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

NCT ID: NCT05828849

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-25
• Study Completion Date: 2026-07-31

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.

Conditions

Cardiovascular Disease; Alcohol Use Disorder; HIV Risk; Substance Use Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Navigation, compensation, and personalization

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald S Braithwaite, Braithwaite

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYC H+H/Bellevue

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

22-01584

Identifier Type: -

Identifier Source: org_study_id