The Navigator Project (NAV)

University of California San Francisco (UCSF)

Status: Completed

Conditions: HIV

Treatments: Behavioral: Navigator enhanced case-management; Behavioral: Forensic AIDS Project

Study type: Interventional

Funder types: Other

Identifiers

NCT02106702

R01DA027209

Details and patient eligibility

About

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.

Enrollment: 271 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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271 participants in 2 patient groups

FAP counseling

Active Comparator group

Description:

Control arm utilizing the standard of care: access to services provided by the Forensic AIDS Project for up to 90 days after release

Treatment:

Behavioral: Forensic AIDS Project

Navigator enhanced case-management

Experimental group

Description:

Experimental arm: access to Navigator enhanced case-management services for one year after release

Treatment:

Behavioral: Navigator enhanced case-management