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Completed

NCT Number: NCT05447962

Community-engaged Hypertension Prevention Program in Black Men

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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.

Primary outcomes

  1. Change in Systolic Blood Pressure (SBP) Levels

    Time frame: Baseline, Month 12

    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

Secondary outcomes

  1. Change in Diastolic Blood Pressure (DBP) Levels

    Time frame: Baseline, Month 12

    All participants will have office blood pressure (BP) measured on their non-dominant arm with an Omron HEM-907XL BP device.

    At each visit, 3 BP readings separated by one minute will be obtained. The 3 BP readings will be averaged to obtain study BP.

    DBP Levels are classified as follows:

    • Normal: Lower than 80 millimeters of mercury (mm Hg)
    • Stage 1 hypertension: 80-89 mm Hg
    • Stage 2 hypertension: 90 mm Hg or more
    • Hypertensive crisis: 120 mm Hg or more.

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

    Time frame: Baseline

    Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit.

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

    Time frame: Month 6

    Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit.

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

    Time frame: Month 12

    Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit.

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

    Time frame: Month 18

    Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit.

  6. Number of Barbershops Completing all Components of CLIP

    Time frame: Month 12

    Measurement of the rate of adoption of Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP).

  7. Number of Barbershops Continuing to Use CLIP at 6 Months Post-Completion of Intervention

    Time frame: Month 18

    Measurement of the sustainability of Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP).

  8. Number of Participants Presenting with Incident Stage 2 HTN

    Time frame: Baseline

    Incident Stage 2 hypertension (HTN) is defined as:

    • Systolic Blood Pressure (SBP) of at least 140 millimeters of mercury (mm Hg)/Diastolic Blood Pressure (DBP) of at least 90 mm Hg; or
    • Antihypertensive medication initiation.

  9. Number of Participants Presenting with Incident Stage 2 HTN

    Time frame: Month 6

    Incident Stage 2 hypertension (HTN) is defined as:

    • Systolic Blood Pressure (SBP) of at least 140 millimeters of mercury (mm Hg)/Diastolic Blood Pressure (DBP) of at least 90 mm Hg; or
    • Antihypertensive medication initiation.

  10. Number of Participants Presenting with Incident Stage 2 HTN

    Time frame: Month 12

    Incident Stage 2 hypertension (HTN) is defined as:

    • Systolic Blood Pressure (SBP) of at least 140 millimeters of mercury (mm Hg)/Diastolic Blood Pressure (DBP) of at least 90 mm Hg; or
    • Antihypertensive medication initiation.

  11. Number of Participants Presenting with Incident Stage 2 HTN

    Time frame: Month 18

    Incident Stage 2 hypertension (HTN) is defined as:

    • Systolic Blood Pressure (SBP) of at least 140 millimeters of mercury (mm Hg)/Diastolic Blood Pressure (DBP) of at least 90 mm Hg; or
    • Antihypertensive medication initiation.

  12. 12-Item Short Form Survey (SF-12) Questionnaire Score

    Time frame: Baseline

    The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality-of-life measure. SF-12 consists of 12 questions that are scored in various ways. The total score range is 12-48; the higher the score, the better the physical and mental health functioning.

  13. 12-Item Short Form Survey (SF-12) Questionnaire Score

    Time frame: Month 6

    The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality-of-life measure. SF-12 consists of 12 questions that are scored in various ways. The total score range is 12-48; the higher the score, the better the physical and mental health functioning.

  14. 12-Item Short Form Survey (SF-12) Questionnaire Score

    Time frame: Month 12

    The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality-of-life measure. SF-12 consists of 12 questions that are scored in various ways. The total score range is 12-48; the higher the score, the better the physical and mental health functioning.

  15. 12-Item Short Form Survey (SF-12) Questionnaire Score

    Time frame: Month 18

    The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality-of-life measure. SF-12 consists of 12 questions that are scored in various ways. The total score range is 12-48; the higher the score, the better the physical and mental health functioning.

  16. Cost per Millimeters of Mercury (mm Hg) Reduction in Blood Pressure (BP)

    Time frame: Up to Month 18

    Dollar amount associated with a 1-mm Hg reduction in BP. Lower costs are considered more desirable outcomes.

  17. Cost per Incident Stage 2 Hypertension (HTN) Case Prevented

    Time frame: Up to Month 18

    Dollar amount associated with the prevention of an Incident Stage 2 HTN case. Lower costs are considered more desirable outcomes.

    Incident Stage 2 HTN is defined as:

    • Systolic Blood Pressure (SBP) of at least 140 millimeters of mercury (mm Hg)/Diastolic Blood Pressure (DBP) of at least 90 mm Hg; or
    • Antihypertensive medication initiation.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 7, 2022
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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