Addressing Risk Through Community Treatment for Infectious Disease and Opioid Use Disorder Now (A… (NCT05286879) | Clinical Trial Compass
CompletedNot Applicable
Addressing Risk Through Community Treatment for Infectious Disease and Opioid Use Disorder Now (ACTION) Among Justice-involved Populations
United States601 participantsStarted 2022-03-31
Plain-language summary
This is a 5-year Hybrid Type 1 Effectiveness-Implementation Randomized Control Trial (RCT) that compares two models of linking and retaining individuals recently released from justice involvement to the continuum of community-based HIV prevention and treatment, HCV treatment, STI treatment, and opioid use disorder (OUD) prevention and treatment, medication for opioid use disorder (MOUD) service cascades of care.
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:
* Living in one of our research areas
* Age 18 or older
* Able to provide written informed consent in English or Spanish
* Involvement with the criminal justice system within the last 6 months
* Living with HIV or being at risk of acquiring HIV and willing to learn about PrEP
* Willing to be tested for HIV (unless already confirmed via medical record)
* Having a history of opioid and/or stimulant use within 12 months prior to being in a controlled setting and/or in the last 6 months within the community
* Having a history of condomless sexual intercourse, STI diagnosis, and/or IDU within 6 months prior to being in a controlled setting and/or in the last 6 months within the community
Exclusion Criteria:
* Severe medical or psychiatric disability making participation unsafe
* Unable to provide consent
* Not remaining in the local area after release from custody
* Being released to inpatient care
* Potential risk to research staff
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
1
Time to post-release initiation of ART medication
Timeframe: From the day of release/randomization to initiation of ART up to 6 months
2
Time to post-release initiation of PrEP medication
Timeframe: From the day of release/randomization to initiation of PrEP up to 6 months