Trial Outcomes & Findings for Criminal Justice Coordinated Transitional Care (NCT NCT05376371)
NCT ID: NCT05376371
Last Updated: 2025-11-17
Results Overview
Of participants who enroll and complete a follow up assessment, percentage of participants who responded to questions soliciting their perspectives about the intervention usefulness.
COMPLETED
NA
219 participants
within 3-months following release (up to 6 months on study)
2025-11-17
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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219
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Overall Study
COMPLETED
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209
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Overall Study
NOT COMPLETED
|
10
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Reasons for withdrawal
| Measure |
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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|---|---|
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Overall Study
change in release date
|
10
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Baseline Characteristics
Criminal Justice Coordinated Transitional Care
Baseline characteristics by cohort
| Measure |
CJC-TraC Intervention
n=219 Participants
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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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=39 Participants
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Age, Categorical
Between 18 and 65 years
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213 Participants
n=39 Participants
|
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Age, Categorical
>=65 years
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6 Participants
n=39 Participants
|
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Age, Continuous
|
41 Years
n=39 Participants
|
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Sex/Gender, Customized
Female
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105 Participants
n=39 Participants
|
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Sex/Gender, Customized
Male
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112 Participants
n=39 Participants
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Sex/Gender, Customized
Unknown: Missing Data
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2 Participants
n=39 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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16 Participants
n=39 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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203 Participants
n=39 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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11 Participants
n=39 Participants
|
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Race (NIH/OMB)
Asian
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2 Participants
n=39 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Black or African American
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57 Participants
n=39 Participants
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Race (NIH/OMB)
White
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121 Participants
n=39 Participants
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Race (NIH/OMB)
More than one race
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15 Participants
n=39 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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13 Participants
n=39 Participants
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Region of Enrollment
United States
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219 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: at enrollment, up to 1 dayThe number who successfully enrolled and completed the baseline assessment demonstrates the feasibility of engaging the target population in the prison setting.
Outcome measures
| Measure |
CJC-TraC Intervention
n=219 Participants
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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|---|---|
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Feasibility Outcome: Number of Participants Who Are Enrolled and Complete the Baseline Study Assessment
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219 Participants
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PRIMARY outcome
Timeframe: pre-release, up to 3 monthsPopulation: All enrolled participants were eligible to receive pre-release intervention sessions
The investigators plan for 3 pre-release sessions with additional sessions as needed. The results will be reported in total and for each institution.
Outcome measures
| Measure |
CJC-TraC Intervention
n=679 pre-release sessions
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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|---|---|
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Feasibility Outcome: Number of Pre-release CJC-TraC Intervention Sessions Completed With the Nurse Case Manager for Each Participant
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3.1 sessions
Standard Deviation 1.2
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PRIMARY outcome
Timeframe: post-release, up to 6 monthsPopulation: 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.
The investigators plan for 2 post-release sessions with additional sessions as needed.
Outcome measures
| Measure |
CJC-TraC Intervention
n=1212 telephone contact attempts
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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|---|---|
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Feasibility Outcome: Number of Post-release Telephone Contact Attempts Between the CJC-TraC Nurse Case Manager and Study Participants
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5.8 telephone contact attempts
Standard Deviation 3.7
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
CJC-TraC Intervention
n=209 Participants
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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|---|---|
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Feasibility Outcome: Number of Study Participants Who Are Retained in Follow-up for Three Months and Complete the End-of-study Assessment
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158 Participants
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PRIMARY outcome
Timeframe: 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.
Of participants who enroll and complete a follow up assessment, percentage of participants who responded to questions soliciting their perspectives about the intervention usefulness.
Outcome measures
| Measure |
CJC-TraC Intervention
n=209 Participants
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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|---|---|
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Acceptability Measured by the Number of Study Participants Who Rated the Volume of Pre-release Intervention Sessions as Appropriate
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116 Participants
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PRIMARY outcome
Timeframe: 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.
Of participants who enroll and complete a follow up assessment, percentage of participants who responded to questions soliciting their perspectives about the intervention usefulness.
Outcome measures
| Measure |
CJC-TraC Intervention
n=209 Participants
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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|---|---|
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Acceptability Measured by the Number of Study Participants Who Rated the Volume of Post-release Intervention Contacts as Appropriate
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123 Participants
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PRIMARY outcome
Timeframe: up to 3 monthsPopulation: 5 Staff from the prison system responded to the feedback survey
Outcome measures
| Measure |
CJC-TraC Intervention
n=5 Participants
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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|---|---|
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Acceptability Measured by the Number of Department of Corrections (DOC) Staff Who Rated the Intervention Acceptable, Useful, or Appropriate
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5 staff members from prison system
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PRIMARY outcome
Timeframe: 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
Exploratory results of qualitative interviews among a subset of intervention participants.
Outcome measures
| Measure |
CJC-TraC Intervention
n=30 Participants
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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|---|---|
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Acceptability Assessed by Subjective Experience of the Participant (Qualitative Measure) Reported Here as Number of Participants Completing Acceptability Interviews
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30 Participants
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SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
CJC-TraC Intervention
n=209 Participants
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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|---|---|
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Attendance at Non-emergency Outpatient Care Visits Within 3-months Following Release
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149 Participants
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SECONDARY outcome
Timeframe: within 3-months following release (up to 6 months on study)Outcome measures
| Measure |
CJC-TraC Intervention
n=209 Participants
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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|---|---|
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Number Days Until the First Non-emergency Outpatient Visit Following Release, Reported Here as Number of Participants With Visits Occurring Within 60 Days
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141 Participants
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Adverse Events
CJC-TRAC Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place