MedDataX Logo

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

NCT ID: NCT07298785

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-12

Study Completion Date

2027-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV/AIDS

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Biomedical HIV Prevention Peer Mentor Intervention Uganda Dynamic Choice HIV Prevention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-arm pilot trial to refine and pilot test the Peer-led DCP intervention.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Peer-led Dynamic Choice HIV Prevention (DCP) intervention

Group Type EXPERIMENTAL

Peer-led Dynamic Choice HIV Prevention (DCP) intervention

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Infectious Diseases Research Collaboration, Uganda

OTHER

Sponsor Role collaborator

University of California, Berkeley

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Catherine Koss, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Jane Kabami, MPH, PhD(c)

Role: PRINCIPAL_INVESTIGATOR

Infectious Diseases Research Collaboration

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Infectious Diseases Research Collaboration

Kampala, , Uganda

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Uganda

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Catherine Koss, MD

Role: CONTACT

Phone: 415-476-4082

Email: [email protected]

Lisa Georgetti Gomez, MSPH

Role: CONTACT

Phone: 415-539-5688

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jane Kabami, MPH, PhDc

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01MH137799

Identifier Type: NIH

Identifier Source: secondary_id

View Link

25-43821

Identifier Type: -

Identifier Source: org_study_id