A Latino MSM Focused Pre-Exposure Prophylaxis Uptake Intervention

Not Applicable

• Conditions: HIV
• Interventions: Behavioral: Usual Care; Behavioral: Estoy PrEParado/ I am PrEPared intervention

• Registration Number: NCT05434390
• Lead Sponsor: University of California, Los Angeles

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.

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 Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-21
• Study First Posted: 2022-06-28
• Study Start: 2022-10-03
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-08
• Primary Completion: 2023-12
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control condition	Usual Care	The control condition consists of usual care at the study site (i.e., referrals to PrEP services).
Latino MSM PrEP intervention	Estoy PrEParado/ I am PrEPared intervention	The Latino MSM PrEP intervention consists of 4 small group sessions with concurrent peer navigation and counseling.

Primary Outcome Measures

Name	Time	Method
PrEP initiation	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).
PrEP adherence urine sample	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.
PrEP adherence single measure	assessed at 3-month follow-up	We will assess adherence to the PrEP medication using a single-item self-rating adherence measure.

Secondary Outcome Measures

Name	Time	Method
Changes in Readiness to Adopt PrEP	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).

Trial Locations

Locations (1)

Bienestar Human Services; 🇺🇸 Los Angeles, California, United States