HIV
Conditions
Keywords
Drug users, criminal justice, HIV care, HAART, incarceration
Brief summary
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
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.
Interventions
BEHAVIORALStandard Referral
Participants randomized to this arm will be referred to local HIV care resources
BEHAVIORALProject Bridge
Arm 2
Sponsors
National Institute of Mental Health (NIMH)
RTI International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * HIV antibody positive * not currently receiving HIV care
Exclusion criteria
* already in care * unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Log10 viral load | Every 3 months for 2 years | Changes in viral load over time will be compared between the standard referral and Project Bridge Groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Engagement in HIV Care | Every 3 months for 2 years | The proportion of participants entering HIV care will be compared between the standard referral and Project Bridge groups |
| Initiation of Highly Active Antiretroviral Therapy (HAART) | Every 3 months for 2 years | The proportion of participants initiating HAART will be compared between the standard referral and Project Bridge groups |
Countries
United States
Outcome results
None listed