HIVNAVNCT02106702
The Navigator Project
A study testing Navigator enhanced case-management and Forensic AIDS Project in people with HIV, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Navigator enhanced case-management and Forensic AIDS Project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Undocumented HIV status
- Inability to speak English or Spanish
- Unable or unwilling to provide informed consent
- Not under routine level of jail security
Trial locations and contacts
1 site in 1 country.
United States1 site
Tenderloin Clinical Research Foundation
San Francisco, California, 94102
About this study
Official title: Navigator-Enhanced Case Management for HIV-Infected Jail Inmates Reentering the Community
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.
- Conditions
- HIV
- Being tested
- Navigator enhanced case-management, Forensic AIDS Project
- Keywords
- HIV, detention, substance abuse
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigator enhanced case-managementBehavioural
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 ProjectBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Forensic AIDS Project |
| Navigator enhanced case-management | Experimental | Experimental arm: access to Navigator enhanced case-management services for one year after release Receives: Behavioral: Navigator enhanced case-management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months, 6 months, 12 months
recidivism
number of times re-detained during the twelve-month study period, collected from jail records
Measured: 12 months
Secondary outcomes (2)
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
Measured: 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
Measured: 2 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startFeb 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco Jail Health Services - HIV and Integrated Services, San Francisco Pretrial Diversion Project
- Responsible party
- Sponsor
- Investigators
- Janet J Myers, PhD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106702
- Sponsor's protocol ID
- R01DA027209
- Acronym
- NAV
- Status last verified
- Jun 2015
- First submitted
- 1 Apr 2014
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigator-Enhanced Case Management for HIV-Infected Jail Inmates Reentering the Community
- ClinicalTrials.gov ID
- NCT02106702
- Acronym / sponsor ID
- NAV / R01DA027209
- Conditions
- HIV
- Keywords
- HIV, detention, substance abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco Jail Health Services - HIV and Integrated Services, San Francisco Pretrial Diversion Project
- Study start
- Feb 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAP counseling | Active comparator | Behavioral: Forensic AIDS ProjectControl arm utilizing the standard of care: access to services provided by the Forensic AIDS Project for up to 90 days after release |
| Navigator enhanced case-management | Experimental | Behavioral: Navigator enhanced case-managementExperimental arm: access to Navigator enhanced case-management services for one year after release |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Undocumented HIV status
- Inability to speak English or Spanish
- Unable or unwilling to provide informed consent
- Not under routine level of jail security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navigator enhanced case-managementPatient 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. | Behavioural | Navigator enhanced case-management |
| Forensic AIDS ProjectThe 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. | Behavioural | FAP counseling |
Primary outcome
substance use
Time frame: 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
Time frame: 12 months
number of times re-detained during the twelve-month study period, collected from jail records
2 secondary outcomes
sexual risk behavior
Time frame: 2 months, 6 months, 12 months
adherence to HIV medications
Time frame: 2 months, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet J Myers, PhD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigator enhanced case-management and Forensic AIDS Project in people with HIV, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
substance use (time frame: 2 months, 6 months, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.