Community-engaged Hypertension Prevention Program in Black Men

NYU Langone Health

Status: Active, not recruiting

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:

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.

Enrollment: 430 patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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430 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: Barbershop-Based Facilitation (BF)

Behavioral: Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP)

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)