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Actively Recruiting
Healthy Volunteer
Researchers are investigating ways to improve HIV prevention for cis-gender African women aged 15 to 39 years, particularly by increasing the use of pre-exposure prophylaxis (PrEP). The study focuses on women in eastern and southern Africa, where new HIV infections are high and often occur outside known key populations. The research evaluates whether adding testing for curable sexually transmitted infections (cSTIs)—such as chlamydia, gonorrhea, trichomonas, and syphilis—to standard self-reported risk screening can better identify women at high HIV risk and enhance their awareness of this risk, potentially leading to increased PrEP use. This trial is nested within the Rakai Community Cohort Study in Uganda and aims to address challenges including underreporting of risk factors and early PrEP discontinuation among women. The study randomly assigns about 4,500 HIV-negative women into two groups: one receiving standard self-reported risk screening plus cSTI diagnostic testing (intervention), and the other receiving only the standard self-reported risk screening (control). Both groups receive syndromic management for STIs and syphilis testing for pregnant women as part of standard care. Women testing positive for cSTIs or who are eligible for PrEP are referred for same-day PrEP initiation and offered free treatment for themselves and their partners if infections are found. The study also includes an implementation science evaluation using surveys and in-depth interviews to understand factors affecting PrEP use and the impact of cSTI testing. Participants will be followed from enrollment up to six months to assess PrEP uptake, adherence, and persistence through clinical records, drug level testing, and surveys. Qualitative interviews will be conducted at one and six months post-screening to explore barriers and facilitators to PrEP use. Mathematical modeling will be used to evaluate different cSTI screening strategies for reducing HIV incidence at the population level. Results aim to inform better integration of HIV and cSTI services to improve prevention efforts among African women at high risk for HIV.