to support and develop advanced centres of excellence in health care, education and research in the African countries, through information technology (IT). Progress WHO carried out a survey among the Africa Build users during August to October 2013, to evaluate the Africa Build portal. The report will be completed by January 2014. Two pilot courses in HIV/AIDS research and evidence-based medicine, and in writing recommendations and guidelines and research protocols, were conducted. Annual Technical Report 201344 Interactive communities of practice have been developed on the Africa Build portal, for exchange and sharing of knowledge between users. In addition, 145 dissemination activities have been completed to date, from the beginning of the project, such as: scientific presentations, newsletters, fact sheets, meetings and conferences. Several interactive communities of practice have been developed and published on the Africa Build portal, to facilitate exchange and sharing of knowledge. As a concrete output, 19 scientific peer-reviewed papers have been published, based on collaborative research work fostered by the project. Planned activities � HRP/RHR is responsible for the dissemination of activities and will develop the final report of activities carried out during the execution of the project. A meeting with the Africa Build expert committee was held in Cameroon on 25 November 2013, mainly to discuss a roadmap on how the Africa Build portal can continue to be sustained for an effective and shared use. 6.5 The cartography of controversies on family planning/ contraception Family planning has often been at the centre of scientific, political and cultural debates, with major ramifications for individuals and societies. These debates have focused on four main topic areas: demographic factors, health benefits/ risks, human rights, and religious and cultural beliefs. The ongoing global effort to increase the supply of, and demand for, contraceptive methods could benefit from an exhaustive analysis of all the issues and actors involved in contemporary discussions of family planning. To contribute to this analysis, the cartography of controversies methodology was applied to the complex debates surrounding family planning. The cartography of controversies, developed by sociologist of science Bruno Latour, is a set of methodologically sound techniques to explore and visualize controversial issues, which is based on analysis of website content, including sites that foster active debate on specific subjects. Progress The results of the analysis were presented at the International Conference on Family Planning in Addis Ababa 12–15 November 2013, where they generated positive interest. Interesting and unexpected results of the analyses include the very central position in the debate of issues related to religion and pregnancy prevention in young populations. Deserving further analysis is the very limited and marginal presence of the concept of “population growth”, which seems to have lost its centrality in debates on family planning. Planned activities � Further in-depth analysis will continue in 2014, as preliminary results show how the cartography of controversies approach can help elicit keywords, hot issues and relevant actors shaping the family planning debate. This information can be used to define the best strategies/approaches to interact with/influence this debate and to defuse potentially sensitive issues that can result in negative reactions to the introduction or scale-up of family planning services. Human Reproduction 45 Sexually transmitted infections, including HIV/AIDS 6.6 Partnerships to eliminate mother-to-child transmission of HIV and syphilis EMTCT of HIV and syphilis will require engagement of global, regional and in-country partners. RHR is working jointly with the WHO Department of HIV to engage partners to attain dual EMTCT of HIV and syphilis. Progress WHO initiated a project called “Dual Testing for Elimination of Congenital Syphilis”, with PATH (funded by the Bill and Melinda Gates Foundation), with a goal to develop investment cases for dual EMTCT of HIV and syphilis in India, Nigeria and Zambia. As part of this project, WHO developed an online tool for countries to estimate the burden of syphilis in pregnancy and associated adverse outcomes (44), and conducted estimation exercises in four countries. These estimates are now being used to guide discussion around national policy, programmatic focus, and improved monitoring strategies, and engage in-country partners. In 2013 at Women Deliver, RHR launched the Investment case for eliminating mother-to-child transmission of syphilis: promoting better maternal and child health and stronger health systems (45), in order to engage global maternal and child health partners. In order to reinvigorate the engagement of the STI and HIV community, it also highlighted dual EMTCT of HIV and syphilis at the International Society for Sexually Transmitted Diseases Research/International Union against Sexually transmitted Infections (ISSTDR/IUSTI) conference in Vienna, Austria and at the International Conference on AIDS and STIs in Africa (ICASA) in Cape Town, South Africa. WHO is also working with priority countries such as Madagascar, Indonesia and Papua New Guinea, on strategies to accelerate EMTCT. WHO continued to keep over 100 partners supporting EMTCT of syphilis updated on a routine basis, through the Battling Against Syphilis, a Team Approach (BASTA) newsletter. Planned activities � Work with PATH to finalize the investment case for dual EMTCT of HIV and syphilis in India, Nigeria and Zambia, to improve the evidence on the burden of mother-to-child transmission of syphilis. � Work with ministries of health in 12 priority countries to create country profiles that summarize the data necessary to engage countries and partners in EMTCT of syphilis. 6.7 Contributions to work with the Global Fund to Fight AIDS, Tuberculosis and Malaria The Global Fund to Fight AIDS, Tuberculosis and Malaria Strategy Framework 2012–2016 (48) seeks to improve its business model by investing more strategically, to have greater impact on these diseases and to align with the broader MDGs. This new business model has offered Global Fund partners an opportunity to rethink about how grants impact the health outcomes of women and children, through the following areas of support: � contributing to increased health expenditures at a macro level; Annual Technical Report 201346 � supporting gender equality and creating an enabling environment for women and young girls; � supporting health interventions that impact the health of women and children; � strengthening health systems. It was designed to enable strategic investment for maximum impact, and central to this is support for RMNCH. Progress HRP/RHR, in coordination with other relevant unit in the Family, Women’s and Children’s Health Cluster, has been instrumental in identifying challenges and opportunities to maximize the impact of the Global Fund’s investments on women and children. Through the promotion of interventions such as malaria in pregnancy (MiP) and the prevention of mother-to-child transmission, HRP has encouraged integration of services as a priority for the New Funding Mechanism. Specific activities in 2013 included: (i) working closely with the Global Malaria Programme, HIV and Global TB Programme departments in WHO, and with UNAIDS, Roll Back Malaria, and Stop TB partnerships, to ensure that areas of RMNCH are included in their Global Fund-related documents and activities; (ii) representing RHR in the interagency working group on Global Fund issues; and (iii) update of the RMNCH technical guidance (49) for inclusion of RMNCH in Global Fund proposals. Planned activities � Assist 5–6 countries during the process for the application to the New Funding Model, ensuring linkages/integration with RMNCH interventions. 6.8 Tenofovir Gel Implementation Steering Committee for woman-controlled HIV prevention RHR manages the Tenofovir Gel Implementation Steering Committee (TFV ISC), which has been created to steer, coordinate, and accelerate delivery of this new HIV-prevention tool. The committee is a mechanism for coordination, sharing information and ensuring that key stakeholders work together and are accountable for the key decisions needed to ensure timely availability and delivery of this product. Progress At present, the Steering Committee includes representatives of the licence and sub-licence holders and manufacturer (CONRAD and the South Africa Technology Innovations Agency respectively); the representatives of a cooperation agreement to manufacture and distribute TFV gel; possible commercialization vehicle companies; donors for product development; and global and national health authorities and civil society members. The TFV ISC meetings (Washington, DC, United States of America, March 2013 and Cape Town, South Africa, September 2013) prioritized actions to ensure TFV gets to market after clinical research confirms product safety and effectiveness. These actions include defining implications for: (i) ongoing and planned clinical, social and operations research; (ii) introductory strategies in countries; (iii) listing requirements for how to support effective, safe and sustained product use; and (d) targeting key user populations. A web presence was developed to share information on pre-exposure prophylaxis (50). Human Reproduction 47 Planned activities � Plans include maintaining an inventory of the regulatory process in different jurisdictions, progress in relevant research activities, development of alternative formulations to deliver TFV vaginally, impact and cost-effectiveness modelling, demand forecasting, and developments in financing product implementation. � A stakeholders’ consultation is planned (March 2014, Durban, South Africa) to identify and prioritize issues in programme implementation and research on novel topical HIV-prevention products. � Web content on topical microbicides is to be updated. 6.9 The inter-agency working group on sexual and reproductive health and HIV linkages The international community has reiterated calls for integrating and strengthening linkages between strategies and services for SRH and for the prevention and treatment of HIV/AIDS. Key challenges are lack of collaborative approaches by technical and funding agencies, vertical donor priorities, and poor communication. In order to overcome these barriers, and to advance, accelerate and harmonize approaches, an inter-agency working group (IAWG) on linkages between SRH and HIV was established by RHR. RHR co-convenes the IAWG with UNFPA and continues to support a variety of tools and approaches to strengthen SRH and HIV linkages including the SRH and HIV linkages resource pack (51), which is an adaptable set of resource materials targeted to national governments, and international and national nongovernmental organizations, United Nations agencies, and donors. This material is updated prior to the International AIDS Conference and World AIDS Day each year, and widely disseminated through the IAWG and other partners. Progress An overview document to promote the work of the SRH/HIV IAWG has been finalized and the website for SRH and HIV linkages reconfigured and updated (51). Planned activities � The next SRH/HIV IAWG meeting is planned for early 2014, to bridge dialogue and activities related to multipurpose prevention technologies (MPTs). 6.10 Initiative for Multipurpose Prevention Technologies MPTs are products that address multiple threats to SRH – unintended pregnancy, HIV and other STIs. HRP/RHR plays an active role in the Initiative for Multipurpose Technologies (IMPT) as steering committee member, provides technical support to the Scientific Advisory Working Group of the IMPT, and co-chairs the committee with the National Institutes of Health and the STI sub-working group of the IMPT. Progress HRP/RHR provided support to IMPT to identify lead products, establish target product profiles and assess the most efficient pathways for clinical evaluation, and in extensive advocacy and communication efforts (e.g. Fig. 5). While condoms do prevent both pregnancy and STIs if used correctly and consistently, new methods have been identified and prioritized, including (i) devices – SILCS diaphragms and condoms; (ii) vaginal rings; (iii) matrix rings versus reservoir rings; (iv) vaginal tablets; and (v) vaginal film. Annual Technical Report 201348 HRP/RHR submitted two funding proposals on MPTs to the Bill and Melinda Gates Foundation, in collaboration with CONRAD and the University of Ghent, Belgium. Fig. 5. MPT infographic developed in collaboration with partners in the IMPT Planned activities � A special supplement on MPTs will be published in BJOG: An International Journal of Obstetrics and Gynaecology in 2014. Infertility/subfertility 6.11 Activities for infertility/subfertility programmes A growing body of evidence is showing that pre-pregnancy care can increase the health and well-being of women and couples and improve subsequent pregnancy and child health outcomes. The evidence has shown that, in addition to addressing stigmatization, misconceptions and a gap in the continuum of care, those who require assistance to achieve pregnancy – especially those from low- and middle- income countries and in low-resource settings – require greater clinical and programmatic support. Progress The WHO global consensus document on preconception care (52) identified immediate pre-pregnancy as an important period to address within the strategy to prevent maternal and childhood mortality and morbidity. Infertility/subfertility- related health problems, behaviours and risk factors that contribute to mortality/ morbidity have been described, as well as evidence-based interventions for delivery of public health care. The first WHO dedicated pages on infertility/subfertility care were developed and first published in 2013 (53). Human Reproduction 49 Planned activities � With the present nongovernmental organization partners – the International Federation for Fertility Societies (IFFS) and the International Committee for Monitoring Assisted Reproductive Technologies (ICMART), new plans of work (2014–2016) have been completed. These include generating a joint country- level surveillance of assisted reproductive technology policy, services and practices; and revision and expansion of the infertility/subfertility glossary (54, 55). � In collaboration with the University of Sheffield (UK) Departments of Communication/Reproductive and Developmental Medicine, a commissioned plan for a communication strategy for infertility/subfertility will be developed and implemented. � To address the environment and effects on reproductive health fitness, a congress has been planned for January 2014, with technical support from two departments in the Family, Women’s and Children’s Health Cluster – RHR and Public Health and the Environment. 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Geneva: World Health Organization; 2006 (http://www.who.int/hiv/pub/guidelines/sexualreproduc- tivehealth.pdf, accessed 13 December 2013). 27. Comprehensive cervical cancer control: a guide to essential practice. Ge- neva: World Health Organization; 2006 (http://whqlibdoc.who.int/publica- tions/2006/9241547006_eng.pdf, accessed 13 December 2013). 28. WHO, PAHO. Monitoring national cervical cancer prevention and control programmes. Quality control and quality assurance for visual inspection with acetic acid (VIA)-based programmes. Geneva: World Health Organization; 2013 (http://apps.who.int/iris/bitstream/10665/79316/1/9789241505260_eng. pdf, accessed 13 December 2013). 29. Comprehensive cervical cancer prevention and control – a healthier future for girls and women: WHO guidance note. Geneva: World Health Organi- zation; 2013 (http://www.who.int/reproductivehealth/publications/can- cers/9789241505147/en/index.html, accessed 13 December 2013). 30. 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Zegers-Hochschild F, Adamson GD, de Mouzon J, Ishihara O, Mansour R, Nygren K et al. The International Committee for Monitoring Assisted Repro- ductive Technology and the World Health Organization revised glossary on assisted reproduction, 2009. Fertil. Steril. 2009;92(5):1520–4. doi:10.1016/j. fertnstert.2009.09.009. 55. Zegers-Hochschild F, Adamson GD, de Mouzon J, Ishihara O, Mansour R, Nygren K et al. The International Committee for Monitoring Assisted Repro- ductiveTtechnology and the World Health Organization Revised Glossary on assisted reproduction, 2009. Hum. Reprod. 2009;24(11):2683–7. doi:10.1093/ humrep/dep343. Annual Technical Report 201354 Improving Maternal and Perinatal Health 55 Improving Maternal and Perinatal Health Summary Despite significant progress in reducing maternal mortality globally, many important challenges remain. As countries increase institutional births and reduce the number of deaths, issues relating to quality of care and equity become more visible and pertinent. For maternal and perinatal health, poor quality of antenatal and intrapartum care, over medicalization during pregnancy and childbirth, with overuse of technologies such as ultrasound and caesarean section, have become important. On the other hand, access to safe and high-quality abortion services continues to be restricted and challenging in most countries. For both maternal health care and prevention of unsafe abortion, disrespect and abuse of women at health-care facilities have become important public health issues. These issues are relevant to most low- and middle-income countries and it is therefore essential for the World Health Organization (WHO) Department of Reproductive Health and Research (RHR) to focus on all Member States with such problems. As recommended by the Scientific and Technical Advisory Group (STAG) in 2013, the Department has increased its focus on quality of intrapartum care and caesarean section, and the work on these areas will expand in 2014. Similarly, the Department continues to focus on access to safe abortion services, through its work on midlevel providers and, in particular, expanding the use of medical abortion methods. Key objectives The RHR/MPA (Maternal and Perinatal Health and Preventing Unsafe Abortion) team is responsible for research and normative work on maternal and perinatal heath. The team has a large portfolio of activities based on its rich collaboration within the HRP research network, to answer questions that can be addressed through large, multicountry projects. Specifically, the team strives to generate new knowledge and develop evidence-based recommendations to promote quality and respectful care for pregnant women. The RHR/MPA team has special interest and focus on developing new research methodologies and improving the science of implementing evidence-based practices based on WHO recommendations. In 2013, the team has increased collaborative activities with academic institutions as well as nongovernmental organizations (NGOs), and with private institutions through public–private partnerships. Major achievements � The Lancet publication of the WHO multicountry survey on maternal and newborn health 2010–2012 in March 2013, together with the British Journal of Obstetrics and Gynaecology supplement, including 12 secondary analyses. This study provided the largest international evidence base in the area of severe maternal morbidity and mortality in facilities and confirmed that, while coverage of effective interventions is high, it is not sufficient to reduce avoidable morbidity and mortality. Annual Technical Report 201356 � Completion of the short-term catheter stay trial following simple vesicovaginal fistula repair. This non-inferiority, randomized controlled trial is the largest trial in this field and demonstrated that a 7-day catheter stay is the recommended practice following surgery. � Two large-scale research projects, namely the fetal growth study and the implementation research on antenatal care in Mozambique, have regained momentum after suffering delays in earlier years, and will be completed in the 2014–2015 biennium. � The large multi-year multicountry research initiative on medical abortion has been completed. Although several results still need to be written, 21 studies in 30 countries on clinical, health systems and social science evidence on this topic have been completed. � The WHO publication Safe abortion: technical and policy guidance for health systems was translated into seven languages and is one of the most in-demand publications of the Department. 1. Introduction In recent years, several trends in maternal and perinatal health and preventing unsafe abortion have emerged. These include significant reductions in maternal deaths globally, although the progress is largely uneven between regions and countries and within countries. With the reduction in deaths, two issues have become important. First, is the increasing focus on severe maternal morbidity, which could serve as a proxy for high-quality and humane maternity care. The second is the changing patterns of causes of maternal death. Indirect causes are becoming increasingly important, although understanding of how that works in specific settings is not adequate. These changes could represent an “obstetric transition”, which is conceptually similar to the so-called “epidemiologic transition” that describes the shift from a pattern of high prevalence of communicable diseases to a pattern of high prevalence of noncommunicable diseases (1). In anticipation of these changes, the World Health Organization (WHO) Department of Reproductive Health and Research (RHR)/Maternal and Perinatal Health and Preventing Unsafe Abortion (MPA) team has been working on maternal severe morbidity and near-miss mortality for some time. In addition, it has identified new priority areas such as intrapartum care (including caesarean section), which were endorsed by the Scientific and Technical Advisory Group (STAG) in 2013. In addition, in the 2014–2015 biennium, the team plans to expand the work to cover antenatal care, and disrespect and abuse during childbirth. The same concepts express themselves in a slightly different way in the area of preventing unsafe abortion. While the proportion of deaths due to unsafe abortion is likely to be smaller – probably due to increased use of medical methods – significant problems remain and new challenges emerge in the provision of safe abortion services. Stigma, disrespect and abuse are prevalent, while conscientious objection by health-care providers as a barrier to provision of abortion services is an emerging issue. The team will continue to focus on research and normative work on best practices in this area. Concurrently, it will focus on developing and assessing the value of new methodologies in both research and research synthesis, and developing research capacity through the newly formed Academic Alliance. Improving Maternal and Perinatal Health 57 2. Research and development 2.1 Care during pregnancy Progress Implementation of the WHO antenatal care model in Mozambique Implementation bottlenecks and health-system constraints often limit the full availability and accessibility of antenatal care services at health-facility level. To address these constraints, a multi-year implementation research project in Mozambique aiming to increase the delivery of evidence-based antenatal care practices by midwives, and promoting the integration of key interventions into routine antenatal care, is being undertaken. On the basis of the formative research undertaken in 2012–2013, an intervention package that is tailored to the local service context, and acceptable to local pregnant women and health-care providers, will be implemented, following a facility-based cluster randomized controlled trial (RCT), with a stepped-wedge design. The intervention includes provision of antenatal kits, a storage system, a tracking system, and training sessions for health-care providers. In 2013, four types of kits were designed and ordered. The protocol has been published and baseline data collection has commenced. Multicountry study to develop fetal growth standards The United Nations Development Programme (UNDP)/United Nations Population Fund (UNFPA)/United Nations Children’s Fund (UNICEF)/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP)/RHR is implementing a multicountry study to develop fetal growth standards for international application, by assessing fetal growth under nutritionally unrestricted conditions in populations of different ethnic and geographic backgrounds. The study is ongoing; 10 countries are participating and 806 pregnant women had been recruited by 31 October 2013. The study aims to achieve a sample size of 1400 women by July 2014. Planned activities � Ten facilities in different regions of Mozambique, selected by the Ministry of Health to implement the antenatal care project, will start receiving the intervention in 2014. � Recruitment to the fetal growth study will be completed in July 2014 and the results will be available by mid-2015. 2.2 Severe maternal morbidity, maternal near-miss and maternal mortality Progress WHO multicountry survey on maternal and newborn health The WHO multicountry survey on maternal and newborn health (WHO MCS) (2) was a cross-sectional, facility-based survey conducted from May 2010 to December 2011. The survey aimed to assess the management of severe maternal complications and the prevalence of maternal near-miss. It captured information on over 314 000 women in 359 facilities across 29 countries in five WHO regions. Annual Technical Report 201358 The primary findings of the WHO MCS were published in The Lancet in May 2013 (3), concluding that, to achieve a substantial reduction in maternal mortality, a comprehensive approach to emergency obstetric care, and overall improvements in the quality of maternal health care, will be needed. In parallel, the WHO MCS network collaborators conducted several global analyses of the dataset, including social determinants of health, major causes of maternal mortality and morbidity, neonatal care, and other aspects of maternal and perinatal health. Twelve scientific papers have been accepted for publication in a British Journal of Obstetrics and Gynaecology special supplement dedicated to maternal and perinatal health (January 2014). Planned activities � The team is coordinating several lines of secondary analysis of the WHO MCS on preterm birth in low- and middle-income countries, in cooperation with the Preterm Birth International Collaborative (PREBIC). 2.3 Hypertensive disorders of pregnancy Progress Screening for pre-eclampsia: evaluation of the predictive ability of angiogenic factors The objective of this multicentre observational study is to evaluate whether changes in serum and urinary angiogenic proteins, substances potentially involved in the genesis of hypertension in pregnancy, can be used as an effective method for identifying women at high risk of developing pre-eclampsia. Recruitment is finished and blood/urine samples have been analysed. Results of the study are going through statistical analysis. The final results will be submitted for publication in January 2014. Long-term calcium supplementation in women at high risk of pre-eclampsia: a multicountry, double-blind, randomized controlled trial Calcium supplementation has been shown to reduce the severity of pre-eclampsia, maternal morbidity and neonatal mortality when the supplementation starts around mid-pregnancy, particularly in women with low calcium intake. Current WHO guidelines recommend 1.5–2.0 g daily elemental calcium supplementation in pregnant women, from 20 weeks’ gestation until the end of the pregnancy. However, calcium supplementation in the second half of pregnancy may be too late to affect pre-eclamptic processes, which could be addressed by earlier supplementation. HRP/RHR is conducting a multicountry randomized, double blind, placebo-controlled trial to assess whether calcium supplementation before, and in the first half of, pregnancy reduces the incidence of recurrent pre-eclampsia more effectively than supplementation starting at 20 weeks. The trial started in 2011 and, as of November 2013, 1093 women have been screened; 472 have been recruited and 141 pregnancies have been recorded in sites in Argentina, South Africa and Zimbabwe. The required sample size (1440 women) will be reached in 2015. The Data and Safety Monitoring Board met in February 2013 and the second steering committee meeting was held in East London, South Africa, in March 2013. Improving Maternal and Perinatal Health 59 Simplified Treatment for Eclampsia Prevention using Magnesium Sulfate: a multicentre randomized non-inferiority trial (STEPMAG trial) Magnesium sulfate is widely accepted as a life-saving drug for preventing the progression of pre-eclampsia to eclampsia and avoiding associated complications. There is compelling evidence that it halves the risk of eclampsia and probably reduces the risk of maternal mortality in women with pre-eclampsia. While coverage relating to the use of magnesium sulfate as prophylaxis and treatment for eclampsia seems to be improving worldwide, its use is still largely limited to hospitals where skilled health workers are available to provide care. A technical consultation was held in June 2013, where international research partners identified a clear need for a randomized trial of a simpler magnesium sulfate regimen for treating women with pre-eclampsia/eclampsia. The first meeting of the project technical working group was held in October 2013, to review evidence and research plans. The key outcome of the meeting was an agreement on a stepwise approach to identify a simpler regimen that is not inferior to the current standard regimens. Planned activities � STEPMAG trial: a pharmacokinetic–pharmacodynamic modelling activity will be conducted, led by experts from Merck in collaboration with HRP/RHR staff. Two new systematic reviews, a Cochrane review update and protocols for an international survey of hospital practices are being developed. The next meeting of the technical working group to review the findings of the ongoing work will be in April/May 2014. Once this formative work is completed, it is anticipated that the trial will commence in 2015. 2.4 Intrapartum care and obstructed labour Progress Non-inferiority of short-term catheterization following fistula repair surgery HRP/RHR, jointly with EngenderHealth, coordinated and implemented the non- inferiority of short-term catheterization following fistula repair surgery trial. The trial’s main objective was to evaluate whether short-term (7-day) catheterization is not inferior to longer-term (14-day) catheterization, in terms of incidence of fistula repair breakdown. Eight facilities across eight African countries (Democratic Republic of the Congo, Ethiopia, Guinea, Kenya, Niger, Nigeria, Sierra Leone and Uganda) participated in the study. The trial started in December 2011 and completed recruitment in August 2013, achieving a sample size of 524 women with simple fistula. The trial showed that 7 days’ catheterization is not inferior to 14 days’ catheterization after fistula repair surgery. The results of the trial will be submitted for publication in December 2013. Feasibility and safety study of a new device (Odón device) for assisted vaginal delivery: phase I trial The objective of this study is to evaluate the safety and feasibility of the Odón device (see Fig. 1) in assisting vaginal delivery in singleton term pregnancies during the second stage of labour, under normal conditions. This study is a hospital-based, multicentre prospective phase I cohort study with no control group. One-hundred and thirty pregnant women will be recruited in tertiary care facilities. The protocol was published in 2013; data are available for the first Annual Technical Report 201360 30 women recruited in Argentina and a manuscript describing the results and the experience with this innovative proposal is in preparation. In 2013, HRP/ RHR signed a partnership agreement with Becton Dickenson to ensure technical optimization, large-scale manufacturing and global distribution of the device, at affordable prices for low-resource countries. Fig. 1. The Odón device Disrespect and abuse of women during childbirth in facilities Increasing skilled birth attendance during childbirth is required to improve maternal care and reduce maternal mortality at birth worldwide. However, disrespectful and/or abusive treatment of women by skilled attendants in facilities is a significant barrier to increasing skilled birth attendance. A 2010 landscape analysis by the United States Agency for International Development (USAID)–TRAction project identified physical abuse, non-consented care, non- confidential care, non-dignified care, discrimination based on specific patient attributes, abandonment of care, and detention in facilities as occurring in facilities during childbirth globally. However, there is a lack of clear, universally accepted definitions of what constitutes disrespectful and/or abusive care in these settings, as well as a lack of operational definitions, of validated measurement methods that encompass basic human rights principles, and of reliable prevalence estimates. A mixed methods systematic review is being conducted to provide a comprehensive synthesis of qualitative and quantitative evidence on disrespect and abuse in facilities during childbirth. This review is informing a technical consultation of international experts (including researchers, clinicians, advocacy groups and other stakeholders) on disrespect and abuse, being held in Geneva in November 2013. At the consultation, the current evidence on definitions, measurement and prevalence of disrespect and abuse were reviewed and a disrespect and abuse research strategy was developed. Planned activities � Better Outcomes in Labour Difficulty (BOLD) project: following several technical consultations and bilateral discussions with the Bill and Melinda Gates Foundation, a 2-year planning grant for an intervention trial was received in October 2013. The project aims to develop tools that will (i) facilitate monitoring of the woman and the baby during childbirth and (ii) create demand for good-quality and respectful care in the facility. The project is a Improving Maternal and Perinatal Health 61 partnership between HRP, M4ID (a social enterprise leveraging communication technology for development and health based in Finland), the University of São Paulo, Brazil, Ibadan University, Nigeria, and Makerere University, Uganda. The team will conduct a cohort study to develop and validate labour-management algorithm, tentatively named SELMA (Simplified, Effective, Labor-Monitoring Assistant), formative research to assess the quality of care in district-level facilities, and community-level work to develop a “Passport to Safe Childbirth”, which will be carried by the women when they come to the facility for birth. � Gentle Assisted Pushing (GAP) trial: a three-arm randomized controlled trial of GAP and/or upright posture compared with current routine practice (recumbent/supine posture) to reduce prolonged second stage of labour. A prolonged second stage of labour is hazardous for the baby; therefore, fundal pressure is frequently applied to expedite delivery. However, there is very little objective evidence of the effectiveness or safety of applying fundal pressure. The recumbent/supine posture for the second stage of labour has become routine in health services in low-resource settings. There is some evidence that upright postures may have advantages for mother and baby, but more evidence is needed. This trial aims to evaluate a gentle, innovative method of applying fundal pressure (GAP), and/or postural variations, to reduce the incidence of prolonged second stage of labour and the risk of associated maternal and neonatal complications, at all levels of care. � iDeliver – Developing a Scalable Solution to improve the Quality of Care for Institutional Deliveries in Low-Income Settings – moving beyond contact to content: HRP will collaborate with Merck for Mothers to develop an eHealth tool that supports both measurement and delivery of quality intrapartum care. The project will take advantage of existing mobile health (mHealth) platforms that the department has developed, and the BOLD project, specifically the SELMA tool. � Feasibility and safety study of a new device (Odón device) for assisted vaginal delivery – phase I trial: phase I will be completed in 2014, with the recruitment of 100 additional women, both multiparous and nulliparous, in Argentina and South Africa. 2.5 Postpartum haemorrhage Progress Carbetocin room temperature stable (RTS) for preventing postpartum haemorrhage: a randomized non-inferiority controlled trial This trial, which is a hospital-based, multicentre, double-blind, randomized, non- inferiority, active controlled trial, will be implemented in collaboration with Merck for Mothers and Ferring Pharmaceuticals, who manufacture carbetocin. The main objective of this trial is to evaluate whether carbetocin RTS 100 μg intramuscular (IM) is non-inferior to oxytocin 10 IU IM, as a uterotonic during the third stage of labour, in preventing postpartum haemorrhage in women delivering vaginally. Centres from 12 countries are expected to recruit 29 000 women over a period of Annual Technical Report 201362 12 months. The trial will start in July 2014. If carbetocin is shown to be non-inferior (or superior) to oxytocin, the findings of this trial will facilitate registration and wider access to carbetocin in low- and middle-income countries. Planned activities � During 2013, preparatory activities with Ferring and Merck for Mothers were conducted. The trial protocol was developed and a presentation was made to the United Kingdom of Great Britain and Northern Ireland Medicines and Health Regulatory Authority. The trial recruitment will start in the second half of 2014. 2.6 Preventing unsafe abortion Progress Research to expand access to medical abortion The 5-year project on “Social Science and Operations Research to Expand Access to Medical Abortion” drew to a close. However, while no new projects will be taken up, several of the research studies that were developed or supported as part of this initiative are still in the implementation or analysis phase. Thirty research projects, covering 21 countries and spanning most of WHO’s geographic regions, were supported through this initiative. Fig. 2 shows the geographical distribution of the projects. Results from some of the studies are under review in journals, and a special supplement in Reproductive Health Matters highlighting the study findings is also under development. Fig. 2. Countries where studies were conducted as part of the initiative to expand access to medical abortion The countries included Argentina, Bangladesh, Bolivia (Plurinational State of ), Brazil, China, Colombia, Ghana, India, Kenya, Kyrgyzstan, Lao People’s Democratic Republic, Mexico, Myanmar, Nepal, Nigeria, South Africa, Turkey, Uganda, Uruguay and Zimbabwe. Improving Maternal and Perinatal Health 63 The earlier years of the grant period (phase 1) focused on studies that examined the perspectives and attitudes of potential and current providers to using medical abortion. These have been reported on in previous years. More recently, the grant has focused on exploring the roles of non-physician providers, or of supportive technology like mHealth to expand access, or on documenting the health impacts of moving from unsafe to safe abortion. Specific research projects included are presented next. Nurse provision of medical abortion: Mexico A non-inferiority RCT was conducted in three public sector clinics in Mexico City. A total of 1017 women with gestational age <70 days were randomized to receive medical abortion by a physician or a nurse. The rate of successful medical abortion without the need for surgery was 98.7% for physician-led care and 97.7% for nurse-led care, which is well within the predetermined margins of non-inferiority. Contraceptive acceptance was similar in the two arms and both physicians and nurses estimated gestational age as well as estimates made with ultrasound. In this study, nurses provided medical abortion to 10 weeks and successfully managed the process using a protocol that allowed home use of misoprostol. Midwife management of incomplete abortion: Uganda A two-sided equivalence RCT comparing the safety and efficacy of incomplete abortion management using misoprostol, between midwives and physicians in primary care settings, is ongoing. A total of 880 women presenting for treatment of incomplete abortion at the six facilities (district hospitals and level IV health centres) were randomized to management by a physician or a midwife. The pilot study showed a 98% success rate for midwives (similar to physicians) in correctly diagnosing and managing incomplete abortion. The acceptability of the task shifting was high among women, as well as among the providers themselves. There were no serious adverse events. Early results from the main trial (based on analysis of the first 260 cases) show a similar pattern. The final results are expected by March 2014. Primary care, midlevel provision of medical menstrual regulation in Bangladesh This feasibility study is being conducted in collaboration with the Directorate General of Family Planning, Population Council, Bangladesh and Marie Stopes Bangladesh. A total of 1882 women received menstrual regulation (MR) with medications at 11 public primary care facilities and two NGO facilities outside of the capital. A total of 1882 women received medical abortion during the study period; care at all the government facilities was offered by auxiliary health workers. Ninety-two per cent of the women returned for follow-up and, of these, 95% had a successful MR without needing surgical intervention. No serious adverse events were reported and the referral system functioned well. Medical MR was found to be acceptable to women as well as providers. Feasibility of nurse provision of medical abortion in rural Kyrgyzstan Following a national situation assessment, the Kyrgyz Ministry of Health requested technical support from HRP/RHR to design a feasibility study to train midwives to provide medical abortion, in order to extend safe abortion care to women living in rural, underserved areas. The study is being conducted in collaboration with the Kyrgyz Alliance of Midwives at one reproductive health centre, a maternity hospital, and 28 primary care Felsher Obstetric Points (primary care centres). Midwives provide pre-abortion counselling, assess gestational age and eligibility Annual Technical Report 201364 for medical abortion, provide combination mifepristone and misoprostol to 9 weeks’ gestation, and assess the woman at the follow-up visit. Safety and acceptability are being monitored over a 9-month observation period. Data- collection forms have been finalized and training in data management is being held. Study enrolment is expected to commence in January 2014. Pharmacy workers: Nepal A quasi-experimental design was used to test the effects of a training intervention with pharmacy workers. Staff from 214 pharmacies selected through cluster sampling in the intervention district received baseline and refresher training on providing accurate information about medical abortion drugs and referral. Baseline and end-line data were compared to similarly selected pharmacies from a neighbouring control district. There were significant increases in the accuracy of knowledge among the intervention group. However, despite the emphasis placed in the training on the importance of client referral to safe abortion facilities, only one fifth of the intervention pharmacies made such referrals. It is likely that the profit margin involved in the sale of these drugs was a deterrent to making referrals. Those who did make referrals were most often staff from pharmacies that did not themselves stock or sell mifepristone/misoprostol. Pharmacy workers: Kenya Based on a mapping of pharmacy shops in the urban slum areas of Nairobi and its outskirts, 135 pharmacies were randomized into intervention and control groups. Pharmacy workers from the intervention pharmacies received 8 hours of training on the national laws, post-abortion care, misoprostol, contraceptives and the referral of clients for reproductive health services. Monitoring data were collected for 6 months, using structured questionnaires and log books, and by simulated clients. At the end-line interviews, providers in the intervention group (71.4%) were more likely to offer information on when to seek help after dispensing misoprostol, compared to 39.3% in the control group. The intervention group was also more likely to offer information on, and to dispense, medication and contraceptive technologies when compared with their counterparts in the control group; however, referrals to safe providers did not increase significantly. Medical abortion provision with auxiliary nurse midwives: Nepal This quasi-experimental study studied the effectiveness of engaging female community health volunteers (FCHVs) and auxiliary nurse midwives (ANMs) in enhancing clients’ accessibility, acceptability, confidence and satisfaction with medical abortion. ANMs (see Fig. 3) at 16 public sector primary care sites in the intervention district were trained to provide medical abortion. Community health volunteers in the catchment areas of these facilities were trained to administer urine pregnancy tests and to provide accurate information and referral to women with an unintended pregnancy, as well as to raise awareness about safe abortion in the community at large. At the end of one year, 304 women had received medical abortion from auxiliary nurses stationed at health posts, with complete abortion without surgical intervention in 98.6% of cases. There was a significant increase in FCHV knowledge about medical abortion, and also in their ability to correctly use urine pregnancy-testing kits. Hover, referral patterns did not change significantly and most women who reached the health posts did so as a result of direct contact with the auxiliary nurses in the community. Improving Maternal and Perinatal Health 65 Fig. 3. Auxiliary nurse midwives at the launch of medical abortion services Medical abortion eligibility assessment by community health workers in Ethiopia, India and South Africa The extent to which community health workers can use simple evaluation checklists to accurately determine eligibility for medical abortion, and to identify women who need follow-up care after a medical abortion, is being conducted in three diverse countries where, despite liberalizations to the law, major challenges in access to safe abortion, and a shortage of trained providers in the public sector, persist (see Fig. 4). All three countries have an interest and potential to expand the role of community-level workers to abortion-related care. Data collection is complete in Ethiopia and South Africa but still ongoing in India. Preliminary results from the first 461 cases show that there is close agreement between physician and community health worker assessments using the checklists. The final results are expected in January 2014. Fig. 4. Community health worker assessing eligibility for medical abortion at a clinic in India C Annual Technical Report 201366 mHealth for supporting women having medical abortion: South Africa This study evaluated the role of text messaging (SMS) support for women having a medical abortion. A total of 469 women undergoing a medical abortion at four Cape Town clinics were randomized to receive usual care or intervention in the form of mobile messaging support. The SMS messages were written to coach women through medical abortion, with timed reminders to take medication and information on managing side-effects or potential problems, as well as providing family planning information through the iChooseWhen mobi-site. Members of the intervention group felt considerably more satisfied and had less stress and anxiety over the medical abortion process than did the individuals in the control arm. The intervention did not alter contraceptive uptake rates, which were high in both groups, nor did the text messages reduce unscheduled calls to the provider. Assessment of the cost of abortion care provision: Colombia Data were obtained from 1411 unlinked anonymous hospital billing records from three hospitals in Cartagena and Medellin. The average cost of an uncomplicated manual vacuum aspiration (MVA) at a clinic was nearly half the cost of the same procedure at a hospital (US$ 197 versus US$ 374). The cost of an uncomplicated, clinic-based MVA was nearly one third of the cost of a hospital-based dilatation and curettage (D&C; US$ 197 versus US$ 657). Post-abortion care with complications cost more to treat than legal induced abortion. The health systems could save costs by increasing existing medical abortion services and switching from D&C to MVA. If all of the current post-abortion care cases could be replaced with legal abortion (medical or surgical), the health system would save an additional US$ 163 000 dollars. The health system could potentially save an additional US$ 177 000 (per 1000 women) from baseline, by replacing D&C with medical abortion or MVA. Misoprostol availability and the changing the nature and severity of unsafe abortion (Ghana, Lao People’s Democratic Republic, Myanmar, Nigeria and Sri Lanka) This multicountry study is a descriptive hospital-based study in five countries that is attempting to test the hypothesis that the increasing the availability of misoprostol, even in restrictive legal environments, is decreasing the severity of abortion complications. Data collection includes a 5-year retrospective case record review to determine whether the volume and nature of abortion complications has changed, as well as structured interviews with 4000 women (800 per country) presenting with abortion complications, in order to determine the nature and severity of complications and possible linkages to the methods of abortion used. In-depth interviews with a subset of women who admit to using medical abortion are also being carried out, in order to understand their information sources and care-seeking pathways. Planned activities � Development of a proposal on using community-based information and vouchers to increase access to safe abortion: planning is under way to conduct research to examine the feasibility of increasing access to safe abortion through the use of community-based information, referral and vouchers. The research, including both a formative and implementation component, would address several of the research gaps – evaluation of the role of provider incentives and identification of how women pay for abortions – identified in the 2010 safe Action Research and Training for Health (ARTH); Udaipur; India Improving Maternal and Perinatal Health 67 abortion consultation that preceded publication of the second edition of the WHO Safe abortion technical and policy guidance for health systems (4). � Sex selection and abortion: as a follow-up to the interagency statement on Preventing gender-biased sex selection (5), a consultation was held to discuss the effectiveness of policies to reduce sex selection and the relative roles of restrictive policies (like bans on sex-determination tests or on legal, safe abortion) versus proactive policies that address issues of discrimination. A paper looking at these issues in five Asian countries (China, India, Nepal, the Republic of Korea and Viet Nam) is under preparation. An in-country consultation in Nepal is planned for November 2013 and one in India in 2014. � Study on pain control in medical abortion: WHO recommends the use of non-steroidal anti-inflammatory drugs (NSAIDs) during medical abortion with mifepristone and misoprostol. Previous studies have shown that NSAIDs, particularly ibuprofen, reduce pain once uterine cramping has started, and are superior to paracetamol; however, they do not appear to be effective at preventing or minimizing the moderate to severe pain of medical abortion when administered prior to pain onset. As pain is often cited as one of the worst features of medical abortion, and given that inadequate pain management may motivate some women to seek unnecessary clinical care, there is a clear need to identify the most effective methods of pain control in this setting. A proposal has been developed for a RCT to evaluate two novel strategies to address pain associated with early medical abortion. The proposal is currently undergoing technical review; however, it is anticipated that technical and ethical approval will be achieved in the next several months, with a goal of study initiation in 2014 across three sites in Nepal, South Africa and Viet Nam. � A systematic review on the use of medical abortion medications without direct medical supervision is ongoing. 3. Norms, standards and tools 3.1 Care during pregnancy Progress Antenatal care Since the publication of the WHO antenatal care randomized trial (6) and Integrated Management of Pregnancy and Childbirth manual on normal antenatal care (7), many countries have implemented antenatal care models, commonly known as focused antenatal care or basic antenatal care, which rely heavily on delivering antenatal care services with a four-visit model. However, a recent Cochrane review on models of antenatal care (8), and a secondary analysis of the WHO trial, suggested that the fewer-visit model may be associated with increased fetal death. Furthermore, in several countries demographic and health survey studies suggest declining antenatal care attendances, probably due to poor quality of care. RHR is a partner in the “Antenatal care: adding content to contact” project, funded by the Bill and Melinda Gates Foundation and led by the Woman and Health Initiative, based at Harvard University, and has started working on a comprehensive antenatal care guideline. Annual Technical Report 201368 Planned activities � Two technical consultations in 2014 will determine the scope of this guideline. The recommendations will be issued in 2015. � A technical consultation to discuss the evidence base and research needs and measurement of antenatal, intrapartum and postnatal care will be convened in April 2014. 3.2 Intrapartum care and obstructed labour Progress WHO recommendations for augmentation of labour Prolonged labour is an important cause of maternal and perinatal mortality and morbidity. Augmentation of labour has commonly been used to treat delayed labour when poor uterine contractions are assessed to be the underlying cause. While interventions within the context of augmentation of labour may be beneficial, their inappropriate use can cause harm, and unnecessary clinical intervention in a natural birth process undermines women’s autonomy and dignity as care recipients and may negatively impact their childbirth experience. The primary objective of this guideline was to consolidate the guidance for effective interventions that are needed to reduce the global burden of prolonged labour and its consequences. The guideline panel meeting was held in September 2013 at WHO in Geneva. The guideline document and evidence tables have been completed according to the WHO Guideline Review Committee guidelines, and were submitted for final review in November 2013. It is anticipated they will be published by early 2014. WHO recommendation on optimal caesarean section rate Since the 1985 publication by WHO of a proposed ideal caesarean section rate of 5–15%, what constitutes best practice has been debated. This is especially pertinent since many low- and middle-income countries have caesarean section rates around 30–40%. In 2013, RHR conducted several activities to issue normative guidance on this issue in 2014: � Implementation of the Robson classification for caesarean section: what do users think? A systematic review: despite the lack of scientific evidence indicating any substantial maternal and perinatal benefits from increasing caesarean rates, and some studies showing that high rates can be linked to negative consequences, caesarean section rates continue to increase worldwide, particularly in middle- and high-income countries. In 2013, HRP/ RHR conducted a systematic review of the literature to collect and synthesize the experience of users related to the pros and cons of the adoption, implementation and interpretation of the Robson classification for caesarean section, as well as their adaptations, modifications or recommendations on the use of this classification. Seventy-four studies were included, reporting on the use of the Robson classification in over 35 000 000 women in 31 countries. A manuscript for publication has been prepared and submitted to a peer-review journal. This review will assist facilities and countries as they work towards implementation of the Robson classification. Improving Maternal and Perinatal Health 69 � Secondary analyses of the WHO MCS (2) to develop an institutional benchmark for excessive caesarean sections: a model to monitor caesarean section rates at facility level will help to determine whether the facility is performing excess caesarean sections for its institutional characteristics. Planned activities � In 2014 WHO will issue guidance on facility-level caesarean section rates and monitoring of these rates. These will be based on (i) a caesarean section benchmark model developed using the WHO MCS (2) dataset; and (ii) a systematic review of the Robson classification system experience. In addition, a separate systematic review assessing the impact of population-level caesarean section rates on maternal and neonatal mortality in both developed and developing countries will inform acceptable country-/population-level caesarean section rates for individual countries. 3.3 Preterm birth Progress Preterm birth is the single most important cause of mortality and morbidity for the neonate. Providing guidance on the safety and effectiveness of interventions to prevent preterm birth, as well as supportive health-system characteristics, is crucial to improving maternal and neonatal outcomes. HRP/RHR and the MCA department are leading the development of a guideline that addresses questions relating to the effectiveness and safety of interventions and organization of care issues for management of both women in preterm labour and preterm newborn infants. Key questions relating to this guideline have been prioritized at an initial scoping meeting in April 2013, by a group of international stakeholders. Planned activities � WHO recommendations will be published in 2014 following the guideline development panel meeting in early May 2014. 3.4 Postpartum haemorrhage Progress Since the 2012 WHO recommendations for the prevention and treatment of postpartum haemorrhage (9) were published, several areas of active research have been left without a firm recommendation. These are advance misoprostol distribution during pregnancy, use of a non-pneumatic anti-shock garment, and oxytocin in a compact prefilled auto-destructive device. RHR commissioned a review of advance misoprostol distribution programmes in 2013. The review is currently going through peer review. Planned activities � The Department will issue a small update of the postpartum haemorrhage guidelines, focusing on the above-mentioned areas where new evidence has become available or will be available in 2014. Annual Technical Report 201370 3.5 Birth spacing Progress In 2012, HRP/RHR and the Centro Rosarino de Estudios Perinatales (CREP), New Mexico, United States of America, conducted a systematic review on birth spacing intervals, including 117 studies from 57 different countries. It was found that although the available evidence seems to indicate that shorter and longer interpregnancy intervals are associated with poorer maternal and perinatal outcomes in general, the variety of definitions for outcomes and the heterogeneity in length of intervals make it impossible to make recommendations regarding the optimal birth interval. In 2013, HRP/RHR, the Latin American Centre for Perinatology and Human Development, Uruguay, and CREP conducted an analysis of the Perinatal Information System database (Montevideo, Uruguay), to evaluate how interpregnancy interval is associated with risks of adverse maternal and perinatal outcomes in Latin American women. The results indicate that women with short interpregnancy intervals (<12 months) are at increased risk of having a low-birth-weight baby, preterm delivery and neonatal death, but not fetal death. Moreover, intermediate and long interpregnancy intervals (>24 months) were associated with higher risks of pre eclampsia, but not eclampsia, postpartum haemorrhage, puerperal infection or maternal mortality. A manuscript presenting the findings has been prepared and is currently under peer review. Planned activities � No new formal guideline work is planned for this activity. 3.6 Task shifting in safe abortion care Progress Work on a new task-shifting guideline for safe abortion care was initiated. This guideline will consider recommendations on options for shifting and/or sharing of tasks among health workers (including pharmacy workers and community workers) and the role of the woman herself. The preliminary scoping meeting, held in November 2003, outlined the scope of interventions and cadres that will be considered. Evidence retrieval and synthesis will be done in collaboration with the Norwegian Knowledge Centre. The guideline is expected in 2014. Planned activities � The evidence synthesis will be completed and the technical consultation to finalize the recommendations will be held in 2014. 3.7 WHO recommendations for the management of sepsis around childbirth Progress Work on a new guideline on prevention and management of maternal infections was initiated. Currently, the scoping work is being carried out by Department of Health Policy, National Center for Child Health and Development in Tokyo, Japan. The plan is to focus primarily on bacterial infections around the time of childbirth but the final scope will be determined after the electronic survey. Planned activities The systematic reviews, grading of evidence and the recommendations will be completed in 2014. Improving Maternal and Perinatal Health 71 4. Monitoring and evaluation 4.1 Maternal mortality and morbidity Progress Maternal mortality estimates The Department leads the collaborative effort with UNICEF, UNFPA and the World Bank to provide up-to-date estimates of global maternal mortality levels, as part of monitoring progress towards Millennium Development Goal (MDG) 5, target 5A (reducing the maternal mortality ratio [MMR] by three quarters, between 1990 and 2015). The MMR consultation process has served as a starting point to engage countries in improving the quality of data collection, and the processes in the estimation procedure have been recognized as transparent and a good example of how WHO estimates should be undertaken. In 2013, a preliminary revision was undertaken, with review of input data and draft estimates by Member States. With the addition of new data points and increased country engagement, it is now evident that the statistical model used to estimate maternal mortality will require additional refinement to better reflect good-quality country-level data. A document on the use of censuses to collect maternal mortality data was published online (10). Updates of global databases of maternal and perinatal health-care coverage indicators Annual updates of a range of global databases were continued and updated figures were published in the World Health Statistics 2013 (11). They include: births attended by a skilled health professional (MDG 5.2), antenatal care coverage (MDG 5.5), caesarean section rates, and facility deliveries and coverage of postnatal care. Systematic reviews of epidemiological data on reproductive health conditions: Pre-eclampsia and eclampsia A systematic review of the incidence of hypertensive disorders of pregnancy was conducted, with the objective of evaluating its magnitude globally and in different regions and settings (12). Using a logistic model, the global and regional incidences of hypertensive disorders of pregnancy were estimated using prespecified predictor variables. The systematic review includes nearly 39 million women from 40 countries. The overall estimates of hypertensive disorders of pregnancy are 4.6% (95% uncertainty range 2.7 to 8.2), and 1.4% (95% uncertainty range 1.0 to 2.0) of all deliveries for pre-eclampsia and eclampsia, respectively. Wide variation across regions was observed. The absence of data in many countries is of concern, however (see Fig. 5), and efforts should be made to implement data collection and reporting for substantial statistics. Improving Maternal and Perinatal Health 73 4.2 Maternal morbidity Progress With reductions in maternal mortality, increased emphasis is being placed on maternal morbidity, although a common definition of what constitutes maternal morbidity does not exist. Accurate and routine measurement of maternal morbidity are needed to inform policy and programme decisions and resource allocations. The Department received a grant from the Bill and Melinda Gates Foundation for a project that aims to address this challenge and to improve the scientific basis for defining, estimating and monitoring the magnitude of maternal morbidity. A Maternal Morbidity Working Group has been established, with representation from all WHO regions and relevant technical expertise in quantitative and qualitative measurement of maternal morbidities and patient advocacy. The group drafted a working definition and framework upon which to ultimately develop a tool to measure maternal morbidity. In 2013, the Maternal Morbidity Working Group continued to refine the maternal morbidity framework to develop the basis for a community-based tool for measurement of morbidity. Two papers, (i) discussing the rationale of the project and to invite collaboration (6), and (ii) describing the background scoping exercise conducted to inform the project (7) were published. A methodological paper has been submitted for publication. 4.3 Preventing unsafe abortion Progress Estimates of unsafe abortion In 2013, a comprehensive review of the methodologies used in producing estimates of unsafe abortion was conducted, which will feed into the work in 2014. Planned activities � The seventh edition of the unsafe abortion estimates will be produced in 2014. Current methods of estimation are being reviewed and approaches to enhance the estimates as well as nuance them, keeping in mind the changing nature of unsafe abortion, are being developed. An expert group consultation is planned for spring 2014. A systematic review of existing studies on the incidence of unsafe abortion is also under way. 5. Dissemination, advocacy and partnerships 5.1 Shaping the research agenda Progress Global research prioritization in maternal and perinatal health and preventing unsafe abortion In 2013, a global research-prioritization activity was undertaken to identify priority themes in the area of maternal and perinatal health and preventing unsafe abortion, for the period 2015–2025. The exercise was based on the methodology of the Child, Health and Nutrition Research Initiative. A total of 339 stakeholders provided input to a consolidated list of 190 priority research questions. Most priority research questions (89%) were concerned with the implementation and Annual Technical Report 201374 delivery of existing interventions, with research subthemes frequently concerned with training and/or awareness interventions (11%), and access to interventions and/or services (14%). Twenty-one questions (11%) involved the discovery of new interventions or technologies. Questions on abortion research constituted 25% of the 20 highest-scoring questions overall, followed by research on health systems (20%), obstetric haemorrhage (15%), neonatal care (15%), labour and delivery (10%), and other areas (15%). The results of this exercise were submitted for publication in November 2013. Conscientious objection to abortion as a potential barrier to access to safe abortion HRP/RHR staff contributed to an article on “Conscientious objection to provision of legal abortion care”, for a special supplement of the International Journal of Gynecology and Obstetrics, focused on conscientious refusal of reproductive health care to be published in 2014. Safe abortion: technical and policy guidance for health systems (5) identifies conscientious objection to providing abortion services by health-care providers as a potential barrier to accessing safe abortion services. There is little evidence on the prevalence and impact of conscientious objection; RHR has committed to developing a collaborative research proposal to study the implications of conscientious objection for women, service providers and health systems, with a focus on South Africa. Planned activities � Global research priori
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