Kentucky Women's Justice Community Opioid Innovation Network (W-JCOIN)
Primary Purpose
Opioid-use Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MOUD Pre-Treatment Telehealth
MOUD Pre-Treatment Telehealth and Peer Navigator
Services as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-use Disorder focused on measuring MOUD, OUD, Telehealth, Navigator
Eligibility Criteria
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
Sites / Locations
- Hardin County Detention CenterRecruiting
- Harlan County Detention CenterRecruiting
- Henderson County Detention CenterRecruiting
- Marion County Detention CenterRecruiting
- Grayson County Detention CenterRecruiting
- Laurel County Correctional CenterRecruiting
- Pike County Detention CenterRecruiting
- Shelby County Detention CenterRecruiting
- Grant County Detention CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Services as Usual (SAU)
MOUD Pre-Treatment Telehealth
MOUD Pre-Treatment Telehealth and Peer Navigator
Arm Description
Substance abuse program (SAP) managed by the Kentucky Department of Corrections, with the option to initiate MOUD prior to jail release.
Telehealth connection to a community MOUD provider.
Telehealth connection to a community MOUD provider, in addition to a peer navigator
Outcomes
Primary Outcome Measures
The number of participants who initiate MOUD
Any initiation of MOUD post-release over the study period
Secondary Outcome Measures
Medication Type
Percentage of participants on naltrexone, buprenorphine or methadone.
Opioid Relapse
Percentage of participants relapsing, measured by self-report or drug screen.
Treatment Retention
Length of time in treatment
Recidivism
Percent of participants returning to custody
Overdose Rates
Percentage of participants who overdose (medical attention needed for revival)
Criminal Activity
Percent of participants engaging in criminal activity (self-report or arrest records)
Full Information
NCT ID
NCT04069624
First Posted
August 23, 2019
Last Updated
August 13, 2023
Sponsor
Michele Staton
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04069624
Brief Title
Kentucky Women's Justice Community Opioid Innovation Network
Acronym
W-JCOIN
Official Title
Kentucky Women's Justice Community Opioid Innovation Network
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michele Staton
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
Keywords
MOUD, OUD, Telehealth, Navigator
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Services as Usual (SAU)
Arm Type
Active Comparator
Arm Description
Substance abuse program (SAP) managed by the Kentucky Department of Corrections, with the option to initiate MOUD prior to jail release.
Arm Title
MOUD Pre-Treatment Telehealth
Arm Type
Experimental
Arm Description
Telehealth connection to a community MOUD provider.
Arm Title
MOUD Pre-Treatment Telehealth and Peer Navigator
Arm Type
Experimental
Arm Description
Telehealth connection to a community MOUD provider, in addition to a peer navigator
Intervention Type
Behavioral
Intervention Name(s)
MOUD Pre-Treatment Telehealth
Intervention Description
Opioid use disorder (OUD) assessment, medical evaluation, and medications to treat opioid use disorder (MOUD) education with a MOUD provider during incarceration via telehealth
Intervention Type
Behavioral
Intervention Name(s)
MOUD Pre-Treatment Telehealth and Peer Navigator
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Services as Usual
Intervention Description
Medications to treat opioid use disorder (MOUD) pre-treatment.
Primary Outcome Measure Information:
Title
The number of participants who initiate MOUD
Description
Any initiation of MOUD post-release over the study period
Time Frame
13 months
Secondary Outcome Measure Information:
Title
Medication Type
Description
Percentage of participants on naltrexone, buprenorphine or methadone.
Time Frame
13 months
Title
Opioid Relapse
Description
Percentage of participants relapsing, measured by self-report or drug screen.
Time Frame
13 months
Title
Treatment Retention
Description
Length of time in treatment
Time Frame
13 months
Title
Recidivism
Description
Percent of participants returning to custody
Time Frame
12 months
Title
Overdose Rates
Description
Percentage of participants who overdose (medical attention needed for revival)
Time Frame
13 months
Title
Criminal Activity
Description
Percent of participants engaging in criminal activity (self-report or arrest records)
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Total Annual Intervention Cost
Description
Total annual intervention cost
Time Frame
5 years
Title
Average Participant Cost
Description
Average intervention cost per participant
Time Frame
13 months
Title
Incremental Cost-Effectiveness Ratio
Description
Cost per unit outcome of interventions versus services as usual
Time Frame
5 years
Title
Public Health Cost of Opioid Relapse
Description
Cumulative estimated cost of hospitalizations, treatments, loss of work, child welfare, and other services related to relapse.
Time Frame
5 years
Title
Public Safety Cost of Recidivism and Criminal Activity
Description
Cumulative estimated cost of return to custody, arrests, and other social costs of recidivism.
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michele Staton, MSW, PhD
Phone
859-257-2483
Email
mstaton@uky.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Winston, MPA
Phone
859-257-1720
Email
ermcne0@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Staton, MSW, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hardin County Detention Center
City
Elizabethtown
State/Province
Kentucky
ZIP/Postal Code
42701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheryl Shook
Facility Name
Harlan County Detention Center
City
Harlan
State/Province
Kentucky
ZIP/Postal Code
40828
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Derrick Moore
Facility Name
Henderson County Detention Center
City
Henderson
State/Province
Kentucky
ZIP/Postal Code
42420
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff Harris
Facility Name
Marion County Detention Center
City
Lebanon
State/Province
Kentucky
ZIP/Postal Code
40033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maggie Lockard
Facility Name
Grayson County Detention Center
City
Leitchfield
State/Province
Kentucky
ZIP/Postal Code
42754
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyndi Lively
Facility Name
Laurel County Correctional Center
City
London
State/Province
Kentucky
ZIP/Postal Code
40741
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shawn Davis
Facility Name
Pike County Detention Center
City
Pikeville
State/Province
Kentucky
ZIP/Postal Code
41501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Sammons
Facility Name
Shelby County Detention Center
City
Shelbyville
State/Province
Kentucky
ZIP/Postal Code
40065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelsey Torres
Facility Name
Grant County Detention Center
City
Williamstown
State/Province
Kentucky
ZIP/Postal Code
41097
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Penny Stacy
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data at this time.
Learn more about this trial
Kentucky Women's Justice Community Opioid Innovation Network
We'll reach out to this number within 24 hrs