Community-engaged Hypertension Prevention Program in Black Men

NYU Langone Health logo

NYU Langone Health

Status

Enrolling

Conditions

Hypertension

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05447962
21-01586

Details and patient eligibility

About

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.

Full description

The study will consist of: 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 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.

Enrollment

420 estimated patients

Sex

Male

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18 years of age as of date of data extraction
  • Repeat customer within the last 3 months
  • Self-identify as Black
  • Self-identify as male
  • 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

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

Trial design

420 participants in 2 patient groups

Barbershop-Based Facilitation (BF)
Experimental group
Description:
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.
Treatment:
Behavioral: Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP)
Behavioral: Barbershop-Based Facilitation (BF)
Self-Directed
Active Comparator group
Description:
Participants will receive the Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) program manual.
Treatment:
Behavioral: Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP)

Trial contacts and locations

0

Loading...

Central trial contact

Joseph Ravenell, MD; Tanisha Green

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems