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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069624
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : July 28, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Michele Staton, University of Kentucky

Tracking Information
First Submitted Date  ICMJE August 23, 2019
First Posted Date  ICMJE August 28, 2019
Last Update Posted Date July 28, 2020
Estimated Study Start Date  ICMJE August 2020
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2019)
The number of participants who initiate MOUD [ Time Frame: 13 months ]
Any initiation of MOUD post-release over the study period
Original Primary Outcome Measures  ICMJE
 (submitted: August 23, 2019)
MOUD Initiation [ Time Frame: 13 months ]
Any initiation of MOUD post-release over the study period
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2019)
  • Medication Type [ Time Frame: 13 months ]
    Percentage of participants on naltrexone, buprenorphine or methadone.
  • Opioid Relapse [ Time Frame: 13 months ]
    Percentage of participants relapsing, measured by self-report or drug screen.
  • Treatment Retention [ Time Frame: 13 months ]
    Length of time in treatment
  • Recidivism [ Time Frame: 12 months ]
    Percent of participants returning to custody
  • Overdose Rates [ Time Frame: 13 months ]
    Percentage of participants who overdose (medical attention needed for revival)
  • Criminal Activity [ Time Frame: 12 months ]
    Percent of participants engaging in criminal activity (self-report or arrest records)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 23, 2019)
  • Total Annual Intervention Cost [ Time Frame: 5 years ]
    Total annual intervention cost
  • Average Participant Cost [ Time Frame: 13 months ]
    Average intervention cost per participant
  • Incremental Cost-Effectiveness Ratio [ Time Frame: 5 years ]
    Cost per unit outcome of interventions versus services as usual
  • Public Health Cost of Opioid Relapse [ Time Frame: 5 years ]
    Cumulative estimated cost of hospitalizations, treatments, loss of work, child welfare, and other services related to relapse.
  • Public Safety Cost of Recidivism and Criminal Activity [ Time Frame: 5 years ]
    Cumulative estimated cost of return to custody, arrests, and other social costs of recidivism.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Kentucky Women's Justice Community Opioid Innovation Network
Official Title  ICMJE Kentucky Women's Justice Community Opioid Innovation Network
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.

  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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Opioid-use Disorder
Intervention  ICMJE
  • 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
  • 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.
  • Other: Services as Usual
    Medications to treat opioid use disorder (MOUD) pre-treatment.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Services as Usual
  • Experimental: MOUD Pre-Treatment Telehealth
    Telehealth connection to a community MOUD provider.
    Intervention: Behavioral: MOUD Pre-Treatment Telehealth
  • Experimental: MOUD Pre-Treatment Telehealth and Peer Navigator
    Telehealth connection to a community MOUD provider, in addition to a peer navigator
    Intervention: Behavioral: MOUD Pre-Treatment Telehealth and Peer Navigator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 23, 2019)
900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2024
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • Active psychosis
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Michele Staton, MSW, PhD 859-257-2483 mstaton@uky.edu
Contact: Erin Winston, MPA 859-257-1720 ermcne0@uky.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04069624
Other Study ID Numbers  ICMJE 51656
1UG1DA050069-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data at this time.
Responsible Party Michele Staton, University of Kentucky
Study Sponsor  ICMJE Michele Staton
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Michele Staton, MSW, PhD University of Kentucky
PRS Account University of Kentucky
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP