Hepatitis C, HIV, Substance Use Disorders
Conditions
Keywords
incarcerated, transition, release
Brief summary
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.
Detailed description
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) Primary Objectives: To evaluate the feasibility and acceptability of CJC-TraC when implemented in a state prison system. Secondary Objectives: To gather preliminary evidence describing the effectiveness of CJC-TraC for improving the rate of outpatient care utilization.
Interventions
OTHERCJC-TraC
CJC-TraC utilizes a nurse case manager (NCM) to coordinate the participant's transitional care through release from a correctional facility. The NCM will visit either in person or via telehealth with the participant up to 4 times while incarcerated, and up to 4 times after release.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability Assessed by Subjective Experience of the Participant (Qualitative Measure) Reported Here as Number of Participants Completing Acceptability Interviews | within 3-months following release (up to 6 months on study) | Exploratory results of qualitative interviews among a subset of intervention participants. |
| Acceptability Measured by the Number of Study Participants Who Rated the Volume of Post-release Intervention Contacts as Appropriate | 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 Department of Corrections (DOC) Staff Who Rated the Intervention Acceptable, Useful, or Appropriate | up to 3 months | — |
| Feasibility Outcome: Number of Participants Who Are Enrolled and Complete the Baseline Study Assessment | 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. |
| Feasibility Outcome: Number of Pre-release CJC-TraC Intervention Sessions Completed With the Nurse Case Manager for Each Participant | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| Attendance at Non-emergency Outpatient Care Visits Within 3-months Following Release | within 3-months following release (up to 6 months on study) | Based on review of medical records and Wisconsin Medicaid claims data, the occurrence of outpatient medical care visits, not including emergency department or urgent care visits. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CJC-TraC Intervention Incarcerated individuals with HIV, hepatitis C, or substance use disorder readying for release will enroll in the CJC-TraC intervention intended to assist in transitioning their health care.
CJC-TraC: CJC-TraC utilizes a nurse case manager (NCM) to coordinate the participant's transitional care through release from a correctional facility. The NCM will visit either in person or via telehealth with the participant up to 4 times while incarcerated, and up to 4 times after release. | 219 |
| Total | 219 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | change in release date | 10 |
Baseline characteristics
| Characteristic | CJC-TraC Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 213 Participants |
| Age, Continuous | 41 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 203 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 11 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 57 Participants |
| Race (NIH/OMB) More than one race | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) White | 121 Participants |
| Region of Enrollment United States | 219 participants |
| Sex/Gender, Customized Female | 105 Participants |
| Sex/Gender, Customized Male | 112 Participants |
| Sex/Gender, Customized Unknown: Missing Data | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 209 |
| other Total, other adverse events | 0 / 209 |
| serious Total, serious adverse events | 0 / 209 |
Outcome results
Primary
Acceptability Assessed by Subjective Experience of the Participant (Qualitative Measure) Reported Here as Number of Participants Completing Acceptability Interviews
Exploratory results of qualitative interviews among a subset of intervention participants.
Time frame: within 3-months following release (up to 6 months on study)
Population: In total, 30 individuals (15 men and 15 women) participated in interviews between April 2023 and December 2024
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CJC-TraC Intervention | Acceptability Assessed by Subjective Experience of the Participant (Qualitative Measure) Reported Here as Number of Participants Completing Acceptability Interviews | 30 Participants |
Primary
Acceptability Measured by the Number of Department of Corrections (DOC) Staff Who Rated the Intervention Acceptable, Useful, or Appropriate
Time frame: up to 3 months
Population: 5 Staff from the prison system responded to the feedback survey
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CJC-TraC Intervention | Acceptability Measured by the Number of Department of Corrections (DOC) Staff Who Rated the Intervention Acceptable, Useful, or Appropriate | 5 staff members from prison system |
Primary
Acceptability Measured by the Number of Study Participants Who Rated the Volume of Post-release Intervention Contacts as Appropriate
Of participants who enroll and complete a follow up assessment, percentage of participants who responded to questions soliciting their perspectives about the intervention usefulness.
Time frame: within 3-months following release (up to 6 months on study)
Population: Of 219 individuals enrolled in the study, 10 were withdrawn because of a change in their release date after enrollment. The 209 who were released from prison during the study period were evaluated for the study outcomes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CJC-TraC Intervention | Acceptability Measured by the Number of Study Participants Who Rated the Volume of Post-release Intervention Contacts as Appropriate | 123 Participants |
Primary
Acceptability Measured by the Number of Study Participants Who Rated the Volume of Pre-release Intervention Sessions as Appropriate
Of participants who enroll and complete a follow up assessment, percentage of participants who responded to questions soliciting their perspectives about the intervention usefulness.
Time frame: within 3-months following release (up to 6 months on study)
Population: Of 219 individuals enrolled in the study, 10 were withdrawn because of a change in their release date after enrollment. The 209 who were released from prison during the study period were evaluated for the study outcomes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CJC-TraC Intervention | Acceptability Measured by the Number of Study Participants Who Rated the Volume of Pre-release Intervention Sessions as Appropriate | 116 Participants |
Primary
Feasibility Outcome: Number of Participants Who Are Enrolled and Complete the Baseline Study Assessment
The number who successfully enrolled and completed the baseline assessment demonstrates the feasibility of engaging the target population in the prison setting.
Time frame: at enrollment, up to 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CJC-TraC Intervention | Feasibility Outcome: Number of Participants Who Are Enrolled and Complete the Baseline Study Assessment | 219 Participants |
Primary
Feasibility Outcome: Number of Post-release Telephone Contact Attempts Between the CJC-TraC Nurse Case Manager and Study Participants
The investigators plan for 2 post-release sessions with additional sessions as needed.
Time frame: post-release, up to 6 months
Population: Of 219 individuals enrolled in the study, 10 were withdrawn because of a change in their release date after enrollment. The 209 who were released from prison during the study period were evaluated for the study outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CJC-TraC Intervention | Feasibility Outcome: Number of Post-release Telephone Contact Attempts Between the CJC-TraC Nurse Case Manager and Study Participants | 5.8 telephone contact attempts | Standard Deviation 3.7 |
Primary
Feasibility Outcome: Number of Pre-release CJC-TraC Intervention Sessions Completed With the Nurse Case Manager for Each Participant
The investigators plan for 3 pre-release sessions with additional sessions as needed. The results will be reported in total and for each institution.
Time frame: pre-release, up to 3 months
Population: All enrolled participants were eligible to receive pre-release intervention sessions
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CJC-TraC Intervention | Feasibility Outcome: Number of Pre-release CJC-TraC Intervention Sessions Completed With the Nurse Case Manager for Each Participant | 3.1 sessions | Standard Deviation 1.2 |
Primary
Feasibility Outcome: Number of Study Participants Who Are Retained in Follow-up for Three Months and Complete the End-of-study Assessment
Time frame: within 3-months following release (up to 6 months on study)
Population: Of 219 individuals enrolled in the study, 10 were withdrawn because of a change in their release date after enrollment. The 209 who were released from prison during the study period were evaluated for the study outcomes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CJC-TraC Intervention | Feasibility Outcome: Number of Study Participants Who Are Retained in Follow-up for Three Months and Complete the End-of-study Assessment | 158 Participants |
Secondary
Attendance at Non-emergency Outpatient Care Visits Within 3-months Following Release
Based on review of medical records and Wisconsin Medicaid claims data, the occurrence of outpatient medical care visits, not including emergency department or urgent care visits.
Time frame: within 3-months following release (up to 6 months on study)
Population: Of 219 individuals enrolled in the study, 10 were withdrawn because of a change in their release date after enrollment. The 209 who were released from prison during the study period were evaluated for the study outcomes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CJC-TraC Intervention | Attendance at Non-emergency Outpatient Care Visits Within 3-months Following Release | 149 Participants |
Secondary
Number Days Until the First Non-emergency Outpatient Visit Following Release, Reported Here as Number of Participants With Visits Occurring Within 60 Days
Time frame: within 3-months following release (up to 6 months on study)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CJC-TraC Intervention | Number Days Until the First Non-emergency Outpatient Visit Following Release, Reported Here as Number of Participants With Visits Occurring Within 60 Days | 141 Participants |