Status:
COMPLETED
Integrating Enhanced HIV PrEP Into a STI Clinic in Lilongwe
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
HIV Infections
Sexually Transmitted Diseases
Eligibility:
All Genders
15+ years
Brief Summary
This is a prospective cohort study evaluating acceptability, feasibility, and effectiveness of integrating HIV pre-exposure prophylaxis (PrEP) into a sexually transmitted infection (STI) clinic alongs...
Eligibility Criteria
Inclusion
- Patient Participant
- ≥15 years of age.
- Eligible for PrEP according to Malawi PrEP guidelines (see below)
- Presenting for care at STI clinic (primary presentation or referral from partner based on STI or HIV exposure)
- Able to consent for study participation and willing to provide locator information for follow-up tracing
- \*Malawi PrEP eligibility criteria:
- Age ≥15 years
- HIV seronegative iii. At substantial risk for HIV, with prioritization of persons who:
- Buy or sell sex; Key population (female sex worker, men who have sex with other men, transgendered persons; Vulnerable population included adolescent girls and young women aged 15-24; STI clients; Serodiscordant couples including HIV-negative women who are pregnant or breast feeding or HIV-negative men or women for whom their HIV-infected partner is: not on ART, on ART \<6 months, has an unsuppressed or high viral load, or is non-adherent to ART, iv. Have ruled out acute HIV infection, or defer PrEP initiation for anyone with signs or symptoms consistent with acute HIV infection, v. Willingness to attend scheduled PrEP visits, vi. No contraindication to use of TDF and 3TC, vii. Bodyweight ≥30 kg, viii. Estimated glomerular filtration rate (eGFR) ≥60mL/min, ix. No known renal diseases, x. No diabetes mellitus.
Exclusion
- Current imprisonment or incarceration in a medical or psychiatric facility
- Provider Participant:
- Inclusion Criteria:
- ≥18 years of age.
- Duties relevant to integration or provision of PrEP and/or aPN at STI clinic
Key Trial Info
Start Date :
March 9 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT05307991
Start Date
March 9 2022
End Date
August 1 2023
Last Update
October 5 2023
Active Locations (1)
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1
Bwaila STI clinic
Lilongwe, Malawi