Kentucky Women's Justice Community Overdose Innovation Network - Phase II

Not Applicable

Not yet recruiting

• Conditions: Overdose Risk; Opioid Use Disorder; Stimulant Use Disorders

• Registration Number: NCT07179614
• Lead Sponsor: University of Kentucky

Brief Summary

This project continues our work with women in the Kentucky Women's Justice Community Overdose Innovation Network Phase II (WJCOIN-II) with the overall aim of reducing overdose risk during the transition from jail to rural communities. WJCOIN-II has potential for significant impact regarding the effectiveness, implementation, and sustainability of innovative overdose prevention strategies during the high-risk time of community re-entry among vulnerable, CLS-involved women in rural communities. This research will impact the field by increasing the capacity of the criminal legal system to respond to the overdose crisis through increased access to prevention strategies to reduce overdose risk.

Detailed Description

Overdose deaths among women rose nearly 500% in the past two decades, a rate considerably higher than men. Yet, overdose prevention approaches that target the unique risks of women, particularly those involved in the criminal legal system (CLS) in underserved rural areas, are limited. This application proposes to continue our work with women in the Kentucky Women's Justice Community Overdose Innovation Network Phase II (WJCOIN-II) with the overall aim of reducing overdose risk during the transition from jail to rural communities. Specific aims include: Aim 1: Compare the effectiveness of pre-release RC to RC+SPE in decreasing women's overdose risk during re-entry to rural communities. Through a multi-site 2 X 2 factorial design, women will be randomly assigned to two pre-release conditions (1) Recovery Coaching (RC) only or (2) RC + support person engagement (SPE) to reduce overdose risk through the development of an overdose prevention plan and increase motivation for treatment entry within one-month post-release. Aim 2: Compare the additive effectiveness of CM initiated post-release to RC alone and RC+SPE in decreasing overdose risk and increasing treatment entry and retention among women during re-entry to rural communities. The 2 X 2 factorial randomized design also includes assignment to one of two post-release conditions: 1) continuation of pre-release intervention (RC or RC+SPE) only in the community through ongoing sessions, or 2) addition of contingency management (RC+CM or RC+SPE+CM) to incentivize target behaviors (reduced days of drug use). Depending on treatment entry by the one-month post-release period (non-initiators vs. initiators of treatment), the following aims will be examined post-release from jail: Aim 2a. Among non-initiators, examine the additive effectiveness of post-release CM to reduce overdose risk. Aim 2b. Among treatment initiators, examine the additive effectiveness of post-release CM to increase treatment retention. Aim 3: Contextualize effectiveness of intervention components by examining the roles of perceived acceptability and appropriateness, and identify barriers and facilitators to intervention implementation across the re-entry continuum. Acceptability and appropriateness of intervention components from the perspectives of women and public safety/public health stakeholders (e.g., jail staff, RCs, treatment providers) will be measured through individual-level survey data collection. Aim 4: Examine economic impact of the WJCOIN-II interventions pre-release and post-release in reducing women's overdose risk in rural communities. Cost effectiveness and net societal costs will be assessed by incorporating clinical (overdose risk) and service utilization (treatment entry) outcomes using tailored budget impact tools. The study will make a significant impact regarding the effectiveness, implementation, and sustainability of innovative overdose prevention strategies during the high-risk time of community re-entry among vulnerable, CLS-involved women in rural communities.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-16
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18
• Study Start: 2025-11-01
• Primary Completion: 2030-10-30
• Study Completion: 2030-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

1. DSM-5 scores of 2+ for opioids (OUD) and/or stimulants (StUD),
2. no evidence of cognitive impairment in providing consent,
3. a release date within 7-60 days to allow for time for intervention sessions,
4. willingness to consider SUD treatment post-release, and
5. willingness to provide the name and contact information of at least one person in the community who will support the woman's recovery pre/post-release (SP).

Exclusion Criteria

• Not living in a rural area
• Any condition that would not allow capable informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Overdose risk	3, 6, and 12 months post-release	Overdose risk score based on days of opioid, stimulant, and polysubstance use
Treatment entry	1 month postrelease	Entry into any formal ASAM level of SUD treatment (e.g., outpatient, intensive outpatient, residential, inpatient, MOUD) (yes/no)