The Navigator Project

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: Navigator enhanced case-management; Behavioral: Forensic AIDS Project

• Registration Number: NCT02106702
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2014-04-01
• Study First Submitted QC: 2014-04-03
• Study First Posted: 2014-04-08
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-15
• Last Update Posted: 2015-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Navigator enhanced case-management	Navigator enhanced case-management	Experimental arm: access to Navigator enhanced case-management services for one year after release
FAP counseling	Forensic AIDS Project	Control arm utilizing the standard of care: access to services provided by the Forensic AIDS Project for up to 90 days after release

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Tenderloin Clinical Research Foundation; 🇺🇸 San Francisco, California, United States