Integrated STI testing to improve HIV prevention with PrEP for women in Rakai, Uganda

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.