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Study identifier: NCT06743204 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Gonorrhea Female · Chlamydia Females · Syphilis Female  ·  Sponsor: Johns Hopkins University

PhaseNA
Planned participants5560
Who can joinFemale, 15 Years to 39 Years
Healthy volunteersYes

About this study

Globally, new HIV infections are concentrated in eastern and southern Africa where the infections are largely acquired by women outside of known key populations. Identifying African women at high risk for HIV acquisition and successfully engaging them in HIV prevention services, particularly pre-exposure prophylaxis (PrEP) programs, is an urgent global health priority. The U.S. President's Emergency Plan for AIDS Relief program in Africa typically relies on self-reported risk screening tools (SRST) to target HIV testing and refer individuals for PrEP. However, these tools have low to moderate sensitivity, missing many women at high risk for HIV. This is partly due to underreporting of risk factors, but also because many African women are at heightened HIV risk solely through relationships with high-risk male partners. Moreover, many African women enrolled into PrEP programs stop using PrEP within months of initiation. Decades of research shows that curable sexually transmitted infections (cSTI) are objective markers of future HIV risk, but cSTI testing largely has been omitted from African HIV programs. With the advent of lower cost multiplex cSTI testing and point of care diagnostics, there is new opportunity to determine whether integrating female cSTI testing services into HIV programs can improve HIV epidemic control. Here, the investigators will conduct an individually randomized effectiveness implementation trial of SRST plus cSTI diagnostic testing for chlamydia, gonor…

This description comes directly from the study's public registry record.

Talk to the study team

Mary Kathryn Grabowski, Associate Professor, PhD  ·  443-287-5736  ·  mgrabow2@jh.edu

Ronald M Galiwango, Ugandan PI, PhD  ·  rmgaliwango@rhsp.org

Always discuss trial participation with your own doctor first.

Locations (1)

Rakai Health Sciences ProgramKalisizo, UgandaRecruiting

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Source record: clinicaltrials.gov/study/NCT06743204