The Navigator Project (NAV)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
San Francisco Jail Health Services - HIV and Integrated Services
San Francisco Pretrial Diversion Project
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02106702
First received: April 1, 2014
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
HIV
Behavioral: Navigator enhanced case-management
Behavioral: Forensic AIDS Project

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Navigator-Enhanced Case Management for HIV-Infected Jail Inmates Reentering the Community

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • substance use [ Time Frame: 2 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    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

  • recidivism [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    number of times re-detained during the twelve-month study period, collected from jail records


Secondary Outcome Measures:
  • sexual risk behavior [ Time Frame: 2 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    change from baseline in self-reported sexual risk behaviors, measured by a survey tool at three time points after the initial detention

  • adherence to HIV medications [ Time Frame: 2 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • housing [ Time Frame: 2 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    change from baseline in self-reported housing status, measured by a survey tool at three time points after the initial detention

  • medical coverage [ Time Frame: 2 months, 6 months,12 months ] [ Designated as safety issue: No ]
    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

  • needle use [ Time Frame: 2 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    change from baseline in self-reported needle-use and needle-sharing, measured by a survey tool at three time points after the initial detention


Enrollment: 271
Study Start Date: February 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02106702

Locations
United States, California
Tenderloin Clinical Research Foundation
San Francisco, California, United States, 94102
Sponsors and Collaborators
University of California, San Francisco
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
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02106702     History of Changes
Other Study ID Numbers: R01DA027209
Study First Received: April 1, 2014
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
HIV
detention
substance abuse

ClinicalTrials.gov processed this record on October 20, 2014