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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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The CLIP program will train Community Health Workers (CHWs) to screen and identify Black men with elevated blood pressure (BP) or stage 1 hypertension (HTN), initiate lifestyle counseling; and link them to primary care and social services.
The study will consist of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Barbershop-Based Facilitation (BF) | Experimental | Participants will receive the Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) program manual and receive exposure to Barbershop-Based Facilitation (BF), which is designed to stimulate specific, actionable steps that community health workers (CHWs) can undertake to implement CLIP at the barbershop. |
|
| Self-Directed | Active Comparator | Participants will receive the Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) program manual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) | Behavioral | Multilevel intervention designed to mitigate adverse social determinants of health (SDoH) via linkage to care, health system navigation, and referral to social services. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure (SBP) Levels | All participants will have office blood pressure (BP) measured on their non-dominant arm with an Omron HEM-907XL BP device. 3 BP readings separated by one minute will be obtained at each visit. The 3 BP readings will be averaged to obtain mean BP. SBP Levels are classified as follows:
| Baseline, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diastolic Blood Pressure (DBP) Levels | All participants will have office blood pressure (BP) measured on their non-dominant arm with an Omron HEM-907XL BP device. At each visit, 3 BP readings separated by one minute will be obtained. The 3 BP readings will be averaged to obtain study BP. DBP Levels are classified as follows:
|
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Inclusion Criteria:
Exclusion Criteria:
Based on self-identification.
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Ravenell, MD | NYU Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40482027 | Derived | Arabadjian M, Green T, Foti K, Dubal M, Poudel B, Christenson A, Wang Z, Dietz K, Brown D, Liriano K, Onaga E, Mantello G, Schoenthaler A, Cooper LA, Spruill TM, Ogedegbe G, Ravenell J. Community Engagement for Effective Recruitment of Black Men at Risk for Hypertension: Baseline Data From the Community-to-Clinic Program (CLIP) Randomized Controlled Trial. Am J Hypertens. 2025 Oct 14;38(11):888-895. doi: 10.1093/ajh/hpaf099. | |
| 37061797 |
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The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to:
Joseph Ravenell, MD Telephone: 646-501-9932 Email: Joseph.Ravenell@nyulangone.org
The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will have access upon reasonable request. Requests should be directed to Joseph.Ravenell@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Barbershop-Based Facilitation (BF) | Behavioral | Trained and qualified facilitators assist community health workers (CHWs) to: 1) increase their confidence in delivering CLIP; 2) understand participants' concerns and beliefs about hypertension (HTN); and 3) develop skills in lifestyle counseling to help the men initiate lifestyle modification. |
|
| Baseline, Month 12 |
| Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral | Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit. | Baseline |
| Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral | Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit. | Month 6 |
| Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral | Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit. | Month 12 |
| Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral | Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit. | Month 18 |
| Number of Barbershops Completing all Components of CLIP | Measurement of the rate of adoption of Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP). | Month 12 |
| Number of Barbershops Continuing to Use CLIP at 6 Months Post-Completion of Intervention | Measurement of the sustainability of Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP). | Month 18 |
| Number of Participants Presenting with Incident Stage 2 HTN | Incident Stage 2 hypertension (HTN) is defined as:
| Baseline |
| Number of Participants Presenting with Incident Stage 2 HTN | Incident Stage 2 hypertension (HTN) is defined as:
| Month 6 |
| Number of Participants Presenting with Incident Stage 2 HTN | Incident Stage 2 hypertension (HTN) is defined as:
| Month 12 |
| Number of Participants Presenting with Incident Stage 2 HTN | Incident Stage 2 hypertension (HTN) is defined as:
| Month 18 |
| 12-Item Short Form Survey (SF-12) Questionnaire Score | The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality-of-life measure. SF-12 consists of 12 questions that are scored in various ways. The total score range is 12-48; the higher the score, the better the physical and mental health functioning. | Baseline |
| 12-Item Short Form Survey (SF-12) Questionnaire Score | The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality-of-life measure. SF-12 consists of 12 questions that are scored in various ways. The total score range is 12-48; the higher the score, the better the physical and mental health functioning. | Month 6 |
| 12-Item Short Form Survey (SF-12) Questionnaire Score | The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality-of-life measure. SF-12 consists of 12 questions that are scored in various ways. The total score range is 12-48; the higher the score, the better the physical and mental health functioning. | Month 12 |
| 12-Item Short Form Survey (SF-12) Questionnaire Score | The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality-of-life measure. SF-12 consists of 12 questions that are scored in various ways. The total score range is 12-48; the higher the score, the better the physical and mental health functioning. | Month 18 |
| Cost per Millimeters of Mercury (mm Hg) Reduction in Blood Pressure (BP) | Dollar amount associated with a 1-mm Hg reduction in BP. Lower costs are considered more desirable outcomes. | Up to Month 18 |
| Cost per Incident Stage 2 Hypertension (HTN) Case Prevented | Dollar amount associated with the prevention of an Incident Stage 2 HTN case. Lower costs are considered more desirable outcomes. Incident Stage 2 HTN is defined as:
| Up to Month 18 |
| Derived |
| Ravenell J, Green T, Arabadjian M, Schoenthaler A, Ogedegbe O. Barbershop-Facilitated Community-to-Clinic Linkage Implementation Program: Rationale and Protocol for a Novel Program to Prevent Hypertension Among Black Men. Am J Hypertens. 2023 Apr 15;36(5):240-247. doi: 10.1093/ajh/hpac133. |