HIV InfectionsNCT01852877
Seek, Test, Treat, Retain: An Integrated Jail-Prison-Community Model for Illinois
An observational study of HIV Infections, run by University of Illinois Chicago at 3 sites in United States.
Trial summary
Aim-1: Evaluate opt-out versus opt-in testing for the human immunodeficiency virus (HIV) at the Cook County jail and the Illinois Department of Corrections Northern Intake facilities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Corrections case management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 784 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2013to 30 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Detainees in Cook County Jail, prisoners in the Illinois Department of Corrections
Who may be able to join
- For assessing opt-out and opt-in HIV testing: all detainees in Cook County Jail and all prisoners in the Northern Intake facilities of the Illinois Department of Corrections (IDOC)
- For assessing telemedicine: all HIV-positive IDOC prisoners who have received treatment for HIV. -- For assessing case management: all IDOC HIV telemedicine patients who have been released from prison and returned to Chicago in the past 60 days, and all known HIV-positive jail detainees likely to be returning the community (Chicago) within 60 days of contact with the jail's HIV clinic
- For assessing a post-release incentive to visit an HIV service organization, and uptake of post-release partner notification and social network HIV testing: all former detainees participating in the case management evaluation
Who cannot join
- Less than 18 years old
- Unable to speak English or Spanish
- Incapable of providing informed consent
- For jail detainees: being under extradition to a locale outside Cook County or a high likelihood of being sent to prison rather than being released to the community
- For prison inmates: being under extradition to a locale outside Illinois
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Illinois Department of Corrections
Chicago, Illinois, 60601
University of Illinois at Chicago, School of Public Health, COIP
Chicago, Illinois, 60607
Cermak Health Services, Cook County Jail
Chicago, Illinois, 60608
About this study
Official title: Seek, Test, Treat: An Integrated Jail-Prison-Community Model for Illinois
Aim-1: Evaluate opt-out versus opt-in testing for the human immunodeficiency virus (HIV) at the Cook County jail and the Illinois Department of Corrections Northern Intake facilities. Outcomes of interest include a) uptake of each HIV testing strategy, b) comparative effectiveness of identifying HIV-positive cases, new cases and undisclosed cases, and c) predictors of HIV testing.
Aim-2: Evaluate two case management strategies - "correctional case management" and "transitional case management" - designed to improve linkage and adherence to appropriate medical care after release from incarceration. Correctional case management is a longer-term, more intense approach while transitional case management seeks to meet the clients' immediate needs, link them to Ryan White case management, and then support the Ryan White case manager in assisting these clients. Correctional case management will be compared to the standard of care for jail detainees, and to transitional case management for persons leaving prison. Outcomes of interest include, (a) HIV viral load and CD4 cell counts over time, (b) adherence to medication, and (c) visits to medical providers.
Read more
Aim-3: Evaluate the impact of an incentive for HIV-positive detainees released from jail to visit an HIV service organization where they can be linked to medical care and case management. Outcomes of interest are essentially the same as Aim-2.
Aim-4: Assess university-based telemedicine as means to improve care of state prison inmates living with HIV. Outcomes of interest include medication regimens, HIV viral load and CD4 cell counts, and associated health conditions.
Aim-5: Assess the uptake of partner notification and social network HIV counseling and testing involving HIV-positive persons released from jail and prison as a means to extend the reach of the 'seek, test, treat and retain' (STTR) model into the community.
- Conditions
- HIV Infections
- Being tested
- Corrections case management
- Keywords
- HIV Diagnosis, Case Management, Telemedicine, Patient Compliance, Prisoners
- Medical subject headings
- HIV Infections, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corrections case managementBehavioural
Corrections case management is a long-term (18-24 months) program that seeks to improve the linkage of HIV-positive persons recently released from jail or prison to community-based HIV care, retain them in care, and reduce recidivism. Compared to the long-standing Ryan White case management program, corrections case management has greater access to housing and a greater emphasis on employment. Clients completing the program are then linked to the Ryan White case management program.
| Study group | Role | What they receive |
|---|---|---|
| Jail: HIV testing, corrections case mgt | For all jail detainees regardless of HIV status, we observed the uptake of opt-out and opt-in HIV testing. For HIV-positive jail detainees leaving jail, we observed 1) health outcomes for corrections case management versus other than corrections case management, 2) the impact of an incentive to visit an HIV service organization after release from jail Receives: Behavioral: Corrections case management | |
| Prison: telemed, corrections case mgt | We compared outcomes for for HIV-positive prisoners before and after the implementation of telemedicine to deliver HIV medical care. For HIV-positive prisoners released from prison and returning to Chicago, we observed health outcomes for those enrolled in corrections case management those not enrolled in corrections case management. Receives: Behavioral: Corrections case management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HIV viral load
Measured: baseline and 6, 12, 18 months post-baseline
Secondary outcomes (2)
Change in CD4 cell count
Measured: baseline and 6, 12, 18 months post-baseline
Change in community-level HIV viral load
Measured: baseline and 18 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startJul 2013
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 784 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Lawrence J. Ouellet, Ph.D., University of Illinois Chicago
- Investigators
- Lawrence J Ouellet, PhD, Principal investigator, University of Illinois ChicagoJeremy D Young, MD, Principal investigator, University of Illinois ChicagoChad Zawitz, MD, Principal investigator, Cermak Health Services, Cook County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852877
- Sponsor's protocol ID
- 2011-0619
- Other IDs
- 1R01DA030796
- Status last verified
- Nov 2019
- First submitted
- 8 May 2013
- Last updated
- 15 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seek, Test, Treat: An Integrated Jail-Prison-Community Model for Illinois
- ClinicalTrials.gov ID
- NCT01852877
- Acronym / sponsor ID
- 2011-0619
- Conditions
- HIV Infections
- Keywords
- HIV Diagnosis, Case Management, Telemedicine, Patient Compliance, Prisoners
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 784 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2013 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 14 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim-1: Evaluate opt-out versus opt-in testing for the human immunodeficiency virus (HIV) at the Cook County jail and the Illinois Department of Corrections Northern Intake facilities. Outcomes of interest include a) uptake of each HIV testing strategy, b) comparative effectiveness of identifying HIV-positive cases, new cases and undisclosed cases, and c) predictors of HIV testing.
Aim-2: Evaluate two case management strategies - "correctional case management" and "transitional case management" - designed to improve linkage and adherence to appropriate medical care after release from incarceration. Correctional case management is a longer-term, more intense approach while transitional case management seeks to meet the clients' immediate needs, link them to Ryan White case management, and then support the Ryan White case manager in assisting these clients. Correctional case management will be compared to the standard of care for jail detainees, and to transitional case management for persons leaving prison. Outcomes of interest include, (a) HIV viral load and CD4 cell counts over time, (b) adherence to medication, and (c) visits to medical providers.
Aim-3: Evaluate the impact of an incentive for HIV-positive detainees released from jail to visit an HIV service organization where they can be linked to medical care and case management. Outcomes of interest are essentially the same as Aim-2.
Aim-4: Assess university-based telemedicine as means to improve care of state prison inmates living with HIV. Outcomes of interest include medication regimens, HIV viral load and CD4 cell counts, and associated health conditions.
Aim-5: Assess the uptake of partner notification and social network HIV counseling and testing involving HIV-positive persons released from jail and prison as a means to extend the reach of the 'seek, test, treat and retain' (STTR) model into the community.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jail: HIV testing, corrections case mgt | – | Behavioral: Corrections case managementFor all jail detainees regardless of HIV status, we observed the uptake of opt-out and opt-in HIV testing. For HIV-positive jail detainees leaving jail, we observed 1) health outcomes for corrections case management versus other than corrections case management, 2) the impact of an incentive to visit an HIV service organization after release from jail |
| Prison: telemed, corrections case mgt | – | Behavioral: Corrections case managementWe compared outcomes for for HIV-positive prisoners before and after the implementation of telemedicine to deliver HIV medical care. For HIV-positive prisoners released from prison and returning to Chicago, we observed health outcomes for those enrolled in corrections case management those not enrolled in corrections case management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Detainees in Cook County Jail, prisoners in the Illinois Department of Corrections
Key inclusion criteria (3 listed)
- For assessing opt-out and opt-in HIV testing: all detainees in Cook County Jail and all prisoners in the Northern Intake facilities of the Illinois Department of Corrections (IDOC)
- For assessing telemedicine: all HIV-positive IDOC prisoners who have received treatment for HIV. -- For assessing case management: all IDOC HIV telemedicine patients who have been released from prison and returned to Chicago in the past 60 days, and all known HIV-positive jail detainees likely to be returning the community (Chicago) within 60 days of contact with the jail's HIV clinic
- For assessing a post-release incentive to visit an HIV service organization, and uptake of post-release partner notification and social network HIV testing: all former detainees participating in the case management evaluation
Key exclusion criteria (5 listed)
- Less than 18 years old
- Unable to speak English or Spanish
- Incapable of providing informed consent
- For jail detainees: being under extradition to a locale outside Cook County or a high likelihood of being sent to prison rather than being released to the community
- For prison inmates: being under extradition to a locale outside Illinois
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 |
|---|---|---|
| Corrections case managementCorrections case management is a long-term (18-24 months) program that seeks to improve the linkage of HIV-positive persons recently released from jail or prison to community-based HIV care, retain them in care, and reduce recidivism. Compared to the long-standing Ryan White case management program, corrections case management has greater access to housing and a greater emphasis on employment. Clients completing the program are then linked to the Ryan White case management program. | Behavioural | Jail: HIV testing, corrections case mgt, Prison: telemed, corrections case mgt |
Primary outcome
Change in HIV viral load
Time frame: baseline and 6, 12, 18 months post-baseline
2 secondary outcomes
Change in CD4 cell count
Time frame: baseline and 6, 12, 18 months post-baseline
Change in community-level HIV viral load
Time frame: baseline and 18 months post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
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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.
Lawrence J Ouellet, PhD principal investigator
University of Illinois Chicago
Jeremy D Young, MD principal investigator
University of Illinois Chicago
Chad Zawitz, MD principal investigator
Cermak Health Services, Cook County
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by University of Illinois Chicago at 3 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 3 inclusion and 5 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 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in HIV viral load (time frame: baseline and 6, 12, 18 months post-baseline). 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 15 Nov 2019.