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ComBaCaL HIV Prevention TwiCs
ComBaCaL HIV Prevention TwiCs

NCT07581600

Not Yet RecruitingNA

Sponsor: University Hospital, Basel, Switzerland

Conditions: Human Immunodeficiency Virus (HIV)

Interventions: CoPrev model, Referral to the nearest responsible health facility

Countries: Lesotho, Switzerland

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 overview

Sex: ALL

Age: 15 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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)
* At substantial risk of HIV acquisition as per behavioural risk factors in the Lesotho's national HIV prevention and treatment guidelines:

  * Report of serodiscordant partner who are not virally suppressed or have an unknown viral suppression status (either not on ART, initiated ART within the last 6 months, known virally unsuppressed or unknown virally suppression status but believed not to be taking treatment regularly)
  * Report of sexual partner with unknown HIV status
  * Report of unprotected sex with more than one partner in the last 6 months
  * Report of STI by lab-testing or self-report of STI syndromic management in the last 6 months
  * Report of exchanging money/goods for sex in the last 6 months (as recipient and vice versa)
  * Report of intravenous drug use with shared equipment in the last 6 months
  * Request for biomedical HIV prevention

Exclusion Criteria:

* Known allergies to PEP/oral PrEP
* Known glomerular filtration rate (GFR) \< 60 ml/min or diagnosis of moderate/severe kidney disease or kidney failure
Locations (2)
  • Maseru, Lesotho
  • Basel, Switzerland