The Navigator Project

HIV Clinical Trial

— NAV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106702
• Other study ID #: R01DA027209
• Status: Completed
• Phase: N/A
• First received: April 1, 2014
• Last updated: June 15, 2015
• Start date: February 2010
• Est. completion date: June 2014

Study information

• Verified date: June 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Tenderloin Clinical Research Foundation	San Francisco	California

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	housing	change from baseline in self-reported housing status, measured by a survey tool at three time points after the initial detention	2 months, 6 months, 12 months	No
Other	medical coverage	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	2 months, 6 months,12 months	No
Other	needle use	change from baseline in self-reported needle-use and needle-sharing, measured by a survey tool at three time points after the initial detention	2 months, 6 months, 12 months	No
Primary	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	No
Primary	recidivism	number of times re-detained during the twelve-month study period, collected from jail records	12 months	No
Secondary	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	No
Secondary	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	No