Community Health Programs for High Blood Pressure

Overseen By Joseph Ravenell, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Antihypertensives

Disqualifiers: End-stage renal disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

430 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial excludes people who are already prescribed antihypertensive medication, so you would not be eligible if you are taking such medications.

What data supports the effectiveness of the treatment Barbershop-Based Facilitation (BF) and Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) for high blood pressure?

Research shows that barbershop-based programs can effectively lower blood pressure in Black men by linking health promotion with medication management, resulting in significant blood pressure reductions. These programs have been successful in creating sustainable health improvements, making them promising for addressing high blood pressure in community settings. ^{1 2 3 4 5}

Is the barbershop-based program for high blood pressure safe for participants?

The barbershop-based programs for high blood pressure, involving community health workers and pharmacists, have been studied for their effectiveness in managing blood pressure, but there is no specific mention of safety concerns in the available research. ^{1 2 3 5 6}

How is the Barbershop-Based Facilitation (BF) treatment for high blood pressure unique?

This treatment is unique because it uses barbershops as community health centers to screen and manage high blood pressure in Black men, involving barbers and community health workers to connect clients to healthcare services, which is different from traditional clinical settings. ^{1 2 3 5 7}

What is the purpose of this trial?

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.

Research Team

Joseph Ravenell, MD

Principal Investigator

NYU Langone Medical Center

Eligibility Criteria

This trial is for Black men who are regular customers at participating barbershops, aged 18 or older, with elevated blood pressure or untreated stage 1 hypertension. They must not be on blood pressure medication, have severe kidney disease, life-limiting conditions like advanced cancer, cognitive impairments that prevent participation in the intervention, an arm too large for BP cuffs used in the study, active substance abuse issues, or be involved in another BP-focused study.

Inclusion Criteria

I identify as male.

Repeat customer within the last 3 months

My blood pressure is slightly high or I have stage 1 hypertension.

Exclusion Criteria

I have a serious health condition that needs ongoing treatment.

I do not have any mental conditions that prevent me from participating.

You have a condition that makes it hard to measure how well the treatment is working (for example, if you are on dialysis).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Cluster randomized trial in barbershops to compare Barbershop-based Facilitation strategy vs. self-directed control on BP reduction and HTN prevention

12 months

Regular visits to barbershops

Post-implementation

Evaluation of the sustainability of the Barbershop-based Facilitation strategy and cost-effectiveness over a 10-year horizon

6 months

Follow-up

Participants are monitored for safety and effectiveness after the main trial

6 months

Treatment Details

Interventions

• Barbershop-Based Facilitation (BF)
• Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP)

Trial Overview The trial is testing two programs: Barbershop-Based Facilitation (BF) and Community-to-Clinic Linkage Implementation Program (CLIP). BF involves lifestyle counseling within barbershops while CLIP trains community health workers to screen for high blood pressure among Black men and connect them to primary care and social services.

Participant Groups

Group I: Barbershop-Based Facilitation (BF) Experimental Treatment 2 Interventions

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.

Group II: Self-Directed Active Control 1 Intervention

Participants will receive the Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) program manual.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Findings from Research

A community pharmacist-based home blood pressure monitoring program showed that a high-intensity intervention led to a greater reduction in diastolic blood pressure (DBP) compared to a low-intensity intervention, with a decrease of 3.2 mmHg (P=0.03).

The high-intensity group, which involved more personalized education and home monitoring, resulted in a significant decline in systolic blood pressure (SBP) by 13.4 mmHg, compared to a 9.0 mmHg decline in the low-intensity group, suggesting that more intensive pharmacist involvement can be beneficial for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertension outcomes through blood pressure monitoring and evaluation by pharmacists (HOME study). Zillich, AJ., Sutherland, JM., Kumbera, PA., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Barbershop-Facilitated Community-to-Clinic Linkage Implementation Program: Rationale and Protocol for a Novel Program to Prevent Hypertension Among Black Men. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Barbershops as hypertension detection, referral, and follow-up centers for black men. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A barber-based intervention for hypertension in African American men: design of a group randomized trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

It's Time for a Haircut: a Perspective on Barbershop Health Interventions Serving Black Men. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Sustainability of Blood Pressure Reduction in Black Barbershops. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of Hypertension Treatment by Pharmacists in Black Barbershops. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Hypertension outcomes through blood pressure monitoring and evaluation by pharmacists (HOME study). [2022]