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Not yet recruitingNCT07787988Updated Sep 2, 2026

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

An interventional study of Peer-led Dynamic Choice HIV Prevention (DCP) intervention in HIV/AIDS and HIV/AIDS Prevention, sponsored by University of California, San Francisco. Not yet recruiting at 1 site in Uganda. Open to female participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
560
Allocation
Randomized
Ages
15 Years and older
Sex
Female
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • HIV/AIDS
  • HIV/AIDS Prevention

Keywords

  • Biomedical HIV Prevention
  • Peer Mentor Intervention
  • Uganda
  • Dynamic Choice HIV Prevention
03

Who can participate

Ages eligible
15 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age >=15 years (with parent/guardian consent required for age 15 to \<18 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/PEP based on Uganda Ministry of Health Guidelines or b) work in bar or guesthouse

Exclusion criteria

Exclusion Criteria:

  1. Contraindication to recommended PrEP/PEP regimen per Ministry of Health guidelines
  2. Participation in another HIV prevention study
  3. Aged 15 to \<18 years with no parent or guardian to provide consent
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
560 participants (estimated)

Study arms

  • Experimental
    Peer-led Dynamic Choice HIV Prevention (DCP) intervention

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

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

  • No intervention
    Standard of Care

    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

  • OtherPeer-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 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.

05

What researchers measure

Primary outcomes

  1. Biomedical HIV prevention coverage

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

    Time frame: 48 weeks

Secondary outcomes

  1. Biomedical HIV prevention coverage

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

    Time frame: 96 weeks

06

Study locations

1 site
  • Infectious Diseases Research Collaboration
    Kampala, Uganda
07

References and documents

Individual participant data

Plan to share: Yes — Select de-identified data will be shared with the NIMH Data Archive.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07787988
Lead sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH), Infectious Diseases Research Collaboration, Uganda, University of California, Berkeley
Responsible party
Sponsor
First posted
Aug 26, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Aug 30, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Sep 2, 2026

Study contacts

Catherine Koss, MD
Contact
catherine.koss@ucsf.edu
415-476-4082
Lisa Georgetti Gomez, MSPH
Contact
lisa.georgetti@ucsf.edu
415-539-5688
Catherine Koss, MD
principal investigator · University of California, San Francisco
Jane Kabami, PhD, MPH
principal investigator · Infectious Diseases Research Collaboration

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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