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| ID | Type | Description | Link |
|---|---|---|---|
| 5P20MD006875 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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This program utilizes a community-engaged research approach to implementing and evaluating a program that seeks to reduce sexual risk behavior among Black adult heterosexual men. The investigators aims are to assess the impact of this linguistically and culturally tailored HIV prevention program on the sexual risk of heterosexual, African American men aged 18 and older, to assess the intervention's impact on the more proximal social and psychosocial variables that the program is designed to change, and to identify key contextual level factors that may impact the intervention's impact across segments of this priority population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTWB intervention | Experimental | Barbershops are assigned to either experimental or active control condition. Men recruited from experimental barbershops receive a single-session group intervention focused on HIV prevention. |
|
| Cancer prevention and screening | Active Comparator | Barbershops are assigned to either experimental or control condition. Men recruited from control barbershops receive information on cancer prevention and control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTWB intervention | Behavioral | Men work in groups to complete a intervention that takes approximately two hours to complete. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sexual Behavior | Self-reported sexual behavior is the number of participants that report any unprotected anal and/or vaginal sex in the past ninety days. | Six month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tracey E Wilson, PhD | State University of New York - Downstate Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur Ashe Institute for Urban Health, Inc. | Brooklyn | New York | 11203 | United States | ||
| SUNY Downstate Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31219715 | Derived | Wilson TE, Gousse Y, Joseph MA, Browne RC, Camilien B, McFarlane D, Mitchell S, Brown H, Urraca N, Romeo D, Johnson S, Salifu M, Stewart M, Vavagiakis P, Fraser M. HIV Prevention for Black Heterosexual Men: The Barbershop Talk with Brothers Cluster Randomized Trial. Am J Public Health. 2019 Aug;109(8):1131-1137. doi: 10.2105/AJPH.2019.305121. Epub 2019 Jun 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | BTWB Intervention | Barbershops are assigned to either experimental or active control condition. Men recruited from experimental barbershops receive a single-session group intervention focused on HIV prevention. BTWB intervention: Men work in groups to complete a intervention that takes approximately two hours to complete. |
| FG001 | Cancer Prevention and Screening | Barbershops are assigned to either experimental or control condition. Men recruited from control barbershops receive information on cancer prevention and control. Cancer prevention and screening: Men are provided health education about cancer screening and prevention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BTWB Intervention | Barbershops are assigned to either experimental or active control condition. Men recruited from experimental barbershops receive a single-session group intervention focused on HIV prevention. BTWB intervention: Men work in groups to complete a intervention that takes approximately two hours to complete. |
| BG001 |
| 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 | Sexual Behavior | Self-reported sexual behavior is the number of participants that report any unprotected anal and/or vaginal sex in the past ninety days. | 352 men completed the six month assessment in the intervention arm; of these 347 provided complete data needed to calculate the outcome measure. 305 men completed the six month assessment in the control arm; of these 303 provided complete data needed to calculate the outcome measure. | Posted | Count of Participants | Participants | Six month follow-up |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BTWB Intervention | Men work in groups on a single session intervention. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incarceration | Social circumstances | Non-systematic Assessment | Participants incarcerated or at an in-patient facility as reported by contacts |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tracey Wilson, Principal Investigator | State University of New York, Downstate Medical Center | 718 270 2105 | Tracey.Wilson@downstate.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 16, 2018 | Sep 11, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 16, 2018 | Oct 16, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D018761 | Multiple Endocrine Neoplasia Type 1 |
| ID | Term |
|---|---|
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
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| Cancer prevention and screening | Behavioral | Men are provided health education about cancer screening and prevention |
|
| Brooklyn |
| New York |
| 11203 |
| United States |
| Cancer Prevention and Screening |
Barbershops are assigned to either experimental or control condition. Men recruited from control barbershops receive information on cancer prevention and control. Cancer prevention and screening: Men are provided health education about cancer screening and prevention |
| 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 | Count of Participants | Participants |
|
| Living with a sexual partner | Missing baseline data; respondent did not answer | Count of Participants | Participants |
|
| Current health insurance | Missing baseline data; respondent did not answer | Count of Participants | Participants |
|
| Currently employed | Missing baseline data; respondent did not answer | Count of Participants | Participants |
|
| High school degree or equivalent | Missing baseline data; respondent did not answer | Count of Participants | Participants |
|
| Born in U.S. | Count of Participants | Participants |
|
| In stable housing | Missing baseline data; respondent did not answer | Count of Participants | Participants |
|
| No substance use (excludes marijuana) | Missing baseline data; respondent did not answer | Count of Participants | Participants |
|
| No alcohol use | Missing baseline data; respondent did not answer | Count of Participants | Participants |
|
| No incarceration history | Missing baseline data; respondent did not answer | Count of Participants | Participants |
|
| No condomless sex | Missing baseline data; respondent did not answer | Count of Participants | Participants |
|
Men are provided with health education about prostate cancer screening and prevention in a single-session group format.
|
|
|
| 436 |
| 0 |
| 436 |
| 2 |
| 436 |
| EG001 | Cancer Prevention and Screening | Men are provided with health education about prostate cancer screening and prevention in a single-session group format. | 0 | 424 | 0 | 424 | 3 | 424 |
|
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| D009378 |
| Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|