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Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care (LINK LA)

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ClinicalTrials.gov Identifier: NCT01406626
Recruitment Status : Unknown
Verified January 2016 by William Cunningham, University of California, Los Angeles.
Recruitment status was:  Active, not recruiting
First Posted : August 1, 2011
Last Update Posted : January 20, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will implement a health navigation intervention to improve linkage to and retention in HIV care for inmates released from L.A. county jail into the community.

Condition or disease Intervention/treatment
HIV-infection/Aids Behavioral: Health Navigator

Detailed Description:

The proposed study has two Primary Specific Aims:

  1. To examine individual-level and structural-level barriers to HIV care after release from jail, using formative semi-structured interviews with ex-inmates, case managers, and HIV care providers; and to use the information we obtain to inform the adaptation and tailoring of an intervention designed to improve linkage with and retention to HIV care for HIV+ ex-inmates (Complete);
  2. Using a two-group experimental RCT design, to test the adapted health navigation intervention condition for HIV+ inmates upon release from jail compared to a usual care condition, and to evaluate the intervention's effectiveness at improving linkage with and retention in HIV care, self-reported ART adherence, and HIV RNA viral load suppression;

We hypothesize that the intervention will result in more rapid linkage to care, a greater proportion completing at least three HIV care visits per year, increased self-reported ART adherence, and decreased levels of HIV RNA viral load compared to the usual care control group.

Secondary Aims of the study include assessing the potential moderating effects of substance abuse, the potential mediating effects of substance abuse treatment, and the program's effects on recidivism, and costs.

We hypothesize that active substance abuse will moderate the effect of the intervention, so the intervention will be less effective among participants who report substance use.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care
Study Start Date : December 2012
Primary Completion Date : January 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Health Navigation Intervention Arm

Subjects will receive the following health navigation services:

1) 10 Navigator meetings: Navigators will meet with participants in person to teach linkage/retention skills and knowledge

2a) 2 Navigator accompaniment sessions: the health navigator will accompany participants to HIV care appointment. Before and after the appointment, participants and navigators will review linkage and retention skills/knowledge things that make it hard or easy for him to get regular HIV care

2b) Optional health navigator accompaniment sessions: If the participant requests, the health navigator will provide accompaniment to supportive HIV care appointments (one per month max)

3) 14 Health navigator care calls: During these calls, navigators and participants will talk about any problems that could make it difficult to get regular HIV care.

Behavioral: Health Navigator
Health navigation intervention to improve linkage to and retention in HIV care and suppress viral load for underserved HIV+ persons in Los Angeles
No Intervention: Usual Care
Participants assigned to the control arm will receive the transitional case management (TCM) services that are currently offered at the jail

Outcome Measures

Primary Outcome Measures :
  1. Linkage to HIV Care [ Time Frame: 12 months (baseline, 2, 6, and 12 month follow ups) ]
    Linking HIV+ ex jail inmates to HIV care

  2. Retention in Treatment [ Time Frame: 12 months total (baseline, 2, 6, and 12 month follow ups) ]
    This assesses whether or not the HIV+ ex jail inmates were retained in their HIV care after first accessing care.

  3. Adherence to Treatment [ Time Frame: 12 months (baseline, 2, 6, and 12 month follow ups) ]
    This measures how adherent the HIV+ ex jail inmates are to their treatment regiment.

  4. Viral Load [ Time Frame: 12 months total (Baseline, 2 and 12 month follow ups) ]
    This measures the HIV+ ex jail inmates' viral load to see how effective their treatment adherence has been.

Secondary Outcome Measures :
  1. Costs [ Time Frame: Assessed at one point only toward the end of the study period ]
    To examine whether the costs of the intervention and HIV care are offset by reductions in healthcare and recidivism costs from the perspective of LA County.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age: 18 years or older
  2. Male or male-to-female transgender
  3. Fluency in English
  4. Residing in LA County upon release

Exclusion Criteria:

  1. Inability to give informed consent
  2. stays in jail <5 days
  3. Lack of English fluency
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406626

United States, California
LA County Jail
Los Angeles, California, United States, 90012
Sponsors and Collaborators
University of California, Los Angeles
Los Angeles County Department of Public Health
Principal Investigator: William E Cunningham, MD, MPH University of California, Los Angeles
More Information

Responsible Party: William Cunningham, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01406626     History of Changes
Other Study ID Numbers: R01DA030781 ( U.S. NIH Grant/Contract )
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016

Keywords provided by William Cunningham, University of California, Los Angeles:
Health navigation
Viral load

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases