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WITHDRAWN
NCT07581600
NA

ComBaCaL HIV Prevention TwiCs

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

15 Years - Any

Study Type

INTERVENTIONAL

Enrollment

0

Start Date

2026-06

Completion Date

2027-06

Last Updated

2026-09-16

Healthy Volunteers

Yes

Interventions

OTHER

CoPrev model

* prescribe and deliver drugs for biomedical HIV prevenTion (PEP (TDF/3TC/DTG 300mg/300mg/50mg) or oral PrEP (TDF/3TC 300mg/300mg)) * offer refills for contraception (EE/LNG 30mcg/15mcg or 50mcg/15mcg) or self-injectable contraception (s.c. 104mg/0.65ml medroxypregosteronacetate * monitoring for all dispensed drug regimens

OTHER

Referral to the nearest responsible health facility

* refer participants eligible for biomedical HIV prevention to the nearest health facility * offer family planning education, pregnancy screening, and refer participants for contraception.

Locations (2)

SolidarMed Lesotho

Maseru, Lesotho

University of Basel, Division of Clinical Epidemiology

Basel, Switzerland