A Latino MSM Focused Pre-Exposure Prophylaxis Uptake Intervention

April 16, 2026 updated by: Ronald Andrew Brooks, University of California, Los Angeles

Evaluating the Feasibility and Acceptability of a Latino MSM Focused PrEP Uptake Intervention

The clinical study will evaluate the feasibility and acceptability of a culturally tailored behavioral intervention to improve uptake of pre-exposure prophylaxis for HIV prevention among at-risk Latino men who have sex with men.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The clinical study will evaluate the feasibility and acceptability of a brief small group and peer navigation behavioral intervention to improve uptake of pre-exposure prophylaxis (PrEP) for HIV prevention among at-risk Latino men who have sex with men. The brief intervention consists of 4 small group sessions with concurrent peer navigation and counseling. Study participants will be randomized to either an intervention or control condition. Participants in the control condition will receive usual care for PrEP promotion (i.e., referral to PrEP services). The study will determine the feasibility and acceptability of the intervention among Latino men who have sex with men and assess the preliminary impact of the intervention compared to control condition in facilitating PrEP uptake.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90022
        • Bienestar Human Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years of age or older
  • assigned male at birth
  • Identifies as Latino/Hispanic origin
  • HIV-negative or HIV status unknown
  • Man who has had sex with other men in the past 24 months
  • Not currently using PrEP for HIV prevention

Exclusion Criteria:

  • Male under 18 years of age
  • Not identifying as being of Latino/Hispanic origin
  • Man who has not had sex with other men in the past 24 months
  • Identifies as cisgender or transgender Female/woman
  • Assigned female at birth

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Latino MSM PrEP intervention
The Latino MSM PrEP intervention consists of 4 small group sessions with concurrent peer navigation and counseling.
Behavioral: Estoy PrEParado/ I am PrEPared intervention
Participants will receive an Information, Motivation, and Behavioral skills model PrEP intervention tailored for mixed immigrant status Latino men who have sex with men
Active Comparator: Control condition
The control condition consists of usual care at the study site (i.e., referrals to PrEP services).
Behavioral: Usual Care
Participants will be offered PrEP navigation services as part of usual care at the study site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP initiation
Time Frame: assessed at 1-month follow-up
We will assess PrEP uptake using evidence of a prescription for Truvada® or Descovy® (participant shows us their prescription bottle in person or via a text photo).
assessed at 1-month follow-up
PrEP initiation
Time Frame: assessed at 3-month follow-up
We will assess PrEP uptake using evidence of a prescription for Truvada® or Descovy® (participant shows us their prescription bottle in person or via a text photo).
assessed at 3-month follow-up
PrEP adherence single measure
Time Frame: assessed at 1-month follow-up
We will assess adherence to the PrEP medication using a single-item self-rating adherence measure.
assessed at 1-month follow-up
PrEP adherence single measure
Time Frame: assessed at 3-month follow-up
We will assess adherence to the PrEP medication using a single-item self-rating adherence measure.
assessed at 3-month follow-up
PrEP adherence urine sample
Time Frame: assessed at 1-month follow-up
We will assess adherence to the PrEP medication by analyzing participants' urine sample to determine the presence of the medication tenofovir, a key medication in the PrEP medication.
assessed at 1-month follow-up
PrEP adherence urine sample
Time Frame: assessed at 3-month follow-up
We will assess adherence to the PrEP medication by analyzing participants' urine sample to determine the presence of the medication tenofovir, a key medication in the PrEP medication.
assessed at 3-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Readiness to Adopt PrEP
Time Frame: assessed at 1-month follow-up
We will assess changes in readiness to adopt PrEP using the PrEP Transtheoretical Stages of Change Model measure (pre-contemplation, contemplation, preparation, action & initiation, and maintenance).
assessed at 1-month follow-up
Changes in Readiness to Adopt PrEP
Time Frame: assessed at 3-month follow-up
We will assess changes in readiness to adopt PrEP using the PrEP Transtheoretical Stages of Change Model measure (pre-contemplation, contemplation, preparation, action & initiation, and maintenance).
assessed at 3-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

Bienestar Human Services, Inc.

Investigators

  • Principal Investigator: Ronald A Brooks, PhD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2022

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

August 31, 2024

Study Registration Dates

First Submitted

June 9, 2022

First Submitted That Met QC Criteria

June 21, 2022

First Posted (Actual)

June 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB#21-002132

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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