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

Study Description

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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	Phase
HIV-infection/Aids	Behavioral: Health 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 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

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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
Actual Primary Completion Date :	January 2016
Estimated Study Completion Date :	June 2016

Arms and Interventions

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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

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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

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

Criteria

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

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Locations

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

Investigators

Principal Investigator:	William E Cunningham, MD, MPH	University of California, Los Angeles

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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
Last Update Posted:	January 20, 2016
Last Verified:	January 2016

Keywords provided by William Cunningham, University of California, Los Angeles:

HIV; AIDS; Health navigation; Viral load; Corrections

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