NCT05447962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
430

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

June 29, 2022

Last Update Submit

February 24, 2026

Conditions

Hypertension

Keywords

Barbershop-based facilitationBlood pressure

Outcome Measures

Primary Outcomes (1)

  • Change in Systolic Blood Pressure (SBP) Levels

    All participants will have office blood pressure (BP) measured on their non-dominant arm with an Omron HEM-907XL BP device. 3 BP readings separated by one minute will be obtained at each visit. The 3 BP readings will be averaged to obtain mean BP. SBP Levels are classified as follows: * Normal: Below 120 millimeters of mercury (mm Hg) * Elevated: 120-129 mm Hg * Stage 1 hypertension: 130-139 mm Hg * Stage 2 hypertension: 140 mm Hg or more * Hypertensive crisis: 180 mm Hg or more

    Baseline, Month 12

Secondary Outcomes (17)

  • Change in Diastolic Blood Pressure (DBP) Levels

    Baseline, Month 12

  • Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral

    Baseline

  • Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral

    Month 6

  • Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral

    Month 12

  • Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral

    Month 18

  • +12 more secondary outcomes

Study Arms (2)

Barbershop-Based Facilitation (BF)

EXPERIMENTAL

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.

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

Self-Directed

ACTIVE COMPARATOR

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

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

Interventions

Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP)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)Self-Directed
Barbershop-Based Facilitation (BF)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.

Barbershop-Based Facilitation (BF)

Eligibility Criteria

Age18 Years - 85 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsBased on self-identification.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (2)

  • 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.

    PMID: 40482027DERIVED

  • 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.

    PMID: 37061797DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Joseph Ravenell, MD

    NYU Langone Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 7, 2022

Study Start

October 1, 2022

Primary Completion

March 18, 2025

Study Completion

September 30, 2025

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Joseph Ravenell, MD Telephone: 646-501-9932 Email: Joseph.Ravenell@nyulangone.org The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria
The investigator who proposed to use the data will have access upon reasonable request. Requests should be directed to Joseph.Ravenell@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US(1)