FHI 360 Envision FP Year 1 Semi-Annual Report

The proposed research agenda aligns with the three specific aims outlined in the original USAID Annual Program Statement: refining existing methods, responding to product-related issues, and developing new methods to fill gaps. Envision FP focuses on key challenges and opportunities significant for users and programs in an effort to achieve the overall goal of broadening choice of and access to quality, affordable, and acceptable contraceptives to meet the changing needs and desires of women and girls throughout their reproductive lives. The initiative is led by Family Health International (FHI 360) and is funded by the U.S. Agency for International Development (USAID) through Cooperative Agreement Number AID-OAA-A-15-00045. The project's objective is to develop, introduce, and expand understanding of contraceptive technologies and approaches to enhance choice and reduce unmet need. The proposed research agenda aligns with the three specific aims outlined in the original USAID Annual Program Statement. One of the key activities of Envision FP is to refine existing contraceptive methods. In Year 1, the project proposed to address known challenges associated with existing contraceptives through three activities: initiating a study to assess lower doses of injectable depot-medroxyprogesterone acetate (DMPA), conducting preparatory work to support initiation of a study to assess extending the reinjection interval for Sayana Press, and providing technical support for the registration and introduction of a post-partum IUD (PPIUD) inserter. The project aims to develop a lower-dose SQ DMPA product that would offer a highly effective and safer contraceptive option for women, with reduced side effects enhancing acceptability and increasing continuation. The project also aims to extend the reinjection interval of Sayana Press (SP) to four months, which would reduce commodity costs for a year of protection by 25% and allow countries to serve 33% more women annually. The team will develop a 12-month, single-arm clinical trial to determine the effectiveness, safety, and acceptability of SP given every four months, and to determine the appropriate grace period for re-injection. The project will also provide technical assistance to Pregna in preparation for submission to obtain CE Marking, achieve WHO Prequalification (PQ), and qualify for USAID procurement for a simple, inexpensive, easy-to-use pre-loaded, pre-sterilized PPIUD inserter. The project has made significant progress in Year 1, with three study sites selected to conduct the study on lower-dose injectable contraception, the protocol approved by USAID and FHI 360's IRB, and the IND submission to the FDA scheduled for April. The project has also drafted a white paper on drug levels for a 4-month interval, using all available SC MPA data, and has consulted with experts from WHO/USAID/PATH/Pfizer re: data requirements to modify reinjection guidance. The project has also identified potential clinical sites and drafted site contracts prepared.