Not_yet_recruitingNANCT07581600

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

ConditionHuman Immunodeficiency Virus
InterventionCoPrev model; Referral to the nearest responsible health facility
PhaseNA
StatusNot_yet_recruiting
Participants380
Est. Completion1 June 2027
Last Updated22 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

LesothoSwitzerland
View Registry Entry

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