Community-engaged Hypertension Prevention Program in Black Men

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypertension

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Barbershop-Based Facilitation (BF)<br>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)<br>* Multilevel intervention designed to mitigate adverse social determinants of health (SDoH) via linkage to care, health system navigation, and referral to social services.<br>Behavioral: Barbershop-Based Facilitation (BF)<br>* 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.<br>|
| Active Comparator: Self-Directed<br>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)<br>* Multilevel intervention designed to mitigate adverse social determinants of health (SDoH) via linkage to care, health system navigation, and referral to social services.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Diastolic Blood Pressure (DBP) Levels | 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. | Baseline, Month 12 | 
| Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral | Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit. | Baseline | 
| Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral | Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit. | Month 6 | 
| Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral | Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit. | Month 12 | 
| Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral | Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit. | Month 18 | 
| Number of Barbershops Completing all Components of CLIP | Measurement of the rate of adoption of Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP). | Month 12 | 
| Number of Barbershops Continuing to Use CLIP at 6 Months Post-Completion of Intervention | Measurement of the sustainability of Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP). | Month 18 | 
| Number of Participants Presenting with Incident Stage 2 HTN | 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. | Baseline | 
| Number of Participants Presenting with Incident Stage 2 HTN | 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. | Month 6 | 
| Number of Participants Presenting with Incident Stage 2 HTN | 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. | Month 12 | 
| Number of Participants Presenting with Incident Stage 2 HTN | 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. | Month 18 | 
| 12-Item Short Form Survey (SF-12) Questionnaire Score | 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. | Baseline | 
| 12-Item Short Form Survey (SF-12) Questionnaire Score | 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. | Month 6 | 
| 12-Item Short Form Survey (SF-12) Questionnaire Score | 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. | Month 12 | 
| 12-Item Short Form Survey (SF-12) Questionnaire Score | 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. | Month 18 | 
| Cost per Millimeters of Mercury (mm Hg) Reduction in Blood Pressure (BP) | Dollar amount associated with a 1-mm Hg reduction in BP. Lower costs are considered more desirable outcomes. | Up to Month 18 | 
| Cost per Incident Stage 2 Hypertension (HTN) Case Prevented | 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. | Up to Month 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barbershop-based facilitation, Blood pressure