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

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ClinicalTrials.gov Identifier: NCT04225832
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : April 19, 2022
Sponsor:
Collaborator:
Bienestar Human Services, Inc.
Information provided by (Responsible Party):
RAND

Study Description
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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).

Condition or disease Intervention/treatment Phase
HIV Behavioral: CBT Coping Intervention Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessor does not randomize participant until after the baseline assessment
Primary Purpose: Prevention
Official Title: A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among Latinx Sexual Minority Men
Actual Study Start Date : January 20, 2020
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CBT Coping Intervention
The intervention is an 8-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 among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM).
 Behavioral: CBT Coping Intervention
A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.
No Intervention: Control
Participants who are randomized to the control condition will be referred to the standard of care program at Bienestar, which includes an ongoing weekly open wellness-oriented support group available to all clients.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants who are HIV tested at least annually [ Time Frame: from baseline to 12-months ]
    Participants report being tested for HIV at least once in the past 12 months

  2. Proportion of participants who have taken PrEP in the past 12 months [ Time Frame: from baseline to 12-months ]
    Participants report taking PrEP at any follow-up time-point


Secondary Outcome Measures :
  1. Change in average level of adaptive coping, measured by the Brief COPE [ Time Frame: from baseline to 12-months ]
    Average adaptive coping rating on the Brief COPE scale (higher=better coping; range=1-4)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:  
  • biologically male at birth
  • identify as male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04225832


Contacts
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Contact: Laura Bogart, PhD (310) 393-0411 ext 7281 lbogart@rand.org
Contact: Terry Marsh, MPH (310) 393-0411 ext 6846 tmarsh@rand.org

Locations
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United States, California
Bienestar Human Services, Inc Recruiting
Los Angeles, California, United States, 90022
Contact: Ronald Brooks, PhD         
Sponsors and Collaborators
RAND
Bienestar Human Services, Inc.
Investigators
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Principal Investigator: Laura Bogart, PhD RAND
  Study Documents (Full-Text)

Documents provided by RAND:
Study Protocol and Statistical Analysis Plan  [PDF] January 6, 2020

More Information
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Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT04225832    
Other Study ID Numbers: R01MH121256 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: April 19, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RAND:
Latino/Hispanic/Latinx
men who have sex with men