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

NARecruitingINTERVENTIONAL
Enrollment

5,560

Participants

Timeline

Start Date

September 8, 2025

Primary Completion Date

January 31, 2028

Study Completion Date

January 31, 2029

Conditions
Gonorrhea FemaleChlamydia FemalesSyphilis FemaleTrichomonas VaginalisHIVPrEP Uptake
Interventions
OTHER

Self-Reported Risk Screening for PrEP and Diagnostic STI testing

The intervention arm will include: 1) Standard-of-care STI symptom screening: The investigators will ask participants if any STI symptoms 2) PrEP screening (if HIV- only): PrEP eligibility screening will be done using the standard-care Ministry Health self-reported risk screening (SRST) tool for PrEP 3) STI laboratory diagnostic testing: Regardless of HIV serostatus, vaginal swabs will be collected to test for chlamydia, gonorrhea, trichomonas, and human papilloma virus. Syphilis testing will be performed using blood samples participants provided in the Rakai Community Cohort Study. Participants who test positive for a curable sexually transmitted infection (chlamydia, gonorrhea, trichomonas, or syphilis) OR who screen eligible for PrEP using the Ministry of Health SRST AND are HIV- will be referred for same-day PrEP initiation. Participants who have symptoms indicative of STIs or who test positive for an STI will be provided with free treatment, as will the partner(s).

OTHER

Self-reported risk screening for PrEP and syndromic management for STIs

This active comparator (control) arm will receive the following: 1) Standard-of-care STI symptom screening: Regardless of HIV serostatus, participants will be asked if any STI symptoms 2) Syphilis testing for pregnant participants: Regardless of HIV serostatus, syphilis testing will be performed using blood samples provided in the Rakai Community Cohort Study. 3) PrEP screening (if HIV- only): Participants will be screened for PrEP eligibility using the standard-care Ministry Health self-reported risk screening (SRST) tool for PrEP. Participants who screen eligible for PrEP using the Ministry of Health SRST OR pregnant participant's who test positive for syphilis AND are HIV- will be referred for same-day PrEP initiation. Participants who have symptoms indicative of STIs or who test positive for syphilis will be provided with free treatment, as will the partner(s).

Trial Locations (1)

Unknown

RECRUITING

Rakai Health Sciences Program, Kalisizo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

Abbott

INDUSTRY

collaborator

Bill and Melinda Gates Foundation

OTHER

lead

Johns Hopkins University

OTHER

NCT06743204 - The Integrated Female Sexually Transmitted Infection Testing for HIV Epidemic Control Through PrEP (IN-STEP) Study | Biotech Hunter | Biotech Hunter