Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04587869
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2020-10-01
Brief Title:
Still Climbin An Intervention to Improve Coping Among Black Sexual Minority Men
Sponsor:
RAND
Organization:
RAND
Study Overview
Official Title:
Still Climbin A Randomized Controlled Trial to Improve Coping Medical Mistrust and Healthcare Engagement Among Black Sexual Minority Men
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None