Seek, Test, Treat, Retain: An Integrated Jail-Prison-Community Model for Illinois

This study is not yet open for participant recruitment.
Verified May 2013 by University of Illinois at Chicago
Sponsor:
Information provided by (Responsible Party):
Lawrence J. Ouellet, Ph.D., University of Illinois
ClinicalTrials.gov Identifier:
NCT01852877
First received: May 8, 2013
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

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.

Aim-6: Assess the impact of this STTR model on community viral load in the six Chicago community areas with the largest number of incarcerated persons. Two outcome measures will be used: mean and total HIV viral load.


Condition Intervention
HIV Infections
Behavioral: Correctional case management
Behavioral: Transitional case management

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Seek, Test, Treat: An Integrated Jail-Prison-Community Model for Illinois

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Change in HIV viral load [ Time Frame: baseline and 6, 12, 18 months post-baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in CD4 cell count [ Time Frame: baseline and 6, 12, 18 months post-baseline ] [ Designated as safety issue: No ]
  • Change in community-level HIV viral load [ Time Frame: baseline and 18 months post-baseline ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in adherence to HIV medication [ Time Frame: baseline and 6, 12, 18 months post-baseline ] [ Designated as safety issue: No ]
  • Change in visits to HIV medical care provider [ Time Frame: baseline and 6, 12, 18 months post-baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood serum


Estimated Enrollment: 3487
Study Start Date: July 2013
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Jail detainees
For all jail detainees, we will observe the uptake of opt-out and opt-in HIV testing. For HIV-positive jail detainees leaving jail, we will observe 1) health outcomes for corrections case management versus the standard of care, 2) the impact of an incentive to visit an HIV service organization after release from jail, and 3) the uptake of partner notification and social network HIV counseling and testing after release from jail.
Behavioral: Correctional case management
Correctional 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.
HIV-positive prisoners
We will compare 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 will observe health outcomes for corrections case management versus transition case management.
Behavioral: Correctional case management
Correctional 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.
Behavioral: Transitional case management
Transitional case management seeks to meet the immediate needs of HIV-positive persons leaving prison, then link them to Ryan White case management and support the Ryan White case manager in assisting these clients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Detainees in Cook County Jail Prisoners in the Illinois Department of Corrections

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01852877

Contacts
Contact: Lawrence J Ouellet, PhD 312-355-0145 ljo@uic.edu
Contact: Karen Zynda, MPH, RD 312-355-0227 kzynda@uic.edu

Locations
United States, Illinois
University of Illinois at Chicago, School of Public Health, COIP Not yet recruiting
Chicago, Illinois, United States, 60607
Contact: Lawrence J Ouellet, PhD    312-355-0145    ljo@uic.edu   
Contact: Karen Zynda, MPH, RD    312-355-0227    kzynda@uic.edu   
Principal Investigator: Lawrence J Ouellet, PhD         
Cermak Health Services, Cook County Jail Not yet recruiting
Chicago, Illinois, United States, 60608
Principal Investigator: Michael Puisis, DO         
Illinois Department of Corrections Not yet recruiting
Chicago, Illinois, United States, 60601
Principal Investigator: Jeremy D Young, MD         
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Lawrence J Ouellet, PhD University of Illinois at Chicago
Principal Investigator: Jeremy D Young, MD University of Illinois at Chicago
Principal Investigator: Michael Puisis, DO Cermak Health Services, Cook County
  More Information

No publications provided

Responsible Party: Lawrence J. Ouellet, Ph.D., Research Professor, University of Illinois
ClinicalTrials.gov Identifier: NCT01852877     History of Changes
Other Study ID Numbers: 1R01DA030796
Study First Received: May 8, 2013
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
HIV Diagnosis
Case Management
Telemedicine
Patient Compliance
Prisoners

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 23, 2014