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Clinical Trials/NCT04225832
NCT04225832
Terminated
Not Applicable

A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among Latinx Sexual Minority Men

RAND1 site in 1 country289 target enrollmentJanuary 20, 2020
ConditionsHIV

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
RAND
Enrollment
289
Locations
1
Primary Endpoint
HIV Test at Least Annually
Status
Terminated
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 20, 2020
End Date
November 27, 2024
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
RAND
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

HIV Test at Least Annually

Time Frame: from baseline to 12-months

Participants report being tested for HIV at least once in the 12 months after baseline

Took PrEP in the Past 12 Months

Time Frame: from baseline to 12-months

Participants report taking PrEP at any follow-up time-point (within the 12-month follow-up time period)

Secondary Outcomes

  • Level of Adaptive Coping(measured at 4-months, 8-months, and 12-months post baseline)

Study Sites (1)

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