Urban Health Study II

NCT ID: NCT01402466

Last Updated: 2016-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-12-31

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.

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard Referral

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

Group Type ACTIVE_COMPARATOR

Standard Referral

Intervention Type BEHAVIORAL

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

Project Bridge

Participants randomized to this arm will be given the Project Bridge intervention

Group Type EXPERIMENTAL

Project Bridge

Intervention Type BEHAVIORAL

Arm 2

Interventions

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Standard Referral

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

Intervention Type BEHAVIORAL

Project Bridge

Arm 2

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

RTI International

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alex H Kral, PhD

Role: PRINCIPAL_INVESTIGATOR

RTI International

Locations

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RTI International Urban Health Program

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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R01MH094090

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12690

Identifier Type: -

Identifier Source: org_study_id

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