HypertensionNCT05447962
Community-engaged Hypertension Prevention Program in Black Men
A study testing Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) and Barbershop-Based Facilitation (BF) in people with Hypertension, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Hypertension
- What is being tested?
- Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) and Barbershop-Based Facilitation (BF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community-engaged Implementation Study of Hypertension Prevention and Navigation 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.
Read the detailed description
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.
- Conditions
- Hypertension
- Being tested
- Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP), Barbershop-Based Facilitation (BF)
- Keywords
- Barbershop-based facilitation, Blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Month 12
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Oct 2022
- Primary completion18 Mar 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Joseph Ravenell, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447962
- Sponsor's protocol ID
- 21-01586
- Status last verified
- Feb 2026
- First submitted
- 29 Jun 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40482027Ravenell 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.
PubMed 37061797
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-engaged Implementation Study of Hypertension Prevention and Navigation in Black Men
- ClinicalTrials.gov ID
- NCT05447962
- Acronym / sponsor ID
- 21-01586
- Conditions
- Hypertension
- Keywords
- Barbershop-based facilitation, Blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Barbershop-Based Facilitation (BF) | Experimental | Behavioral: Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP), Behavioral: 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. |
| Self-Directed | Active comparator | Behavioral: Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP)Participants will receive the Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) program manual. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Barbershop-Based Facilitation (BF), Self-Directed |
| 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. | Behavioural | Barbershop-Based Facilitation (BF) |
Primary outcome
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
17 secondary outcomes
Change in Diastolic Blood Pressure (DBP) Levels
Time frame: Baseline, Month 12
Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral
Time frame: Baseline
Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral
Time frame: Month 6
Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral
Time frame: Month 12
Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral
Time frame: Month 18
Number of Barbershops Completing all Components of CLIP
Time frame: Month 12
Number of Barbershops Continuing to Use CLIP at 6 Months Post-Completion of Intervention
Time frame: Month 18
Number of Participants Presenting with Incident Stage 2 HTN
Time frame: Baseline
Number of Participants Presenting with Incident Stage 2 HTN
Time frame: Month 6
Number of Participants Presenting with Incident Stage 2 HTN
Time frame: Month 12
Number of Participants Presenting with Incident Stage 2 HTN
Time frame: Month 18
12-Item Short Form Survey (SF-12) Questionnaire Score
Time frame: Baseline
12-Item Short Form Survey (SF-12) Questionnaire Score
Time frame: Month 6
12-Item Short Form Survey (SF-12) Questionnaire Score
Time frame: Month 12
12-Item Short Form Survey (SF-12) Questionnaire Score
Time frame: Month 18
Cost per Millimeters of Mercury (mm Hg) Reduction in Blood Pressure (BP)
Time frame: Up to Month 18
Cost per Incident Stage 2 Hypertension (HTN) Case Prevented
Time frame: Up to Month 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Derived from this study: PubMed 40482027Arabadjian 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.
- Derived from this study: PubMed 37061797Ravenell 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Ravenell, MD principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) and Barbershop-Based Facilitation (BF) in people with Hypertension, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic Blood Pressure (SBP) Levels (time frame: Baseline, Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05447962, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.