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Original Investigation
July 12, 2016

Effect of Patient Navigation With or Without Financial Incentives on Viral Suppression Among Hospitalized Patients With HIV Infection and Substance UseA Randomized Clinical Trial

Author Affiliations
  • 1Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, New York
  • 2Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida
  • 3San Francisco Department of Public Health, San Francisco, California
  • 4Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland
  • 5San Francisco General Hospital, San Francisco, California
  • 6University of California, San Francisco
  • 7Division of Infectious Diseases, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas
  • 8Parkland Health and Hospital System, Dallas, Texas
  • 9Division of Infectious Diseases, Department of Medicine, Miller School of Medicine, University of Miami, Miami, Florida
  • 10Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia
  • 11Johns Hopkins University School of Medicine, Baltimore, Maryland
  • 12Department of Health Law, Policy and Management, Boston University School of Public Health, Boston, Massachusetts
  • 13Section of Infectious Diseases, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts
  • 14Ruth M. Rothstein CORE Center, John H. Stroger, Jr, Hospital of Cook County, Chicago, Illinois
  • 15Division of Infectious Diseases, Drexel University College of Medicine, Philadelphia, Pennsylvania
  • 16Department of Medicine, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania
  • 17Department of Neuroscience, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania
  • 18Institute of Translational AIDS Research, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania
  • 19Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham
  • 20Los Angeles Biomedical Research Institute at Harbor-University of California Los Angeles Medical Center, Torrance
  • 21University of Pittsburgh, Pittsburgh, Pennsylvania
  • 22Mount Sinai St Luke's and Mount Sinai West Hospitals, New York, New York
  • 23Icahn School of Medicine at Mount Sinai, New York, New York
  • 24The Emmes Corporation, Rockville, Maryland
  • 25HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, Department of Psychiatry, Columbia University Medical Center, New York, New York
  • 26Greater New York Node, National Drug Abuse Treatment Clinical Trials Network, Substance Use Research Center, Department of Psychiatry, Columbia University, New York, New York
  • 27Division of Addiction Sciences, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina
  • 28University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
  • 29Western States Node, National Drug Abuse Treatment Clinical Trials Network, Department of Psychiatry, University of California, San Francisco
  • 30Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia
  • 31Treatment Research Institute, Philadelphia, Pennsylvania
  • 32Center for the Clinical Trials Network, National Institute on Drug Abuse, National Institutes of Health, Bethesda, Maryland
  • 33Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, Georgia
JAMA. 2016;316(2):156-170. doi:10.1001/jama.2016.8914
Abstract

Importance  Substance use is a major driver of the HIV epidemic and is associated with poor HIV care outcomes. Patient navigation (care coordination with case management) and the use of financial incentives for achieving predetermined outcomes are interventions increasingly promoted to engage patients in substance use disorders treatment and HIV care, but there is little evidence for their efficacy in improving HIV-1 viral suppression rates.

Objective  To assess the effect of a structured patient navigation intervention with or without financial incentives to improve HIV-1 viral suppression rates among patients with elevated HIV-1 viral loads and substance use recruited as hospital inpatients.

Design, Setting, and Participants  From July 2012 through January 2014, 801 patients with HIV infection and substance use from 11 hospitals across the United States were randomly assigned to receive patient navigation alone (n = 266), patient navigation plus financial incentives (n = 271), or treatment as usual (n = 264). HIV-1 plasma viral load was measured at baseline and at 6 and 12 months.

Interventions  Patient navigation included up to 11 sessions of care coordination with case management and motivational interviewing techniques over 6 months. Financial incentives (up to $1160) were provided for achieving targeted behaviors aimed at reducing substance use, increasing engagement in HIV care, and improving HIV outcomes. Treatment as usual was the standard practice at each hospital for linking hospitalized patients to outpatient HIV care and substance use disorders treatment.

Main Outcomes and Measures  The primary outcome was HIV viral suppression (≤200 copies/mL) relative to viral nonsuppression or death at the 12-month follow-up.

Results  Of 801 patients randomized, 261 (32.6%) were women (mean [SD] age, 44.6 years [10.0 years]). There were no differences in rates of HIV viral suppression versus nonsuppression or death among the 3 groups at 12 months. Eighty-five of 249 patients (34.1%) in the usual-treatment group experienced treatment success compared with 89 of 249 patients (35.7%) in the navigation-only group for a treatment difference of 1.6% (95% CI, −6.8% to 10.0%; P = .80) and compared with 98 of 254 patients (38.6%) in the navigation-plus-incentives group for a treatment difference of 4.5% (95% CI −4.0% to 12.8%; P = .68). The treatment difference between the navigation-only and the navigation-plus-incentives group was −2.8% (95% CI, −11.3% to 5.6%; P = .68).

Conclusions and Relevance  Among hospitalized patients with HIV infection and substance use, patient navigation with or without financial incentives did not have a beneficial effect on HIV viral suppression relative to nonsuppression or death at 12 months vs treatment as usual. These findings do not support these interventions in this setting.

Trial Registration  clinicaltrials.gov Identifier: NCT01612169

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