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Completed

NCT Number: NCT04069624

Kentucky Women's Justice Community Opioid Innovation Network

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hardin County Detention Center, Elizabethtown, Kentucky, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MOUD Pre-Treatment Telehealth

Behavioral

Opioid use disorder (OUD) assessment, medical evaluation, and medications to treat opioid use disorder (MOUD) education with a MOUD provider during incarceration via telehealth

MOUD Pre-Treatment Telehealth and Peer Navigator

Behavioral

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.

Services as Usual

Other

Medications to treat opioid use disorder (MOUD) pre-treatment.

Primary outcomes

  1. The number of participants who initiate MOUD

    Time frame: 13 months

    Any initiation of MOUD post-release over the study period

Secondary outcomes

  1. Medication Type

    Time frame: 13 months

    Percentage of participants on naltrexone, buprenorphine or methadone.

  2. Opioid Relapse

    Time frame: 13 months

    Percentage of participants relapsing, measured by self-report or drug screen.

  3. Treatment Retention

    Time frame: 13 months

    Length of time in treatment

  4. Recidivism

    Time frame: 12 months

    Percent of participants returning to custody

  5. Overdose Rates

    Time frame: 13 months

    Percentage of participants who overdose (medical attention needed for revival)

  6. Criminal Activity

    Time frame: 12 months

    Percent of participants engaging in criminal activity (self-report or arrest records)

Other outcomes

  1. Total Annual Intervention Cost

    Time frame: 5 years

    Total annual intervention cost

  2. Average Participant Cost

    Time frame: 13 months

    Average intervention cost per participant

  3. Incremental Cost-Effectiveness Ratio

    Time frame: 5 years

    Cost per unit outcome of interventions versus services as usual

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Michele Staton

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: W-JCOIN

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2019
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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