HIVCJC-TraCNCT05376371
Criminal Justice Coordinated Transitional Care
A study testing CJC-TraC in people with HIV and Hepatitis C, run by University of Wisconsin, Madison at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Hepatitis C, Substance Use Disorders
- What is being tested?
- CJC-TraC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Nov 2022to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oakhill Correctional Institution
Oregon, Wisconsin, 53575
Robert E. Ellsworth Correctional Center
Union Grove, Wisconsin, 53182
About this study
Official title: Health Systems Innovations for Supporting Transitions of Care for Incarcerated People Living With HIV, Hepatitis C, and Substance Use Disorder
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.
Read the 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.
- Conditions
- HIV, Hepatitis C, Substance Use Disorders
- Being tested
- CJC-TraC
- Keywords
- incarcerated, transition, release
- Medical subject headings
- Hepatitis C, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJC-TraCOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: CJC-TraC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Of participants who enroll and complete a follow up assessment, percentage of participants who responded to questions soliciting their perspectives about the intervention usefulness.
Measured: 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
Measured: 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.
Measured: within 3-months following release (up to 6 months on study)
Secondary outcomes (2)
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.
Measured: 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
Measured: within 3-months following release (up to 6 months on study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start29 Nov 2022
- Primary completion3 Dec 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Ryan Westergaard, MD, PhD, MPH, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376371
- Sponsor's protocol ID
- 2022-0398
- Other IDs
- 1R01DA047889-01A1, Protocol Version 6/9/2024, A534265
- Acronym
- CJC-TraC
- Status last verified
- Nov 2025
- First submitted
- 11 May 2022
- Last updated
- 17 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Systems Innovations for Supporting Transitions of Care for Incarcerated People Living With HIV, Hepatitis C, and Substance Use Disorder
- ClinicalTrials.gov ID
- NCT05376371
- Acronym / sponsor ID
- CJC-TraC / 2022-0398
- Conditions
- HIV, Hepatitis C, Substance Use Disorders
- Keywords
- incarcerated, transition, release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Posted 17 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CJC-TraC Intervention | Experimental | Other: CJC-TraCIncarcerated 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CJC-TraCCJC-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. | Other | CJC-TraC Intervention |
Primary outcome
Feasibility Outcome: Number of Participants Who Are Enrolled and Complete the Baseline Study Assessment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 3 months
Acceptability Assessed by Subjective Experience of the Participant (Qualitative Measure) Reported Here as Number of Participants Completing Acceptability Interviews
Time frame: within 3-months following release (up to 6 months on study)
Exploratory results of qualitative interviews among a subset of intervention participants.
2 secondary outcomes
Attendance at Non-emergency Outpatient Care Visits Within 3-months Following Release
Time frame: 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
Time frame: within 3-months following release (up to 6 months on study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Westergaard, MD, PhD, MPH principal investigator
UW School of Medicine and Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CJC-TraC in people with HIV and Hepatitis C, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Outcome: Number of Participants Who Are Enrolled and Complete the Baseline Study Assessment (time frame: at enrollment, up to 1 day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025; AzTrials last refreshed its copy on 29 Oct 2026.