The Navigator Project (NAV)

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

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Forensic AIDS Project; Behavioral: Navigator enhanced case-management

• Study Type: Interventional
• Enrollment (Actual): 271
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94102
      • Tenderloin Clinical Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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.
Experimental: Navigator enhanced case-management; Experimental arm: access to Navigator enhanced case-management services for one year after release	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
substance use	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 months, 6 months, 12 months
recidivism	number of times re-detained during the twelve-month study period, collected from jail records	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sexual risk behavior	change from baseline in self-reported sexual risk behaviors, measured by a survey tool at three time points after the initial detention	2 months, 6 months, 12 months
adherence to HIV medications	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	2 months, 6 months, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
housing	change from baseline in self-reported housing status, measured by a survey tool at three time points after the initial detention	2 months, 6 months, 12 months
medical coverage	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	2 months, 6 months,12 months
needle use	change from baseline in self-reported needle-use and needle-sharing, measured by a survey tool at three time points after the initial detention	2 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: San Francisco Jail Health Services - HIV and Integrated Services; San Francisco Pretrial Diversion Project
• Investigators: Principal Investigator: Janet J Myers, PhD, MPH, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: April 1, 2014
• First Submitted That Met QC Criteria: April 3, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Estimate): June 16, 2015
• Last Update Submitted That Met QC Criteria: June 15, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: HIV; substance abuse; detention
• Other Study ID Numbers: R01DA027209 (U.S. NIH Grant/Contract)