Still Climbin': A Randomized Controlled Trial to Improve Coping, Medical Mistrust, and Healthcare Engagement Among Black Sexual Minority Men

  • STATUS
    Recruiting
  • End date
    Nov 30, 2024
  • participants needed
    370
  • sponsor
    RAND
Updated on 23 October 2022
Accepts healthy volunteers

Summary

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.

Description

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.

Details
Condition Discrimination, Social, Health Care Utilization
Treatment CBT Coping Intervention
Clinical Study IdentifierNCT04587869
SponsorRAND
Last Modified on23 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 in Los Angeles County and 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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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