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Peer-led Dynamic Choice HIV Prevention for Women: The Peer-led DCP Randomized Trial

ConditionsHIV/AIDSHIV/AIDS Prevention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15+
SponsorUniversity of California, San Francisco

About this trial

This Hybrid Type 1 cluster randomized trial will test the Peer-led Dynamic Choice HIV Prevention (DCP) intervention compared to standard of care.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age >=15 years (with parent/guardian consent required for age 15 to <18 years)

Female sex at birth;

HIV negative by country-standard testing algorithm;

Elevated risk of HIV exposure, defined as at least 1 of the following: a) eligible for PrEP/PEP based on Uganda Ministry of Health Guidelines or b) work in bar or guesthouse

Disqualifiers

Contraindication to recommended PrEP/PEP regimen per Ministry of Health guidelines

Participation in another HIV prevention study

Aged 15 to <18 years with no parent or guardian to provide consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Peer-led Dynamic Choice HIV Prevention (DCP) intervention

    Other intervention

    The intervention consists of peer mentor training on patient-centered choice counseling and Peer-led DCP services, and will be delivered by the peer mentor with remote clinician support: 1) HIV prevention product choice, with the option to switch over time, 2) HIV testing, 3) Low-barrier PEP, 4) STI integration, 5) Travel kit, and 6) Phone/SMS contact and peer support.

Treatment groups

560 Participants
are divided into 2 treatment groups
Group A: Peer-led Dynamic Choice HIV Prevention (DCP) interventionExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Biomedical HIV prevention coverage

Percentage of follow-up time that a participant uses a biomedical HIV prevention product.

Time frame
48 weeks

Secondary outcomes

1

Biomedical HIV prevention coverage

Percentage of follow-up time that a participant uses a biomedical HIV prevention product.

Time frame
96 weeks

Other outcomes

Sponsors and contacts

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

University of California, San Francisco

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Infectious Diseases Research Collaboration, Uganda

Collaborator

University of California, Berkeley

Collaborator

Source ClinicalTrials.gov

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