Trial Outcomes & Findings for Criminal Justice Coordinated Transitional Care (NCT NCT05376371)

NCT ID: NCT05376371

Last Updated: 2025-11-17

Results Overview

The investigators plan for 2 post-release sessions with additional sessions as needed.

Recruitment status

COMPLETED

Study phase

Target enrollment

219 participants

Primary outcome timeframe

post-release, up to 6 months

Results posted on

2025-11-17

Participant Flow

Participant milestones

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.
Overall Study STARTED	219
Overall Study COMPLETED	209
Overall Study NOT COMPLETED	10

Reasons for withdrawal

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.
Overall Study change in release date	10

Baseline Characteristics

Criminal Justice Coordinated Transitional Care

Baseline characteristics by cohort

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.
Age, Categorical <=18 years	0 Participants n=202 Participants
Age, Categorical Between 18 and 65 years	213 Participants n=202 Participants
Age, Categorical >=65 years	6 Participants n=202 Participants
Age, Continuous	41 Years n=202 Participants
Sex/Gender, Customized Female	105 Participants n=202 Participants
Sex/Gender, Customized Male	112 Participants n=202 Participants
Sex/Gender, Customized Unknown: Missing Data	2 Participants n=202 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=202 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	203 Participants n=202 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=202 Participants
Race (NIH/OMB) American Indian or Alaska Native	11 Participants n=202 Participants
Race (NIH/OMB) Asian	2 Participants n=202 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=202 Participants
Race (NIH/OMB) Black or African American	57 Participants n=202 Participants
Race (NIH/OMB) White	121 Participants n=202 Participants
Race (NIH/OMB) More than one race	15 Participants n=202 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=202 Participants
Region of Enrollment United States	219 participants n=202 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

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.
Feasibility Outcome: Number of Participants Who Are Enrolled and Complete the Baseline Study Assessment	219 Participants

PRIMARY outcome

Timeframe: pre-release, up to 3 months

Population: 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

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.
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 outcome

Timeframe: 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.

The investigators plan for 2 post-release sessions with additional sessions as needed.

Outcome measures

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.
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 outcome

Timeframe: within 3-months following release (up to 6 months on study)

Outcome measures

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.
Feasibility Outcome: Number of Study Participants Who Are Retained in Follow-up for Three Months and Complete the End-of-study Assessment	158 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

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.
Acceptability Measured by the Number of Study Participants Who Rated the Volume of Pre-release Intervention Sessions as Appropriate	116 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

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.
Acceptability Measured by the Number of Study Participants Who Rated the Volume of Post-release Intervention Contacts as Appropriate	123 Participants

PRIMARY outcome

Timeframe: up to 3 months

Population: 5 Staff from the prison system responded to the feedback survey

Outcome measures

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.
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 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

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.
Acceptability Assessed by Subjective Experience of the Participant (Qualitative Measure) Reported Here as Number of Participants Completing Acceptability Interviews	30 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

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.
Attendance at Non-emergency Outpatient Care Visits Within 3-months Following Release	149 Participants

SECONDARY outcome

Timeframe: within 3-months following release (up to 6 months on study)

Outcome measures

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.
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

Adverse Events

CJC-TRAC Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ryan Westergaard

University or Wisconsin-Madison

Phone: 6082657927

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place