The Navigator Project

NCT ID: NCT02106702

Last Updated: 2015-06-16

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

NA

Total Enrollment

271 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-06-30

Brief Summary

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Each year, there are over 600 unduplicated HIV-infected persons incarcerated in the San Francisco jail. Two thirds of those released with HIV-focused discharge planning are reincarcerated within one year. More than half of HIV-infected jail inmates are diagnosed with mental health conditions severe enough to require medication and a similar proportion report substance use disorders at the time of detention. While some community-based services exist, there remains a critical need to improve linkages to care and adherence to care plans for HIV-infected adults as they move between community and jail. The Navigator Project is a five-year randomized study that will test the effectiveness of an intensive enhanced case management intervention to reduce sex and drug-related HIV transmission risk; increase HIV medication adherence; reduce drug dependence; and reduce reincarceration.

Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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FAP counseling

Control arm utilizing the standard of care: access to services provided by the Forensic AIDS Project for up to 90 days after release

Group Type ACTIVE_COMPARATOR

Forensic AIDS Project

Intervention Type BEHAVIORAL

The Forensics AIDS Project provides primary care to HIV-infected detainees, as well as up to 90 post-release case-management services which include discharge planning.

Navigator enhanced case-management

Experimental arm: access to Navigator enhanced case-management services for one year after release

Group Type EXPERIMENTAL

Navigator enhanced case-management

Intervention Type BEHAVIORAL

Patient navigators are non-clinical, paraprofessional peers who are HIV-infected and have lifetime histories of detention and substance abuse. Working with the patient, they facilitate adherence to a comprehensive care plan designed to address clients' multiple risks and needs. Patients have access to Navigator services for one year after study enrollment.

Interventions

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Navigator enhanced case-management

Patient navigators are non-clinical, paraprofessional peers who are HIV-infected and have lifetime histories of detention and substance abuse. Working with the patient, they facilitate adherence to a comprehensive care plan designed to address clients' multiple risks and needs. Patients have access to Navigator services for one year after study enrollment.

Intervention Type BEHAVIORAL

Forensic AIDS Project

The Forensics AIDS Project provides primary care to HIV-infected detainees, as well as up to 90 post-release case-management services which include discharge planning.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Detention in the San Francisco jail system
* Confirmed HIV infection
* Lifetime history of ever having met standardized criteria for drug or alcohol addiction
* Likely release back into San Francisco without transfer to another facility
* Agreement to work with Forensic AIDS Project to plan post-release care
* Able and willing to provide informed consent
* Not scheduled for release within 36 hours

Exclusion Criteria

* Undocumented HIV status
* Inability to speak English or Spanish
* Unable or unwilling to provide informed consent
* Not under routine level of jail security
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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San Francisco Jail Health Services - HIV and Integrated Services

UNKNOWN

Sponsor Role collaborator

San Francisco Pretrial Diversion Project

UNKNOWN

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janet J Myers, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Tenderloin Clinical Research Foundation

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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R01DA027209

Identifier Type: NIH

Identifier Source: org_study_id

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