title: Effect of Patient Navigation With or Without Financial Incentives on Viral Suppression Among Hospitalized Patients With HIV Infection and Substance Use: A Randomized Clinical Trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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
  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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01612169.
authors.affiliation: Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, New York.
authors.forename: Lisa R
authors.initials: LR
authors.lastname: Metsch
authors.affiliation: Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Feaster
authors.affiliation: Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, New York.
authors.forename: Lauren
authors.initials: L
authors.lastname: Gooden
authors.affiliation: San Francisco Department of Public Health, San Francisco, California.
authors.forename: Tim
authors.initials: T
authors.lastname: Matheson
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Maxine
authors.initials: M
authors.lastname: Stitzer
authors.affiliation: San Francisco Department of Public Health, San Francisco, California5San Francisco General Hospital, San Francisco, California6University of California, San Francisco.
authors.forename: Moupali
authors.initials: M
authors.lastname: Das
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas8Parkland Health and Hospital System, Dallas, Texas.
authors.forename: Mamta K
authors.initials: MK
authors.lastname: Jain
authors.affiliation: Division of Infectious Diseases, Department of Medicine, Miller School of Medicine, University of Miami, Miami, Florida.
authors.forename: Allan E
authors.initials: AE
authors.lastname: Rodriguez
authors.affiliation: Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Wendy S
authors.initials: WS
authors.lastname: Armstrong
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Gregory M
authors.initials: GM
authors.lastname: Lucas
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas.
authors.forename: Ank E
authors.initials: AE
authors.lastname: Nijhawan
authors.affiliation: Department of Health Law, Policy and Management, Boston University School of Public Health, Boston, Massachusetts13Section of Infectious Diseases, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts.
authors.forename: Mari-Lynn
authors.initials: ML
authors.lastname: Drainoni
authors.affiliation: Ruth M. Rothstein CORE Center, John H. Stroger, Jr, Hospital of Cook County, Chicago, Illinois.
authors.forename: Patricia
authors.initials: P
authors.lastname: Herrera
authors.affiliation: Ruth M. Rothstein CORE Center, John H. Stroger, Jr, Hospital of Cook County, Chicago, Illinois.
authors.forename: Pamela
authors.initials: P
authors.lastname: Vergara-Rodriguez
authors.affiliation: Division of Infectious Diseases, Drexel University College of Medicine, Philadelphia, Pennsylvania16Department of Medicine, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania17Department of Neuroscience, Lewis Katz School of Medi.
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Jacobson
authors.affiliation: Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mugavero
authors.affiliation: Section of Infectious Diseases, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts.
authors.forename: Meg
authors.initials: M
authors.lastname: Sullivan
authors.affiliation: Los Angeles Biomedical Research Institute at Harbor-University of California Los Angeles Medical Center, Torrance.
authors.forename: Eric S
authors.initials: ES
authors.lastname: Daar
authors.affiliation: University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Deborah K
authors.initials: DK
authors.lastname: McMahon
authors.affiliation: Mount Sinai St Luke's and Mount Sinai West Hospitals, New York, New York23Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: David C
authors.initials: DC
authors.lastname: Ferris
authors.affiliation: The Emmes Corporation, Rockville, Maryland.
authors.forename: Robert
authors.initials: R
authors.lastname: Lindblad
authors.affiliation: The Emmes Corporation, Rockville, Maryland.
authors.forename: Paul
authors.initials: P
authors.lastname: VanVeldhuisen
authors.affiliation: The Emmes Corporation, Rockville, Maryland.
authors.forename: Neal
authors.initials: N
authors.lastname: Oden
authors.affiliation: Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, New York.
authors.forename: Pedro C
authors.initials: PC
authors.lastname: Castellón
authors.affiliation: HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, Department of Psychiatry, Columbia University Medical Center, New York, New York26Greater New York Node, National Drug Abuse Treatment Clinical Trials Network, Subst.
authors.forename: Susan
authors.initials: S
authors.lastname: Tross
authors.affiliation: Division of Addiction Sciences, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina.
authors.forename: Louise F
authors.initials: LF
authors.lastname: Haynes
authors.affiliation: University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
authors.forename: Antoine
authors.initials: A
authors.lastname: Douaihy
authors.affiliation: Western States Node, National Drug Abuse Treatment Clinical Trials Network, Department of Psychiatry, University of California, San Francisco.
authors.forename: James L
authors.initials: JL
authors.lastname: Sorensen
authors.affiliation: Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia31Treatment Research Institute, Philadelphia, Pennsylvania.
authors.forename: David S
authors.initials: DS
authors.lastname: Metzger
authors.affiliation: Center for the Clinical Trials Network, National Institute on Drug Abuse, National Institutes of Health, Bethesda, Maryland.
authors.forename: Raul N
authors.initials: RN
authors.lastname: Mandler
authors.affiliation: San Francisco Department of Public Health, San Francisco, California.
authors.forename: Grant N
authors.initials: GN
authors.lastname: Colfax
authors.affiliation: Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia33Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, Georgia.
authors.forename: Carlos
authors.initials: C
authors.lastname: del Rio
mesh_terms: D000328:Adult; D019090:Case Management; D002648:Child; D002675:Child, Preschool; D005260:Female; D005382:Financing, Personal; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy* / Q000453:epidemiology / Q000821:virology; D015497:HIV-1; D006801:Humans; D007223:Infant; D007297:Inpatients; D008297:Male; D008875:Middle Aged; D009042:Motivation; D062405:Motivational Interviewing; D062526:Patient Navigation; D019966:Substance-Related Disorders / Q000150:complications*; D016896:Treatment Outcome; D019562:Viral Load