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Peer mentors may help women stay HIV-Free – trial tests new approach

NCT ID NCT07787988

Prevention Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This trial tests whether a peer-led program that lets women choose and switch HIV prevention methods can increase consistent use compared to standard care. The program includes peer mentor support, HIV testing, access to PEP, and STI care. It enrolls HIV-negative women at elevated risk, such as those eligible for PrEP or working in bars or guesthouses. The study measures how much time participants use a biomedical prevention product.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Peer-led Dynamic Choice HIV Prevention (DCP) intervention, including peer mentor training, HIV prevention product choice, testing, PEP, STI integration, travel kit, and phone support
What this could lead to
If effective, this approach could increase consistent use of HIV prevention methods among at-risk women, reducing new infections.
What could go wrong
The trial is early and results may not show a significant difference. The intervention relies on peer mentors and remote support, which may not work in all settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 560 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV/AIDS HIV/AIDS prevention

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Infectious Diseases Research Collaboration

    Kampala, Uganda

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