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

Not Applicable

Recruiting

• Conditions: Alcohol Use Disorder; Cardiovascular Disease; Substance Use Disorders; HIV Risk
• Interventions: Behavioral: Navigation, compensation, and personalization

• Registration Number: NCT05828849
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-13
• Study First Submitted QC: 2023-04-13
• Study First Posted: 2023-04-25
• Study Start: 2024-06-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Age 35 to 64

2. Low SES (≤ $38,000 annual income, based on 2019 20th percentile NYC income, adjusted for family size)

3. Expected mortality ≥1% per year (based on age, sex, race/ethnicity), with ≥1 of the following contributors:

   1. 10-year cardiovascular risk ≥10% (assessed by ASCVD risk tool)
   2. 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)

4. Willing to be navigated to Health and Hospitals Corporation of New York health system.

5. Ability to provide written informed consent in English or Spanish

Exclusion Criteria

1. Receives regular care elsewhere than Health and Hospitals Corporation of New York
2. Already diagnosed with high mortality-condition(s) that are not included in the simulation model.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low SES Population - Intervention	Navigation, compensation, and personalization	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.

Primary Outcome Measures

Name	Time	Method
Change in Ethanol Glucuronide (ETG) Levels	Baseline, Month 12	ETG (ng/ml) will be measured via urine test.
Change in 2-Week Timeline Follow-Back (TLFB) for Alcohol Use	Baseline, Month 12	The TLFB allows participants to indicate how many drinks they have had over the previous two weeks.
Change in Alcohol Use Disorders Identification Test (AUDIT) Score	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)	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)	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 Phosphatidylethanol (PeTH) Levels	Baseline, Month 12	PeTH (ng/ml) will be measured via blood test.
Change in CDC HIV Incidence Risk Index Score	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	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 Diastolic Blood Pressure	Up to Month 12
Mean Systolic Blood Pressure	Up to Month 12
Percent Change in Participants Determined to be "High-Risk" for SUD per TAPS Screening Tool	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.

Trial Locations

Locations (1)

NYC H+H/Bellevue; 🇺🇸 New York, New York, United States