FHI 360 Envision FP Semi-Annual Report Year 6

The project 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 project is divided into three specific aims: refine existing methods, respond to product-related issues that arise from the field and impact provision, and develop new methods to fill gaps. The first aim, refine existing methods, involves developing and refining existing contraceptive methods to improve their effectiveness, safety, and acceptability. One of the key activities under this aim is the development of a lower-dose injectable contraceptive. The goal is to develop and receive regulatory approval for a low-cost, lower-dose, three-month subcutaneous depot-medroxyprogesterone acetate (SQ DMPA) injectable contraceptive. This product would offer a highly effective and safer contraceptive option for women, with reduced side effects enhancing acceptability and increasing continuation. The approach involves using a marketed DMPA IM formulation (Pfizer) to develop a lower-dose SQ product. A partially-blinded randomized trial will be conducted to assess pharmacokinetics (PK) and pharmacodynamics (PD) of three doses of Pfizer's current DMPA formulation (45 mg, 75 mg, and 105 mg) compared with Depo-subQ 104. MPA levels and ovarian activity will be evaluated after a single injection and all women will be followed for 7.5 months. In the past six months, the main manuscript was submitted to Contraception: X, the open access journal of Contraception. Plans for the next six months include posting the study dataset on an open access platform, submitting an additional manuscript based on the PK/PD data from this study, and conducting a secondary analysis of the supportive PD data from this study to explore the role of secondary mechanisms of contraceptive action of MPA and provide information on potential biomarkers of contraceptive effectiveness. Another key activity under this aim is extending the reinjection interval of Sayana Press (SP). The goal is to determine effectiveness, safety, and acceptability of extending the reinjection interval for SP and to determine the appropriate grace period for re-injection. Evidence suggests that SP is effective for four months or longer but is currently indicated for three months. This study is being co-funded by the Bill & Melinda Gates Foundation, under the Contraceptive Technology Innovation Initiative (CTII) and Advancing priority CT leads to meet user needs (CTII-2). The project also aims to respond to product-related issues that arise from the field and impact provision. One of the key activities under this aim is rapid response and proactive risk mitigation for contraceptive programs. This involves identifying and addressing potential risks and issues related to contraceptive products and programs, and developing strategies to mitigate these risks and ensure the safe and effective use of these products. Another key activity under this aim is access to implant removal study. This study aims to assess the feasibility and acceptability of implant removal services in different settings, and to identify the factors that influence the decision to remove an implant. This study is being conducted in collaboration with the World Health Organization (WHO) and the International Planned Parenthood Federation (IPPF). The project also aims to develop new methods to fill gaps in the contraceptive market. One of the key activities under this aim is the development of a contraceptive microneedle patch. This involves developing a patch that can deliver a contraceptive hormone through the skin, providing a convenient and discreet method of contraception. The patch is being developed using a biodegradable material that can be easily absorbed by the body, reducing the risk of adverse effects. The project is being implemented in collaboration with various partners, including the Bill & Melinda Gates Foundation, the World Health Organization (WHO), and the International Planned Parenthood Federation (IPPF). The project is also being supported by the U.S. Agency for International Development (USAID) through a cooperative agreement. The project has made significant progress in the past six months, with several key activities and accomplishments reported. These include the submission of the main manuscript on the development of a lower-dose injectable contraceptive, the initiation of a study on extending the reinjection interval of Sayana Press (SP), and the development of a contraceptive microneedle patch. The project plans to continue making progress in the next six months, with several key activities and accomplishments planned. These include the posting of the study dataset on an open access platform, the submission of additional manuscripts based on the PK/PD data from this study, and the development of a biodegradable contraceptive implant. Overall, the Envision FP project is making significant progress in developing, introducing, and expanding understanding of contraceptive technologies and approaches to enhance choice and reduce unmet need. The project is being implemented in collaboration with various partners and is being supported by the U.S. Agency for International Development