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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01406626
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : November 18, 2020
Los Angeles County Department of Public Health
Information provided by (Responsible Party):
University of California, Los Angeles

Brief Summary:
This study will implement a peer 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 Phase
HIV-infection/Aids Behavioral: Peer Navigator Not Applicable

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 peer 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;

The intervention is hypothesized to result in greater 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.

Active substance abuse is hypothesized to moderate the effect of the intervention, such that the intervention will be less effective among participants who report substance use.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 356 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
Actual Study Start Date : December 2012
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Peer Navigation Intervention Arm

Subjects will receive the following peer 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 peer navigator will accompany participants to HIV care appointment. Before and after the appointment, participants and navigators will review linkage and retention skills/knowledge and things that make it hard or easy for him/her to get regular HIV care

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

3) 14 peer 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: Peer Navigator
Peer 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

Primary Outcome Measures :
  1. Linkage to HIV Care [ Time Frame: 12 months ]
    Number of HIV+ ex jail inmates accessing HIV care

  2. Retention in Treatment [ Time Frame: 12 months ]
    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 ]
    How adherent the HIV+ ex jail inmates are to their treatment regiment, by self-report.

  4. Viral Load [ Time Frame: 12 months ]
    HIV+ ex jail inmates' viral load

Secondary Outcome Measures :
  1. Costs [ Time Frame: 12 months ]
    Cost of the intervention and HIV care

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-represented transgender women.
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Age 18 or older
  • Men or TGW diagnosed HIV-positive
  • English or bilingual Spanish speaking
  • Selected for the TCM program (control condition) prior to LINK LA enrollment
  • Residing in LA County upon release
  • Eligible for ART or incarcerated on ART.

Exclusion criteria:

  • Inability to give informed consent
  • Parole hold or planned transfer to prison
  • Stay in jail <5 days.

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 identifier (NCT number): NCT01406626

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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
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Principal Investigator: William E Cunningham, MD, MPH University of California, Los Angeles
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of California, Los Angeles Identifier: NCT01406626    
Other Study ID Numbers: R01DA030781 ( U.S. NIH Grant/Contract )
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Keywords provided by University of California, Los Angeles:
Peer navigation
Viral load
Additional relevant MeSH terms:
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HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases