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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01852877
Other study ID # 2011-0619
Secondary ID 1R01DA030796
Status Completed
Phase
First received
Last updated
Start date July 2013
Est. completion date June 30, 2016

Study information

Verified date November 2019
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 784
Est. completion date June 30, 2016
Est. primary completion date June 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Corrections case management
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.

Locations

Country Name City State
United States Cermak Health Services, Cook County Jail Chicago Illinois
United States Illinois Department of Corrections Chicago Illinois
United States University of Illinois at Chicago, School of Public Health, COIP Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Illinois at Chicago National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in adherence to HIV medication baseline and 6, 12, 18 months post-baseline
Other Change in visits to HIV medical care provider baseline and 6, 12, 18 months post-baseline
Primary Change in HIV viral load baseline and 6, 12, 18 months post-baseline
Secondary Change in CD4 cell count baseline and 6, 12, 18 months post-baseline
Secondary Change in community-level HIV viral load baseline and 18 months post-baseline
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