The Navigator Project

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Navigator enhanced case-management
* Behavioral: Forensic AIDS Project


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FAP counseling<br>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<br>* 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.<br>|
| Experimental: Navigator enhanced case-management<br>Experimental arm: access to Navigator enhanced case-management services for one year after release | Behavioral: Navigator enhanced case-management<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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detention, substance abuse, HIV