Peer-led Dynamic Choice HIV Prevention for Women: The Peer-led DCP Pilot Study

February 3, 2026 updated by: University of California, San Francisco
This study will refine and pilot test the Peer-led Dynamic Choice HIV Prevention (DCP) intervention in a single-arm pilot trial. The study will test the hypothesis that the Peer-led Dynamic Choice HIV Prevention intervention will be feasible and increase biomedical HIV prevention coverage in the 6 months after receipt of the Peer-led DCP intervention compared to the standard of care in the 6 months prior to intervention implementation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The overall goal of this study is to refine and pilot test a Peer-led Dynamic Choice HIV Prevention intervention tailored to women at elevated HIV risk in southwestern Uganda. We will conduct a single-arm pilot trial of the intervention enrolling approximately 60 women to assess the feasibility, acceptability, and preliminary effectiveness of the Peer-led Dynamic Choice Prevention intervention.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Uganda
      • Kampala, Uganda
        • Recruiting
        • Infectious Diseases Research Collaboration
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age >=18 years or mature or mature minor >=15 years;
  2. Female sex at birth;
  3. HIV negative by country-standard testing algorithm
  4. Elevated risk of HIV exposure, defined as at least 1 of the following: a) eligible for PrEP based on Uganda Ministry of Health Guidelines; b) exchange of sex for goods or money in last 6 months; or c) work in bar or guesthouse

Exclusion Criteria:

  • Contraindication to country-recommended PrEP regimen per national guidelines
  • Participation in another HIV prevention study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peer-led Dynamic Choice HIV Prevention (DCP) intervention
Other: Peer-led Dynamic Choice HIV Prevention (DCP) 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 clinician support:

  1. HIV prevention product choice with option to switch over time
  2. Rapid access to PEP from peer mentor for unplanned exposures
  3. Integration of STI testing and treatment
  4. Travel kit
  5. Phone/SMS contact for peer support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomedical HIV prevention coverage
Time Frame: 24 weeks
Percentage of follow-up months that a participant uses a biomedical HIV prevention product
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
At-risk biomedical HIV prevention coverage
Time Frame: 24 weeks
Percentage of at-risk follow-up months that a participant uses a biomedical HIV prevention product
24 weeks
Feasibility of delivery of the Peer-Led DCP intervention by peers
Time Frame: 24 weeks
Proportion of participants with Peer-led DCP intervention services delivered by peer mentor
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute of Mental Health (NIMH)
University of California, Berkeley
Infectious Diseases Research Collaboration, Uganda

Investigators

  • Principal Investigator: Catherine Koss, MD, University of California, San Francisco
  • Principal Investigator: Jane Kabami, MPH, PhD(c), Infectious Diseases Research Collaboration

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

December 19, 2025

First Posted (Actual)

December 23, 2025

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-43821
  • R01MH137799 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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