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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07787988

Enrollment

560

Registered

2026-08-26

Start date

2026-09-15

Completion date

2029-12-31

Last updated

2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS, HIV/AIDS Prevention

Keywords

Biomedical HIV Prevention, Peer Mentor Intervention, Uganda, Dynamic Choice HIV Prevention

Brief summary

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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention 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.

Eligibility

Sex/Gender

FEMALE

Age

15 Years to No maximum

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

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

Design outcomes

Primary

Measure	Time frame	Description
Biomedical HIV prevention coverage	48 weeks	Percentage of follow-up time that a participant uses a biomedical HIV prevention product.

Secondary

Measure	Time frame	Description
Biomedical HIV prevention coverage	96 weeks	Percentage of follow-up time that a participant uses a biomedical HIV prevention product.

Countries

Uganda

Contacts

CONTACTCatherine Koss, MD

catherine.koss@ucsf.edu415-476-4082

CONTACTLisa Georgetti Gomez, MSPH

lisa.georgetti@ucsf.edu415-539-5688

PRINCIPAL_INVESTIGATORCatherine Koss, MD

University of California, San Francisco

PRINCIPAL_INVESTIGATORJane Kabami, PhD, MPH

Infectious Diseases Research Collaboration

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026