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Health Linkage for Opioid Use Disorder

N/A
Waitlist Available
Led By April M Young, PhD, MPH
Research Sponsored by University of Kentucky
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have used opioids to get high in the past 30 days or have injected any drug to get high during that same period (if incarcerated at home under digital monitoring program or on probation or parole: have used opioids to get high or injected any drug to get high in 30 days before the date of incarceration or start of the probation or parole term);
Have been recently involved in the criminal justice system defined as being incarcerated in jail or prison, out on bond, under warrant for arrest, arrested, under pre-trial supervision, on probation or parole, court-involved, or individuals who are incarcerated at home under an electronic monitoring program (i.e., digital jail) in the past 30 days.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at 3 months and 6 months after the baseline, change at 3 months reported
Awards & highlights

Study Summary

This trial will study the effects of an intervention to help reduce substance use and related harms among people leaving rural jails or who are otherwise involved in the criminal justice system. The intervention will be compared with those who will only receive overdose education. The study will collect surveys and overdose education from all participants. Some participants will be chosen at random to be in the intervention group or the comparison group. The investigators hope to learn if providing linkage to health services, HIV, hepatitis C virus (HCV), and overdose education to people leaving rural jails or who are otherwise involved in the criminal justice system will reduce substance use and related harms.

Eligible Conditions
  • Opioid Use Disorder
  • Substance Abuse
  • Human Immunodeficiency Virus Infection
  • Hepatitis C
  • Sexually Transmitted Diseases
  • Drug Overdose

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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A resident of one of the 12 CARE2HOPE counties.
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You have used opioids or injected any drug to get high in the 30 days before you were incarcerated, or have injected any drug to get high during that period.
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You are incarcerated in a local jail and expected to be released in <21 days.
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You are a resident of or anticipate being released to one of the 12 CARE2HOPE counties.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at 3 months and 6 months after the baseline, change at 3 months reported
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 3 months and 6 months after the baseline, change at 3 months reported for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Substance Use Frequency
Secondary outcome measures
Change in Engagement in HCV Risk Behaviors - Receptive Syringe Sharing
Change in Engagement in HCV Risk Behaviors - Shared Injection Equipment
Change in Engagement in HIV Risk Behaviors - Condomless Sex
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Overdose EducationExperimental Treatment1 Intervention
The investigators will initiate the comparison group in Group 2 counties six months before the intervention begins. Research staff will conduct an overdose intervention with the comparison cohort. This will occur pre-release if individual is recruited in jail. The comparison group participants will watch a video on preventing, recognizing, and responding effectively to an opioid OD, accompanied by information about Kentucky's Good Samaritan Law and Naloxone Access Law. Research staff will answer questions after the video. Individuals will receive a Community Resource Guide at this visit. As in the intervention group, the comparison group participants will complete surveys at the baseline (in jail if recruited in jail, in a community setting if recruited in the community), and at 3 months and 6 months after the baseline. Surveys will be identical to those delivered to the intervention cohort.
Group II: Health LinkageExperimental Treatment2 Interventions
Research staff will: 1) meet with participants in person or virtually to ask questions about drug use and related behaviors, service access, and personal goals; provide overdose education and help develop a plan for reducing risks and accessing services; conduct drug testing, offer HIV and HCV testing and counseling, naloxone, and harm reduction supplies, and connection with needed services; 2) follow up with participants monthly for three months to help overcome challenges; and 3) six months post-enrollment, contact participants to conduct drug testing. Participants will complete surveys at baseline, 3 months, and 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Health Linkage
2019
N/A
~240
Overdose Education
2019
N/A
~240

Find a Location

Who is running the clinical trial?

Centers for Disease Control and PreventionFED
873 Previous Clinical Trials
22,467,346 Total Patients Enrolled
Substance Abuse and Mental Health Services Administration (SAMHSA)FED
30 Previous Clinical Trials
23,074 Total Patients Enrolled
Appalachian Regional CommissionUNKNOWN

Frequently Asked Questions

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

Are new participants currently being enrolled into this research project?

"Affirmative. According to the data on clinicaltrials.gov, this study is actively searching for participants and was first posted in November of 2019. As it stands now, 960 patients needs be recruited from a single center."

Answered by AI

What is the magnitude of individuals enrolled in this research project?

"Correct. Per clinicaltrials.gov, this research is actively pursuing participants which were initially posted on November 15th 2019 and last updated on July 26th 2022. The project requires 960 individuals to be recruited from 1 medical centre."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
What site did they apply to?
University of Kentucky
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I need money and had previously been part of the U.K. GATE Study for an entire year (completed it). I was just released from jail after being falsely charged (my case was dismissed) and my parole was revoked prematurely (but reinstated 3 months after dismissal of charges). I was released from jail to a halfway house on 1/6/2023 and then came to the Oxford House Karleigh, a women's sober living home, in Georgetown, Kentucky on 1/9/2023. I am transgender, born male and identify as female. I've not had any hormone treatment nor surgery, but am wanting to receive both. I have a long history of drug abuse and an extensive criminal record. I have served long periods of incarceration in both jails and prison. I haven't used since June 8, 2022. I need money so I can continue to live here and that is why I'm doing this. Last year my daughter died and I am extremely depressed. I did not get to go to her funeral, as I was in jail for 3 months after the charges were dismissed due to the parole violation. I have PTSD and my symptoms are noticeable to me. I just need a break and if being a part of a study will pay me and help people and possibly help me, then I need in. Thanks.
PatientReceived 1 prior treatment
~44 spots leftby Mar 2025