Mortality Reductions Based on AUD/Heavy Alcohol Use, HIV Risk, and Cardiovascular Risk (NCT05828849) | Clinical Trial Compass
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.
1This trial is tracking alcohol use, HIV risk, and cardiovascular risk all together — is that combination of concerns relevant to my own health situation, and would my doctor think this kind of integrated approach could be right for me?
2The trial is already active but no longer enrolling new participants — does that mean there's a chance I could still get involved, or should my doctor help me look for similar studies that are still open?
3The study measures things like blood pressure, HIV risk scores, and alcohol biomarkers like ETG and PeTH — what would my doctor expect my own numbers to look like in those areas right now, and how does that affect which treatment path makes the most sense for me?
4Since this trial is listed as Phase NA, meaning it may be more of an observational or behavioral study than a drug trial, can my doctor explain what that means for what's actually known about the safety and effectiveness of whatever approach is being tested here?
5If this trial isn't an option for me, are there other programs my doctor could recommend that address alcohol use disorder and cardiovascular or HIV risk together, rather than treating each one separately?
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
1
Change in Alcohol Use Disorders Identification Test (AUDIT) Score
Timeframe: Baseline, Month 12
2
Change in Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
Timeframe: Baseline, Month 12
3
Change in National Institute on Alcohol Abuse and Alcoholism (NIAAA) single-item alcohol use screen (NIAAA-1)
Timeframe: Baseline, Month 12
4
Change in 2-Week Timeline Follow-Back (TLFB) for Alcohol Use