HIV/AIDSNCT07298785
Peer-led Dynamic Choice HIV Prevention for Women: The Peer-led DCP Pilot Study
A study testing Peer-led Dynamic Choice HIV Prevention (DCP) intervention in people with HIV/AIDS, run by University of California, San Francisco at 1 site in Uganda.
Trial summary
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… 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
- 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
- 60 participants
- Where
- 1 siteUganda
- Study dates
- 27 Jan 2026to 14 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 >=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
Who cannot join
- Contraindication to country-recommended PrEP regimen per national guidelines
- Participation in another HIV prevention study
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the detailed description
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.
- Conditions
- HIV/AIDS
- 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 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
| Study group | Role | What they receive |
|---|---|---|
| Peer-led Dynamic Choice HIV Prevention (DCP) intervention | Experimental | Not described Receives: Other: Peer-led Dynamic Choice HIV Prevention (DCP) intervention |
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 months that a participant uses a biomedical HIV prevention product
Measured: 24 weeks
Secondary outcomes (2)
At-risk biomedical HIV prevention coverage
Percentage of at-risk follow-up months that a participant uses a biomedical HIV prevention product
Measured: 24 weeks
Feasibility of delivery of the Peer-Led DCP intervention by peers
Proportion of participants with Peer-led DCP intervention services delivered by peer mentor
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start27 Jan 2026
- Primary completion14 Aug 2026
- Study completion14 Aug 2026
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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm pilot trial to refine and pilot test the Peer-led DCP intervention.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
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, MPH, PhD(c), Principal investigator, Infectious Diseases Research Collaboration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298785
- Sponsor's protocol ID
- 25-43821
- Other IDs
- R01MH137799
- Status last verified
- Oct 2026
- First submitted
- 19 Dec 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Pilot Study
- ClinicalTrials.gov ID
- NCT07298785
- Acronym / sponsor ID
- 25-43821
- Conditions
- HIV/AIDS
- Keywords
- Biomedical HIV Prevention, Peer Mentor Intervention, Uganda, Dynamic Choice HIV Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- 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
- 27 Jan 2026 (actual)
- Primary completion
- 14 Aug 2026 (actual)
- Study completion
- 14 Aug 2026 (actual)
- First posted
- 23 Dec 2025 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm pilot trial to refine and pilot test the Peer-led DCP intervention.
| Arm | Type | Receives |
|---|---|---|
| Peer-led Dynamic Choice HIV Prevention (DCP) intervention | Experimental | Other: Peer-led Dynamic Choice HIV Prevention (DCP) intervention |
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 >=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
Key exclusion criteria (2 listed)
- Contraindication to country-recommended PrEP regimen per national guidelines
- Participation in another HIV prevention study
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 clinician support: 1. HIV prevention product choice with option to switch over time 2. Rapid access to PEP from peer mentor for unplanned exposures 3. Integration of STI testing and treatment 4. Travel kit 5. Phone/SMS contact for peer support | Other | Peer-led Dynamic Choice HIV Prevention (DCP) intervention |
Primary outcome
Biomedical HIV prevention coverage
Time frame: 24 weeks
Percentage of follow-up months that a participant uses a biomedical HIV prevention product
2 secondary outcomes
At-risk biomedical HIV prevention coverage
Time frame: 24 weeks
Feasibility of delivery of the Peer-Led DCP intervention by peers
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Catherine Koss, MD principal investigator
University of California, San Francisco
Jane Kabami, MPH, PhD(c) 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, 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 2 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomedical HIV prevention coverage (time frame: 24 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.