NCT07787988

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
560

participants targeted

Target at P75+ for not_applicable

Timeline
40mo left

Started Sep 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

August 21, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

September 15, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2029

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

3 years

First QC Date

August 21, 2026

Last Update Submit

August 21, 2026

Conditions

HIV/AIDSHIV/AIDS Prevention

Keywords

Biomedical HIV PreventionPeer Mentor InterventionUgandaDynamic Choice HIV Prevention

Outcome Measures

Primary Outcomes (1)

  • Biomedical HIV prevention coverage

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

    48 weeks

Secondary Outcomes (1)

  • Biomedical HIV prevention coverage

    96 weeks

Study Arms (2)

Peer-led Dynamic Choice HIV Prevention (DCP) intervention

EXPERIMENTAL

Participants in the experimental arm will receive the Peer-led Dynamic Choice HIV Prevention intervention.

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

Standard of Care

NO INTERVENTION

Participants in the standard of care arm will receive brief education on HIV prevention and will be referred to the nearby health facility for HIV prevention services per national guidelines.

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 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.

Peer-led Dynamic Choice HIV Prevention (DCP) intervention

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infectious Diseases Research Collaboration

Kampala, Uganda

Location

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, PhD, MPH

    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
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Hybrid Type 1 cluster randomized trial to test the effectiveness and implementation outcomes of a Peer-led Dynamic Choice HIV Prevention intervention for women.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2026

First Posted

August 26, 2026

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

August 30, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

August 26, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Select de-identified data will be shared with the NIMH Data Archive.

Time Frame
IPD will be made available following publication.
Access Criteria
Access will be determined by NIMH Data Archive policies.

Locations

UG(1)