The Integrated Female Sexually Transmitted Infection Testing for HIV Epidemic Control Through PrEP (IN-STEP) Study

What this Trial Is About

This research aims to evaluate how adding testing for curable sexually transmitted infections (cSTIs) like chlamydia, gonorrhea, trichomonas, and syphilis to standard HIV risk screening can improve use of pre-exposure prophylaxis (PrEP) among cis-gender African women aged 15 to 39 years. The study focuses on women in eastern and southern Africa who are at high risk of HIV, often due to relationships with high-risk male partners, and who are often missed by self-reported risk screening tools alone. The goal is to see if integrated cSTI testing can better identify women at risk and increase their self-perceived HIV risk, thereby improving PrEP uptake and persistence. Participants will be randomly assigned to one of two groups: one receiving standard self-reported risk screening (SRST) plus diagnostic cSTI testing, and the other receiving SRST alone. Both groups will get symptom screening and treatment for STIs as needed, plus syphilis testing for pregnant women. Those testing positive for cSTIs or eligible by SRST will be referred for same-day PrEP initiation. The study will be conducted within a population-based HIV surveillance cohort in Uganda, following participants for PrEP use outcomes. During the study, researchers will monitor PrEP uptake, adherence, and persistence up to six months after enrollment through clinical records, surveys, and drug level testing. They will also conduct interviews to understand barriers and facilitators to PrEP use, and use mathematical models to evaluate population-level impacts of different cSTI testing strategies. The study will last several years, providing insights to better integrate HIV prevention and STI testing programs for African women.

The Integrated Female Sexually Transmitted Infection Testing for HIV Epidemic Control Through PrEP (IN-STEP) Study