Urban Health Study II
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | August 2011 |
| End Date: | December 2014 |
Finding, Testing and Treating High-Risk Probationers and Parolees With HIV
The study will test an intervention to help HIV-positive people achieve consistency of HIV
care while transitioning in and out of jail.
care while transitioning in and out of jail.
The study has two research objectives: (1) to expand access and options for HIV testing with
individuals in the criminal justice system, by focusing on high-risk intravenous drug users
(IDUs) and crack cocaine smokers in community settings; and (2) to improve access and
maintenance of highly active antiretroviral treatment (HAART) among HIV-positive persons in
this population, by implementing a promising intervention focused on continuity of HIV care,
and evaluating it using a rigorous experimental design.
HIV-positive persons will be identified through the testing activities described in
Objective 1. They will then be offered enrollment in a randomized controlled trial (RCT) of
an intervention designed to engage and maintain HIV-positive people with criminal justice
involvement in medical care. The intervention, Project Bridge, has shown great promise but
has not yet been rigorously evaluated. The RCT will assess the efficacy of Project Bridge
compared with a Usual Care arm. Our hypotheses are that, at quarterly data collection
visits: (1) Intervention participants will have lower HIV viral load than usual care
participants 2b: (2) Intervention participants will be more likely to be in HIV care than
usual care participants (3) Intervention participants will be more likely to be on HAART
than usual care participants.
The study design was changed from a randomized controlled trial to a quasi-experimental
comparison group design. This change was approved by the NIMH Program Officer and the RTI
IRB in June, 2012.
individuals in the criminal justice system, by focusing on high-risk intravenous drug users
(IDUs) and crack cocaine smokers in community settings; and (2) to improve access and
maintenance of highly active antiretroviral treatment (HAART) among HIV-positive persons in
this population, by implementing a promising intervention focused on continuity of HIV care,
and evaluating it using a rigorous experimental design.
HIV-positive persons will be identified through the testing activities described in
Objective 1. They will then be offered enrollment in a randomized controlled trial (RCT) of
an intervention designed to engage and maintain HIV-positive people with criminal justice
involvement in medical care. The intervention, Project Bridge, has shown great promise but
has not yet been rigorously evaluated. The RCT will assess the efficacy of Project Bridge
compared with a Usual Care arm. Our hypotheses are that, at quarterly data collection
visits: (1) Intervention participants will have lower HIV viral load than usual care
participants 2b: (2) Intervention participants will be more likely to be in HIV care than
usual care participants (3) Intervention participants will be more likely to be on HAART
than usual care participants.
The study design was changed from a randomized controlled trial to a quasi-experimental
comparison group design. This change was approved by the NIMH Program Officer and the RTI
IRB in June, 2012.
Inclusion Criteria:
- Age 18 or older
- HIV antibody positive
- not currently receiving HIV care
Exclusion Criteria:
- already in care
- unable to provide informed consent
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