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PrEP goes local: Community-Based HIV prevention trial launches in rio

NCT ID NCT07584122

Prevention Sponsor: Oswaldo Cruz Foundation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aims to make HIV prevention easier to access for underserved groups in Rio de Janeiro, such as gay and bisexual men, transgender women, and sex workers. Instead of requiring clinic visits, participants can get daily PrEP pills and support through community organizations, mobile units, or telehealth. Researchers will see if this approach helps more people start and stay on PrEP, with the goal of reducing new HIV infections.

What this could mean

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

Active substance
Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) oral PrEP
What this could lead to
If successful, this could show that offering PrEP in community settings helps more at-risk people start and stay on HIV prevention, reducing new infections in underserved areas.
What could go wrong
This is an early feasibility study with 400 participants, so results may not apply broadly. Daily pill adherence can be challenging, and the study does not directly measure HIV infection rates.

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 400 people

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

Started

Sep 2025

Expected to finish

Dec 2026

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

Anyone

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: * Individuals aged 15 years or older * Gay, bisexual, and other men who have sex with men (MSM) * Transgender women and travestis * Other sexual and gender minorities (SGM) * Cisgender women in situations of social or economic vulnerability * Sex workers * Individuals seeking HIV testing and/or pre-exposure prophylaxis (PrEP) * HIV-negative at screening * Willing and interested in initiating PrEP * Eligible for PrEP according to Brazilian national guidelines Exclusion Criteria: * Positive HIV test result at screening or during study participation * Individuals not eligible for PrEP according to Brazilian national guidelines

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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 infections

How to take part

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

  1. The places running it

    2 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

  • Hospital Geral de Nova Iguaçu

    RECRUITING

    Nova Iguaçu, Rio de Janeiro, 26030-380, Brazil

  • Instituto Nacional de Infectologia Evandro Chagas

    RECRUITING

    Rio de Janeiro, Rio de Janeiro, 21040360, Brazil

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