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.
Full Title of Study: “Still Climbin’: A Randomized Controlled Trial to Improve Coping, Medical Mistrust, and Healthcare Engagement Among Black Sexual Minority Men”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: September 2024
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 300 Black participants will be recruited and randomly assign 150 to receive the coping intervention and 150 to a wait-list control. There will be about 10 groups of about 15 participants each for both intervention and control. Those assigned to a wait-list control group will be offered the opportunity to participate in the program after they complete their 12-month follow-up, but additional data will not be collected from them after then complete the intervention sessions. 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.
- Behavioral: CBT Coping Intervention
- A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).
Arms, Groups and Cohorts
- Experimental: 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).
- No Intervention: Wait-list control
- Participants who are referred to the wait-list control group will be offered the opportunity to participate in intervention sessions after they have completed their 12-month study participation.
Clinical Trial Outcome Measures
- Reduced proportion of participants who have inadequate healthcare utilization
- Time Frame: 12-month pre-baseline to 12-month post-baseline
- Participants report (1) fewer than 1 ambulatory visit, (2) at least 1 emergency department visit (without subsequent hospitalization), or (3) at least 1 hospitalization
- Increased proportion of participants receiving evidence-based care across conditions
- Time Frame: 12 months pre-baseline to 12 months post-baseline
- Receipt of screening and prevention for chronic diseases (e.g., cancer, cardiovascular disease, diabetes), and receipt of recommended immunizations (e.g., influenza)
- Change in adaptive coping strategies
- Time Frame: Baseline to 4-, 8-, and 12-months
- Average adaptive coping rating on the Brief COPE scale (higher=better coping; range=1-4)
Participating in This Clinical Trial
- 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 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.
- Unwilling/Unable to provide informed consent
- Cisgender women
- Transgender women
- Transgender men
Gender Eligibility: Male
Biologically male at birth; Identify as male
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- University of Massachusetts, Boston
- Provider of Information About this Clinical Study
- Overall Official(s)
- Laura Bogart, PhD, Principal Investigator, RAND
- Overall Contact(s)
- Laura Bogart, PhD, (310) 393-0411, email@example.com
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