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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-led Dynamic Choice HIV Prevention for Women: The Peer-led DCP Randomized Trial
- ClinicalTrials.gov ID
- NCT07787988
- Acronym / sponsor ID
- 26-46409
- Conditions
- HIV/AIDS, HIV/AIDS Prevention
- Keywords
- Biomedical HIV Prevention, Peer Mentor Intervention, Uganda, Dynamic Choice HIV Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Infectious Diseases Research Collaboration, Uganda, University of California, Berkeley
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 30 Aug 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Hybrid Type 1 cluster randomized trial will test the Peer-led Dynamic Choice HIV Prevention (DCP) intervention compared to standard of care.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Peer-led Dynamic Choice HIV Prevention (DCP) intervention | Experimental | Other: Peer-led Dynamic Choice HIV Prevention (DCP) interventionParticipants in the experimental arm will receive the Peer-led Dynamic Choice HIV Prevention 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer-led Dynamic Choice HIV Prevention (DCP) interventionThe 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. | Other | Peer-led Dynamic Choice HIV Prevention (DCP) intervention |
Primary outcome
Biomedical HIV prevention coverage
Time frame: 48 weeks
Percentage of follow-up time that a participant uses a biomedical HIV prevention product.
1 secondary outcome
Biomedical HIV prevention coverage
Time frame: 96 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes. Select de-identified data will be shared with the NIMH Data Archive.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catherine Koss, MD principal investigator
University of California, San Francisco
Jane Kabami, PhD, MPH principal investigator
Infectious Diseases Research Collaboration
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Koss, MD (415-476-4082, catherine.koss@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomedical HIV prevention coverage (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.