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The Navigator Project

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02106702
Acronym
NAV
Enrollment
271
Registered
2014-04-08
Start date
2010-02-28
Completion date
2014-06-30
Last updated
2015-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV, detention, substance abuse

Brief summary

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.

Interventions

BEHAVIORALNavigator 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.

BEHAVIORALForensic 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.

Sponsors

San Francisco Jail Health Services - HIV and Integrated Services
CollaboratorUNKNOWN
San Francisco Pretrial Diversion Project
CollaboratorUNKNOWN
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
substance use2 months, 6 months, 12 monthschange 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
recidivism12 monthsnumber of times re-detained during the twelve-month study period, collected from jail records

Secondary

MeasureTime frameDescription
sexual risk behavior2 months, 6 months, 12 monthschange from baseline in self-reported sexual risk behaviors, measured by a survey tool at three time points after the initial detention
adherence to HIV medications2 months, 6 months, 12 monthschange 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

MeasureTime frameDescription
medical coverage2 months, 6 months,12 monthschange 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 use2 months, 6 months, 12 monthschange from baseline in self-reported needle-use and needle-sharing, measured by a survey tool at three time points after the initial detention
housing2 months, 6 months, 12 monthschange from baseline in self-reported housing status, measured by a survey tool at three time points after the initial detention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026