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ComBaCaL HIV Prevention TwiCs

NCT07581600 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Human Immunodeficiency Virus (HIV)

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.

Sponsors & Collaborators

  • Swiss Agency for Development and Cooperation (SDC)

    collaborator UNKNOWN

  • World Diabetes Foundation (WDF)

    collaborator UNKNOWN

  • SolidarMed

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Niklaus Labhardt · Division of Clinical Epidemiology, University Hospital Basel

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Lesotho
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07581600 on ClinicalTrials.gov