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Completed

NCT Number: NCT01402466

Urban Health Study II

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

RTI International Urban Health Program

San Francisco, California, 94104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • HIV antibody positive
  • not currently receiving HIV care

Exclusion criteria

  • already in care
  • unable to provide informed consent

Treatment and study plan

Standard Referral

Behavioral

Participants randomized to this arm will be referred to local HIV care resources

Project Bridge

Behavioral

Arm 2

Primary outcomes

  1. Log10 viral load

    Time frame: Every 3 months for 2 years

    Changes in viral load over time will be compared between the standard referral and Project Bridge Groups

Secondary outcomes

  1. Engagement in HIV Care

    Time frame: Every 3 months for 2 years

    The proportion of participants entering HIV care will be compared between the standard referral and Project Bridge groups

  2. Initiation of Highly Active Antiretroviral Therapy (HAART)

    Time frame: Every 3 months for 2 years

    The proportion of participants initiating HAART will be compared between the standard referral and Project Bridge groups

Sponsors and collaborators

Lead sponsor

RTI International

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 26, 2011
Registry last updated
Mar 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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