NCT07581600Withdrawn
ComBaCaL HIV Prevention TwiCs
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
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO\_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local lay chronic care village health workers (CC-VHWs). This study is to evaluate the effectiveness and safety of the CoPrev model in regard to biomedical HIV prevention utilization compared with an enhanced standard of care, in which VHWs assisted by a tablet-based CDS application, perform the same activities except for the prescription and/or delivery of PEP, oral PrEP, COC and self-injectable contraception. Additionally, this study aims to assess the outcomes and processes related to the implementation of such a model.
- Status (registry)
- Withdrawn
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 5 May 2026
- Start date
- Jun 2026
- Primary completion date
- Jun 2027
- Lead sponsor
- University Hospital, Basel, Switzerland
- Diseases
- HIV
- NCT number
- NCT07581600
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known allergies to PEP/oral PrEP
Lab values
- Known glomerular filtration rate (GFR) \< 60 ml/min or diagnosis of moderate/severe kidney disease or kidney failure
Who the study is looking for
- 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
Age in the registry: 15 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Basel, Division of Clinical Epidemiology Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Solidarmed Lesotho Coordinator of this site? Confirm its status | Maseru | Lesotho | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.