Integrated STI testing to improve HIV prevention with PrEP for women in Rakai, Uganda
The Integrated Female Sexually Transmitted Infection Testing for HIV Epidemic Control Through PrEP (IN-STEP) Study
This project will test whether adding diagnostic tests for curable STIs to routine risk screening helps women in Rakai start and stay on PrEP to prevent HIV.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5560 (estimated) |
| Ages | 15 Years to 39 Years |
| Sex | Female |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Kalisizo) |
| Trial ID | NCT06743204 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study enrolls sexually active cisgender women aged 15–39 from the Rakai Community Cohort Study and randomizes them to self-reported risk screening (SRST) with either diagnostic STI testing or syndromic management. The primary aim is to see if adding laboratory-based testing for curable STIs increases PrEP uptake, adherence, and persistence compared with SRST alone. The protocol leverages stored plasma specimens and existing RCCS infrastructure and includes pregnant women, with outcomes measured over months following PrEP referral and initiation. Study procedures reflect real-world PEPFAR screening practices while introducing diagnostic STI results as a potential trigger for enhanced PrEP engagement.
Who should consider this trial
Good fit: Sexually active women aged 15–39 who live in Rakai cohort communities, participated in the most recent RCCS survey, consented to specimen storage and recontact, and agree to be randomized (pregnant women are eligible).
Not a fit: Women who live outside the Rakai cohort, are younger than 15 or older than 39, are not sexually active, cannot provide consent, or are already living with HIV (and therefore not eligible for PrEP) are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, integrating STI diagnostics into routine screening could help identify more at-risk women and increase the number who start and continue PrEP, potentially reducing HIV infections.
How similar studies have performed: Previous work shows that curable STIs mark higher HIV risk and that PrEP prevents HIV, but combining diagnostic STI testing with routine PrEP screening for cisgender African women is relatively novel and not yet widely proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Sexually active females aged 15-39 years, * resident in Rakai Community Cohort Study (RCCS) communities and who have participated in the most recent RCCS survey will be eligible to participate irrespective of their HIV serostatus. * Pregnant women will be included in this study * Additionally, eligibility criteria include participation in the most recent RCCS with consent to store and test plasma specimens collected during the RCCS visit, * consent to be re-contacted for future studies, and * willingness to be randomized in IN-STEP. Exclusion criteria: * Individuals incapable of providing consent or * not meeting the above criteria will be excluded from the study.
Where this trial is running
Kalisizo
- Rakai Health Sciences Program — Kalisizo, Uganda (Recruiting)
Study contacts
- Principal investigator: Mary Kathryn Grabowski, Associate Professor, PhD — Johns Hopkins School of Medicine
- Study coordinator: Mary Kathryn Grabowski, Associate Professor, PhD
- Email: mgrabow2@jh.edu
- Phone: 443-287-5736
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.