Increasing Same-Day Access to FP through Available, Affordable Pregnancy Tests - Final Detailed Report of SHOPS Plus Market Shaping Analysis in 5 Countries

Publication date: 2017

January 17, 2017 Increasing Same-Day Access to FP through Available, Affordable Pregnancy Tests Final Detailed Report of SHOPS Plus Market Shaping Analysis in 5 Countries 2 Table of Contents Methodology / Caveats 5 PT Market Shaping Executive Summary 10 Country / Region Findings 22 PT Types and Costs 23 Public Procurement of PTs 29 Clinical Practice, Service Delivery and Client Behavior 34 PT Pricing Data Comparison 41 Country / Region Conclusions 46 Evaluation of Possible Interventions to Reduce Risk of Client Drop-Off and Recommended Set of Interventions 56 Interventions Recommended by SHOPS Plus 69 Appendix 74 3 Overview • Premise: Studies have suggested that women seeking hormonal FP methods outside their menstrual period risk being turned away by providers, and improving access to pregnancy tests can result in improved same day access to FP methods • Purpose: To determine whether market shaping can be used to improve access to same-day hormonal FP methods through PTs. • Method: The SHOPS Plus project conducted market assessments in India, Kenya, Madagascar, Malawi, and Zambia between June-September 2016. – Collected information included: price, availability, quality perceptions, use of PTs, use of the Pregnancy Checklist or other protocols, and past procurements in the public, for- profit and NGO sector. – The project then analyzed the findings with the CII market shaping framework, and used a consultative process to identify the most promising interventions. 4 Assessment overview • Key questions: – What are market conditions for PTs at the global and local level? – What barriers to the use of PTs may cause FP clients to drop out? – What interventions might reduce these barriers? • Caveats: – The assessment was qualitative, with a small sample of respondents – The geographic scope was limited to capital cities or other urban centers – Affordability and quality could not be precisely assessed 5 Project Methodology & Caveats 6 Project Methodology: In-country qualitative research and analysis using the CII market shaping framework Source: USAID Healthy Markets for Global Health: A Market Shaping Primer, www.usaid.gov/cii/market-shaping-primer 7 Project Methodology In-Country Research Market Shaping Analysis Assessment of Possible Interventions ---------------------------------------------------------------------------------------------------------------------- • Topical discussion guides developed & provided to country consultants for in- person and telephone interviews • Participation rates varied by country region / individual audiences • Completed by SHOPS PLUS team • In collaboration with USAID project liaison • Utilized the CII market shaping framework • Ideation of possible interventions based on root causes • Completed by SHOPS PLUS team, drawing upon private sector expertise • Conducted a consultative process with FP practitioners and experts from multiple organizations • Final selection of most promising interventions In-country qualitative research + secondary data review informed the market shaping assessment and intervention ideation; followed by consultative process Recommendations 8 Country Number of site visits /interviews Public clinics Private clinics Distributors Wholesalers Retailers Total India 13 23 2 8 46 Kenya 3 14 3 7 27 Madagascar 2 7 6 11 26 Malawi 13 24 5 18 60 Zambia 13 7 5 22 47 Total 44 75 21 66 206 Information Sources • Global: – IMS Health, public records – USAID procurement records – Consultation with procurers • Local: – IMS Health (India) – Local tenders – Interviews and site visits  Including MOH contacts and NGOs managing private pharmacies 9 Abbreviations & Project Caveats Abbreviations and caveats pertaining to this research are included below: Abbreviations: • EML: essential medicines list • FP: family planning • KEMSA: Kenya Medical Supplies Authority • MCH: maternal & child Health • MOH: ministry of health • NGO: non-government organization • OC: oral contraceptive • PT: pregnancy test Project Caveats • This assessment is based on qualitative small sample research; findings should be viewed as directional • Research represents findings from a single urban region in each of the five countries • Affordability could not be precisely assessed • Several respondents declined to share PT purchase price and margin information • Product quality was not evaluated, therefore any findings on quality refer to user experience as described 10 PT Market Shaping Assessment Executive Summary 11 Global Level Findings Mixed signals to providers; and varying clinical practice • PTs and Checklist are included in WHO Decision-Making Tool for Family Planning Clients and Providers* • However, national guidelines are mixed; and providers do not routinely follow the WHO guidance • PTs are not included in the WHO Essential Medicines List • Only nine countries list PTs in their EMLs Small, local ad hoc procurement • USAID missions procure PTs locally from wholesalers • UNFPA orders very small quantities of PTs for a few countries Low procurement costs due to a competitive market • Procurement costs range from $0.04 - $0.40 (dipsticks) • There are many manufacturers of PTs, mostly from China, India, the US and EU http://www.who.int/reproductivehealth/publications/family_planning/9241593229/en/ and http://apps.who.int/iris/bitstream/10665/43225/2/9241593229_eng.pdf 12 PT availability and use is driven by programmatic and procurement failures rather than market factors in these five urban regions Availability issues are programmatic and procurement-related, rather than market based • Market supply of PTs was adequate in the five areas studied, relative to manufacturer capacity and participation, based on private sector availability • Inadequate availability and utilization of PTs in public clinics are due to demand issues deriving from country policy, clinical practice, funding and procurement not market conditions Affordability may be an issue for sub-segments but was not determined to be a cross- cutting issue based upon this research and assessment • A range of procurement prices indicate that widespread cost-effective use of PTs is possible • PT pricing variance across regions and provider types results from:  Inefficient public procurement  Mark-ups applied at both retail and clinic outlets • Affordability may be a barrier in under-served and rural areas (not fully represented in this research sample), but requires population research to determine 13 PT quality and design are not inhibiting use in FP services; the barriers are policy, protocol and behaviorally based Assured Quality • Qualitative research in the five country regions did not indicate evidence or a pattern of expressed concern or negative health outcomes due to problems with PT quality and reliability, however… • A possible market shortcoming is insufficient information and assurance on the quality of available PTs Appropriate Design • Across the five regions, PT product design was not identified as a potential market shortcoming, nor as a reason for non-use, nor for any negative impact on health outcomes • Dipstick and cassette tests were the most common, with midstream tests also available Awareness • This research reaffirmed that national policy and healthcare provider behavior (both public and private sector, including training, adherence and motivation) are significant shortcomings and barriers to appropriate and consistent use of PTs as well as the pregnancy checklist 14 Cultural norms, provider and client behavior all block use of checklist / PTs, and delay initiation of method-start The practice of turning women away who are not in their menses is deeply entrenched • Most prominent in India, but evident in other country regions as well • Clients also self-delay visits to FP providers for this reason Use of the pregnancy checklist is inconsistent across both public and private sector providers • Coordinated and sequential use of both the checklist and PT is not routinely occurring Purchase and use of PTs does not necessarily result in FP counseling or initiation • Common practice of clients sourcing in the private sector, not demanding provision of PTs at public clinics Client ability and willingness to pay for PTs is not fully understood • Not clear whether clients are unable or choosing not to pay for PTs and leaving the clinic 15 India key findings: clinical practice is the barrier rather than PT availability - opportunity is in provider behavior change • PT market – Public clinics carry PTs – PT public procurement is conducted through centralized tenders – PTs are widely available in the private sector at various prices – There is a high incidence of home use of PTs • Policy and practice – Providers often do not use checklist or a negative PT result to initiate FP – Non-menstruating FP clients are typically asked to return during menses – Use of PTs is appropriately reserved for FP clients with delayed menses 16 Kenya key findings: opportunity is in improving public sector procurement and increasing provider adherence to protocol • PT Market – PTs are available in public sector (county procurement) – Private pharmacies carry wide range of brands – Trade margins are high (see table, next page) • Policy and practice – MOH supports PT use with checklist/history-taking – Practice varies across public and private sector providers 17 Kenya: High trade margins are consistent with PTs as a low-volume, low-cost product Distributor Wholesaler Retail Price Public Clinic* Private Clinic US$ per strip 0.06 0.07 0.50 0.99 1.88 Wholesale margin 12.53% Retail Margin 85% Public clinic margin 93% Private clinic margin 96% (*) FHI360 found that some public clinics did not charge for PTs 18 Madagascar key findings: continued policy support for both checklist and PTs needed, critical for PT procurement and provider use • PT market – PTs are not currently available in public clinics for FP services – USAID funded projects supply PTs at the community level – Commercial brands are widely available in pharmacies at various prices • Policy and practice – MOH supports use of the checklist and supported the introduction of PTs for FP through community-based MIKOLO project – Inconsistent use of checklist in public clinics – FP clients whose pregnancy status cannot be ruled out are given barrier method and asked to return – Clients potentially more likely to self-delay FP visit outside menses, when PTs are not available in public clinics 19 Malawi key findings: policy supports PTs but also client delay, so an opportunity exists to advance new clinical guidance and prioritize PTs • PT market – PTs are not currently available in public clinics for FP services – PTs are not on an essential commodities list – There is a wide range of brands and prices in private pharmacies • Policy and practice – Malawi RHSD guidelines do support use of PT after checklist, but not more than alternatively delaying the client until her next monthly bleeding – Public FP clients with undetermined status must buy PT elsewhere or return during menses – Private franchised clinics use own guidelines when using PTs for FP 20 Zambia key findings: opportunity appears to be predominantly in improving PT supply security through procurement and logistics • PT market – MOH procures PTs for FP – Public sector stockouts are routinely reported but availability has been improving – PTs are widely available in private pharmacies and clinics • Policy and practice – MOH policy supports the use of PTs in the context of FP services – FP clients must buy a PT when they are not available at the public clinic – Private franchised clinics use own guidelines when using PTs for FP 21 • All countries have a vibrant private market for PTs – Market shortcomings do not appear to be upstream or at the sourcing stages before reaching the retailer/provider – Wide product variety and availability, range of prices but retail margins can be high • The availability of PTs for FP in the public sector is mixed – Three out of five countries routinely order PTs for use in FP services, but clinics in Malawi and Zambia do not regularly carry PTs – Clinical and commodity procurement pratices influence actual availability • Issues related to policy and practice are found in all countries – There is variable awareness and use of the checklist for pregnancy screening – Ruling out pregnancy with a PT does not always lead to method initiation Summary 22 Country / Region Findings 23 PT Types and Costs 24 Country Number of Products identified Dipstick Cassette Midstream Number of Manufacturers identified India 19 0 19 0 14 Kenya 14 14 0 0 9 Madagascar 14 7 4 3 8 Malawi 13 12 0 1 11 Zambia 24 13 2 9 11 PT availability in the marketplace: Many brands, mostly for dipstick format Sources: IMS/India. All other data collected in-country in public and private facilities, retail pharmacies, and from wholesalers/distributors. 25 Country PT Cost at Public Clinic PT Cost at Retail Pharmacy PT Cost at Private Provider FP Consultation Cost at Private Provider Other product for comparison (ECP) India Free 0.45–0.96 0.75 –1.49 2.99–4.48 0.75–1.49 Kenya 0.99–1.40 0.29–4.17 0.97–1.94 0.99–3.002 0.99–1.48 Madagascar PTs not available 0.33–3.45 0.49–0.99 0.99–1.66 0.33–3.25 Malawi PTs not available 0.28–1.80 0.69 –2.08 0.14–1.39 0.69–2.08 Zambia Free 0.10–4.501 Included 2.00–6.50 0.15 1. Excludes midstream digital test found in two outlets, at a maximum price of $12.40 2. Typically includes FP method and service. PT costs (USD) imply likely affordability in private clinics, yet public clinic users may face barriers due to non-availability in clinics and cost in private sector 26 Comparing SHOPS Plus PT pricing data with IFP and FPWatch data: PT prices were under $1.00 in all but one country, and as low as $0.10 Observations across the studies • FPWatch, large sample sizes for private, public clinics, and pharmacies / drug shops • SHOPS Plus and IFP are both small sample, qualitative in nature; variation in range is not surprising due to geography and question phrasing • Public clinics charge for PTs in Mali, Malawi, Ethiopia, DRC and Nigeria • India and Zambia free, Kenya mixed • Mali mean prices -- highest across all three studies • Mali and Kenya data from IFP -- highest for public providers • Ethiopia -- lower cost range and median across all outlet types • DRC - 5x higher at private provider than in pharmacy / drug shop Sources: IFP / FHI360, SHOPS PLUS, FPWatch Outlet Type SHOPS PLUS (US$, range) IFP (US$, range) FPWatch (US$, range) Kenya India Madaga scar Malawi Zambia Kenya Mali Malawi DRC Ethiopia Nigeria Private 0.97- 1.94 0.75 - 1.49 0.49 - 0.99 0.69 - 2.08 Incl in consult 0.98-5.87 0.41 - 3.28 0.35 - 1.77 0.55 - 1.10 0.10 - 0.21 0.25 - 1.00 Public 0.99-1.40 Free NA NA Free 0.98 - 4.89 0.82 - 2.46 0.35 - 0.35 0 - 1.10 0 - 0.25 0.25 - 1.00 Pharmacy / Drug Shop 0.29 - 4.17 0.45 - 0.96 0.33 - 3.45 0.28 - 1.80 0.10 - 4.50 0.49 - 1.96 1.15 - 2.46 0.35 - 0.88 0.22 - 0.33 0.10 - 0.25 0.25 - 1.00 27 FPWatch: Ethiopia has best PT availability in both public and private clinics, pharmacies generally have better PT availability than drug shops Outlet Type DRC Ethiopia Nigeria All Urban Rural All Urban Rural All Urban Rural Private 13.3 14.5 10.7 43.7 48.9 40.8 37.7 25.0 41.6 Public 28.9 41.7 21.2 77.5 79.0 77.0 45.0 44.8 45.0 Pharmacy 64.3 64.3 NA 47.0 57.1 37.9 78.3 79.4 72.8 Drug Shop 41.6 51.6 19.5 39.0 40.1 21.5 32.4 32.5 32.4 Source: FPWatch Observations across the countries • FPWatch, large sample sizes for private, public clinics, and pharmacies / drug shops • Comparable availability across urban and rural settings for Ethiopia clinics • DRC private clinics have the lowest PT availability of all segments • DRC public urban segment has better than availability than rural • Nigeria rural private clinics better availability than urban (however a smaller N for rural private clinics) • Of the three countries, Nigeria has best availability in pharmacies, followed by DRC urban segment 28 Retail trade margins tend to be high Country Total Number of Products identified Retail Selling Price (USD) Min Max Retailer Gross Margin Wholesaler Gross Margin India 19 0.45 0.96 69-81% 15-37% Kenya 14 0.29 4.17 85%* 12% Madagascar 14 0.33 3.45 25-45% NA Malawi 13 0.28 1.80 60-93% NA Zambia 24 0.10 4.50** 15-98% 94-95% Sources: Data from products identified by in-country consultants; India number of products supplemented with IMS data. Margins calculated by SHOPS Plus. Country currencies have been converted to USD *Relevant price information available for only 1 brand. **Excludes outlier midstream digital test 29 Public Procurement of PTs (Does not include Madagascar and Malawi because they are not procuring) 30 PTs are not included in the 2015 WHO Model Essential Medicines List, and are included in relatively few country EMLs *Reportedly added to the EML after SHOPS 2013 study; confirmed by country consultant Source: http://www.cecinfo.org/emlsearch/commodity/pregnancy-tests-for-family-planning/ Included in 10 country EMLs • Cape Verde • Cote d’Ivoire • DRC (rapid test) • Guyana (test strips) • Madagascar* • Namibia (diagnostic kit (HCG)) • Papua New Guinea (biochemistry assayed serum control, lyophilised) • Rwanda (Reactifs pour Test de coagulation) • Trinidad and Tobago (disposable sticks) • Uganda (HCG pregnancy test strips) Not included in most country EMLs • Including the SHOPS PLUS, IFP and FPWatch research countries • DRC • Ethiopia • India • Kenya • Malawi • Mali • Nigeria • Zambia 31 India PT public procurement utilizes a centralized tender, does not include quality specifications PTs are part of central procurement process • Central Medical Services Society (CMSS) conducts centralized procurement, storage and inventory of medicines and essential health commodities for national level programs • Each state sends annual requirement to Ministry of Health and Family Welfare, forms basis of forecast and procurement • PTs are received from CMSS at dedicated FP Logistics Management Cell at Lucknow • No quality specifications Source: SHOPS PLUS India Country Consultant Report CMSS LMC at Lucknow 75 Districts 18 Regional Warehouses Public Health Facilities in each district Lucknow Public Supply Chain of PTs 32 Kenya PT public procurement is decentralized, and even highly localized, resulting in clinics charging for PTs and variable pricing PTs are procured at the county level • Kenya’s devolved system includes two units of healthcare management and responsibility: 1) National 2) County level • KEMSA does not routinely procure or distribute PTs • Counties procure PTs for their facilities • Procurement is done largely from the local market Policy and Regulation • PTs fall under Health Products and Technologies • PTs are regulated under the Pharmacy and Poisons Board (PPB) listing route Source: SHOPS PLUS Kenya Country Consultant Report, Consultation with M. Solomon, FHI360 One County’s Process Health facilities compile workload data on tests conducted each month; submit to sub- county lab coordinator County issues tender or RFQ for PTs using quantification from county lab head and completes procurement Sub-county lab coordinator collates reports; submits to county headquarters (including requests for quantities running low with procurement planned quarterly) Health facilities collect PT supplies from county headquarters 33 Zambia PT public procurement is in place, challenges are capacity and process related Shift in approach has positively impacted procurement and availability • Until 2014, accessibility was mainly through facility laboratories • Resulted in missed opportunities as clients were sent to lab • Did not always get back to MCH • 2015 forward, deliberate intention to improve FP services • Making PTs available in MCH became a priority Continued challenges • Bottlenecks in supply chain -- due to reporting problems, lack of awareness on stock availability at central level • Coming from background of perpetual PT stock outs, situation seems to be improving with MOH continued scale-up of family planning • With support from cooperating partners, they hope to build awareness in the communities who in turn should demand the services Source: SHOPS PLUS Zambia Country Consultant Report 34 Clinical Practice, Service Delivery and Client Behavior 35 Mapping the client journey revealed that multiple drop-off risks contribute to not obtaining same-day start of contraception *Developed from Country Consultant Interviews, similar flow / risks for private sector Public Sector Client Journey* Both Public and Private Sector • Risks are variously present across FP care delivery sites, although less so in franchised NGO sites Drop-off Risks Include: • Application of clinical protocol • Availability of checklist and PTs • Cost of PT • Pregnancy may be ‘excluded’, yet still does not lead to same-day start of method 36 Clinical practice in public clinics appears highly variable with respect to protocol and use of PTs India (Lucknow) N = 4 Kenya N = 3 Madagascar N = 2 Malawi N = 13 Zambia (Lusaka Region) N = 13 Country Clinical (Defacto) Policy Clients are required to present within first five days of menstrual bleeding to be eligible to receive contraception • PTs are to be used to when history taking and exam have not ruled out pregnancy • Per the MOH, public sector providers use checklist to rule out pregnancy, PTs would be second-line • Malawi National RH Delivery Guidelines 2014-2019 • PTs are to be used after use of checklist • FP protocols followed: FP card (proxy to WHO pregnancy checklist), FP registers, other FP booklets Use of Checklist • Do not use checklist, 1 of 4 reported knowing about it • General awareness of checklist • Checklist was available • Checklist is used • Providers give score of 3/5 on checklist, as clients may not be truthful • Per some but not all the clinics, checklist is used - two versions - 1) Checklist that is in health passport for every woman (used more often) or 2) checklist from Malawi National RH Delivery Guidelines • FP card (similar to checklist) commonly used at all facilities • FP card was considered subjective, not entirely reliable due to either / both staff accuracy in use and client honesty Use of PTs • For clients with delayed or scant menses • Do not report use prior to initiating contraception • For antenatal care • Family planning • School girls as mandated by the institution • No PTs in stock • If needed, clients sent to purchase PT @ pharmacy • Just 3 of 13 public clinics had PTs sometimes available • No quantification of utilization • All staff indicated they were more comfortable with PT in addition to checklist Other Notes 55% of clients presenting at FP clinic during menses Variable practice: • PTs are administered at a cost by sending clients to the clinic’s lab • Clinics without labs send their clients out to get PTs and return • Reported that providers generally find an FP solution, rarely delay to next period • Estimated that <50% of those referred for PT or to return during menses do not return to clinic • PT stocks not consistently adequate, although signs of improvement Estimated % of clients returning during menses Urban = 65%, 40% Rural = 85% • PTs provided by UNFPA are mainly to check pregnancy after gender based violence • PTs are not on EML, not on standard RH quantification list • Client-learned behavior to procure PTs at pharmacy prior to visiting public clinic due to inconsistent availability at clinics 37 Clinical practice in private clinics: India relies on ‘first five days’ practice, Kenya research suggests variable use of pregnancy exclusion protocols India (Lucknow) N = 19 Kenya N = 14 Private Facility Type Independent private clinics and HLFPPT MeriGold rranchisees Independent clinics PSI Tunza and MSI Amua franchisees Use of Checklist Do not use a physical copy of the checklist, two doctors reported using a checklist to rule out pregnancy and using questions based on their knowledge of the checklist Facilities reported different tools / protocols Just one facility (Amua) had checklist Use of PTs To rule out or confirm pregnancy in women presenting with delayed or scanty menses, also in lactating mothers and clients with DMPA- induced amenorrhea Conducted PTs on site, separate service provided at lab Providers largely report that tests are reliable, no constraints in use Other Notes 12 / 19 doctors confirm that between 50-98% of women with delayed menses perform a PT at home before coming to the clinic All doctors indicated they would not be comfortable with same-day initiation of contraception outside first five days of menstruation All private providers indicate they source from commercial market (including Tunza and Amua franchises) Brands vary among suppliers and based on what supplier has in stock at time of order No problem with stock outs, suppliers are responsive 38 Clinical practice in private clinics: variable availability and use of both the checklist and PTs Madagascar N = 7 Malawi N = 24 Zambia (Lusaka Region) N = 7 Private Facility Type PSI Top Reseau network and MSM franchisees FISA and OSTIE Independent clinics PSI Tunza and MSI Banja La Mtsogolo franchisees Independent clinics and MSI BlueStar franchisees Use of Checklist Protocols vary by provider and franchise, but generally: checklist for eligibility and method, WHO disk for choosing FP method, FISA: FP eligibility sheet and decision making tool Ostie: Use checklist issued by USAID/FHI No description of checklist use for either independent or franchised clinics • 5 of 7 clinics did not have checklist • 4-5 of 7 clinics had other forms of FP cards or protocols Use of PTs PTs are used as a final step after use of the checklist, also in some cases clients are asked to come back PTs are used when clients are: breastfeeding, not menstruating at time of visit, delaying appointment for injectable method No specifics on use other than they sell and charge for PTs All had PTs Tunza and Blue star clinics conduct PTs on all new FP clients, as requirement by BLM and PSI PTs are used if history and physical examination cannot rule out pregnancy. Other Notes Estimate that 60% of non-menstruating women who are turned away, return during their menses Clinics have poor record keeping, only a few are tracking PT use through self-made registers • Facilities source bimonthly from wholesaler/distributor in local market 39 Provider interviews revealed that clinical practice is highly inconsistent with respect to both the pregnancy checklist and PTs Considerable variation by region studied, and by provider site • Job aids vary from site to site • Providers express knowledge of requirements and feel no need to use checklist Provider practice of relying on evidence of menses rather than checklist and / or PTs • Most consistently evident in Lucknow region of India, but present in other countries as well 37% 23% 9% 31% Malawi example: Summary estimate of how providers are ‘excluding pregnancy’ for FP clients Whether menstruating PT Checklist use Administer PT Refer for PT Source: Malawi Country Consultant Report 40 Clients routinely purchase and use PTs privately, often prior to clinic visits -- not always resulting in FP counseling or initiation Source: Country Consultant Interviews India • 12 of 19 private sector clinicians indicated that 50% to 90+% of clients with delayed menses perform PT at home before coming to the clinic • All clinicians indicated that in some cases they repeat the test • Six (of eight) retailers indicated that 50% or more of PT purchasers are men Zambia • Historically, PTs have been stocked out at public clinics, and clients have become accustomed to procuring from private retailers • This has led to clients not demanding provision of PTs at public clinics • Now being addressed with MOH’s continued effort to scale-up family planning 41 PT Pricing Data Comparison 42 SHOPS PLUS research included pricing as one of multiple components in small sample research Pricing versus Affordability Distinction • Utilizing the CII market shaping framework leads to use of term ‘Affordability’ which may be misleading • Data collected to-date through SHOPS PLUS and other recent efforts has been pricing, not affordability • Affordability is a subjective measure which requires population data and research SHOPS PLUS: Summary and Conclusions • Focused on pricing and indicators of pricing structure within private sector / commercial settings • While PTs had relatively high markups in percentage terms, not high in absolute value • PT prices are not abnormally expensive in commercial settings • PTs are comparably priced relative to emergency contraception, an appropriate analogue • No evidence in this research that clients are dropping out due to PT cost Two other studies included for comparative purposes • Innovation Fund Project led by FHI360 • FPWatch Survey: Contraceptive Commodity and Service Assessment (with PTs included) 43 Two of the three studies were qualitative with small sample sizes, whereas FPWatch was larger sample, national audit SHOPS PLUS Innovation Fund Project FPWatch Overall Methodology Qualitative, site visits (Public & Private clinics, retailers) Qualitative, site visits Quantitative survey, site audit (Public, Private, CHW, NGO, Drug Shop / Pharmacy) Countries & Overall N (sample size across public & private sector outlet types) India = 44 Kenya = 24 Madagascar = 20 Malawi = 55 Zambia = 42 Kenya = 45 Malawi = 49 Mali = 34 DRC = 915 Ethiopia = 730 Nigeria = 1664 Research Questions Re: clinic (public and private sector) and retail outlet pricing of PTs 1) Does the facility administer PTs for free or at a cost? If at a cost, what is the average cost? 1) Of the PTs currently / usually available at this facility, which test is the least expensive for the client? 2) How much do clients pay for the least expensive PT currently/usually available at this facility? 3) Is this price just for the test itself or for the test plus fees? 4) What fee do clients pay for pregnancy testing, not including the test itself? For how much do you sell one pregnancy test kit <of this brand> to an individual customer who would come in today to purchase this <brand of pregnancy test kit>? 44 In comparing data from each study, it is critical to note that the Ns for each country / outlet type ranged from small qualitative samples to census data Mali Malawi Kenya Kenya India Madagascar Malawi Zambia Ethiopia DRC Nigeria Private (provider) 1.99 (0.41-3.28) 0.95 (0.35-1.77) 1.94 (0.98-5.87) 0.97-1.94 0.75-1.49 0.49-0.99 0.69-2.08 incl in consult 0.10 (0.10-0.21) 1.10 (0.55-1.10) 1.00 (0.25-1.00) n = 15 n = 27 n = 21 n = 14 n = 23 n = 7 n = 24 n = 7 n = 254 n = 70 n = 100 Public (provider) 1.72 (0.82-2.46) 0.35 (0.35-0.35) 1.86 (0.98-4.89) 0.99-1.40 Free NA NA Free 0.14 (0 - 0.25) 0.55 (0-1.10) 0.50 (0.25-1.00) n = 12 n = 11 n = 17 n = 3 n = 13 n = 2 n = 13 n = 13 n = 233 n = 190 n = 95 Pharmacy / Drug Shop2.12 (1.15-2.46) 0.66 (0.35-0.88) 0.84 (0.49-1.96) 0.29-4.17 0.45-0.96 0.33-3.45 0.28-1.80 0.10-4.50 0.16 (0.10-0.25) 0.22 (0.22-0.33) 0.35 (0.25-1.00) n = 7 n = 11 n = 7 n = 7 n = 8 n = 11 n = 18 n = 22 n = 233 n = 636 n = 1437 CHW/CHEW 0.21 (0.10-0.21) 0.55 (0.55-0.55) 0.75 (0.75-0.75) n = 6 n = 1 n = 3 Not for Profit 0.21 (0.16-0.31) 0.55 (0.33-1.10) 0.75 (0.75-2.50) n = 4 n = 18 n = 5 Outlet Type IFP Data (US$) SHOPS PLUS (US$) FPWatch (US$) m e an ( ra n ge ) ra n ge m e d ia n ( ra n ge ) All pricing data represents a blend of product types (except for SHOPS PLUS data where India = only cassettes, Kenya = only dipsticks) Sources: IFP / FHI360, SHOPS Plus, FPWatch Observations across the studies • FPWatch, large sample sizes for private, public clinics, and pharmacies / drug shops • SHOPS Plus and IFP are both small sample, qualitative in nature; variation in range is not surprising due to geography and question phrasing • Public clinics charge for PTs in Mali, Malawi, Ethiopia, DRC and Nigeria • India and Zambia free, Kenya mixed • Mali mean prices -- highest across all three studies • Mali and Kenya data from IFP -- highest for public providers • Ethiopia -- lower cost range and median across all outlet types • DRC - 5x higher at private provider than in pharmacy / drug shop 45 FPWatch data: comparable PT pricing across urban and rural areas within the three countries, with exception of private providers in Nigeria Urban Rural Urban Rural Urban Rural Private (provider) 0.21 (0.21, 0.31) 0.21 (0.16, 0.31) 1.10 (0.55, 1.10) 1.10 (1.10, 1.10) 2.50 (1.00, 2.50) 1.00 (0.25, 1.00) n=160 n=94 n=42 n = 28 n = 78 n = 22 Public (provider) 0.16 (0, 0.31) 0.12 (0.07, 0.21) 0.55 (0, 1.10) 0.55 (0.05, 1.10) 0.50 (0.25, 0.50) 0.50 (0.25, 1.00) n = 90 n=143 n=105 n = 85 n = 51 n = 44 Pharmacy / Drug Shop 0.10 (0.10, 0.16) 0.14 (0.10, 0.21) 0.22 (0.22, 0.33) 0.33 (0.22, 0.55) 0.35 (0.25, 1.00) 0.35 (0.25, 1.00) n = 194 n=39 n=490 n = 146 n = 1229 n = 217 CHW/CHEW 0.12 (0.12, 0.12) 0.21 (0.10, 0.21) NA 0.55 (0.55, 0.55) NA 0.75 (0.75, 0.75) n = 1 n=5 n = 0 n = 1 n = 0 n = 3 Not for Profit 0.14 (0.10, 0.31) 0.25 (0.25, 0.25) 0.55 (0.33, 1.10) 0 (0, 0.55) 2.50 (2.50, 7.50) 0.75 (0.75, 0.75) n = 3 n=1 n = 11 n = 7 n = 4 n = 1 m e d ia n ( ra n ge ) Ethiopia DRC Nigeria FPWatch (US$) Outlet Type Observations • N’s vary across the comparator groups, often considerably larger for urban (exception of Ethiopia public providers) • Ethiopia relatively consistent for urban versus rural (public sector, lower median price) • DRC also relatively consistent for urban versus rural, but notably, 4-5x more expensive than in Ethiopia • Nigeria consistent across the public clinics sampled, more notable difference for private providers Source: FPWatch 2016 46 Conclusions from Market Shaping Analysis 47 India: Root causes of shortcomings are provider related Predominant drop-off risk • Non-menstruating clients asked to return during menses Market observations • Public procurement of PTs in place & ongoing • PTs widely available in both sectors at various prices Shortcomings Root Causes • Providers do not use the checklist to initiate FP • Provider behavior is a clear barrier • Providers use PTs only for clients with delayed menses • High home use results in lost opportunity to reach potential FP users  Cultural norms, provider training, risk aversion  Possibly provider behavioral economics  Disconnect between PT use & access to FP services 48 Kenya: Multiple root causes including policy, demand fragmentation, procurement behavior Predominant drop-off risk • Public clinic clients drop-off if cannot afford the PT cost Market observations • MOH policy supports PT use after checklist/history • PT procurement conducted at county level • Private sector has large array of PTs; wide availability • Franchise clinics often get lower cost or free PTs • Medical product supply disorganized; poorly regulated • Retail and clinic level margins are relatively high Shortcomings Root Causes • Possible lack of affordability as PTs are administered at a cost to public sector clients • Variability in performance in county level procurement • Clinics purchasing from local retail outlets • Mixed familiarity with checklist, variation in practice  Policy does not fund free provision of PTs  Fragmented demand  Inefficient ordering  Clinics purchasing at retail prices  Mixed awareness; adherence to use of FP checklist  Lack of incentives to standardize treatment protocols 49 Madagascar: Root causes are in policy and provider training, norms Predominant drop-off risks • FP clients whose pregnancy status cannot be ruled out are given OCs and asked to return after 10 days • Clients may self-delay FP visit outside menses Market observations • Wide availability of PTs in the private sector • MOH added PTs to EML and supported introduction of community-based distribution of free PTs for FP through MIKOLO project Shortcomings Root Causes • Inconsistent use of WHO checklist in public clinics • PTs not available in public sector • MOH does not procure PTs to be used in the context of FP services • Commercial PTs may not be affordable to some clients  Poor provider training, cultural norms  MOH policy emphasizes checklist; not supportive of PT use for FP in public clinics  Commercial built-in margins drive up PT prices 50 Malawi: Root causes are around policy, awareness and adherence to protocols Predominant drop-off risk • PTs are rarely available at public clinics, so clients sent to buy PT and/or return during menses Market observations • Malawian RH policies support use of PTs after checklist • Public sector not sourcing & providing PTs • PTs are theoretically free (if available) • Limited evidence of PT donations • Private sector has wide availability of PTs • Dipstick is most common (and most affordable) Shortcomings Root Causes • PTs are not being funded or procured by CMST for public clinics for FP services • Public clinics not fully utilizing WHO checklist and practice guidelines • Commercial PTs may not be affordable for some clients  Procurement policy and/or funding absent  Limited PT supply prioritized for ANC  High cost & complexity of guideline provision and training  Mixed awareness; adherence to use of FP checklist in public clinics 51 Zambia: Root causes are in capacity and execution Predominant drop-off risk • FP clients must buy a PT in the private sector when they are not available at the public clinic, incurring delays and added costs Market observations • MOH policy supports PT use for FP • National PT procurement system • PTs widely available in private sector Shortcomings Root Causes • PT stockouts at public clinics • Demand for PTs in public clinics exceeds supply • Commercial PTs may not be affordable to some clients  Ineffective or deprioritized ordering  Insufficient supply chain visibility, weak ordering process, logistics issues  Insufficient funding  Commercial margins drive up PT prices 52 Summary: Availability and Affordability • Availability: No issues related to global or local supply of PTs – No observed or reported issues with manufacturer capacity or participation – Inadequate supply of and use of PTs in public clinics appear to stem from policy and procurement practices • Affordability: Likely not a barrier for private sector clients – Low global procurement prices make use of PTs affordable to NGOs – Mark-ups applied at both retail and clinic outlets are not unusual Caveat: Affordability may be low for public sector users and those living in underserved areas not covered in this assessment, but would need to be further researched at the population level 53 Summary: PT Quality and Design • Assured quality: No reported concerns or negative outcomes – Caveat: PTs were not evaluated against quality standards – A possible shortcoming related to quality is the lack of information about minimum quality standards • Appropriate design: Not identified as a potential market shortcoming – Across the five regions, PT product design was not identified as a reason for non- use – Several designs available in each country; dipstick and cassette tests were the most common 54 Summary: Awareness & Programmatic issues • Awareness: Low knowledge of appropriate use of PTs in FP context – Knowledge of WHO guidelines was found to be low or mixed in both sectors in all countries • Programmatic issues – National policy and healthcare provider behavior are key factors influencing the appropriate and consistent use of PTs according to WHO guidelines – Inappropriate or confusing protocols lower demand for PTs in the public sector, prevent accurate procurement of PTs, and result in stockouts – Non-inclusion of PTs in FP service protocols is a missed opportunity to support integration in RH/FP and MNCH programs 55 India Kenya Madagascar Malawi Zambia Affordability* + public + private - public + private + public + private + public + private + public + private Availability ++ public - / + public - public - public - /+ public PTs are widely available across private sector, including pharmacies and clinics Awareness** Practice in both sectors is to initiate FP during menses. Mixed awareness of checklist; variations in practice. No policy support for use of PTs for FP. Variable practices. Supportive policy; Variable clinical practice MOH support for using both checklist and PTs as needed Assured Quality No provider-reported quality issues for PTs (not evaluated) Appropriate Design Wide variety of PT types and brands generally available. Ease of use is reported for providers and clients. Market shaping analysis (5As) (*) Based on pricing observations. Actual affordability could not be assessed. (**) Includes both awareness of PT use and best practices (e.g. use of checklist). 56 Evaluation of Possible Interventions to Reduce Risk of FP Client Loss; and Recommended Intervention Set Originally generated list of possible PT interventions spanned the Market Shaping/Programmatic Continuum RESEARCH & DEVELOPMENT MANUFACTURING PROCUREMENT DISTRIBUTION SERVICE DELIVERY/USER ADOPTION Market shaping interventions Global health programmatic interventions 15 Pool NGO procurement of PTs 7 Sliding-scale payments for PTs 11 Change contraceptive product labeling 4 Co-locate PTs at public clinics 9 Advocate for use of Checklist in MOH guidelines 1 Include on-site use of PTs in MOH FP protocols 10 Train MOH providers in pregnancy Checklist 5 Aggregate demand in the public sector 8 Provide quick-access pass to returning clients 2 Incentivize data reporting 6 Aggregate orders across countries 3 Joint forecasting of PTs and contraceptives 14 Retailers to provide low- cost PTs 16 PT vouchers for low- income clients 13 Channel subsidy to reduce markups on PTs 12 Social marketing of PTS 17 Lower PT fees in franchised clinics 19 Insert FP information in PT packaging 18 Vouchers for PT buyers to access FP 20 Pharmacy customer referrals to FP clinics 21 Change clinical practice in private clinics 22 Train private healthcare providers 58 ‘Sticker voting’ exercise during RHSC session(s) highlighted first-pass support for select interventions: public sector*, 1 of 2 Client loss risk # Intervention Type Drawbacks/Challenges Prerequisites for Implementation Client with inconclusive pregnancy status drops out because:  PTs are not available on premises  Having to buy a PT causes delays and added costs  Client cannot afford PT cost in public clinic 1 1 - Include on-site use of PTs in FP protocols and enable regular procurement of PTs Policy change can be slow Possible funding issues since stock outs exist for other products in FP protocols Funding available for procurement Supply chain is functional 2 Subsidize or incentivize data reporting on PT usage and improve re-ordering process for PTs Likely not sustainable unless part of an overall effort to improve supply chain MOH support 3 Jointly forecast PTs and contraceptives to increase priority of filling PT demand Complicated by multiple FP methods in use Appropriate formula for forecasting commodity needs 4 Partner with retail pharmacies to co-locate PTs at public clinics May not be legally possible MOH staff must handle $ unless the government buys the PTs 5 Aggregate demand in the public sector to lower procurement costs May not be consistent with decentralization policies in some countries Supportive public procurement systems 6 Aggregate demand and orders across countries that all use the dipstick Does not address high retail margins Supportive public procurement systems 7 Use sliding scale payment in clinics that charge for PTs based on client socioeconomic indicators Loss of revenue for clinics MOH support 8 Provide quick-access pass to clients who have bought a PT elsewhere due to public clinic stockout Loss of revenue for clinic that charge returning clients MOH support P * Interventions highlighted in yellow received the most votes, all were intended for exploratory discussion, not being put forth as recommendations 59 ‘Sticker voting’ exercise during RHSC session(s) highlighted first-pass support for select interventions: public sector*, 2 of 2 Client loss risk # Intervention Type Drawbacks/Challenges Prerequisites for Implementation Client is turned away because norms prevent dispensing FP services outside menses 9 Advocate for use of Pregnancy Checklist in MOH protocols Policy change can be slow MOH support and cooperation at all levels 10 Retrain providers on Pregnancy Checklist and same-day FP initiation to increase quality of FP services. Changing provider behavior may require more than training; Risk aversion not addressed MOH support and available resources 11 Remove from product labeling the requirement to wait until menses to initiate contraception May require multiple manufacturers to change their labels. Slow to implement. Support from manufacturers at the global and local level P P * Interventions highlighted in yellow received the most votes, all were intended for exploratory discussion, not being put forth as recommendations 60 ‘Sticker voting’ exercise during RHSC session(s) highlighted first-pass support for select interventions: private sector*, 1 of 2 Client loss risk # Intervention Type Drawbacks/Challenges Prerequisites for Implementation Client with inconclusive pregnancy status drops out because she cannot afford PT prices in the private sector. 12 Introduce lower-price PTs through social marketing program May not be sustainable over the long term without subsidizing related program costs Donor support or: cross-subsidy program within SMO 13 Channel subsidy to reduce markups on commercially sold PTs May discourage distributors from importing low-cost PTs Donor support 14 Partner with select retailers to provide low- markup PTs to referred clients, including referrals from public sector May not have much impact if most clients are willing to pay current prices Policy framework for facilities to partner with pharmacies 15 Pool or centralize procurement within and/or across procurers to lower costs Does not address high markup in commercial retail outlets Price savings overcome loss of convenience from single supplier/centralized ordering 16 Voucher provided by clinic to low-income clients covers the cost of PT in retail outlets May slow down process of obtaining PT if few clinics participate Management structure Incentive for pharmacies to participate 17 Negotiate lower PT fees from franchised clinics Loss of revenue from low-income clients Must be commercially viable 18 Voucher provided with PTs purchased by low- income clients covers the cost of FP services Difficulty of targeting low-income clients with negative results Voucher management structure Public resources to pay for vouchers * Interventions highlighted in yellow received the most votes, all were intended for exploratory discussion, not being put forth as recommendations 61 ‘Sticker voting’ exercise during RHSC session(s) highlighted first-pass support for select interventions: private sector*, 2 of 2 Client loss risk # Intervention Type Drawbacks/Challenges Prerequisites for Implementation Women who use a home PT and get a negative result may not be aware of what to do next. 19 Partnership with manufacturer or distributors to include “Q&A” printed information in PT packaging. Logistically challenging May only be feasible through social marketing program Motivated private sector partners Legal approvals Women who use a home PT and get a negative result may not know how to access FP services. 20 Partnership with pharmacist association to support customer referrals to FP clinics. Logistically challenging May only be feasible through social marketing program Supportive pharmacist association Non-menstruating client is turned away because norms prevent dispensing FP services outside menses 21 Partner with professional associations and private facilities to change clinical practice Slow pace of changing clinical practice in the private sector Support from medical associations and facilities Changes in medical curriculum 22 Retrain Providers to improve the quality of FP services. Difficult to implement. May not be possible with independent providers Supportive private providers Time and money P P * Interventions highlighted in yellow received the most votes, all were intended for exploratory discussion, not being put forth as recommendations 62 Consultation inputs emphasized the programmatic and inter- dependent theme of improving PT access and use Clinical policy and provider behavior were the focus of multiple interventions • Demand generation and utilization originates with inclusion of PTs in national FP and MNCH policies • Provider clinical practice can be considerably improved in both public and private sector settings • Provider behavior must be mandated through policy, and beyond training Procurement solutions will consist of multiple components • Country policy to support funding, standardized procurement and demand aggregation • Quantification best practices including joint forecasting and utilization tracking Interventions must be pursued in parallel and customized to country conditions • Policy and provider behavior change will support procurement change • Procurement alone will not result in increased access and use of PTs 63 Four possible public sector interventions were highly supported through the consultative process, 1 of 2 Client Loss Risk Intervention Highlighted Support, Key Considerations for the Selected Interventions Non- menstruating clients turned away because PTs are not available on premises Mandate use of PTs in conjunction with pregnancy checklist in MOH protocols • Need top-down advocacy as well as service delivery training to facilitate adoption • Goal should be inclusion in country guidance, then get into pre-service and in-service training; evidence from other programs endorses investment in supportive supervision • Key role of USAID along with WHO to incorporate into bilateral FP projects with countries Enable regular procurement of PTs for FP services in public clinics • Ordering PTs needs to become routine, similar to gloves, gauze pads, other supplies • National policy drives inclusion on tenders, need top level advocacy; consider prior case studies such as auto-disposable syringes and the advocacy efforts with MOHs • Champions within a program area are a key component to success Jointly forecast PTs and contraceptives to avoid stock outs • MSI joint forecasting for PTs and contraceptives was highly successful, resulted in supporting this as a high potential intervention • If countries are currently relying on external vertical contraceptive programs, then need for PTs is likely not recognized, and therefore not on procurement lists • Uganda example provides support and key considerations - recent CHAI / JSI work with Uganda MOH, including PTs in 3-year contraceptives quantification exercise - revealed 1) the issue of little centrally available information, 2) the need to procure PTs for explicit purpose of FP, 3) question of ‘how PTs used currently’ versus ‘how PTs should be used’, 4) inclusion on LMIS and other SOP documentation is critical to documenting demand to then inform procurement and stocking 64 Four possible public sector interventions were highly supported through the consultative process, 2 of 2 Client Loss Risk Intervention Highlighted Support, Key Considerations for the Selected Interventions Non- menstruating clients turned away because PTs are not available on premises Procure FP commodities ‘bundled’ with PTs (donors, governments, NGOs) • Pregna IUD Kit: Dip strip PT included with supplies; this program warrants exploration with manufacturer and consideration for related / additional programs • CHAI implant consumables kit has been offered as a separate kit - likely worth understanding the uptake and provider views • Potential to pursue ‘bundling’ will vary by country, based on strength of procurement systems; avoid ‘bundling’ at points such as the CMS in order to prevent unintended consequences • Need to consider product expiration management Non- menstruating client turned away because norms prevent dispensing FP services outside menses Address clinical practice through policy change and retraining of providers on same-day FP initiation • Consensus view that a sustainable model is key, training should focus on appropriate use; to position checklist as first-line tool and PT as second-line tool • May require customized country research and pilot programs - consider controlled studies to evaluate association of increased PT availability with same-day FP method start • Requires a strong link with country level policies, procurement, national and donor funding • Provider behavior is impacted by existing country policies • Critical to understand provider behavior, including behavioral economics 65 Five possible private sector interventions were highly supported through the consultative process Client Loss Risk Intervention Highlighted Support, Key Considerations for the Selected Interventions Non-menstruating client turned away because norms prevent dispensing FP services outside menses Partner with professional associations and private facilities to change clinical practice • Highly consistent with public sector provider behavior change - the need for normative guidance, supportive supervision, and consideration of provider behavioral economics Women who use a home PT and get a negative result may not know how to access FP services Link PT purchase to information about FP services (e.g. advertise FP services through pharmacies) • Addresses the root cause of client behavior, where pregnancy exclusion does not result in accessing FP counseling and services Client with inconclusive pregnancy status drops out because she cannot afford PT prices in the private sector Introduce lower cost PTs through existing social marketing program linked to community or home-based distribution in underserved areas • Considered most appropriate for underserved and low-income client segments • Link to existing social marketing program rather than a new program, achieves economies of scale and synergies Voucher provided by clinic to low-income clients covers the cost of PT in retail outlets. Can be used in conjunction with quick-return pass for public sector clients • Recognizes the potential affordability issue for target groups • Reduces the barrier of revisiting the clinic Negotiate lower PT fees from franchised clinics, which could increase volume of FP product sales • Must be commercially viable • Requires support of franchising organizations and/or donor-funded social franchises 66 Two possible cross-cutting interventions were highly supported through the consultative process Client Loss Risk Intervention Highlighted Support, Key Considerations for the Selected Interventions Non-menstruating clients turned away because PTs are not available on premises Consider developing new High Impact Practices combining checklist and PT use for dissemination to USAID missions and implementing partners • Foundational to the barriers that are most preventing access to same-day start of contraceptive methods • Highly consistent with recently updated FHI360 guidance / job aids and 2016 updated WHO FP guidelines • Strong synergistic opportunity across multiple implementing partners • Recognizes the cross-sector challenges which are provider-based Client with inconclusive pregnancy status drops out because she cannot afford PT prices in the private sector Population-based and consumer research around affordability and willingness to pay, and impact on initiation of FP services • Client behavior was identified as a barrier to accessing of FP services and same-day start of contraceptive initiation • Deeper understanding of client behavior and willingness to pay can directly inform intervention planning and possible inclusion in existing FP programs, both country and donor-driven 67 Multiple public sector interventions were not supported through the course of the consultations and analysis; should be tabled Intervention Summary Points on Evaluation Subsidize or incentivize data reporting on PT usage and improve re-ordering process for PTs Procurement best practices in general are needed for PTs, not specific to incentivizing data reporting; improving ordering processes would be subsumed within other procurement efforts Partner with retail pharmacies to co-locate PTs at public clinics Likely unfeasible from a legal and operational standpoint; programmatic efforts were deemed more appropriate to address root causes Aggregate demand in the public sector to lower procurement costs This intervention requires further analysis of individual country procurement systems Aggregate demand and orders across countries that all use the dipstick Product fragmentation was not a root cause behind non-availability and non- use of PTs Use sliding scale payment in clinics that charge for PTs based on client socioeconomic indicators Population research would be required to determine whether and where affordability is a barrier to PT access and use Provide quick-access pass to clients who have bought a PT elsewhere due to public clinic stock out Consultations did not demonstrate support for this intervention Remove from OC product labeling the requirement to wait until menses to initiate contraception Consultative views were that changing product labeling (such as for oral contraceptives) would be a resource intensive and slow process, and would not contribute to near term changes in same-day access 68 Multiple private sector interventions were not supported through the course of the consultations and analysis; should be tabled Intervention Summary Points on Evaluation Channel subsidy to reduce markups on commercially sold PTs Could disincentivize distributors from importing PTs Pool or centralize procurement within and/or across procurers to lower costs Would not address root cause of PT cost to end users, which is markup in the channel Negotiate lower PT fees from franchised clinics May not have sufficient impact to justify the loss of revenue Voucher provided with PTs purchased by low-income clients covers the cost of FP services This voucher concept address FP services rather than access to PTs. Better addressed through other private sector interventions, such as more broadly promoting FP services through private sector pharmacies Partnership with manufacturers or distributors to include “Q&A” printed information in PT packaging Linking PT purchase to pursuit of FP services would be better addressed through other partnerships, i.e. with pharmacies 69 Interventions recommended by SHOPS Plus 70 Selection criteria for proposed interventions • Justified: Linked to a demonstrated barrier to access to FP • Feasible: in terms of time, resources, and likely success • Cost effective: high value, low investment (e.g. through integration in existing programs or systems) • Sustainable: with the potential to be owned and supported by the government or private sector • Backed by experts: including FP, service delivery, supply chains and private sector specialists 71 Public sector: Change policy and clinical practice; fund and improve the procurement of PTs Client loss risk Intervention Drawbacks/Challenges Prerequisites for Implementation Non-menstruating clients turned away because PTs are not available on premises Include use of PTs in conjunction with pregnancy checklist in MOH protocols • Policy change can be slow and may not result in desired provider behaviors • Support for policy change from MOH and medical institutions Enable regular procurement of PTs for FP services in public clinics • Risk of over-reliance on PTs • Funding for procurement • Use of checklist in facilities Introduce joint forecasting of PTs and contraceptives to avoid stock outs Possible bundling of PTs with FP commodities (donors, governments, NGOs) • Logistics may be complex • Risk of overstock and waste • Ratios for forecasting commodity needs • Functional procurement and supply chain systems Non-menstruating client turned away due to norms opposing FP method start outside menses Address clinical practice through policy change, provider training on same-day FP initiation • Slow pace of changing clinical practice • Provider resistance • Support for policy change from MOH and medical institutions • Resources for provider training • Better understanding of provider behavior (e.g. risk aversion) 72 Client loss risk Intervention Drawbacks/Challenges Prerequisites for Implementation Non-menstruating client turned away due to norms opposing FP method start outside menses Partner with professional associations and private facilities to change clinical practice • Large number of private facilities • Strong support from medical associations and facilities • May require changes in the medical curriculum for FP • Program mechanism Women who use home PT and get a negative result may not know how to access FP services. Link PT purchase to information about FP services (e.g. advertise FP services through pharmacies) • Likely to be inefficient through pharmacies only • Funding for communication (e.g. mass media campaign) • Targeting mechanism • Best addressed through existing MNCH/FP, or youth-friendly programs Client with inconclusive pregnancy status drops out because she cannot afford PT prices in the private sector. Introduce lower cost PTs through existing social marketing/community- based distribution program in underserved areas • May not be sustainable over the long term without subsidies for related program costs • Existing SM project with links to community-based network Voucher provided by clinic to low-income clients covers the cost of PT in retail outlets; can be used in conjunction with quick-return pass for public sector clients. • May have limited impact if few clinics participate, or if clients are willing to pay current prices • Management burden • Management structure • Incentive for pharmacies to participate • Funding for voucher program • Apply lessons from SHOPS Jordan program Negotiate lower PT fees from franchised clinics, which could increase volume of FP product sales • Loss of revenue from low-income clients • Must be commercially viable Private sector: Country level, context specific interventions 73 Cross-cutting interventions could be applied at the country-level, although perhaps global in design Client loss risk Intervention Drawbacks/Challenges Prerequisites for Implementation Non-menstruating clients turned away because PTs are not available on premises Consider developing new High Impact Practices combining Checklist and PT use for dissemination to USAID missions and implementing partners • None • Consensus on recommended practice Client with inconclusive pregnancy status drops out because she cannot afford PT prices in the private sector. Support population-based and consumer research around affordability and willingness to pay, and impact on initiation of FP services • High cost of population research • May not provide definitive answer • Time and money to support research • Implementing organization or existing MNCH/FP project • Resources for interventions that can mitigate risk of client loss 74 Appendix 75 The pregnancy checklist is included in WHO family planning materials and resources Three tools: PTs, checklist, send client home • Patient history, i.e. the checklist, can effectively rule out pregnancy, was developed in late 1990s • Less desirable is to send the woman home to await menses and then return to clinic Decision-Making Tool for Family Planning Clients and Providers • Prepared by WHO and INFO Project at JH Bloomberg School of Public Health; 2005 • Flipchart tool, also adapted for CHWs Combined simplified MEC + SPR Tool in development for countries’ adoption • Planned for 2017 • Will include pregnancy exclusion questions http://www.who.int/reproductivehealth/publications/family_planning/9241593229/en/ 76 Recently updated WHO recommendations continue to recommend use of patient history / checklist to exclude pregnancy to confirm eligibility for contraception start http://www.who.int/reproductivehealth/publications/family_planning/SPR-3/en/ WHO Selected Practice Recommendations for Contraceptive Use • Exclusion of pregnancy via ‘checklist’ questions has been included since 2001, initial edition • Third Edition, just released December 2016 • WHO plans to promote the updated recommendations at various global and SSA meetings during 2017 • Such as International Confederation of Midwives, 31st Triennial Congress, June 2017 77 Individuals consulted via webinars and 1:1 calls Topic Area Organizations Individuals Clinical Guidance and Policy FHI360 Tracey Brett Marsden Solomon Elena Lebetkin John Stanback Kate Rademacher Service Delivery Abt Associates Emily Mangone May Post Caroline Quijada ICEC Elizabeth Westley USAID Jasmine Baleva Procurement CHAI Raj Gangandi Caitlin Glover FHI360 Tracey Brett JSI Alexis Heaton PSM Anita Deshpande Ellen Thompsett PATH Fay Venegas USAID Kevin Peine WHO Guidelines WHO Mary Lyn Gaffield 78 Abt Associates William Davidson Institute USAID Center for Accelerating Innovation and Impact USAID Office of Population and Reproductive Health • Francoise Armand • Andrea Bare • Amy Lin • Lois Schaefer • April Warren • Janine Hum • Jasmine Baleva • Emma Golub • Caroline Quijada

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