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ComBaCaL HIV Prevention TwiCs

Study acronym: CoPrev
StatusWithdrawn
PhaseNot applicable
Started
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Record History

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  1. Withdrawn before enrolling Sponsor's reason: The study was withdrawn before initiation. Reasons: no ethics approval obtained and anticipated roll-out of lenacapavir Show 4 more changesShow less
    • Enrollment target: estimated 380 to confirmed 0
    • Eligibility criteria expanded, about 14 words
    • Study description revised
    • Site contacts updated at 2 of 2 sites
  2. Re-verified, no change to tracked fieldsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07581600
Lead Sponsor University Hospital, Basel, Switzerland
Collaborators: Swiss Agency for Development and Cooperation, The World Diabetes Foundation, SolidarMed
Conditions
(from sponsor)		 Human Immunodeficiency Virus (HIV)
Related terms Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov