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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA047889-01A1 | U.S. NIH Grant/Contract | View source | |
| Protocol Version 6/9/2024 | Other Identifier | UW Madison | |
| A534265 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CJC-TraC Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJC-TraC | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at enrollment, up to 1 day |
| 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. | pre-release, up to 3 months |
| 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. | post-release, up to 6 months |
| 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 | Of participants who enroll and complete a follow up assessment, percentage of participants who responded to questions soliciting their perspectives about the intervention usefulness. | within 3-months following release (up to 6 months on study) |
| Acceptability Measured by the Number of Study Participants Who Rated the Volume of Post-release Intervention Contacts as Appropriate |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 3-months following release (up to 6 months on study) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Westergaard, MD, PhD, MPH | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oakhill Correctional Institution | Oregon | Wisconsin | 53575 | United States | ||
| Robert E. Ellsworth Correctional Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | at enrollment, up to 1 day |
|
12 weeks
Adverse event was defined as unexpected death from any cause that was reported to the study team during the 12 week follow-up period. Acute hospitalizations and emergency department visits were not considered adverse events because they are common in this population and represented one of the study outcomes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Westergaard | University or Wisconsin-Madison | 6082657927 | rpw@medicine.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 3, 2023 | Oct 9, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 14, 2023 | Apr 22, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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|
Of participants who enroll and complete a follow up assessment, percentage of participants who responded to questions soliciting their perspectives about the intervention usefulness.
| within 3-months following release (up to 6 months on study) |
| Acceptability Measured by the Number of Department of Corrections (DOC) Staff Who Rated the Intervention Acceptable, Useful, or Appropriate | up to 3 months |
| 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. | 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) |
| Union Grove |
| Wisconsin |
| 53182 |
| United States |
| Participants |
| No |
|
| Age, Continuous | Mean | Full Range | Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | All enrolled participants were eligible to receive pre-release intervention sessions | Posted | Mean | Standard Deviation | sessions | pre-release, up to 3 months | pre-release sessions | pre-release sessions |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | telephone contact attempts | post-release, up to 6 months | telephone contact attempts | telephone contact attempts |
|
|
|
| Primary | Feasibility Outcome: Number of Study Participants Who Are Retained in Follow-up for Three Months and Complete the End-of-study Assessment | 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. | Posted | Count of Participants | Participants | within 3-months following release (up to 6 months on study) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | within 3-months following release (up to 6 months on study) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | within 3-months following release (up to 6 months on study) |
|
|
|
| Primary | Acceptability Measured by the Number of Department of Corrections (DOC) Staff Who Rated the Intervention Acceptable, Useful, or Appropriate | 5 Staff from the prison system responded to the feedback survey | Posted | Number | staff members from prison system | up to 3 months |
|
|
|
| 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. | In total, 30 individuals (15 men and 15 women) participated in interviews between April 2023 and December 2024 | Posted | Count of Participants | Participants | within 3-months following release (up to 6 months on study) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | within 3-months following release (up to 6 months on study) |
|
|
|
| Secondary | Number Days Until the First Non-emergency Outpatient Visit Following Release, Reported Here as Number of Participants With Visits Occurring Within 60 Days | Posted | Count of Participants | Participants | within 3-months following release (up to 6 months on study) |
|
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| 2 |
| 209 |
| 0 |
| 209 |
| 0 |
| 209 |
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |