Sayana® Press study evaluating suitability for self-injection
Injectable contraceptives are among the most popular family planning options. They are safe, effective and discreet. But, in many countries, they are not widely available outside clinic settings. Women in rural and remote communities often travel long distances to reach clinics that offer this type of contraceptive.
Sayana® Press is a lower-dose formula of the popular injectable contraceptive Depo-Provera® and provides three months of safe, effective pregnancy prevention with a single injection. It is easy to transport and easy to use with minimal training — ideal for community-based health workers and potentially for women themselves to administer.
The Malawi Ministry of Health and U.S. Agency for International Development (USAID)/Malawi requested that FHI 360, through the Advancing Partners and Communities (APC) project, assess home and self-injection of Sayana Press.
FHI 360 is conducting a one-year, randomized clinical trial with 734 women who opt into the study after seeking family planning services at Malawi Ministry of Health clinics and who are at least 18 years old. The study is titled A 12-Month Open-Label Randomized Controlled Trial to Evaluate Sayana® Press Suitability for At-home Subcutaneous Self-injection Procedures in Adult Women.
Women will receive, at random, either Sayana Press from providers, including community health workers, or training on how to self-inject Sayana Press and the opportunity to self-inject at home. Quarterly visits will be conducted after each reinjection date to assess continuation rates, acceptability and adverse events. Pregnancy will be assessed at the last visit.
In-depth interviews will be conducted with a random sample of participants in the self-injection group to understand participants’ strategies for remembering when to reinject, adherence to the injection procedures, safe injection practices, and storage and waste disposal procedures. FHI 360 will also conduct interviews with a random sample of family planning providers to describe their techniques and recommendations for training and supporting women to self-inject Sayana Press.
The primary objective of this study is to compare continuation rates between women who self-inject Sayana Press and women who receive the Sayana Press injection from a provider.
The study will also:
- Compare reported side effects between the two study groups
- Compare pregnancy rates between the two study groups
- Describe the experiences of women who self-inject Sayana Press
- Describe the experiences and recommendations of family planning providers who train women to self-inject Sayana Press
Findings from this study will guide decision making for procurement and distribution of Sayana Press while informing and refining self-injection training materials, messaging for family planning clients and providers, and scale-up. Additionally, the study findings may lead to increased access to family planning methods for women of reproductive age.