A Latino MSM Focused Pre-Exposure Prophylaxis Uptake Intervention

NCT05434390 | Completed DMC

• 1 other identifier: IRB#21-002132
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV

Keywords

HIV prevention; Pre-exposure prophylaxis; Latino men who have sex with men

Outcome Measures

Primary Outcomes (6)

• PrEP initiation

  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

  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

  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

  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

  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

  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 Outcomes (2)

• Changes in Readiness to Adopt PrEP

  assessed at 1-month follow-up

• Changes in Readiness to Adopt PrEP

  assessed at 3-month follow-up

Study Arms (2)

Latino MSM PrEP intervention

EXPERIMENTAL

The Latino MSM PrEP intervention consists of 4 small group sessions with concurrent peer navigation and counseling.

Behavioral: Estoy PrEParado/ I am PrEPared intervention

Control condition

ACTIVE COMPARATOR

The control condition consists of usual care at the study site (i.e., referrals to PrEP services).

Behavioral: Usual Care

Interventions

Estoy PrEParado/ I am PrEPared intervention BEHAVIORAL

Participants will receive an Information, Motivation, and Behavioral skills model PrEP intervention tailored for mixed immigrant status Latino men who have sex with men

Latino MSM PrEP intervention

Usual Care BEHAVIORAL

Participants will be offered PrEP navigation services as part of usual care at the study site.

Control condition

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: cisgender male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Bienestar Human Services, Inc.: collaborator

Study Sites (1)

Bienestar Human Services

Los Angeles, California, 90022, United States

Location

Study Officials

• Ronald A Brooks, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel model. Participants will be randomly assigned to either an intervention or control arm of the study.

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 28, 2022
• Study Start: October 3, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (1)