Health Trials

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • CoPrev model

    Other intervention

    * 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

  • Referral to the nearest responsible health facility

    Other intervention

    * refer participants eligible for biomedical HIV prevention to the nearest health facility * offer family planning education, pregnancy screening, and refer participants for contraception.

Treatment groups

380 Participants
are divided into 2 treatment groups
Group A: Intervention villagesActive comparator 1 intervention
Group B: Control villagesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Monthly biomedical HIV prevention coverage over 6 months after enrolment

Biomedical HIV prevention coverage is defined at the person- month level as a binary indicator of whether a participant was covered by a biomedical HIV prevention method (PEP (TDF/3TC/DTG), oral PrEP (TDF/3TC), or injectable PrEP) during a given 30-day month within the six-month observation period following enrolment in the ComBaCaL HIV prevention TwiCs .

Time frame
Single assessment visit scheduled approximately six months after enrolment (180 days)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Basel, Switzerland

Lead sponsor

Swiss Agency for Development and Cooperation (SDC)

Collaborator

World Diabetes Foundation (WDF)

Collaborator

SolidarMed

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: