Clinical trial NCT05447962: Community-engaged Hypertension Prevention Program in Black Men
Official title: Community-engaged Implementation Study of Hypertension Prevention and Navigation in Black Men
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Barbershop-based facilitation
Blood pressure
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2022-07-07
Enrollment: 430
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Systolic Blood Pressure (SBP) Levels
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Change in Diastolic Blood Pressure (DBP) Levels
timeFrame: Baseline, Month 12
measure: Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral
timeFrame: Baseline
measure: Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral
timeFrame: Month 6
measure: Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral
timeFrame: Month 12
measure: Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral
timeFrame: Month 18
measure: Number of Barbershops Completing all Components of CLIP
timeFrame: Month 12
measure: Number of Barbershops Continuing to Use CLIP at 6 Months Post-Completion of Intervention
timeFrame: Month 18
measure: Number of Participants Presenting with Incident Stage 2 HTN
timeFrame: Baseline
measure: Number of Participants Presenting with Incident Stage 2 HTN
timeFrame: Month 6
measure: Number of Participants Presenting with Incident Stage 2 HTN
timeFrame: Month 12
measure: Number of Participants Presenting with Incident Stage 2 HTN
timeFrame: Month 18
measure: 12-Item Short Form Survey (SF-12) Questionnaire Score
timeFrame: Baseline
measure: 12-Item Short Form Survey (SF-12) Questionnaire Score
timeFrame: Month 6
measure: 12-Item Short Form Survey (SF-12) Questionnaire Score
timeFrame: Month 12
measure: 12-Item Short Form Survey (SF-12) Questionnaire Score
timeFrame: Month 18
measure: Cost per Millimeters of Mercury (mm Hg) Reduction in Blood Pressure (BP)
timeFrame: Up to Month 18
measure: Cost per Incident Stage 2 Hypertension (HTN) Case Prevented
timeFrame: Up to Month 18
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Joseph Ravenell, MD
role: PRINCIPAL_INVESTIGATOR
References: