Clinical trial NCT04587869: Still Climbin': An Intervention to Improve Coping Among Black Sexual Minority Men
Official title: Still Climbin': A Randomized Controlled Trial to Improve Coping, Medical Mistrust, and Healthcare Engagement Among Black Sexual Minority Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Discrimination, Social
Health Care Utilization
Keywords: Black/African American sexual minority men
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Boston
name: University of Southern California
name: APLA Health
First posted: 2020-10-14
Enrollment: 370
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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 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

Primary outcomes:
measure: Reduced proportion of participants who have inadequate healthcare utilization
timeFrame: 12-month pre-baseline to 12-month post-baseline
measure: Increased proportion of participants receiving evidence-based care across conditions
timeFrame: 12 months pre-baseline to 12 months post-baseline
Secondary outcomes:
measure: Change in adaptive coping strategies
timeFrame: Baseline to 4-, 8-, and 12-months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: APLA Health
state: California
Study officials:
affiliation: RAND
name: Laura Bogart, PhD
role: PRINCIPAL_INVESTIGATOR
References: