A Latino MSM Focused Pre-Exposure Prophylaxis Uptake Intervention

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05434390
• Other study ID #: IRB#21-002132
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: April 2024

Study information

• Verified date: June 2022
• Source: University of California, Los Angeles
• Contact: Ronald A Broooks, PhD
• Phone: 310-794-0773
• Email: rabrooks[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

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

Locations

Country	Name	City	State
United States	Bienestar Human Services	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Bienestar Human Services, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Changes in Readiness to Adopt PrEP	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
Secondary	Changes in Readiness to Adopt PrEP	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