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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Disease; Substance Use Disorders; Alcohol Use Disorder; HIV Risk
• Intervention / Treatment: Behavioral: Navigation, compensation, and personalization

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYC H+H/Bellevue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low SES Population - Intervention; 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.	Behavioral: Navigation, compensation, and personalization; 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.
No Intervention: Low SES Population - 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline, Month 12
Change in Ethanol Glucuronide (ETG) Levels	ETG (ng/ml) will be measured via urine test.	Baseline, Month 12
Change in Phosphatidylethanol (PeTH) Levels	PeTH (ng/ml) will be measured via blood test.	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.	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%)	Baseline, Month 12
Mean Systolic Blood Pressure		Up to Month 12
Mean Diastolic Blood Pressure		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.	Baseline, Month 12

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Ronald S Braithwaite, Braithwaite, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism; Cardiovascular Diseases; Substance-Related Disorders; Health Care Economics and Organizations; Jurisprudence; Social Control, Formal; Economics; Compensation and Redress
• Other Study ID Numbers: 22-01584

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Scott.Braithwaite@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No