ComBaCaL HIV Prevention TwiCs
ConditionHuman Immunodeficiency Virus (HIV)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
Known allergies to PEP/oral PrEP
Known glomerular filtration rate (GFR) < 60 ml/min or diagnosis of moderate/severe kidney disease or kidney failure
Trial design
Treatments tested in this trial
- CoPrev model
- Referral to the nearest responsible health facility
Treatment groups
380 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Hospital, Basel, Switzerland
Lead sponsor
Swiss Agency for Development and Cooperation (SDC)
Collaborator
World Diabetes Foundation (WDF)
Collaborator
SolidarMed
Collaborator
Source ClinicalTrials.gov