Active — Not RecruitingNot Applicable

Mortality Reductions Based on AUD/Heavy Alcohol Use, HIV Risk, and Cardiovascular Risk

United States87 participantsStarted 2024-06-25

Plain-language 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 reduce their chances of dying from preventable causes, including heart attacks, strokes, drinking alcohol, substance abuse, HIV, and other conditions.

Who can participate

Age range

35 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Alcohol Use Disorders Identification Test (AUDIT) Score

Timeframe: Baseline, Month 12

Change in Alcohol Use Disorders Identification Test-Concise (AUDIT-C)

Timeframe: Baseline, Month 12

Change in National Institute on Alcohol Abuse and Alcoholism (NIAAA) single-item alcohol use screen (NIAAA-1)

Timeframe: Baseline, Month 12

Change in 2-Week Timeline Follow-Back (TLFB) for Alcohol Use

Timeframe: Baseline, Month 12

Change in Ethanol Glucuronide (ETG) Levels

Timeframe: Baseline, Month 12

Change in Phosphatidylethanol (PeTH) Levels

Timeframe: Baseline, Month 12

Change in CDC HIV Incidence Risk Index Score

Timeframe: Baseline, Month 12

Trial details

NCT IDNCT05828849

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

View on ClinicalTrials.gov More Cardiovascular Disease trials

Plain-language summary

Who can participate

Age range

35 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

What they're measuring

Change in Alcohol Use Disorders Identification Test (AUDIT) Score

Timeframe: Baseline, Month 12

Change in Alcohol Use Disorders Identification Test-Concise (AUDIT-C)

Timeframe: Baseline, Month 12

Change in National Institute on Alcohol Abuse and Alcoholism (NIAAA) single-item alcohol use screen (NIAAA-1)

Timeframe: Baseline, Month 12

Change in 2-Week Timeline Follow-Back (TLFB) for Alcohol Use

Timeframe: Baseline, Month 12

Change in Ethanol Glucuronide (ETG) Levels

Timeframe: Baseline, Month 12

Change in Phosphatidylethanol (PeTH) Levels

Timeframe: Baseline, Month 12

Change in CDC HIV Incidence Risk Index Score

Timeframe: Baseline, Month 12

Mortality Reductions Based on AUD/Heavy Alcohol Use, HIV Risk, and Cardiovascular Risk

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Mortality Reductions Based on AUD/Heavy Alcohol Use, HIV Risk, and Cardiovascular Risk

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria