Clinical trial NCT01852877: Seek, Test, Treat, Retain: An Integrated Jail-Prison-Community Model for Illinois
Official title: Seek, Test, Treat: An Integrated Jail-Prison-Community Model for Illinois
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV Diagnosis
Case Management
Telemedicine
Patient Compliance
Prisoners
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-05-14
Enrollment: 784
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Detainees in Cook County Jail, prisoners in the Illinois Department of Corrections

Brief 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. 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.


Eligibility 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

Primary outcomes:
measure: Change in HIV viral load
timeFrame: baseline and 6, 12, 18 months post-baseline
Secondary outcomes:
measure: Change in CD4 cell count
timeFrame: baseline and 6, 12, 18 months post-baseline
measure: Change in community-level HIV viral load
timeFrame: baseline and 18 months post-baseline
Other outcomes:
measure: Change in adherence to HIV medication
timeFrame: baseline and 6, 12, 18 months post-baseline
measure: Change in visits to HIV medical care provider
timeFrame: baseline and 6, 12, 18 months post-baseline
Locations:
city: Chicago
country: United States
facility: Illinois Department of Corrections
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago, School of Public Health, COIP
state: Illinois
city: Chicago
country: United States
facility: Cermak Health Services, Cook County Jail
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Lawrence J Ouellet, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Chicago
name: Jeremy D Young, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cermak Health Services, Cook County
name: Chad Zawitz, MD
role: PRINCIPAL_INVESTIGATOR
References: