Urban Health Study II

Study Overview
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Brief Summary
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The study will test an intervention to help HIV-positive people achieve consistency of HIV care while transitioning in and out of jail.

Detailed Description
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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.

Official Title
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Finding, Testing and Treating High-Risk Probationers and Parolees With HIV

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Standard Referral
* Behavioral: Project Bridge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older HIV antibody positive not currently receiving HIV care Exclusion Criteria: already in care unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Referral<br>Participants randomized to this arm will be referred to local HIV care resources | Behavioral: Standard Referral<br>* Participants randomized to this arm will be referred to local HIV care resources<br>|
| Experimental: Project Bridge<br>Participants randomized to this arm will be given the Project Bridge intervention | Behavioral: Project Bridge<br>* Arm 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Log10 viral load | Changes in viral load over time will be compared between the standard referral and Project Bridge Groups | Every 3 months for 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engagement in HIV Care | The proportion of participants entering HIV care will be compared between the standard referral and Project Bridge groups | Every 3 months for 2 years | 
| Initiation of Highly Active Antiretroviral Therapy (HAART) | The proportion of participants initiating HAART will be compared between the standard referral and Project Bridge groups | Every 3 months for 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug users, criminal justice, HIV care, HAART, incarceration