NCT05447962

Community-engaged Hypertension Prevention Program in Black Men

Community-engaged Implementation Study of Hypertension Prevention and Navigation in Black Men

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 430 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP)	Multilevel intervention designed to mitigate adverse social determinants of health (SDoH) via linkage to care, health system navigation, and referral to social services.
BEHAVIORAL	Barbershop-Based Facilitation (BF)	Trained and qualified facilitators assist community health workers (CHWs) to: 1) increase their confidence in delivering CLIP; 2) understand participants' concerns and beliefs about hypertension (HTN); and 3) develop skills in lifestyle counseling to help the men initiate lifestyle modification.

Timeline

• Start date: 2022-10-01
• Primary completion: 2025-03-18
• Completion: 2025-09-30
• First posted: 2022-07-07
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States