Clinical trial NCT04069624: Kentucky Women's Justice Community Opioid Innovation Network
Official title: Kentucky Women's Justice Community Opioid Innovation Network
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid-use Disorder
Keywords: MOUD
OUD
Telehealth
Navigator
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-08-28
Enrollment: 900
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The number of participants who initiate MOUD
timeFrame: 13 months
Secondary outcomes:
measure: Medication Type
timeFrame: 13 months
measure: Opioid Relapse
timeFrame: 13 months
measure: Treatment Retention
timeFrame: 13 months
measure: Recidivism
timeFrame: 12 months
measure: Overdose Rates
timeFrame: 13 months
measure: Criminal Activity
timeFrame: 12 months
Other outcomes:
measure: Total Annual Intervention Cost
timeFrame: 5 years
measure: Average Participant Cost
timeFrame: 13 months
measure: Incremental Cost-Effectiveness Ratio
timeFrame: 5 years
measure: Public Health Cost of Opioid Relapse
timeFrame: 5 years
measure: Public Safety Cost of Recidivism and Criminal Activity
timeFrame: 5 years
Locations:
city: Elizabethtown
country: United States
facility: Hardin County Detention Center
state: Kentucky
city: Harlan
country: United States
facility: Harlan County Detention Center
state: Kentucky
city: Henderson
country: United States
facility: Henderson County Detention Center
state: Kentucky
city: Lebanon
country: United States
facility: Marion County Detention Center
state: Kentucky
city: Leitchfield
country: United States
facility: Grayson County Detention Center
state: Kentucky
city: London
country: United States
facility: Laurel County Correctional Center
state: Kentucky
city: Pikeville
country: United States
facility: Pike County Detention Center
state: Kentucky
city: Shelbyville
country: United States
facility: Shelby County Detention Center
state: Kentucky
city: Williamstown
country: United States
facility: Grant County Detention Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Michele Staton, MSW, PhD
role: PRINCIPAL_INVESTIGATOR
References: