Village health workers lead new HIV prevention effort in lesotho
NCT ID NCT07581600
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times
Summary
This study tests a new program where trained village health workers use tablet-based tools to provide HIV prevention services, including PrEP and emergency PEP, to people at high risk in rural Lesotho. About 380 participants will be enrolled to see if this approach increases monthly use of prevention methods compared to standard care. The goal is to reduce new HIV infections in underserved communities.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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15 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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SolidarMed Lesotho
Maseru, Lesotho
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University of Basel, Division of Clinical Epidemiology
Basel, 4051, Switzerland
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