Community-engaged Hypertension Prevention Program in Black Men

Community-engaged Implementation Study of Hypertension Prevention and Navigation in Black Men

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP); Behavioral: Barbershop-Based Facilitation (BF)

Detailed Description

The study will consist of:

1. An implementation phase that will use a cluster randomized cluster trial of 20 barbershops among Black men with elevated BP or Stage 1 HTN, to compare the effect of the Barbershop-based Facilitation (BF) strategy (n=10 barbershops; n=210 participants) vs. self-directed control (i.e. receipt of information for implementation of CLIP without the BF strategy; n=10 barbershops; n=210 participants), on BP reduction, HTN prevention, linkage to care, and adoption of CLIP at 12 months
2. A post-implementation phase that will use Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM) to evaluate the effect of the BF strategy versus self-directed control on sustainability of CLIP 6 months after completion of the trial; and cost-effectiveness over a 10-year time horizon.

• Study Type: Interventional
• Enrollment (Actual): 430
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 years of age as of date of data extraction
2. Repeat customer within the last 3 months
3. Self-identify as Black
4. Self-identify as male
5. Have elevated blood pressure (PB) (120-129/<80 millimeters of mercury (mm Hg)) or untreated stage 1 hypertension (HTN) (130-139/80-89 mm Hg) (defined by American Heart Association's 2017 HTN clinical guidelines)

Exclusion Criteria:

1. Age <18 years
2. Prescribed antihypertensive medication
3. Diagnosis of end-stage renal disease (ESRD)
4. Condition which interferes with outcome measurement (e.g., dialysis)
5. Serious medical condition which either limits life expectancy or requires active management (e.g., cancer)
6. Cognitive impairment or other condition preventing participation in the intervention
7. Upper arm circumference >50 cm (maximum limit of the extra-large BP cuff)
8. Active alcohol or substance use disorder (i.e., not sober/abstinent for ≥ 30 days)
9. Pregnant or planning pregnancy in the next 24 months
10. Currently nursing a child
11. Current participation in another research study focused on reducing BP
12. Unwillingness to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Barbershop-Based Facilitation (BF); 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.	Behavioral: Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP); Multilevel intervention designed to mitigate adverse social determinants of health (SDoH) via linkage to care, health system navigation, and referral to social services.; Behavioral: Barbershop-Based Facilitation (BF); 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.
Active Comparator: Self-Directed; Participants will receive the Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) program manual.	Behavioral: Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP); Multilevel intervention designed to mitigate adverse social determinants of health (SDoH) via linkage to care, health system navigation, and referral to social services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: Normal: Below 120 millimeters of mercury (mm Hg); Elevated: 120-129 mm Hg; Stage 1 hypertension: 130-139 mm Hg; Stage 2 hypertension: 140 mm Hg or more; Hypertensive crisis: 180 mm Hg or more	Baseline, Month 12

Secondary Outcome Measures

Outcome Measure	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: Normal: Lower than 80 millimeters of mercury (mm Hg); Stage 1 hypertension: 80-89 mm Hg; Stage 2 hypertension: 90 mm Hg or more; Hypertensive crisis: 120 mm Hg or more.	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: Systolic Blood Pressure (SBP) of at least 140 millimeters of mercury (mm Hg)/Diastolic Blood Pressure (DBP) of at least 90 mm Hg; or; Antihypertensive medication initiation.	Baseline
Number of Participants Presenting with Incident Stage 2 HTN	Incident Stage 2 hypertension (HTN) is defined as: Systolic Blood Pressure (SBP) of at least 140 millimeters of mercury (mm Hg)/Diastolic Blood Pressure (DBP) of at least 90 mm Hg; or; Antihypertensive medication initiation.	Month 6
Number of Participants Presenting with Incident Stage 2 HTN	Incident Stage 2 hypertension (HTN) is defined as: Systolic Blood Pressure (SBP) of at least 140 millimeters of mercury (mm Hg)/Diastolic Blood Pressure (DBP) of at least 90 mm Hg; or; Antihypertensive medication initiation.	Month 12
Number of Participants Presenting with Incident Stage 2 HTN	Incident Stage 2 hypertension (HTN) is defined as: Systolic Blood Pressure (SBP) of at least 140 millimeters of mercury (mm Hg)/Diastolic Blood Pressure (DBP) of at least 90 mm Hg; or; Antihypertensive medication initiation.	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: Systolic Blood Pressure (SBP) of at least 140 millimeters of mercury (mm Hg)/Diastolic Blood Pressure (DBP) of at least 90 mm Hg; or; Antihypertensive medication initiation.	Up to Month 18

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Joseph Ravenell, MD, NYU Langone Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): March 18, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Blood pressure; Barbershop-based facilitation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 21-01586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No