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Can a personal guide help more men stay on the HIV prevention pill?

NCT ID NCT06872307

Prevention Sponsor: Brown University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 16, 2026 · Last updated Oct 16, 2026

Summary

Researchers are testing whether a strengths-based patient navigation program helps men start and stay on PrEP, a daily pill that greatly lowers the risk of getting HIV. The trial enrolls 300 men who have sex with men and receive care at community health centers. Half receive the navigation program, which helps them work through insurance, cost, and clinic barriers, and half receive standard care. The study measures whether men pick up their PrEP prescriptions, have protective drug levels, and stay in care over time.

What this could mean

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

Active substance
strengths-based patient navigation, a behavioral program that helps men overcome barriers to getting and staying on PrEP
What this could lead to
If it works, this could give community health centers a practical, cost-effective way to help more men start and stay on PrEP, which may reduce new HIV infections.
What could go wrong
The approach may not work as well in a large, real-world trial as it did in earlier testing, and results can vary by clinic. Navigation cannot fix every barrier, such as lack of insurance or housing.

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 300 people

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

Started

Oct 2024

Expected to finish

Jul 2028

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

18 years and older

Sex

Male 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: * Aged 18 years and older * Assigned male sex at birth * Report at least one male sex partner in the past 12 months * Meet the CDC eligibility criteria for PrEP * Have not taken PrEP for at least 30 days * Are HIV-negative based on antibody testing at the time of enrollment * Understand and speak English * Able to provide informed consent * Agree to authorize study access to their EHR and pharmacy fill data. Eligible patients who are interested in participating will be consented and enrolled into the study. Exclusion Criteria: * Under the age of 18 * Assigned female sex at birth * Has not had a male sex partner in the past 12 months * Does not meet CDC eligibility criteria for PrEP * Has taken PrEP within the last 30 days * HIV-positive or inconclusive HIV status based on antibody testing at the time of enrollment * Does not understand or speak English * Unable to provide informed consent * Does not agree to authorize study access to their EHR and pharmacy fill data.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

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

HIV infection primary HIV prevention

How to take part

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

  1. The places running it

    3 sites. 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

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • The Rhode Island Public Health Institute

    RECRUITING

    Providence, Rhode Island, 02907, United States

  • University of Mississippi Medical Center

    RECRUITING

    Jackson, Mississippi, 39216, United States

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