NAV: The Navigator Project
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- substance use [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
- recidivism [12 months]
number of times re-detained during the twelve-month study period, collected from jail records
Secondary Outcome Measures
- sexual risk behavior [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
- adherence to HIV medications [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 Outcome Measures
- housing [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
- medical coverage [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
- needle use [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Detention in the San Francisco jail system
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Confirmed HIV infection
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Lifetime history of ever having met standardized criteria for drug or alcohol addiction
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Likely release back into San Francisco without transfer to another facility
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Agreement to work with Forensic AIDS Project to plan post-release care
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Able and willing to provide informed consent
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Not scheduled for release within 36 hours
Exclusion Criteria:
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Undocumented HIV status
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Inability to speak English or Spanish
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Unable or unwilling to provide informed consent
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Not under routine level of jail security
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R01DA027209