Advancing HIV Pre-Exposure Prophylaxis (PrEP) for Women: A Review of Ongoing Trials on Drug Development and Behavioral Interventions

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Abstract Purpose of Review Cisgender women experience unique risks of human immunodeficiency virus (HIV) acquisition due to biological, social, and cultural factors. This narrative review provides an overview of ongoing clinical trials focused on emerging biomedical advances and behavioral interventions for pre-exposure prophylaxis (PrEP) among women. Recent Findings The ClinicalTrials.gov database was queried for ongoing trials, and as of March 21, 2025, 6 eligible biomedical intervention and 22 behavioral intervention trials related to HIV PrEP among cisgender women. The sample size of the trials included ranged from 30 to 9,000 participants. The biomedical intervention trials enrolling women spanned diverse geographies and evaluated oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), long- acting cabotegravir, and lenacapavir/tenofovir alafenamide (TAF) regimens for PrEP. Long-acting agents examined in the trials offer innovative options for women to enhance treatment experience and overcome challenges associated with daily oral regimens. Behavioral interventions commonly involved mobile applications, social media, and counseling, with adherence and uptake as the most frequent outcomes assessed. Equity was a major focus in both biomedical and behavioral intervention trials, and trial populations included adolescent girls and young women from underserved communities around the world. Summary Together, these findings underscore the progress in both biomedical and behavioral PrEP research for women. Future trials should continue to prioritize adolescents, young women, and participants from developing countries. Additionally, beyond long-acting formulations, other durable options need to be researched for cisgender women at risk of HIV.

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