ComBaCaL HIV Prevention TwiCs

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.

NCT Number	NCT07581600
Lead Sponsor	University Hospital, Basel, Switzerland Collaborators: Swiss Agency for Development and Cooperation, The World Diabetes Foundation, SolidarMed
Conditions	Human Immunodeficiency Virus (HIV)
Enrollment	380 participants
Start Date	2026-06
Primary Completion	2027-06 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2026-05-22