Clinical trial NCT04225832: A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among Latinx Sexual Minority Men
Official title: A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among Latinx Sexual Minority Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Keywords: Latino/Hispanic/Latinx
men who have sex with men
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Bienestar Human Services, Inc.
First posted: 2020-01-13
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study consists of a randomized controlled trial (RCT) of a multi-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP use among Latinx sexual minority men (SMM).

Detailed description: This study consists of a randomized controlled trial (RCT) of a multi-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP use among Latinx sexual minority men (SMM). We will test intervention effects on regular HIV testing and use of prevention strategies. The intervention was developed in partnership with community stakeholders at Bienestar Human Services, Inc., a Latinx-focused organization in Los Angeles County (LAC), CA. The intervention is flexible for use in community-based organizations, such as in ongoing support groups.

The Specific Aims are:

Aim 1. To conduct a randomized controlled trial of a culturally congruent cognitive behavior therapy group intervention for immigrant Latinx sexual minority men, to test intervention effects on regular HIV testing and PrEP uptake.

Aim 2. To examine mechanisms of intervention effects on regular HIV testing and PrEP uptake, including more effective coping (e.g., reduced internalized stigma).

Aim 3. To conduct a cost-effectiveness analysis of the intervention.

Eligibility criteria: Inclusion Criteria:

* at least 18 years-old
* biologically male at birth
* identify as male
* identify as Latino
* is an immigrant
* report having sex with men in the past 12 months
* report HIV-negative or unknown serostatus
* anticipate being available for the next 12 months to attend study visits
* able to interact and communicate in spoken Spanish or English.

Exclusion Criteria:

* HIV-positive
* cisgender women
* transgender women

Primary outcomes:
measure: Proportion of participants who are HIV tested at least annually
timeFrame: from baseline to 12-months
measure: Proportion of participants who have taken PrEP in the past 12 months
timeFrame: from baseline to 12-months
Secondary outcomes:
measure: Change in average level of adaptive coping, measured by the Brief COPE
timeFrame: from baseline to 12-months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Bienestar Human Services, Inc
state: California
Study officials:
affiliation: RAND
name: Laura Bogart, PhD
role: PRINCIPAL_INVESTIGATOR
References: