NCT07581600Visszavonva
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 16.
Megadott ok: The study was withdrawn before initiation. Reasons: no ethics approval obtained and anticipated roll-out of lenacapavir
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Visszavonva
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 0 (tényleges)
- Első benyújtás
- 2026. máj. 5.
- Kezdés
- 2026. jún.
- Elsődleges befejezés
- 2027. jún.
- Fő szponzor
- University Hospital, Basel, Switzerland
- Betegségek
- HIV-fertőzés
- NCT-szám
- NCT07581600
Ki nem vehet részt
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Más betegség
- Known allergies to PEP/oral PrEP
Laborértékek
- Known glomerular filtration rate (GFR) < 60 ml/min or diagnosis of moderate/severe kidney disease or kidney failure
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 15 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of Basel, Division of Clinical Epidemiology | Basel | Svájc | Ismeretlen állapot |
| Solidarmed Lesotho | Maseru | Lesotho | Ismeretlen állapot |
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