Not provided
Not provided
Not provided
Not provided
Not provided
NIH terminated the study due to shifted policy priorities
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Massachusetts, Boston | OTHER |
| University of Southern California | OTHER |
| APLA Health | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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-treatment control | No Intervention | Participants who are assigned to the control group will not receive the intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT Coping Intervention | Behavioral | A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM). |
| Measure | Description | Time Frame |
|---|---|---|
| Inadequate Healthcare Utilization | Indicator that the individual reported (1) fewer than 1 ambulatory visit AND (2) at least 1 emergency department visit (without subsequent hospitalization) or at least 1 hospitalization in the past 4 months at any of the 3 follow-up assessments (4, 8, and 12 months post-baseline) | baseline to 12-month post-baseline |
| Proportion of Evidence-based Care Components Received Across Follow-up Assessments | For each individual, this measure is the number of components that were received at any time across the 3 follow-up assessments divided by the number of components they were eligible for at any time across the 3 follow-up assessments, expressed as a proportion. 25 components were evaluated and eligibility for each component varies by individual and follow-up period. | baseline to 12 months post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Adaptive Coping Strategies (Social Support Seeking) | Average adaptive coping rating on the Brief COPE scale, social support items (higher=better coping; range=1-4) | 4-, 8-, and 12-months post-baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Biologically male at birth; Identify as male
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laura Bogart, PhD | RAND | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APLA Health | Los Angeles | California | 90016 | United States |
Following publication of the main study papers, de-identified survey data will be made publicly available to researchers who successfully complete a registration process after requesting to use the data. The data made available will not contain any direct or indirect identifiers. Users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.
Not provided
For three years, following publication of the main study papers.
Users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource. Users must notify the institutional review board of their institution of their intention to use the data and their procedures for data management and security. Users must submit proposals regarding intended use of the data; the RAND study team and the RAND Human Subjects Protections Committee (HSPC) will determine the scientific soundness of the proposal as part of the decision for the researcher to be able to access the dataset.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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). CBT Coping Intervention: A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM). |
| FG001 | No-treatment Control | Participants who are assigned to the control group will not receive the intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). CBT Coping Intervention: A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Inadequate Healthcare Utilization | Indicator that the individual reported (1) fewer than 1 ambulatory visit AND (2) at least 1 emergency department visit (without subsequent hospitalization) or at least 1 hospitalization in the past 4 months at any of the 3 follow-up assessments (4, 8, and 12 months post-baseline) | The outcome is missing for all participants (n=53) who did not participate in any follow-up surveys (nonresponse weights were used to account for potential bias). The outcome was never missing among those who participated in any follow-up surveys. | Posted | Count of Participants | Participants | baseline to 12-month post-baseline |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). CBT Coping Intervention: A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke and other nervous system disorder | Nervous system disorders | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Bogart | RAND | 3103930411 | 7281 | lbogart@rand.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2020 | Jun 28, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 4, 2023 | Jun 28, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D063508 | Social Discrimination |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Outcomes assessor does not randomize participant until after the baseline assessment
| Grant Termination |
|
| too busy |
|
| Withdrawal by Subject |
|
| Other |
|
| BG001 | No-treatment Control | Participants who are assigned to the control group will not receive the intervention. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Inadequate healthcare utilization | Indicator that the individual reported (1) fewer than 1 ambulatory visit AND (2) at least 1 emergency department visit (without subsequent hospitalization), or at least 1 hospitalization in the past 4 months before baseline | This outcome was missing for 5 participants (1.4%) who did not respond to at least one of 3 items asking about hospital visits, ER visits, and urgent care visits | Count of Participants | Participants | No |
|
| Proportion of evidence-based care components received | For each individual, this measure is the number of components that were received divided by the number of components they were eligible for, expressed as a proportion. 25 components were evaluated and eligibility for each component varies by individual. | Mean | Standard Deviation | proportion |
|
| Adaptive coping (social support seeking) | This outcome was missing for n=4 (1.1%), participants who did not respond to any of the 4 survey items included in this scale | Mean | Standard Deviation | units on a 4-point scale (range 1-4) |
|
| OG001 | No-treatment Control | Participants who are assigned to the control group will not receive the intervention. |
|
|
|
| Primary | Proportion of Evidence-based Care Components Received Across Follow-up Assessments | For each individual, this measure is the number of components that were received at any time across the 3 follow-up assessments divided by the number of components they were eligible for at any time across the 3 follow-up assessments, expressed as a proportion. 25 components were evaluated and eligibility for each component varies by individual and follow-up period. | The outcome is missing for all participants (n=53) who did not participate in any follow-up surveys (nonresponse weights were used to account for potential bias). The outcome was never missing among those who participated in any follow-up surveys. | Posted | Mean | Standard Deviation | proportion | baseline to 12 months post-baseline |
|
|
|
|
| Secondary | Adaptive Coping Strategies (Social Support Seeking) | Average adaptive coping rating on the Brief COPE scale, social support items (higher=better coping; range=1-4) | The outcome is missing for all participants (n=53) who did not participate in any follow-up surveys. The outcome is missing for an additional n=10 (3.2%) participants who did not complete any of the 4 survey items included in the scale. Because this measure was analyzed in a repeated measures regression framework where each participant may contribute up to 3 observations (and may or may not complete each assessment), the sample size varies by assessment. | Posted | Mean | Standard Deviation | units on a scale (range 1-4) | 4-, 8-, and 12-months post-baseline |
|
|
|
|
| 1 |
| 171 |
| 22 |
| 171 |
| 0 |
| 171 |
| EG001 | No-treatment Control | Participants who are assigned to the control group will not receive the intervention. | 0 | 198 | 17 | 198 | 0 | 198 |
| Cardiac-related hospitalization | Cardiac disorders | Non-systematic Assessment |
|
| GI related hospitalization | Gastrointestinal disorders | Non-systematic Assessment |
|
| Respiratory related hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Infection - hospitalization | Infections and infestations | Non-systematic Assessment |
|
| Accidents | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| General -surgery due to pre-existing conditions | Surgical and medical procedures | Non-systematic Assessment |
|
| Kidney failure | Renal and urinary disorders | Non-systematic Assessment |
|
| General hospitalization | Surgical and medical procedures | Non-systematic Assessment | reason unknown |
|
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 8-month assessment |
|
|
| 12-month assessment |
|
|
| Superiority |