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NCT Number: NCT07787988

Peer-led Dynamic Choice HIV Prevention for Women: The Peer-led DCP Randomized Trial

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

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV/AIDS Prevention 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

About this study

This study will test a Peer-led Dynamic Choice HIV Prevention intervention tailored to women at elevated risk of HIV exposure in Western and South-Central Uganda. The investigators will conduct a cluster randomized trial to test the effectiveness and implementation outcomes of a Peer-led Dynamic Choice HIV Prevention intervention for women.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

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 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.

Primary outcomes

  1. Biomedical HIV prevention coverage

    Time frame: 48 weeks

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

Secondary outcomes

  1. Biomedical HIV prevention coverage

    Time frame: 96 weeks

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

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
2029
Study completion
2029
First posted
Aug 26, 2026
Registry last updated
Sep 2, 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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