Community-based, Village Health Worker-led, eHealth-supported, Integrated HIV Prevention for People at Substantial Risk of HIV Acquisition in Rural Lesotho: Protocol for a Cluster-randomized Hybrid Type 1 effectiveness-implementation Trial Within the ComBaCaL Cohort Study
Sponsor: University Hospital, Basel, Switzerland
Trial Details
| Condition | Human Immunodeficiency Virus |
| Intervention | CoPrev model; Referral to the nearest responsible health facility |
| Phase | NA |
| Status | Not_yet_recruiting |
| Participants | 380 |
| Est. Completion | 1 June 2027 |
| Last Updated | 22 May 2026 |
Primary Outcome
Monthly biomedical HIV prevention coverage over 6 months after enrolment
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: * Participant of the ComBaCaL cohort study (signed informed consent available) * Weight ≥ 35 kg * Negative HIV screening test * No potential exposure to HIV more than 72 hours ago (PEP eligibility window period) and less than 4 weeks ago (window period HIV test) * At substantial risk of HIV acquisition as per behavioural risk factors in the Lesotho's national HIV prevention and treatment guidelines: * Report of serodiscordant partner who are not virally suppressed or have an unknown viral suppression status (either not on ART, initiated ART within the last 6 months, known virally unsuppressed or unknown virally suppression status but believed not to be taking treatment regularly) * Report of sexual partner with unknown HIV status * Report of unprotected sex with more than one partner in the last 6 months * Report of STI by lab-testing or self-report of STI syndromic management in the last 6 months * Report of exchanging money/goods for sex in the last 6 months (as recipient and vice versa) * Report of intravenous drug use with shared equipment in the last 6 months * Request for biomedical HIV prevention Exclusion Criteria: * Known allergies to PEP/oral PrEP * Known glomerular filtration rate (GFR) \< 60 ml/min or diagnosis of moderate/severe kidney disease or kidney failure
Trial Sites
Countries
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