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临床试验/NCT04069624
NCT04069624已完成不适用

Kentucky Women's Justice Community Opioid Innovation Network

Michele Staton9 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2020年12月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
900
试验地点
9
主要终点
The number of participants who initiate MOUD

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • ASSIST opioid (prescription or street) score of 4+
  • Willingness to participate in MOUD pre-treatment
  • Incarceration period of at least 7 days

排除标准

  • Cognitive impairment

研究组 & 干预措施

Services as Usual (SAU)

Active Comparator

Substance abuse program (SAP) managed by the Kentucky Department of Corrections, with the option to initiate MOUD prior to jail release.

干预措施: Services as Usual (Other)

MOUD Pre-Treatment Telehealth

Experimental

Telehealth connection to a community MOUD provider.

干预措施: MOUD Pre-Treatment Telehealth (Behavioral)

MOUD Pre-Treatment Telehealth and Peer Navigator

Experimental

Telehealth connection to a community MOUD provider, in addition to a peer navigator

干预措施: MOUD Pre-Treatment Telehealth and Peer Navigator (Behavioral)

结局指标

主要结局

The number of participants who initiate MOUD

时间窗: 13 months

Any initiation of MOUD post-release over the study period

次要结局

  • Medication Type(13 months)
  • Overdose Rates(13 months)
  • Recidivism(12 months)
  • Opioid Relapse(13 months)
  • Treatment Retention(13 months)
  • Criminal Activity(12 months)

研究者

发起方
Michele Staton
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michele Staton

Professor

University of Kentucky

研究点 (9)

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