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Completed

NCT Number: NCT02106702

The Navigator Project

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.

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Key information

Conditions

HIV Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tenderloin Clinical Research Foundation

San Francisco, California, 94102, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Navigator enhanced case-management

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.

Forensic AIDS Project

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.

Primary outcomes

  1. substance use

    Time frame: 2 months, 6 months, 12 months

    change from baseline in self-reported drug and alcohol use, measured by a survey tool, and actual use of five drugs (methamphetamine, cocaine, tetrahydrocannabinol, opiates, and benzodiazepines), measured by a urine screen, at three time points each

  2. recidivism

    Time frame: 12 months

    number of times re-detained during the twelve-month study period, collected from jail records

Secondary outcomes

  1. sexual risk behavior

    Time frame: 2 months, 6 months, 12 months

    change from baseline in self-reported sexual risk behaviors, measured by a survey tool at three time points after the initial detention

  2. adherence to HIV medications

    Time frame: 2 months, 6 months, 12 months

    change from baseline in self-reported adherence (as a %) to antiretroviral therapy, measured by a survey tool at three time points after the initial detention

Other outcomes

  1. housing

    Time frame: 2 months, 6 months, 12 months

    change from baseline in self-reported housing status, measured by a survey tool at three time points after the initial detention

  2. medical coverage

    Time frame: 2 months, 6 months,12 months

    change from baseline in self-reported insurance coverage, measured by a survey tool at three time points after the initial detention, and use of community health services and jail health services, measured continuously via a community database for 12 months after the initial detention

  3. needle use

    Time frame: 2 months, 6 months, 12 months

    change from baseline in self-reported needle-use and needle-sharing, measured by a survey tool at three time points after the initial detention

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • San Francisco Jail Health Services - HIV and Integrated Services
  • San Francisco Pretrial Diversion Project

Registry information

Official study title

Navigator-Enhanced Case Management for HIV-Infected Jail Inmates Reentering the Community

Acronym: NAV

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Apr 8, 2014
Registry last updated
Jun 16, 2015

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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