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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
Sponsor:
Collaborator:
Los Angeles County Department of Public Health
Information provided by (Responsible Party):
William Cunningham, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE July 28, 2011
First Posted Date  ICMJE August 1, 2011
Last Update Posted Date January 20, 2016
Study Start Date  ICMJE December 2012
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2012)
  • Linkage to HIV Care [ Time Frame: 12 months (baseline, 2, 6, and 12 month follow ups) ]
    Linking HIV+ ex jail inmates to HIV care
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 29, 2011)
  • Linkage to HIV Care [ Time Frame: 14 months (baseline, 2, 6, 10, and 14 month follow ups) ]
    Linking HIV+ ex jail inmates to HIV care
  • Retention in Treatment [ Time Frame: 14 months total (baseline, 2, 6, 10, and 14 month follow ups) ]
    This assesses whether or not the HIV+ ex jail inmates were retained in their HIV care after first accessing care.
  • Adherence to Treatment [ Time Frame: 14 months (baseline, 2, 6, 10, and 14 month follow ups) ]
    This measures how adherent the HIV+ ex jail inmates are to their treatment regiment.
  • Viral Load [ Time Frame: 14 months total (Baseline, 6, and 14 month follow ups) ]
    This measures the HIV+ ex jail inmates' viral load to see how effective their treatment has been.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2012)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2011)
Costs [ Time Frame: 14 months (only assessed at the end of the 14 month follow up) ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care
Official Title  ICMJE Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE HIV-infection/Aids
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.

    Intervention: Behavioral: Health Navigator
  • 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
Publications * Cunningham WE, Weiss RE, Nakazono T, Malek MA, Shoptaw SJ, Ettner SL, Harawa NT. Effectiveness of a Peer Navigation Intervention to Sustain Viral Suppression Among HIV-Positive Men and Transgender Women Released From Jail: The LINK LA Randomized Clinical Trial. JAMA Intern Med. 2018 Apr 1;178(4):542-553. doi: 10.1001/jamainternmed.2018.0150.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 29, 2011)
360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01406626
Other Study ID Numbers  ICMJE R01DA030781( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William Cunningham, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Los Angeles County Department of Public Health
Investigators  ICMJE
Principal Investigator: William E Cunningham, MD, MPH University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP