Health Systems Innovations for Supporting Transitions of Care for Incarcerated People Living With HIV, Hepatitis C, and Substance Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 4
- 主要终点
- Feasibility Outcome: Number of Participants Who Are Enrolled and Complete the Baseline Study Assessment
研究概览
简要总结
This project aims to enroll 220 incarcerated individuals living with HIV, Hepatitis C (HCV), or history of substance misuse preparing for release into a pilot implementation study to test the feasibility and acceptability of an adapted Coordinated Transitional Care intervention in a Criminal Justice setting (CJC-TraC). Participants can expect to be on study for up to 6 months.
详细描述
This protocol describes the second, implementation phase of a 5-year NIH-funded research project designed to evaluate post-incarceration health care utilization and outcomes for underserved people living with HIV, HCV and substance use disorder.
In the first study phase, conducted from 2020-21, the investigators analyzed Wisconsin Medicaid data to characterize the baseline level of outpatient care utilization for adults during their first 6 months after release from prison, and conducted formative research necessary to adapt an existing transitional care intervention, called C-TraC, to support individuals leaving prison.
The current project aims to enroll participants in a pilot implementation study to test the feasibility and acceptability of the adapted intervention in a criminal justice setting, which has been given the name "CJC-TraC."
Participants will be enrolled from one of two institutions:
- men from Oakhill Correctional Institute (OCI)
- women from the Wisconsin Women's Correctional System (WWCS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and speak in English
- •Plans to reside in Wisconsin after release
- •Eligible for Wisconsin Medicaid and willing to enroll prior to release
- •Has a history of one or more of the following: current HIV infection, current or past HCV infection, identified need for substance use related services based on Correctional Offender Management Profiling for Alternative Sanctions (COMPAS) assessment
- •Anticipated release date (must be within 6 months of review)
排除标准
- •Unable to provide informed consent form or impaired ability to make decisions
- •Planned discharge to another correctional facility or other carceral setting (e.g. release to jail or immigration detention center)
结局指标
主要结局
Feasibility Outcome: Number of Participants Who Are Enrolled and Complete the Baseline Study Assessment
时间窗: at enrollment, up to 1 day
The number who successfully enrolled and completed the baseline assessment demonstrates the feasibility of engaging the target population in the prison setting.
Acceptability Measured by the Number of Department of Corrections (DOC) Staff Who Rated the Intervention Acceptable, Useful, or Appropriate
时间窗: up to 3 months
Acceptability Assessed by Subjective Experience of the Participant (Qualitative Measure) Reported Here as Number of Participants Completing Acceptability Interviews
时间窗: within 3-months following release (up to 6 months on study)
Exploratory results of qualitative interviews among a subset of intervention participants.
Feasibility Outcome: Number of Pre-release CJC-TraC Intervention Sessions Completed With the Nurse Case Manager for Each Participant
时间窗: pre-release, up to 3 months
The investigators plan for 3 pre-release sessions with additional sessions as needed. The results will be reported in total and for each institution.
Feasibility Outcome: Number of Post-release Telephone Contact Attempts Between the CJC-TraC Nurse Case Manager and Study Participants
时间窗: post-release, up to 6 months
The investigators plan for 2 post-release sessions with additional sessions as needed.
Feasibility Outcome: Number of Study Participants Who Are Retained in Follow-up for Three Months and Complete the End-of-study Assessment
时间窗: within 3-months following release (up to 6 months on study)
Acceptability Measured by the Number of Study Participants Who Rated the Volume of Pre-release Intervention Sessions as Appropriate
时间窗: within 3-months following release (up to 6 months on study)
Of participants who enroll and complete a follow up assessment, percentage of participants who responded to questions soliciting their perspectives about the intervention usefulness.
Acceptability Measured by the Number of Study Participants Who Rated the Volume of Post-release Intervention Contacts as Appropriate
时间窗: within 3-months following release (up to 6 months on study)
Of participants who enroll and complete a follow up assessment, percentage of participants who responded to questions soliciting their perspectives about the intervention usefulness.
次要结局
- Attendance at Non-emergency Outpatient Care Visits Within 3-months Following Release(within 3-months following release (up to 6 months on study))
- Number Days Until the First Non-emergency Outpatient Visit Following Release, Reported Here as Number of Participants With Visits Occurring Within 60 Days(within 3-months following release (up to 6 months on study))