Sayana Press (DMPA-SC in Uniject) Product and Project Summary

Publication date: 2017

Sayana, Sayana Press, and Depo-Provera are registered trademarks of Pfizer Inc. Uniject is a trademark of BD. S A Y A N A P R E S S P R O J E C T Sayana Press (DMPA-SC in Uniject) Product and Project Summary Injectable contraceptives are among the world’s most widely used methods for preventing pregnancy, offering women safe and effective protection, convenience, and privacy. Until now, access to injectables has often been limited to clinic settings. Sayana® Press can improve contraceptive access; it is small, light, easy to use, and requires minimal training—making it especially suitable for community-based distribution and for women to administer themselves through self-injection. IMPROVING ACCESS TO CONTRACEPTION PATH and partners have coordinated country-led pilot introductions of Sayana Press in sub-Saharan Africa, and are conducting research on the impact of Sayana Press provided through a range of delivery channels, including self-injection. Sayana Press introductions in Burkina Faso, Niger, and Senegal have made injectable contraceptives a routine part of community-level health care for the first time, giving women convenient access in their own villages. In Uganda, the Sayana Press pilot introduction activities built on the Ministry of Health’s commitment to expand community-based delivery of injectable contraceptives. The first Sayana Press introduction launched in Burkina Faso in July 2014. During the pilot period across four countries from July 2014 through June 2016, more than 490,300 doses were administered to women by health workers, and Sayana Press was administered to 135,000 women using modern family planning for the first time. Now all four countries are moving forward with product scale-up in their national family planning programs. Sayana Press is also being introduced in more than ten additional countries. In order to track the progress of Sayana Press introduction in the four pilot countries, PATH worked with ministries of health and other partners to collect and report monitoring data. These data and programmatic experiences with Sayana Press have PATH/Patrick McKern QUICK FACTS: THE PRODUCT  Sayana Press is an all-in-one, three-month, progestin-only injectable contraceptive product prefilled in the Uniject™ injection system.  It is a lower-dose formulation and presentation of Depo-Provera® that contains 104 mg per 0.65 mL dose of depot medroxyprogesterone acetate (DMPA), manufactured by Pfizer Inc.  Sayana Press is administered via subcutaneous injection.  Sayana Press is approved by drug regulatory agencies in the European Union and in more than 25 countries around the world. The formulation of DMPA used in Sayana Press is also approved in the United States.  In 2015, the UK Medicines & Healthcare products Regulatory Agency authorized Sayana Press for self-injection in that country. The World Health Organization also recommends self-administration of Sayana Press in specific circumstances.  In 2014, a public-private collaboration made Sayana Press available for US$1 per dose to qualified purchasers in the world’s 69 poorest countries. January 2017 revealed key lessons learned. For example, monitoring data suggests that introduction strategies that prioritize more peripheral delivery channels—remote locations, community health workers—reach a higher percentage of new users of family planning than facility-based delivery. To learn more about the potential effectiveness of Sayana Press administered by health workers, PATH also launched two research studies in December 2015 in Burkina Faso and Uganda. To measure effectiveness, these studies will assess differences in contraceptive continuation among women who use Sayana Press and those who use intramuscular depot medroxyprogesterone acetate (DMPA-IM). In other words, the studies will assess whether women who receive Sayana Press injections from health workers use the method for a longer period of time than women who receive DMPA-IM injections from health workers. In the Burkina Faso study, women obtain their injectable contraceptives from clinic-based providers, and women in the Uganda study obtain the method from community-based health workers. PATH will use the continuation data, as well as cost data, to compare the cost-effectiveness of Sayana Press and DMPA-IM from different types of family planning health workers, whether community or clinic-based. Results from these studies are expected later in 2017. INCREASING WOMEN’S AUTONOMY PATH is also working closely with the ministries of health in Senegal and Uganda to conduct research on self-injection. Self-injection of Sayana Press could help overcome access barriers and increase women’s ability to manage their health. In 2015, a PATH/Ministry of Health feasibility study in Uganda found that most Ugandan women can successfully self-inject after a single one-on-one training session—even three months later, when they are reinjecting on their own. Results from a similar feasibility study in Senegal will be shared in the first half of 2017. Studies to assess the potential impact of self-injection compared with provider-administered DMPA-IM began in Senegal and Uganda in 2016. These studies are measuring whether women who self-inject use Sayana Press for a longer period of time than women who receive DMPA-IM injections from providers, and will compare the relative costs of each approach. Results are expected in late 2017. NEXT STEPS PATH and partners anticipate that evidence generated through all pilot introduction and research activities will enable stakeholders to make informed decisions on whether and how to include Sayana Press in family planning programs—including through self-injection. Sayana Press introduction and research activities are supported by the Bill & Melinda Gates Foundation, The Children’s Investment Fund Foundation (CIFF), the US Agency for International Development (USAID), the UK Department for International Development (DFID), and the United Nations Population Fund (UNFPA). QUICK FACTS: THE PROJECT  PATH is coordinating country-led partnerships to introduce Sayana Press in four African countries.  More than 490,300 doses of Sayana Press were administered in Burkina Faso, Niger, Senegal, and Uganda from July 2014 to June 2016.  PATH is conducting research to understand the potential impact of Sayana Press administered by health workers compared with DMPA-IM from health workers.  PATH is collaborating with the ministries of health of Senegal and Uganda to conduct research on self-injection as a delivery option.  Women in the first PATH/Uganda Ministry of Health study demonstrated proficiency at self- injection both immediately and three months after self-injection training. For more information: sites.path.org/rh/?p=292.

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