Community Health Programs for High Blood Pressure

TG
JR
Overseen ByJoseph Ravenell, MD
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist Black men with elevated or early-stage high blood pressure. Community Health Workers will train to identify these individuals, offer lifestyle advice, and connect them with healthcare and social services. The trial includes two approaches: a self-guided program and a barbershop-based facilitation program (Barbershop-Based Facilitation, BF), which introduces a more interactive element at local barbershops. This trial suits Black men who frequently visit participating barbershops and have high blood pressure but are not on medication. As an unphased trial, it provides a unique opportunity to explore community-based interventions for managing blood pressure.

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 prior data suggests that these programs are safe for participants?

Research has shown that managing high blood pressure in barbershops is safe and effective. One study found that when barbers discussed health with Black men, it significantly reduced their blood pressure. No major safety issues have arisen because barbers educate and check blood pressure in a familiar setting.

The Community-to-Clinic Linkage Implementation Program (CLIP) screens and connects Black men to primary care through community health workers. This program primarily helps people access existing healthcare services, avoiding the safety concerns associated with new drugs or treatments.

Overall, both strategies are well-received. They use community support to manage blood pressure, which is generally safe and effective.12345

Why are researchers excited about this trial?

Researchers are excited about the Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) and Barbershop-Based Facilitation (BF) because they bring healthcare directly into community spaces, making it easier for people to access help for high blood pressure. Unlike traditional treatments that rely on clinic visits, these programs use barbershops as a hub, making it convenient for participants to receive guidance and support in a familiar setting. This innovative approach aims to bridge the gap between community members and healthcare providers, potentially improving health outcomes by reaching people where they already are and fostering stronger community health networks.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

Research has shown that programs in barbershops can significantly lower blood pressure in Black men. One study found that men who participated in health activities at barbershops reduced their blood pressure by an average of 27 mm Hg, a substantial improvement. Another study discovered that when barbers acted as health educators and monitored blood pressure, patrons managed their high blood pressure more effectively. In this trial, participants in the Barbershop-Based Facilitation (BF) arm will engage with facilitation designed to prompt specific, actionable steps for community health workers to implement the Community-to-Clinic Linkage Implementation Program (CLIP) at the barbershop. Meanwhile, participants in the Self-Directed arm will receive the CLIP program manual. Both methods leverage trusted community spaces to enhance heart health.12367

Who Is on the Research Team?

JR

Joseph Ravenell, MD

Principal Investigator

NYU Langone Medical Center

Are You a Good Fit for This Trial?

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.
See 1 more

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).
See 9 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Barbershop-Based Facilitation (BF)Experimental Treatment2 Interventions
Group II: Self-DirectedActive Control1 Intervention

Find a Clinic Near You

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+

Published Research Related to This Trial

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

Citations

Effectiveness of a Barber-Based Intervention for Improving ...The effect of BP screening on HTN control among black male barbershop patrons was improved when barbers were enabled to become health educators, monitor BP, and ...
A Cluster-Randomized Trial of Blood-Pressure Reduction ...Health promotion by barbers resulted in larger blood-pressure reduction when coupled with medication management in barbershops by specialty-trained pharmacists.
The Los Angeles Barbershop Blood Pressure StudyThe purpose of this study in Metro Los Angeles (LA) is to compare two types of barber-based patient-centered blood pressure programs to see which type is more ...
Barbershop-Based Care Dramatically Trims Blood PressureThe men in the intervention group were able to reduce their blood pressure by an average of 27 mm Hg. This was a remarkably large result for any trial of ...
Cost-effectiveness of Hypertension Treatment by ...Pharmacist-led hypertension care in Los Angeles County Black-owned barbershops significantly improved blood pressure control in non-Hispanic Black men.
Barbershop study sustainably reduces blood pressure for ...Further, a BP <130/80 mmHg was achieved by 68.0% of the intervention group versus 11.0% of the control group (P<0.02). All men in the study received lifestyle ...
Sustainability of Blood Pressure Reduction in Black ...Among black male barbershop patrons with uncontrolled hypertension, health promotion by barbers resulted in large and sustained BP reduction over 12 months.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security