Kentucky Women's Justice Community Opioid Innovation Network (W-JCOIN)

This trial will test the effectiveness of delivering medication for opioid use disorder (MOUD) pre-treatment via telehealth, alone and with peer navigation, to increase MOUD initiation and maintenance in the community following jail release. This trial will focus on incarcerated women in 6 experimental and 3 control sites in Kentucky. Enrollment is not open to the general public.

Study Overview

• Status: Active, not recruiting
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Other: Services as Usual; Behavioral: MOUD Pre-Treatment Telehealth; Behavioral: MOUD Pre-Treatment Telehealth and Peer Navigator

Detailed Description

This study will incorporate random assignment for two study conditions: medication for opioid use disorder (MOUD) PreTreatment Telehealth or MOUD PreTreatment Telehealth with Peer Navigation using a rigorous randomized block design. Women in the experimental conditions will be stratified by sites (6 sites; 3 urban and 3 non-urban) and by offender classification level of felony versus misdemeanor (due to potential differences in community supervision). Three comparison sites with existing jail-based MOUD treatment for women will not be randomized but will be included in analyses within planned, non-randomized comparisons.

1. MOUD PreTreatment Telehealth: Participants who screen positive for moderate to high-risk opioid use and complete the baseline interview will be connected via telehealth to the community MOUD provider for a psychosocial assessment. The study data coordinator will assist with linking the participant to the community MOUD provider via telehealth, as well as collecting initial in-person biological specimens for medical evaluation. The psychosocial assessment with the community MOUD provider will involve a more detailed examination of OUD using the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria. Type of medication (naltrexone, buprenorphine, or methadone) will depend on the psychosocial assessment and medical evaluation. Indications for the most appropriate course of treatment will be determined by the community MOUD provider in conjunction with the study participant. Women in this condition will also receive general education about MOUD options including risks and benefits, and they will be given the opportunity to ask questions about the medication. The community MOUD provider will also use motivational interviewing to assess each woman's readiness to engage in MOUD and to better understand possible barriers to MOUD utilization. At the end of the education session, the study participant and the MOUD community provider will develop a re-entry plan for ongoing care, which will include a plan for insurance coverage of medications in the community.
2. MOUD PreTreatment Telehealth + Peer Navigation: In addition to MOUD PreTreatment Telehealth, women in this arm will be connected with a peer, a woman in recovery who is employed by Voices of Hope (VOH) in Lexington, KY. Peer Navigators will be located in Lexington through a partnership with VOH. VOH is a non-profit recovery support organization which provides peer recovery support services. In conjunction with the study data coordinators, the Peer Navigator will schedule an initial session via telehealth with the participant, assist with scheduling a follow-up appointment with the community MOUD provider, and provide recovery support for community MOUD initiation and maintenance. Peer Navigators will be certified Peer Support Specialists trained and supervised by VOH in accordance with state statutory requirements. When a woman returns to the community, Peer Navigators will engage her in weekly telephone recovery services (TRS) for 12 weeks, which may include identifying personal goals and strength-based, practical strategies for success. In addition to MOUD linkages to care, Peer Navigators will suggest strategies to maintain sobriety and improve recovery capital, including safe housing, transportation, financial counseling, continued education, employment skills, and sober social activities.
3. Services as Usual: Women in this arm will not be randomized, but will receive substance abuse treatment as usual in three comparison jail sites. Each of these jails has a women's substance abuse program (SAP) managed by the Kentucky Department of Corrections (KY-DOC with the option to initiate MOUD prior to jail release. These programs operate as modified therapeutic communities with transitional support following release.

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michele Staton, MSW, PhD; Phone Number: 859-257-2483; Email: mstaton@uky.edu
• Study Contact Backup: Name: Erin Winston, MPA; Phone Number: 859-257-1720; Email: ermcne0@uky.edu

Study Locations

• United States
  • Kentucky
    • Elizabethtown, Kentucky, United States, 42701
      • Hardin County Detention Center
    • Harlan, Kentucky, United States, 40828
      • Harlan County Detention Center
    • Henderson, Kentucky, United States, 42420
      • Henderson County Detention Center
    • Lebanon, Kentucky, United States, 40033
      • Marion County Detention Center
    • Leitchfield, Kentucky, United States, 42754
      • Grayson County Detention Center
    • London, Kentucky, United States, 40741
      • Laurel County Correctional Center
    • Pikeville, Kentucky, United States, 41501
      • Pike County Detention Center
    • Shelbyville, Kentucky, United States, 40065
      • Shelby County Detention Center
    • Williamstown, Kentucky, United States, 41097
      • Grant County Detention Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ASSIST opioid (prescription or street) score of 4+
• Willingness to participate in MOUD pre-treatment
• Incarceration period of at least 7 days

Exclusion Criteria

• Cognitive impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Services as Usual (SAU); Substance abuse program (SAP) managed by the Kentucky Department of Corrections, with the option to initiate MOUD prior to jail release.	Other: Services as Usual; Medications to treat opioid use disorder (MOUD) pre-treatment.
Experimental: MOUD Pre-Treatment Telehealth; Telehealth connection to a community MOUD provider.	Behavioral: MOUD Pre-Treatment Telehealth; Opioid use disorder (OUD) assessment, medical evaluation, and medications to treat opioid use disorder (MOUD) education with a MOUD provider during incarceration via telehealth
Experimental: MOUD Pre-Treatment Telehealth and Peer Navigator; Telehealth connection to a community MOUD provider, in addition to a peer navigator	Behavioral: MOUD Pre-Treatment Telehealth and Peer Navigator; Opioid use disorder (OUD) assessment, medical evaluation, and medications to treat opioid use disorder (MOUD) education with a MOUD provider during incarceration via telehealth. Additionally, participants will be connected with a Peer Navigator who will meet with them via telehealth prior to release and provide ongoing support by telephone post-release.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants who initiate MOUD	Any initiation of MOUD post-release over the study period	13 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Type	Percentage of participants on naltrexone, buprenorphine or methadone.	13 months
Opioid Relapse	Percentage of participants relapsing, measured by self-report or drug screen.	13 months
Treatment Retention	Length of time in treatment	13 months
Recidivism	Percent of participants returning to custody	12 months
Overdose Rates	Percentage of participants who overdose (medical attention needed for revival)	13 months
Criminal Activity	Percent of participants engaging in criminal activity (self-report or arrest records)	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Annual Intervention Cost	Total annual intervention cost	5 years
Average Participant Cost	Average intervention cost per participant	13 months
Incremental Cost-Effectiveness Ratio	Cost per unit outcome of interventions versus services as usual	5 years
Public Health Cost of Opioid Relapse	Cumulative estimated cost of hospitalizations, treatments, loss of work, child welfare, and other services related to relapse.	5 years
Public Safety Cost of Recidivism and Criminal Activity	Cumulative estimated cost of return to custody, arrests, and other social costs of recidivism.	5 years

Collaborators and Investigators

• Sponsor: Michele Staton
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Michele Staton, MSW, PhD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Telehealth; Navigator; OUD; MOUD
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 51656; 1UG1DA050069-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No