HIV
Conditions
Keywords
HIV prevention, Pre-exposure prophylaxis, Latino men who have sex with men
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.
Interventions
BEHAVIORALEstoy 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
BEHAVIORALUsual Care
Participants will be offered PrEP navigation services as part of usual care at the study site.
Sponsors
University of California, Los Angeles
Bienestar Human Services, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Parallel model. Participants will be randomly assigned to either an intervention or control arm of the study.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP initiation | 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). |
| PrEP adherence single measure | assessed at 1-month follow-up | We will assess adherence to the PrEP medication using a single-item self-rating adherence measure. |
| PrEP adherence urine sample | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Readiness to Adopt PrEP | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRonald A Brooks, PhD
University of California, Los Angeles
Outcome results
None listed