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Completed

NCT Number: NCT05434390

A Latino MSM Focused Pre-Exposure Prophylaxis 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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Bienestar Human Services

Los Angeles, California, 90022, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Usual Care

Behavioral

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

Primary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Bienestar Human Services, Inc.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 28, 2022
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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