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Active, Not Recruiting

NCT Number: NCT05828849

Mortality Reductions Based on 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiovascular Disease Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Cardiovascular Diseases Chemically-Induced Disorders HIV Risk Mental Disorders Substance Use Disorders Substance-Related Disorders

Age range

35 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYC H+H/Bellevue

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • 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.

Treatment and study plan

Navigation, compensation, and personalization

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Change in Ethanol Glucuronide (ETG) Levels

    Time frame: Baseline, Month 12

    ETG (ng/ml) will be measured via urine test.

  6. Change in Phosphatidylethanol (PeTH) Levels

    Time frame: Baseline, Month 12

    PeTH (ng/ml) will be measured via blood test.

  7. 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.

  8. 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%)

  9. Mean Systolic Blood Pressure

    Time frame: Up to Month 12

  10. Mean Diastolic Blood Pressure

    Time frame: Up to Month 12

  11. 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2023
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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