Community-engaged Hypertension Prevention Program in Black Men

Not Applicable

Active, not recruiting

• Conditions: Hypertension
• Interventions: Behavioral: Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP); Behavioral: Barbershop-Based Facilitation (BF)

• Registration Number: NCT05447962
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-07-01
• Study First Posted: 2022-07-07
• Study Start: 2022-10-01
• Primary Completion: 2025-03-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-18
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 430

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Barbershop-Based Facilitation (BF)	Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP)	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.
Barbershop-Based Facilitation (BF)	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.
Self-Directed	Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP)	Participants will receive the Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) program manual.

Primary Outcome Measures

Name	Time	Method
Change in Systolic Blood Pressure (SBP) Levels	Baseline, Month 12	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

Secondary Outcome Measures

Name	Time	Method
Number of Barbershops Continuing to Use CLIP at 6 Months Post-Completion of Intervention	Month 18	Measurement of the sustainability of Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP).
Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral	Month 18	Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit.
Number of Participants Presenting with Incident Stage 2 HTN	Month 18	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.
Change in Diastolic Blood Pressure (DBP) Levels	Baseline, Month 12	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.
12-Item Short Form Survey (SF-12) Questionnaire Score	Month 18	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.
Number of Barbershops Completing all Components of CLIP	Month 12	Measurement of the rate of adoption of Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP).
Cost per Millimeters of Mercury (mm Hg) Reduction in Blood Pressure (BP)	Up to Month 18	Dollar amount associated with a 1-mm Hg reduction in BP. Lower costs are considered more desirable outcomes.
Cost per Incident Stage 2 Hypertension (HTN) Case Prevented	Up to Month 18	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States