USAID: HIV Research Cuts Set Back Women’s Prevention Tools

In early 2025, the USAID-funded MATRIX initiative—a planned nine-year, $200 million research program launched in 2021 to develop the next generation of women-centered HIV prevention options was abruptly halted by the stop work order and later terminated. Led by the Magee-Womens Research Institute with partners across the United States and Africa, MATRIX was advancing multiple promising HIV prevention technologies while strengthening scientific capacity across partner countries. The termination halted five major research efforts midstream, disrupting clinical trials, eliminating US research jobs, and damaging trust among African research partners, governments, and participating communities:

1. Fast-dissolving vaginal insert (on-demand HIV prevention)

This product was designed to provide a low-cost, discreet option that women can use on demand. When the stop-work order was issued, researchers had recently completed successful Phase 1 trials in the United States, Kenya, and South Africa and were preparing to launch the next study phase later that year. Biological samples from the earlier studies awaiting analysis when work was halted, leaving samples stranded overseas and preventing analysis and proper study closeout. Emergency philanthropic support ultimately enabled investigators to recover and analyze samples, meet ethical and regulatory obligations and file a new drug application with the US FDA, but further product development is now on hold without funding.

2. Monthly dapivirine vaginal film (monthly HIV prevention)

This dissolvable film was intended to be discreet, affordable, and self-inserted monthly, offering an alternative to daily oral PrEP and long-acting injections. At the time of the stop-work order, researchers had recently completed a safety and acceptability study of two prototype films and were preparing to analyze and report findings, while also developing protocols for a first-in-human trial of an active film in Kenya, South Africa, the United States, and Zimbabwe later in 2025. Those plans were halted. Emergency donor funding allowed the team to assess results and close out the prototype study, but further development has stopped due to a lack of an alternative funding pathway.

3. Monthly dual-purpose vaginal film (HIV + pregnancy prevention)

This product aimed to combine HIV prevention with pregnancy prevention to address a major unmet need for dual protection. The program was in preclinical development when the stop-work order and termination immediately halted further formulation and feasibility work. Further development remains paused due to lack of resources.

4. Monthly non-ARV/nonhormonal dual-purpose vaginal ring (HIV/STIs + pregnancy prevention)

This ring aimed to provide protection against HIV and other sexually transmitted infections (STIs), as well as pregnancy, using a novel antiviral and nonhormonal contraceptive. When work stopped, a Phase 1 trial of placebo rings was underway in the United States, Zimbabwe, and South Africa. The stop-work order triggered an immediate ethical and medical crisis: participants in South Africa and Zimbabwe still had investigational rings in their bodies when investigators were told all work must stop. A request to USAID for a temporary waiver to continue trial and necessary clinical follow-up was denied. Researchers, with their own institutional resources, had to urgently contact participants, arrange clinical visits to remove rings, provide follow-up care, coordinate with local regulators and ministries of health, and counter emerging rumors that the products were unsafe— steps essential to preserving community trust built over years. Other donor support later enabled partial data analysis of study results, but further development is on hold without funding.

5. CARE-PrEP (PrEP safety in pregnancy)

Researchers had begun enrollment and trained sites for a clinical trial in Lesotho, Zimbabwe, and Kenya intended to assess the safety of several PrEP options during pregnancy, including long-acting cabotegravir injections, the dapivirine ring, and daily oral PrEP. The study was expected to enroll 500-800 mothers and infants to generate high-quality safety data critical to inform global guidelines. The study was shut down before meaningful data could be collected, and ministries of health had to be notified that the program would not continue as planned, damaging trust. With no alternative funding path, the trial has not resumed, and global guidelines still lack the pregnancy safety evidence the trial was positioned to provide.

Beyond the direct impacts to the research, the termination forced Magee-Womens Research Institute to lay off approximately 30 US-based staff. Key partner labs across California, Virginia, and Pennsylvania also lost substantial research support, eliminating additional jobs. The abrupt shutdown also damaged trust with governments, partners, and participants affected countries, many of whom had invested years or work or volunteered to take part in these studies. Most importantly, the termination delays or prevents advancement of tools that could have transformed HIV prevention for women, who remain disproportionately at risk. While designed for low-resource settings, these products also help promise for women in the United States seeking discreet, user-controlled prevention options.

Partners: Magee Women’s Research Institute (Pittsburgh, PA); IAVI (US offices in New York, NY; Jersey City, NJ; La Jolla, CA); RTI International (US offices in Durham, NC; Chicago, IL; Waltham, MA); Oak Crest Institute of Science (Monrovia, CA); CONRAD (Norfolk, VA); PATH (US offices in Seattle, WA; Washington, DC); Public Health Institute (Oakland, CA; Sacramento, CA); Jhpiego (Baltimore, MD), and research sites in South Africa, Uganda, Lesotho, Kenya, and Zimbabwe.