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Recruiting NCT07298785

Peer-led Dynamic Choice HIV Prevention for Women: The Peer-led DCP Pilot Study

No phase Interventional HIV/AIDS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peer-led Dynamic Choice HIV Prevention (DCP) intervention.
Who it may be relevant to
Registry conditions: HIV/AIDS. Basic parameters: from 15 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Uganda
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Peer-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 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

Primary outcome measures

  • Biomedical HIV prevention coverage [Time frame: 24 weeks]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Contraindication to country-recommended PrEP regimen per national guidelines
  • Participation in another HIV prevention study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Uganda · 1 center
  • Infectious Diseases Research Collaboration — Kampala

Identifiers

NCT: NCT07298785 · 25-43821 · R01MH137799

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗