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Community Treatment for Infectious Diseases and Opioid Use Disorder (ACTION Trial)

N/A
Recruiting
Led By Sandra A Springer, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Being released to inpatient care
Unable to provide consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two models for linking and retaining people recently released from custody to HIV and opioid use disorder prevention and treatment.

Who is the study for?
This trial is for individuals recently involved with the justice system who have used opioids or stimulants in the past year. Participants should intend to stay locally post-release, consent to HIV testing, and be open to learning about PrEP if HIV-negative. Those with severe medical/psychiatric issues or not staying local are excluded.
What is being tested?
The study compares two methods of connecting people released from custody to community services for HIV prevention and opioid use disorder treatment. It involves a Patient Navigator and Mobile Health Unit over five years, assessing effectiveness in linking participants to care.
What are the potential side effects?
Since this trial focuses on service models rather than medications, traditional side effects aren't applicable. However, there may be indirect effects related to accessing these services such as stress or anxiety.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am being discharged to a hospital for further care.
Select...
I am unable to give consent by myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to post-release initiation of ART medication
Time to post-release initiation of PrEP medication
Secondary study objectives
ART adherence by DBS testing
ART adherence by prescription refill
ART adherence by self-report
+35 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Patient NavigatorExperimental Treatment1 Intervention
Navigators will assist linking study participants to appropriate community service providers
Group II: Mobile Health UnitExperimental Treatment1 Intervention
Study participants will be linked to a MHU within their community
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patient Navigator
2011
N/A
~6070

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,607 Previous Clinical Trials
3,328,975 Total Patients Enrolled
Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,032,498 Total Patients Enrolled
Sandra A Springer, MDPrincipal InvestigatorYale University
2 Previous Clinical Trials
251 Total Patients Enrolled

Media Library

Patient Navigator Clinical Trial Eligibility Overview. Trial Name: NCT05286879 — N/A
Opioid Use Disorder Research Study Groups: Patient Navigator, Mobile Health Unit
Opioid Use Disorder Clinical Trial 2023: Patient Navigator Highlights & Side Effects. Trial Name: NCT05286879 — N/A
Patient Navigator 2023 Treatment Timeline for Medical Study. Trial Name: NCT05286879 — N/A
~262 spots leftby Dec 2025
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