Microbicides: New HIV Prevention Products for Women

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Actresses from the MTV series, Shuga: Down South, discuss HIV prevention options through the PrEP4Youth Campaign in South Africa in 2019.
Actresses from the MTV series, Shuga: Down South, discuss HIV prevention options through the PrEP4Youth Campaign in South Africa in 2019.
Photo Credit: USAID OPTIONS/ FHI 360

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 especially focuses on the R&D of microbicides that can be sustainably provided in key focus countries in sub-Saharan Africa for the women who need them most, including adolescent girls and young women. Building on the success of these R&D activities, USAID also supports activities to prepare for and speed up the introduction of new microbicide products, including daily oral pre-exposure prophylaxis (PrEP).

USAID IMPACT

USAID, through the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), supports:

  • Earlier-stage research for improved prevention products, including those with new active ingredients and innovative delivery systems; and
  • Preparatory activities needed for successful microbicide introduction and access, including targeted behavioral studies, drug-resistance monitoring, implementation and impact modeling, and policy or regulatory development

USAID also focuses on “end-users,” by using research to tailor products to fit into and enhance women’s lives, which have the potential for successful delivery in developing country settings. Research shows that the most effective product use and greatest prevention impact can be achieved when users have a choice to consider several product options – including multi-purpose products that prevent other sexually transmitted infections or pregnancy, as well as HIV, and select the one that best fits their own needs and life circumstances at the time.

Research and Development

USAID supports promising HIV prevention products that are in the later stages of development (e.g., those completing safety and efficacy clinical trials). These are products with the potential to reach regulatory approval within five years and incorporate a range of desirable product characteristics identified through end-user research with women (e.g., related to regimen, duration, reduced side effects, discreetness, etc.). Investments in promising products will be prioritized based on expected potential for impact on the HIV epidemic.

USAID also takes a strategic, forward-looking view to invest in products that have the potential to fill identified gaps in the achievable range of prevention options. Support is provided for targeted research on products with novel characteristics that are expected to significantly increase acceptability and effective use by women at high risk. 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, investments prioritize product characteristics that reduce the burden on strained health care systems. Investing in these optimized products now will expedite and expand their future impact. Research and development investments are inherently dynamic as all products undergo stringent testing for safety and efficacy and not all products meet the necessary standards. Below is a snapshot of some of the HIV prevention product categories that USAID is currently supporting.

R&D Products Duration Partner
Long-acting Injectables 4–6 months CONRAD
Ultra Long-acting Implants > 1 year CONRAD
Long-acting Topicals 1-3 Months Pitt, IPM
Short-acting Topicals On-demand CONRAD
Microarray Patch 1 Month PATH
Multi-purpose Prevention Variable Oak Crest, Population Council
Broadly-neutralizing Antibodies Various International AIDS Vaccine Initiative

Introduction and Access

USAID expands access to new prevention product options that have received approval by stringent regulatory authorities (e.g., oral PrEP) for young women and adolescent girls at high risk of acquiring HIV. The number of countries where oral PrEP is approved for use has increased significantly since 2016 in sub-Saharan Africa and oral PrEP use has grown exponentially in these countries. However, sustained and daily oral PrEP can be challenging to use for many persons at high risk for HIV for a multitude of reasons. Implementation gaps and challenges exist along the introduction, access, and adoption phases of the product development pathway. Addressing these gaps requires collaborative research that brings together end-users, civil society, ministries of health, and other stakeholders to inform how, when, where, and to whom these products are rolled out.

Long-standing local working relationships and extensive experience with service delivery make
USAID well positioned to understand specific country contexts for HIV prevention. USAID fills a unique space by addressing research and technical assistance needs that support the range of activities from regulatory approval of products to subsequent introduction and scale-up.

Initiatives, such as the MOSAIC program, expand on research activities for the introduction of new prevention technologies such as the PrEP Ring and injectable products. Initiatives will support countries and programs to adopt lessons learned from Oral PrEP rollout including marketing, country support and adherence counseling, to build on existing service delivery foundations within communities, and use research as needed to overcome barriers to successful and sustainable scale-up.

Introduction and Access Research to Bring HIV Prevention Methods to Scale for Adolescent Girls & Young Women

Project Goal Partner
MOSAIC Help women and adolescents
protect themselves from HIV by accelerating introduction and scale-up of new biomedical
prevention products. Work with countries to implement user-centered
research and research translation
efforts to identify, understand, and
remove barriers to new product
introduction, access, and use;
coordinate and provide technical assistance to global, national, and subnational stakeholders to expedite
product launch and scale-up; and strengthen the capacity of a wide range of local partners to perform essential
functions that support the introduction of HIV prevention products.
FHI360
ENGAGE Contribute to the advancement of new HIV prevention methods, especially for adolescent
girls and young women, through research activities on acceptability and adherence of PrEP regimens, advancing innovative adherence support and monitoring tools, and developing and validating a new point-of-care (PoC) adherence monitoring assay.
CONRAD
LEADING Advance activities required for licensure and market introduction of a PrEP Ring in sub-Saharan Africa and to bridge opportunities to progress toward licensure of
PrEP ring line-extension products.
International Partnership for Microbicides (IPM)
PROMISE Support early product introduction planning for the monthly PrEP ring in sub-
Saharan Africa, with the goal of shaping the market and establishing a service delivery platform to support future multipurpose and longer-acting vaginal rings.
FHI360

2021 ACHIEVEMENTS

LAUNCHED: Two New Consortia

MATRIX
The USAID Microbicide Program launched the MATRIX consortium, Microbicide Research and Development to Advance HIV Prevention Technologies through Responsive Innovation and Excellence (MATRIX) award, a $125 million five-year cooperative agreement, funded by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). The MATRIX project, led by Magee-Womens Research Institute and Foundation, 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.

U.S.-based partners include: AVAC, CONRAD, FHI 360, IAVI, IPM, 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 will co-lead and collaborate in research product development, end-user product preferences, behavioral support for clinical trials, stakeholder engagement for product development, capacity strengthening and mentoring, and business case development. Ultimately, this will strengthen local scientific capacity and facilitate the development of biomedical prevention products in a way that increases HIV prevention options for women to choose from, and that meet women’s varied needs over their lifetime.

MOSAIC The USAID Microbicide Program launched the MOSAIC consortium,
Maximizing Options to Advance Informed Choice for HIV Prevention (MOSAIC), a $85 million program funded by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) to help women around the world protect themselves from HIV. FHI 360 will lead a consortium of local and international partners.

The core MOSAIC consortium partners include: LVCT Health, based in Kenya; Pangaea Zimbabwe AIDS Trust, based in Zimbabwe; Wits Reproductive Health and HIV Institute, based in South Africa; Jhpiego, a nonprofit organization affiliated with Johns Hopkins University; and New York City - based global HIV prevention advocacy group, AVAC. Local partner leadership and engagement, particularly in sub-Saharan Africa, will be intrinsic to the award's approach to expediting women's access to new HIV prevention products.

Additional Resources

Last updated: May 17, 2022

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