NCT07298785

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
14mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Jan 2026Jun 2027

First Submitted

Initial submission to the registry

December 19, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 27, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

December 19, 2025

Last Update Submit

February 3, 2026

Conditions

HIV/AIDS

Keywords

Biomedical HIV PreventionPeer Mentor InterventionUgandaDynamic Choice HIV Prevention

Outcome Measures

Primary Outcomes (1)

  • Biomedical HIV prevention coverage

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

    24 weeks

Secondary Outcomes (2)

  • At-risk biomedical HIV prevention coverage

    24 weeks

  • Feasibility of delivery of the Peer-Led DCP intervention by peers

    24 weeks

Study Arms (1)

Peer-led Dynamic Choice HIV Prevention (DCP) intervention

EXPERIMENTAL
Other: Peer-led Dynamic Choice HIV Prevention (DCP) intervention

Interventions

Peer-led Dynamic Choice HIV Prevention (DCP) interventionOTHER

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

Peer-led Dynamic Choice HIV Prevention (DCP) intervention

Eligibility Criteria

Age15 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale sex at birth
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>=18 years or mature or mature minor \>=15 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 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infectious Diseases Research Collaboration

Kampala, Uganda

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Methods

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Catherine Koss, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Jane Kabami, MPH, PhD(c)

    Infectious Diseases Research Collaboration

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Koss, MD

CONTACT

415-476-4082catherine.koss@ucsf.edu

Lisa Georgetti Gomez, MSPH

CONTACT

415-539-5688lisa.georgetti@ucsf.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Single-arm pilot trial to refine and pilot test the Peer-led DCP intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2025

First Posted

December 23, 2025

Study Start

January 27, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

UG(1)