Microbicides: New HIV Prevention Products for Women

Image

Caption: A member of the Network for Adolescent and Women Inclusion in Reproductive Health and Rights, Kenya, at a MATRIX Stakeholder Consultation event.
Photo Credit: Jerry Otieno, Sahara Photographers

OVERVIEW

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.  First, investing in the early stage of R&D for microbicides that can be sustainably provided for women and adolescent girls at high risk of HIV in sub-Saharan Africa. Second, building on the success of these R&D activities, supporting activities to prepare for, and speed up, the introduction of newly-approved microbicide products, including various methods of pre-exposure prophylaxis (PrEP), which prevent HIV negative people from being infected.

USAID conducts research to ensure women in countries with the highest HIV burden, have access to a range of HIV prevention products that are safe, effective, easy-to-use, affordable, scalable, and meet women’s evolving HIV protection needs over their lifetimes. USAID focuses on those products that have the potential for successful delivery in developing country settings. Research shows that the effective product use and greatest prevention impact can be achieved when users have a choice of products to consider and are able to select the prevention product that best suits their needs. Simply put, the most effective method is the one that is used consistently.  Prevention methods under development include multi-purpose products that prevent other sexually transmitted infections or pregnancy as well as HIV.

Research and Development

USAID supports promising HIV prevention 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). These products incorporate a range of desirable characteristics identified through user-focused research with women. For example, we ask  women about the regimen, duration, and ability to use a product discreetly while products are being developed to build in desirable features. USAID also prioritizes investments in promising products based on expected potential for impact on the HIV epidemic.

USAID takes a strategic, forward-looking view to invest in products that have the potential to fill anticipated gaps in the prevention options likely to come to market. USAID supports targeted research on products with novel characteristics that are expected to significantly increase acceptability and effective use by women at high risk for 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 impact in the future.

USAID is guided by the “research-to-use” approach in which product R&D is implemented through a dynamic and iterative process to define, design, develop, and deliver new, innovative, and effective products and interventions. For example, through a series of Stakeholder Consultations held in Kenya, Zimbabwe, and South Africa the MATRIX project solicited inputs from over 160 people on the portfolio of HIV prevention products in development. These inputs came from a wide variety of constituents, including policy makers, health care providers, and women who will be the ultimate beneficiaries of expanded HIV prevention product choice.  

Below is a summary of the HIV prevention product categories that USAID is currently supporting.

Introduction and Access 

Image

Caption: The MOSAIC Project's NextGen Squad after the Gender and Youth Leadership Opening Workshop in April 2022.

Photo Credit: USAID MOSAIC/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 (a vaginal 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. Long-standing working relationships with partners in countries experiencing a high burden of new HIV infections and extensive experience with service delivery make USAID well positioned to understand specific country contexts for HIV prevention. 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.

The MOSAIC project is expanding research activities for the introduction and scale-up of new prevention technologies such as the PrEP Ring and injectable HIV prevention. MOSAIC is designed to anticipate, and quickly adapt to, the rapidly-changing HIV prevention landscape by expediting prevention product availability, acceptance, uptake, and impact in PEPFAR programs. MOSAIC supports countries and programs to adopt lessons learned from Oral PrEP rollout including marketing, country support and implementation research, to build on existing service delivery foundations within communities, and to use research as needed to overcome barriers to successful and sustainable scale-up.

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

KEY ACHIEVEMENTS

MATRIX

In 2021, the USAID Microbicide Program launched the  Microbicide Research and Development to Advance HIV Prevention Technologies through Responsive Innovation and Excellence (MATRIX)  consortium, a $125 million five-year cooperative agreement, funded by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). The consortium, led by the Magee-Womens Research Institute and Foundation (MWRI), brings together institutions in the U.S. and sub-Saharan Africa with diverse expertise to work collaboratively in developing new, safe, effective, acceptable, affordable, and scalable HIV prevention products for women. The MATRIX  consortium is co-led by the Wits Reproductive Health Institute (WRHI) in South Africa. 

U.S.-based partners include: AVAC, CONRAD, FHI 360, IAVI, Oak Crest Institute of Science, PATH, Population Council, Public Health Institute, RTI and University of Pittsburgh. Sub-Saharan African partners include: The Aurum Institute, CAPRISA, HHRC, KEMRI, PZAT, UNILAG and Wits RHI. African and U.S.-based scientists are co-leading research product development, end-user product preferences, clinical trials, stakeholder engagement for product development, capacity strengthening and mentoring, and the business case for products in development. Ultimately, these activities will strengthen local scientific capacity while facilitating the development of biomedical prevention products to increase the range of HIV prevention options for young women and adolescent girls.  

MATRIX implements a novel research feedback loop which solicits feedback from end-users and stakeholders to inform product design. In just one of many highlights, in 2022, MATRIX introduced the product portfolio to over 160 stakeholders in Kenya, Zimbabwe, and South Africa. These 160 stakeholders provided invaluable feedback to the product developers who used the feedback to adjust product designs. 

MOSAIC

The MOSAIC (Maximizing Options to Advance Informed Choice for HIV Prevention)   consortium is a $85 million program funded by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and led by FHI360 to help women around the world protect themselves from HIV. 

The core MOSAIC consortium partners include: FHI360, LVCT Health, Pangaea Zimbabwe AIDS Trust, Wits Reproductive Health and HIV Institute, Jhpiego, AVAC, Afton Bloom, Avenir Health, Columbia University, Mann Global Health, RTI International, University of Pittsburgh, and University of Washington. Local partner leadership and engagement, particularly in sub-Saharan Africa, is intrinsic to the award's approach to expediting women's access to new HIV prevention products.

In just one of many highlights, in 2022, MOSAIC supported efforts to create an enabling environment for new HIV prevention products in 10 PEPFAR sub-Saharan African countries through a user-centered approach, research and research utilization, policy and programs, and local partner capacity strengthening. Examples of these MOSAIC activities include: 

• Creating the Template Guidelines for Daily Oral PrEP, Event-Driven PrEP, PrEP Ring, and CAB PrEP to provide national-level, adaptable guidelines that align with World Health Organization (WHO) pre-exposure prophylaxis (PrEP) recommendations and guidance;
• Creating the HIV Prevention User Journey Tool to support adolescent girls and young women to explore methods that would align with their lifestyle, needs and personal preferences; and support healthcare providers to provide informed counseling based on client needs;
• Updating the PrEP-It tool for PrEP implementation planning, monitoring and evaluation. Key features of PrEP-it include setting national and subnational targets, estimating costs and impact associated with targets, monitoring PrEP initiation, and forecasting drug supply needs.

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. This study will provide data and evidence to policy makers and national governments on scaling an HIV prevention program offering method choice. 

Additional Resources

• Learn about the MATRIX Project and MOSAIC Project
• Read more about global PrEP activities from PrEPwatch
• Learn more about USAID’s PEPFAR programs 
• Learn more about USAID’s Center for Accelerating Innovation and Impact