5,560
Participants
Start Date
September 8, 2025
Primary Completion Date
January 31, 2028
Study Completion Date
January 31, 2029
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).
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).
RECRUITING
Rakai Health Sciences Program, Kalisizo
Collaborators (1)
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Abbott
INDUSTRY
Bill and Melinda Gates Foundation
OTHER
Johns Hopkins University
OTHER