Microbicides: New HIV Prevention Products for Women
USAID supports the research and development of HIV prevention products for women that in addition to being safe and effective, will be acceptable, affordable, scalable, and deliverable in settings where they are needed most.
USAID has long been a leader in the research and development (R&D) of safe, effective, and affordable microbicides – biomedical products that women can use to protect themselves from HIV infection. USAID, through the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), strategically focuses on two areas of the product development pathway to have the greatest impact on advancing microbicides.
Investing in the early stage R&D for biomedical HIV prevention products that are safe, effective, easy-to-use, affordable, scalable, and fit to meet the needs of adolescent girls and women most at risk of acquiring HIV.
Supporting activities to prepare for and speed up the introduction of newly-approved microbicides, including various methods of pre-exposure prophylaxis (PrEP) for HIV prevention.
USAID focuses efforts on products that have the greatest potential for use in low-resourced settings. Research shows that the effective product use and greatest prevention impact can be achieved when users are presented with options of products to consider and are able to select the prevention product that best suits their needs.
Our Approach and Results
USAID supports the research and development of HIV prevention products for women that in addition to being safe and effective, will be acceptable, affordable, scalable, and deliverable in the settings where they are needed most. These efforts focus on products that are in the early stages of development (e.g., those completing pre-clinical research and early clinical trials among human volunteers for safety and efficacy) and those designed to protect against both HIV and other sexually transmitted infections or pregnancy.
USAID takes a strategic, forward-looking approach to investing in products with the greatest potential to fill anticipated gaps in the prevention options likely to come to market. To that end, USAID invests in three distinct categories of products to fill the un-met HIV prevention needs of women and girls in low-resourced settings. 1) Ultra-long acting products, that have clear advantages over current long-acting formulations, with the goal of improving user uptake and adherence. 2) Long-acting products that attract users who may have seasons of risk or who desire flexibility to readily switch methods if necessary. 3) Short acting or “on-demand” products that appeal to users who do not desire continuous protection, or who may not perceive themselves at risk until a potential exposure occurs. These products would be used at the time of, or immediately after sex to prevent HIV.
USAID supports targeted research on products with novel characteristics that are expected to significantly increase acceptability and effective use by women at high risk of acquiring HIV. Prioritizing these products requires an understanding of the HIV infection drivers and barriers to prevention that determine correct and effective use of currently-available products. USAID research partners hail from the U.S. and sub-Saharan Africa and engage directly with priority populations to understand and respond to their preferences for prevention products. Additionally, USAID investments prioritize product characteristics that reduce the burden on strained health care systems. Investing in these optimized products now will expedite and expand their impact in the future.
Caption: The MOSIAC Project's NextGen Squad after the Gender and Youth Leadership Opening Workshop in April 2022. Credit: USAID MOSIAC/FHI360
USAID is accelerating access to new HIV prevention products to women in sub-Saharan Africa by bridging the implementation gaps that exist along the introduction, access, and adoption phases of the product development pathway. The number of countries where daily oral PrEP is approved for use has increased significantly since 2016. However, uptake of, and adherence to, oral PrEP is still low among many persons at high risk of acquiring HIV for many reasons. USAID is increasing access to approved and recently approved biomedical HIV prevention products such as oral PrEP, PrEP ring, and injectable PrEP by implementing user-centered research and research translation to identify, understand, and remove barriers to new prevention product introduction, access and use. USAID fills a unique space by meeting research and technical assistance needs during a critical time between regulatory approval of products to their subsequent introduction and scale-up.
Maximizing Options to Advance Informed Choice for HIV Prevention (MOSAIC) is a global project to help women protect themselves from HIV by accelerating the introduction and scale-up of new and emerging biomedical prevention products. Catalyzing Access to New Prevention Products to Stop HIV (CATALYST) is MOSAIC’s flagship product introduction study. The study will provide and assess an enhanced service delivery package that includes oral PrEP, PrEP ring, and injectable PrEP at PEPFAR delivery sites in Kenya, Lesotho, South Africa, Uganda, and Zimbabwe.
Highlights of Research Programs that USAID is investing in to Develop New Prevention Methods and Bring HIV Prevention Methods to Scale for Adolescent Girls & Young Women
MATRIX: The goal of USAID’s, five-year (2021-2026) USAID Microbicide R&D to Advance HIV Prevention Technologies through Responsive Innovation and eXcellence (MATRIX) project is to expand biomedical HIV prevention options for women by accelerating the research and development of products that women can use to protect themselves from HIV. These include novel, high-impact HIV prevention products and technologies including ultra long-acting injectable PrEP and locally-acting inserts, vaginal rings, and other prevention technologies.
MOSAIC: Maximizing Options to Advance Informed Choice for HIV Prevention (MOSAIC) is a global project to help women protect themselves from HIV by accelerating the introduction and scale-up of new and emerging biomedical prevention products. Catalyzing Access to New Prevention Products to Stop HIV (CATALYST) is MOSAIC’s flagship product introduction study. The study will provide and assess an enhanced service delivery package that includes oral PrEP, PrEP ring, and injectable cabotegravir at PEPFAR delivery sites in Kenya, Lesotho, South Africa, Uganda, and Zimbabwe.
ENGAGE: Project ENGAGE is investigating factors associated with the acceptability of, and adherence to, oral PrEP in adolescent girls and young women in Africa who are at risk of HIV, with an eye to ever expanding product choice. This research project is comparing the acceptability of a new oral PrEP option (Descovy®) to traditional oral PrEP (Truvada®), evaluating the effectiveness of a new mHealth app (Vuka+) in increasing oral PrEP adherence, and is developing improved point-of-care assays for clinics to measure PrEP levels in people taking oral PrEP. ENGAGE is led by USAID partner CONRAD.
KEY ACHIEVEMENTS
Over the last two years, USAID’s Microbicide Program has realized its goal of further optimizing R&D investments by prioritizing and advancing only the most scientifically promising new biomedical HIV prevention products in development. Through semi-annual, systematic portfolio reviews, the Agency has monitored the scientific progress of products in development against milestones and benchmarks. This effort has dynamically optimized the R&D portfolio of investments and shed products that do not meet benchmarks while allowing for the on-boarding of new, more promising biomedical products.
Through the MATRIX award, three clinical trials were launched each with concurrent research sites in Africa and the US to examine the acceptability and safety of promising new products that will fill unmet HIV prevention needs for young women. These trials are evaluating a film and a vaginal ring designed to provide month-long protection, and an ‘on demand’ vaginal insert for women who may not want or need continuous HIV protection.
In an exciting collaboration between the MATRIX and MOSAIC awards, USAID’s Microbicide program is funding a pregnancy registry study to examine maternal and infant safety after exposure to new antiretroviral PrEP products which will bolster the evidence base and provide much needed global data to inform international guidelines. This study is under development and is expected to launch in 2024.
Located at the confluence of research and clinical program and service delivery, USAID plays a unique role in making research investments that inform ‘real world’ HIV prevention programs. In 2023, MOSAIC launched the CATALYST study, the project’s flagship implementation science study in 5 PEPFAR countries (Kenya, Lesotho, South Africa, Uganda, Zimbabwe). CATALYST aims to characterize and assess a service delivery platform that offers a choice of the 3 approved HIV prevention methods (oral PrEP, the PrEP ring, and injectable PrEP) for women and the study has a particular focus on reaching and supporting adolescent girls and young women. Implemented in a staged fashion, in 2024 once injectable PrEP became available, CATALYST sites transitioned to the second phase of the study, where injectable PrEP is now being offered to women. This study will provide data and evidence to policy makers and national governments on scaling an HIV prevention program offering method choice.