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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

ACTION Trial 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.Check my eligibility

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.See study design

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.

ACTION Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to post-release initiation of ART medication

Time to post-release initiation of PrEP medication

Secondary outcome measures

ART adherence by DBS testing

ART adherence by prescription refill

ART adherence by self-report

+35 more

ACTION 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH

2,470 Previous Clinical Trials

2,618,866 Total Patients Enrolled

Yale UniversityLead Sponsor

1,852 Previous Clinical Trials

2,737,577 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being monitored as part of this research endeavor?

"Yes, according to clinicaltrials.gov this research endeavor is still in the recruitment phase; it was first posted on March 31st 2022 and recently edited on April 6th 2022. 864 participants are needed from 3 separate sites."

Answered by AI

What is the primary aim of this research endeavor?

"This clinical trial's primary objective is to measure the time between participants' release date and when they initiate Prep medication over a 6 month period. As secondary goals, researchers will assess opioid use days with timeline followback (TLFB) method; confirm DAA treatment completion through self-report at 6 months; and record substance related overdoses via patient interviews, medical provider reports, and mortality index data."

Answered by AI

Is there still availability for participants in this experiment?

"Yes, the clinical trial is open and recruiting participants. As stated on clinicaltrials.gov, this research effort was initially launched on March 31st 2022 with a recent update being posted on April 6th of that same year."

Answered by AI

Recent research and studies

BMC Infectious DiseasesJournal

Study Protocol of a Randomized Controlled Trial Comparing Two Linkage Models for HIV Prevention and Treatment in Justice-involved Persons

Springer, Sandra A., Ank E. Nijhawan, Kevin Knight, Irene Kuo, Angela Di Paola, Esther Schlossberg, Cynthia A. Frank, et al.. 2022. “Study Protocol of a Randomized Controlled Trial Comparing Two Linkage Models for HIV Prevention and Treatment in Justice-involved Persons”. BMC Infectious Diseases. Springer Science and Business Media LLC. doi:10.1186/s12879-022-07354-x.

clinicaltrials.govStudy

Addressing Risk Through Community Treatment for Infectious Disease and Opioid Use Disorder Now (ACTION) Among Justice-involved Populations

2022. "Addressing Risk Through Community Treatment for Infectious Disease and Opioid Use Disorder Now (ACTION) Among Justice-involved Populations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05286879.

All > Substance Abuse > Infectious Disease