NCT04225832

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).

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
289

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2024

Completed
9 months until next milestone

Results Posted

Study results publicly available

August 13, 2025

Completed
Last Updated

August 13, 2025

Status Verified

November 1, 2023

Enrollment Period

4.9 years

First QC Date

January 7, 2020

Results QC Date

June 20, 2025

Last Update Submit

July 21, 2025

Conditions

HIV

Keywords

Latino/Hispanic/Latinxmen who have sex with men

Outcome Measures

Primary Outcomes (2)

  • HIV Test at Least Annually

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

    from baseline to 12-months

  • Took PrEP in the Past 12 Months

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

    from baseline to 12-months

Secondary Outcomes (1)

  • Level of Adaptive Coping

    measured at 4-months, 8-months, and 12-months post baseline

Study Arms (2)

CBT Coping Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

CBT Coping InterventionBEHAVIORAL

A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.

CBT Coping Intervention

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Details* biologically male at birth * identify as male
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • HIV-positive
  • cisgender women
  • transgender women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bienestar Human Services, Inc

Los Angeles, California, 90022, United States

Location

MeSH Terms

Conditions

Homosexuality

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehavior

Limitations and Caveats

Objective HIV testing dates and PrEP prescription data were collected (e.g., from medical records), but the US federal government (NIH) terminated the grant prematurely on March 20, 2025 before these data could be processed. These data were not fully cleaned or tabulated, and thus were not analyzed as an outcome and cannot be entered at baseline: The number of records is unknown and therefore not reported here. Thus, the primary outcomes are reported based on self-reported survey responses.

Results Point of Contact

Title
Laura Bogart, PhD
Organization
RAND
lbogart@rand.org
3103830411

Study Officials

  • Laura Bogart, PhD

    RAND

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessor does not randomize participant until after the baseline assessment
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 13, 2020

Study Start

January 20, 2020

Primary Completion

November 27, 2024

Study Completion

November 27, 2024

Last Updated

August 13, 2025

Results First Posted

August 13, 2025

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)