Not Yet RecruitingNot Applicable

Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans

United States60 participantsStarted 2028-04-03

Plain-language summary

Opioid use disorder (OUD) confers a higher risk of acquiring and transmitting infectious diseases, which may have long-term health consequences in Veterans. Treatment of OUD with medication assisted therapy is highly effective, however this often occurs independently of infectious diseases care. This project will test out a new model that combines infectious diseases and OUD care within one VA clinic appointment. This new care model may improve the health of Veterans and reduce cost and time required for Veterans who often need to attend multiple outpatient appointments.

Who can participate

Age range

18 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: * US Veteran * Able to provide written informed consent in English * Living in the community (Nassau, Suffolk, Kings, Queens, Bronx, Westchester, Rockland counties, NY) * Documented diagnosis of moderate to severe opioid use disorder * Seeking care at the Northport VA substance use disorder clinic for opioid use disorder treatment * Willing to have HIV, HBV, HCV, or bacterial STI testing to determine negative or positive status * Persons who test negative for HIV need to meet CDC PrEP eligibility criteria in the 6 months prior to enrollment Exclusion Criteria: * Severe medical or psychiatric disability making participation unsafe * Unable to provide written consent * PrEP exclusion: HIV positive test; HBV positive test

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Infectious diseases screening uptake during intervention period

Timeframe: 90 days

Trial details

NCT IDNCT06766331

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2029-03-30

Contact for this trial

Audun J Lier, MD

(631) 261-4400 audun.lier@va.gov

View on ClinicalTrials.gov More Opioid Use Disorder trials