NCT02106702

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
271

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 16, 2015

Status Verified

June 1, 2015

Enrollment Period

4.3 years

First QC Date

April 1, 2014

Last Update Submit

June 15, 2015

Conditions

HIV

Keywords

HIVdetentionsubstance abuse

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • sexual risk behavior

    2 months, 6 months, 12 months

  • adherence to HIV medications

    2 months, 6 months, 12 months

Other Outcomes (3)

  • housing

    2 months, 6 months, 12 months

  • medical coverage

    2 months, 6 months,12 months

  • needle use

    2 months, 6 months, 12 months

Study Arms (2)

FAP counseling

ACTIVE COMPARATOR

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

Navigator enhanced case-management

EXPERIMENTAL

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

Behavioral: Navigator enhanced case-management

Interventions

Navigator enhanced case-managementBEHAVIORAL

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.

Navigator enhanced case-management
Forensic AIDS ProjectBEHAVIORAL

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.

FAP counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Undocumented HIV status
  • Inability to speak English or Spanish
  • Unable or unwilling to provide informed consent
  • Not under routine level of jail security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tenderloin Clinical Research Foundation

San Francisco, California, 94102, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Janet J Myers, PhD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2014

First Posted

April 8, 2014

Study Start

February 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 16, 2015

Record last verified: 2015-06

Locations

US(1)