New study aims to end HIV in latinx men with One-Stop PrEP shops
NCT ID NCT06406049
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a program to help Latinx men lower their HIV risk by combining easy access to PrEP medication, social support from friends, and a national pharmacy chain. Researchers will enroll 624 men aged 18-54 and track how many start and stick with PrEP. The goal is to create a simple, community-friendly model that could be used in other cities.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pre-Exposure Prophylaxis (PrEP) medication
- What this could lead to
- If successful, this model could make HIV prevention easier and more accessible for Latinx men, reducing new infections in this community.
- What could go wrong
- This is a behavioral and service-delivery study, not a drug trial. Success depends on participants actually using PrEP, and results may not apply to other groups or regions.
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
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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
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About 624 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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May 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 54 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Being 18 to 54 years of age 4. Being a cis-gender male 5. Self-report one or more of the following behaviors and health conditions in the last 6 months which meet the Centers for Disease Control and Prevention (CDC) clinical guidelines for PrEP eligibility * Diagnosed with bacterial sexually transmitted infection (e.g., syphilis, gonorrhea, or chlamydia) * Sex with a partner who is living with HIV * Sex without a condom with two or more partners whose HIV status were unknown * Injection drug use and sharing injection equipment 6. Self-reported status as HIV negative 7. Willing to be tested for HIV Exclusion Criteria 1. Display diminished capacity to consent because of: * An inability to provide informed consent (e.g., cognitive impairment) * Severe psychiatric symptoms (e.g., mania, psychosis) that impair capacity to provide informed consent, as assessed by interviewers with Collaborative Institutional Training Initiative (CITI) Human Subjects Research and National Institutes of Health (NIH) Good Clinical Practice training 2. \<18 years old or \>54 years old 3. Self-reported living with HIV 4. Reactive HIV test (for "Amigx" seeds or "Yo Quiero" control participants) 5. Refusal of HIV test 6. Identifies as Non-Latinx 7. Individuals enrolled in other PrEP initiation interventions 8. Individuals with an active PrEP prescription in the last 6-months (oral or injectable)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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University of Miami
RECRUITINGMiami, Florida, 33136, United States
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