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Still Climbin': An Intervention to Improve Coping Among Black Sexual Minority Men

NCT ID: NCT04587869

Last Updated: 2025-11-13

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

369 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-09

Study Completion Date

2025-03-20

Brief Summary

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This study consists of a randomized controlled trial of a multi-session cognitive behavior therapy (CBT) group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM). Primary intervention objectives include increasing health care engagement and receipt of evidence-based preventive care, as well as better coping and reduced anticipated and internalized stigma, and medical mistrust among intervention participants.

Detailed Description

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This study is a randomized controlled trial of Still Climbin', an 8-session cognitive behavior therapy (CBT) group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM). Designed to be flexible for use in community settings, this intervention was developed in partnership with community stakeholders who emphasized the need for a community-based program outside of the health care system, and without a specific disease focus. It intends to give Black SMM a safe space to receive support for the whole of their identity and to openly discuss barriers to health care. Participants will be followed for 12 months. The effectiveness of the Still Climbin' intervention will be assessed on health care engagement and receipt of evidence-based preventive care, through surveys administered at multiple points throughout the intervention period. These outcomes will be confirmed with information from medical records. A total of 370 Black participants will be recruited and randomly assign 185 to receive the coping intervention and 185 to a no-treatment control. There will be about 10 groups of about 15 participants each for both intervention and control. Participants will be randomized to an intervention or control group after they complete the baseline survey. Participants will complete four surveys, starting with the baseline survey, and followed by 4-, 8-, and 12-month post-baseline follow-up surveys to assess health care engagement and receipt of evidence-based preventive care (e.g., cancer and diabetes screening, cardiovascular disease prevention, influenza vaccination, HIV prevention), and other topics such as coping strategies, stigma, and discrimination. The intervention is hypothesized to show increased health care engagement and receipt of evidence-based preventive care, in addition to better coping and reduced medical mistrust than the control group.

Conditions

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Discrimination, Social Health Care Utilization

Keywords

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Black/African American sexual minority men

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes assessor does not randomize participant until after the baseline assessment

Study Groups

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Intervention

The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).

Group Type EXPERIMENTAL

CBT Coping Intervention

Intervention Type BEHAVIORAL

A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).

No-treatment control

Participants who are assigned to the control group will not receive the intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CBT Coping Intervention

A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Biologically male at birth
* Identify as male
* Self-identify as a Black/African American
* Report having sex with men in the past 24 months
* Anticipate being available for the next 12 months to attend study visits
* Able to interact and communicate in written and spoken English.

Exclusion Criteria

* Unwilling/Unable to provide informed consent
* Cisgender women
* Transgender women
* Transgender men
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Massachusetts, Boston

OTHER

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role collaborator

APLA Health

UNKNOWN

Sponsor Role collaborator

RAND

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Bogart, PhD

Role: PRINCIPAL_INVESTIGATOR

RAND

Locations

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APLA Health

Los Angeles, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01MD014722

Identifier Type: NIH

Identifier Source: org_study_id

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