NCT06743204 The Integrated Female Sexually Transmitted Infection Testing for HIV Epidemic Control Through PrEP (IN-STEP) Study
| NCT ID | NCT06743204 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Gonorrhea Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,560 participants |
| Start Date | 2025-09-08 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5,560 participants in total. It began in 2025-09-08 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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, gonorrhea, trichomonas, and syphilis compared to SRST alone to increase PrEP use among cis-gender African women aged 15-39 years. The investigators hypothesize that cSTI testing will increase PrEP use primarily through (i) improved identification of women at high risk for HIV and (ii) enhancement of self-perceived HIV risk. The proposed research will be nested within the Rakai Community Cohort Study, a population-based HIV surveillance cohort in Uganda. In Aim 1, \~4,500 HIV-negative women will be individually randomized 1:1 to PrEP screening based on SRST plus cSTI diagnostic testing (intervention) versus PrEP screening based on SRST alone (control arm). Both arms will be offered syndromic case management for cSTIs and syphilis testing for pregnant women (standard of care). The primary outcomes will be PrEP uptake, adherence, and persistence, assessed through clinical records and drug level testing. In Aim 2, the investigators will perform a mixed-methods, implementation science evaluation of female cSTI testing for HIV prevention and control. The investigators will use qualitative and quantitative methods to assess the mechanisms, barriers, and facilitators to improving PrEP outcomes through cSTI testing and how this varies by cSTI pathogen, SRST outcomes, and demographic profiles. In Aim 3, the investigators will use mathematical models to evaluate different cSTI testing approaches to reduce HIV incidence at a population level by considering what cSTIs to screen for, in what health care settings, and at what cost thresholds. The investigators will also model broader health benefits of cSTI testing. Results from this study will provide actionable, population-level information to inform strategic delivery of high impact HIV prevention through integrated HIV and cSTI programming in Africa.
Eligibility 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.
Contact & Investigator
Mary Kathryn Grabowski, Associate Professor, PhD
PRINCIPAL INVESTIGATOR
Johns Hopkins School of Medicine
Frequently Asked Questions
Who can join the NCT06743204 clinical trial?
This trial is open to female participants only, aged 15 Years or older, up to 39 Years, studying Gonorrhea Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06743204 currently recruiting?
Yes, NCT06743204 is actively recruiting participants. Contact the research team at mgrabow2@jh.edu for enrollment information.
Where is the NCT06743204 trial being conducted?
This trial is being conducted at Kalisizo, Uganda.
Who is sponsoring the NCT06743204 clinical trial?
NCT06743204 is sponsored by Johns Hopkins University. The principal investigator is Mary Kathryn Grabowski, Associate Professor, PhD at Johns Hopkins School of Medicine. The trial plans to enroll 5,560 participants.