Clinical trial NCT05434390: A Latino MSM Focused Pre-Exposure Prophylaxis Uptake Intervention
Official title: Evaluating the Feasibility and Acceptability of a Latino MSM Focused PrEP Uptake Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Keywords: HIV prevention
Pre-exposure prophylaxis
Latino men who have sex with men
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Bienestar Human Services, Inc.
First posted: 2022-06-28
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel model. Participants will be randomly assigned to either an intervention or control arm of the study.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: PrEP initiation
timeFrame: assessed at 1-month follow-up
measure: PrEP initiation
timeFrame: assessed at 3-month follow-up
measure: PrEP adherence single measure
timeFrame: assessed at 1-month follow-up
measure: PrEP adherence single measure
timeFrame: assessed at 3-month follow-up
measure: PrEP adherence urine sample
timeFrame: assessed at 1-month follow-up
measure: PrEP adherence urine sample
timeFrame: assessed at 3-month follow-up
Secondary outcomes:
measure: Changes in Readiness to Adopt PrEP
timeFrame: assessed at 1-month follow-up
measure: Changes in Readiness to Adopt PrEP
timeFrame: assessed at 3-month follow-up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Bienestar Human Services
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Ronald A Brooks, PhD
role: PRINCIPAL_INVESTIGATOR
References: