Community-engaged Hypertension Prevention Program in Black Men

NCT ID: NCT05447962

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2025-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Barbershop-Based Facilitation (BF)

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 Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

Multilevel intervention designed to mitigate adverse social determinants of health (SDoH) via linkage to care, health system navigation, and referral to social services.

Barbershop-Based Facilitation (BF)

Intervention Type: BEHAVIORAL

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.

Self-Directed

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

Multilevel intervention designed to mitigate adverse social determinants of health (SDoH) via linkage to care, health system navigation, and referral to social services.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Ravenell, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

References

Arabadjian M, Green T, Foti K, Dubal M, Poudel B, Christenson A, Wang Z, Dietz K, Brown D, Liriano K, Onaga E, Mantello G, Schoenthaler A, Cooper LA, Spruill TM, Ogedegbe G, Ravenell J. Community Engagement for Effective Recruitment of Black Men at Risk for Hypertension: Baseline Data From the Community-to-Clinic Program (CLIP) Randomized Controlled Trial. Am J Hypertens. 2025 Oct 14;38(11):888-895. doi: 10.1093/ajh/hpaf099.

Reference Type: DERIVED

PMID: 40482027 (View on PubMed)

Ravenell J, Green T, Arabadjian M, Schoenthaler A, Ogedegbe O. Barbershop-Facilitated Community-to-Clinic Linkage Implementation Program: Rationale and Protocol for a Novel Program to Prevent Hypertension Among Black Men. Am J Hypertens. 2023 Apr 15;36(5):240-247. doi: 10.1093/ajh/hpac133.

Reference Type: DERIVED

PMID: 37061797 (View on PubMed)

Other Identifiers

21-01586

Identifier Type: -

Identifier Source: org_study_id