Cardiovascular DiseaseNCT05828849
Mortality Reductions Based on AUD/Heavy Alcohol Use, HIV Risk, and Cardiovascular Risk
A study testing Navigation, compensation, and personalization in people with Cardiovascular Disease and Alcohol Use Disorder, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this research study is to investigate if a personalized intervention including parts such as navigation (focus on patient outreach efforts, missed and completed encounters), personalization (individual health benefits) and compensation (value health-related costs borne by patients) will help people… Read more about this study
- Who is it for?
- Ages 35 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Alcohol Use Disorder, HIV Risk
- What is being tested?
- Navigation, compensation, and personalization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2024to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 35 to 64
- Low SES (≤ $38,000 annual income, based on 2019 20th percentile NYC income, adjusted for family size)
- Expected mortality ≥1% per year (based on age, sex, race/ethnicity), with ≥1 of the following contributors:
- 10-year cardiovascular risk ≥10% (assessed by ASCVD risk tool)
- Heavy alcohol consumption (defined using SAMHSA binge drinking definition, drinking >4 standard drinks for men and >3 standard drinks for women on same occasion in past month)
- Willing to be navigated to Health and Hospitals Corporation of New York health system.
- Ability to provide written informed consent in English or Spanish
Who cannot join
- Receives regular care elsewhere than Health and Hospitals Corporation of New York
- Already diagnosed with high mortality-condition(s) that are not included in the simulation model.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can a Radical Transformation of Preventive Care Reduce Mortality by 20% in Low Socioeconomic (SES) Populations? Preparatory Work Focusing on Alcohol Use Disorder (AUD)/Heavy Alcohol Use, HIV Risk, and Cardiovascular Risk
The purpose of this research study is to investigate if a personalized intervention including parts such as navigation (focus on patient outreach efforts, missed and completed encounters), personalization (individual health benefits) and compensation (value health-related costs borne by patients) will help people reduce their chances of dying from preventable causes, including heart attacks, strokes, drinking alcohol, substance abuse, HIV, and other conditions.
- Being tested
- Navigation, compensation, and personalization
- Medical subject headings
- Cardiovascular Diseases, Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigation, compensation, and personalizationBehavioural
The study intervention is composed of navigation, compensation, and personalization. Navigation refers to reducing barriers posed by fragmentation of health and social systems. Compensation refers to reimbursement of out-of-pocket expenses to offset dependent care, time costs, and travel expenditures necessary to access care for the different conditions and goals of the intervention. Personalization refers to preventative interventions that are personalized based on individual for potential benefit.
| Study group | Role | What they receive |
|---|---|---|
| Low SES Population - Intervention | Experimental | Participants receive the study intervention, composed of navigation, compensation, and personalization for study participants. The intervention will be administered in person to the participants recruited for the study and will be administered by peer navigators who will be trained on Motivational Interviewing (MINT) techniques. Receives: Behavioral: Navigation, compensation, and personalization |
| Low SES Population - No Intervention | No intervention | Participants receive no intervention components of navigation, compensation, and personalization. Participants will receive their normal medical care through regular doctor visits without any intervention or personalization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alcohol Use Disorders Identification Test (AUDIT) Score
10-item self-assessment of alcohol use disorders. Items are rated on a scale from 0 to 4. The total score is the sum of responses and ranges from 0-40; higher scores indicate it is more likely the patient's drinking is affecting their health and safety.
Measured: Baseline, Month 12
Change in Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
4-item self-assessment of alcohol use disorders. Items are rated on a scale from 0 to 4. The total score is the sum of responses and ranges from 0-12; higher scores indicate it is more likely the patient's drinking is affecting their health and safety.
Measured: Baseline, Month 12
Change in National Institute on Alcohol Abuse and Alcoholism (NIAAA) single-item alcohol use screen (NIAAA-1)
The NIAAA-1 asks participants how many times in the past year they have had four or more drinks (for females) or five or more drinks (for males) in a day. The responses are 0 (never), 1 (Less than once a month), 2 (One to three times per month), 3 (One to three times per week) and 4 (More than three times per week). The total score is the item response and ranges from 0-4; higher scores indicate greater unhealthy alcohol use.
Measured: Baseline, Month 12
Change in 2-Week Timeline Follow-Back (TLFB) for Alcohol Use
The TLFB allows participants to indicate how many drinks they have had over the previous two weeks.
Measured: Baseline, Month 12
Change in Ethanol Glucuronide (ETG) Levels
ETG (ng/ml) will be measured via urine test.
Measured: Baseline, Month 12
Change in Phosphatidylethanol (PeTH) Levels
PeTH (ng/ml) will be measured via blood test.
Measured: Baseline, Month 12
Change in CDC HIV Incidence Risk Index Score
3-item assessment of HIV risk among people who inject drugs. The total score ranges from 0 to 100; higher scores indicate greater risk of HIV.
Measured: Baseline, Month 12
Change in American Heart Association/American College of Cardiology (AHA/ACC) ASCVD Risk Calculator Score
The AHA/ACC Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator is a questionnaire that uses responses to calculate the lifetime risk of ASCVD as a percentage (0%-100%); higher percentages indicate greater lifetime risk of ASCVD. The percentages are classified as follows:
- Low-risk (<5%)
- Borderline risk (5% to 7.4%)
- Intermediate risk (7.5% to 19.9%)
- High risk (≥20%)
Measured: Baseline, Month 12
Mean Systolic Blood Pressure
Measured: Up to Month 12
Mean Diastolic Blood Pressure
Measured: Up to Month 12
Percent Change in Participants Determined to be "High-Risk" for SUD per TAPS Screening Tool
The Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool is used to assess primary care patients for tobacco, alcohol, prescription drug, and illicit substance use and problems related to their use. Based on patient responses, the tool classifies the patient risk levels as "High Risk," "Problem Use," "Undetermined Risk" and "Minimal Risk." This outcome measures the percent change in participants determined to be "High Risk" for substance abuse disorder (SUD) from baseline to Month 12.
Measured: Baseline, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start25 Jun 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Ronald S Braithwaite, Braithwaite, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828849
- Sponsor's protocol ID
- 22-01584
- Status last verified
- Mar 2026
- First submitted
- 13 Apr 2023
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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: \[Dr. Ronald Scott Braithwaite, Scott.Braithwaite@nyulangone.org\]. 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Radical Transformation of Preventive Care Reduce Mortality by 20% in Low Socioeconomic (SES) Populations? Preparatory Work Focusing on Alcohol Use Disorder (AUD)/Heavy Alcohol Use, HIV Risk, and Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT05828849
- Acronym / sponsor ID
- 22-01584
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 87 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 25 Apr 2023 (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 purpose of this research study is to investigate if a personalized intervention including parts such as navigation (focus on patient outreach efforts, missed and completed encounters), personalization (individual health benefits) and compensation (value health-related costs borne by patients) will help people reduce their chances of dying from preventable causes, including heart attacks, strokes, drinking alcohol, substance abuse, HIV, and other conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low SES Population - Intervention | Experimental | Behavioral: Navigation, compensation, and personalizationParticipants receive the study intervention, composed of navigation, compensation, and personalization for study participants. The intervention will be administered in person to the participants recruited for the study and will be administered by peer navigators who will be trained on Motivational Interviewing (MINT) techniques. |
| Low SES Population - No Intervention | No intervention | –Participants receive no intervention components of navigation, compensation, and personalization. Participants will receive their normal medical care through regular doctor visits without any intervention or personalization. |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 35 to 64
- Low SES (≤ $38,000 annual income, based on 2019 20th percentile NYC income, adjusted for family size)
- Expected mortality ≥1% per year (based on age, sex, race/ethnicity), with ≥1 of the following contributors:
- Willing to be navigated to Health and Hospitals Corporation of New York health system.
- Ability to provide written informed consent in English or Spanish
Key exclusion criteria (2 listed)
- Receives regular care elsewhere than Health and Hospitals Corporation of New York
- Already diagnosed with high mortality-condition(s) that are not included in the simulation model.
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 |
|---|---|---|
| Navigation, compensation, and personalizationThe study intervention is composed of navigation, compensation, and personalization. Navigation refers to reducing barriers posed by fragmentation of health and social systems. Compensation refers to reimbursement of out-of-pocket expenses to offset dependent care, time costs, and travel expenditures necessary to access care for the different conditions and goals of the intervention. Personalization refers to preventative interventions that are personalized based on individual for potential benefit. | Behavioural | Low SES Population - Intervention |
Primary outcome
Change in Alcohol Use Disorders Identification Test (AUDIT) Score
Time frame: Baseline, Month 12
10-item self-assessment of alcohol use disorders. Items are rated on a scale from 0 to 4. The total score is the sum of responses and ranges from 0-40; higher scores indicate it is more likely the patient's drinking is affecting their health and safety.
Change in Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
Time frame: Baseline, Month 12
4-item self-assessment of alcohol use disorders. Items are rated on a scale from 0 to 4. The total score is the sum of responses and ranges from 0-12; higher scores indicate it is more likely the patient's drinking is affecting their health and safety.
Change in National Institute on Alcohol Abuse and Alcoholism (NIAAA) single-item alcohol use screen (NIAAA-1)
Time frame: Baseline, Month 12
The NIAAA-1 asks participants how many times in the past year they have had four or more drinks (for females) or five or more drinks (for males) in a day. The responses are 0 (never), 1 (Less than once a month), 2 (One to three times per month), 3 (One to three times per week) and 4 (More than three times per week). The total score is the item response and ranges from 0-4; higher scores indicate greater unhealthy alcohol use.
Change in 2-Week Timeline Follow-Back (TLFB) for Alcohol Use
Time frame: Baseline, Month 12
The TLFB allows participants to indicate how many drinks they have had over the previous two weeks.
Change in Ethanol Glucuronide (ETG) Levels
Time frame: Baseline, Month 12
ETG (ng/ml) will be measured via urine test.
Change in Phosphatidylethanol (PeTH) Levels
Time frame: Baseline, Month 12
PeTH (ng/ml) will be measured via blood test.
Change in CDC HIV Incidence Risk Index Score
Time frame: Baseline, Month 12
3-item assessment of HIV risk among people who inject drugs. The total score ranges from 0 to 100; higher scores indicate greater risk of HIV.
Change in American Heart Association/American College of Cardiology (AHA/ACC) ASCVD Risk Calculator Score
Time frame: Baseline, Month 12
The AHA/ACC Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator is a questionnaire that uses responses to calculate the lifetime risk of ASCVD as a percentage (0%-100%); higher percentages indicate greater lifetime risk of ASCVD. The percentages are classified as follows: * Low-risk (<5%) * Borderline risk (5% to 7.4%) * Intermediate risk (7.5% to 19.9%) * High risk (≥20%)
Mean Systolic Blood Pressure
Time frame: Up to Month 12
Mean Diastolic Blood Pressure
Time frame: Up to Month 12
Percent Change in Participants Determined to be "High-Risk" for SUD per TAPS Screening Tool
Time frame: Baseline, Month 12
The Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool is used to assess primary care patients for tobacco, alcohol, prescription drug, and illicit substance use and problems related to their use. Based on patient responses, the tool classifies the patient risk levels as "High Risk," "Problem Use," "Undetermined Risk" and "Minimal Risk." This outcome measures the percent change in participants determined to be "High Risk" for substance abuse disorder (SUD) from baseline to Month 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- 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: [Dr. Ronald Scott Braithwaite, Scott.Braithwaite@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.
Related trials for Cardiovascular Disease
RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
RecruitingObservational study
Atrial Fibrillation Patients Treated With Catheter Ablation
Atrial Fibrillation, Atrial Fibrillation Recurrent
RecruitingPhase 1
Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers
AML, Multiple Myeloma
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
RecruitingPhase 2
A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel
Multiple Myeloma
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.
Ronald S Braithwaite, Braithwaite principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigation, compensation, and personalization in people with Cardiovascular Disease and Alcohol Use Disorder, 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 7 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 3 Mar 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?
This study is still under way. Results are not available in the source record yet.
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 Alcohol Use Disorders Identification Test (AUDIT) Score (time frame: Baseline, Month 12). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2026.