HIV/AIDSNCT07787988
Peer-led Dynamic Choice HIV Prevention for Women: The Peer-led DCP Randomized Trial
A study testing Peer-led Dynamic Choice HIV Prevention (DCP) intervention in people with HIV/AIDS and HIV/AIDS Prevention, run by University of California, San Francisco at 1 site in Uganda.
Trial 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 more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, HIV/AIDS Prevention
- What is being tested?
- Peer-led Dynamic Choice HIV Prevention (DCP) intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteUganda
- Study dates
- 1 Oct 2026to 31 Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site, 1 recruiting
- Recruiting
Infectious Diseases Research Collaboration
Kampala
Jane Kabami, MPH, PhDc, +256 312 281-479, jkabami@idrc-uganda.org
About this study
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.
- Conditions
- HIV/AIDS, HIV/AIDS Prevention
- Being tested
- Peer-led Dynamic Choice HIV Prevention (DCP) intervention
- Keywords
- Biomedical HIV Prevention, Peer Mentor Intervention, Uganda, Dynamic Choice HIV Prevention
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Peer-led Dynamic Choice HIV Prevention (DCP) intervention | Experimental | Participants in the experimental arm will receive the Peer-led Dynamic Choice HIV Prevention intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomedical HIV prevention coverage
Percentage of follow-up time that a participant uses a biomedical HIV prevention product.
Measured: 48 weeks
Secondary outcomes (1)
Biomedical HIV prevention coverage
Percentage of follow-up time that a participant uses a biomedical HIV prevention product.
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Oct 2026
- Primary completion30 Aug 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hybrid Type 1 cluster randomized trial to test the effectiveness and implementation outcomes of a Peer-led Dynamic Choice HIV Prevention intervention for women.
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Infectious Diseases Research Collaboration, Uganda, University of California, Berkeley
- Responsible party
- Sponsor
- Investigators
- Catherine Koss, MD, Principal investigator, University of California, San FranciscoJane Kabami, PhD, MPH, Principal investigator, Infectious Diseases Research Collaboration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787988
- Sponsor's protocol ID
- 26-46409
- Other IDs
- R01MH137799
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Select de-identified data will be shared with the NIMH Data Archive.