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NCT Number: NCT07298785

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

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Infectious Diseases Research Collaboration

Kampala, Uganda

Location status: Recruiting

Location contact

Jane Kabami, MPH, PhDc

CONTACT

[email protected]

+256 312 281-479

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Peer-led Dynamic Choice HIV Prevention (DCP) intervention

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:

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

Primary outcomes

  1. Biomedical HIV prevention coverage

    Time frame: 24 weeks

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

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Koss, MD

CONTACT

[email protected]

415-476-4082

Lisa Georgetti Gomez, MSPH

CONTACT

[email protected]

415-539-5688

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

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

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 23, 2025
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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