FHI 360 Innovate FP Year 1 Report (July-Dec 2020)

The proposed research agenda aligns with three specific aims outlined in the original USAID Annual Program Statement: refining existing methods to address method-related reasons for non-use, responding to product-related issues about existing methods, and developing new methods that address method-related non-use and/or fill gaps. Strengthening current and building new partnerships are key to advancing the aims of Innovate FP. Aim 1 focuses on refining and advancing knowledge on mid- to long-acting contraceptives, with a specific focus on extending duration and lowering the overall dose of depot medroxyprogesterone acetate (DMPA) injectables. The highest priority is implementing a safety and effectiveness trial of a 6-month DMPA product, known as DMPA XT. This product has the potential to be approved as early as 2025/26 by a European regulatory agency, far ahead of other 6-month injectables currently in development. The new product will use the same 150mg/mL vial as the 3-month DMPA IM formulation and will be co-packaged with an SC syringe, keeping manufacturing costs low and contributing to a substantially shorter time to market. The pivotal Phase 3 trial for DMPA XT will enroll 710 women willing to use the product every 6 months as their only means of contraception for 12 months and evaluate efficacy, safety, bleeding changes, and acceptability. Additional important aspects of this study will be to assess the impact of this lower-dose strategy on bone mineral density and characterize how pharmacogenomic differences among participants may influence side effects or outcomes. Major milestones include enrollment completion, interim analysis, follow-up completion, final analysis, and clinical study report. In the past six months, the project team conducted a project kick-off meeting, formed the core DMPA XT project team, and conducted preliminary site identification activities. They also revised the study synopsis, shared it with potential investigators, and drafted a Collaboration and Commercialization Agreement with the manufacturing partner. The team selected the Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K. as the national competent authority for this trial and submitted a request letter to MHRA with updated strategic regulatory questions for a Scientific Advice meeting. Plans for the next nine months include finalizing the protocol, submitting it to the FHI 360 IRB, and sharing it with USAID for review. The team will complete site identification efforts, finalize clinical site selection, and gather budgets and execute subagreements with clinical trial sites. They will also submit the study protocol to all local IRBs, register the study on the EU Clinical Trials Register, and execute the Collaboration and Commercialization Agreement with the manufacturing partner. By July 2021, the team plans to obtain Qualified Person certification for IMP import (UK) and develop clinical trial applications for regulatory submissions in the EU and SA. Aim 2 focuses on DMPA SC Extended use: user and service delivery considerations. This study is being co-funded by the Children’s Investment Fund Foundation (CIFF) and aims to evaluate and understand market implications, including user, provider, and other stakeholder perspectives, on adding multiple extended DMPA SC products to the method mix. The study will use multiple methods, including qualitative interviews and human-centered design (HCD) research, to gather data from users and stakeholders in varying contexts to inform introduction decisions.