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Original Investigation |

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

Lisa R. Metsch, PhD1; Daniel J. Feaster, PhD2; Lauren Gooden, PhD1; Tim Matheson, PhD3; Maxine Stitzer, PhD4; Moupali Das, MD3,5,6; Mamta K. Jain, MD7,8; Allan E. Rodriguez, MD9; Wendy S. Armstrong, MD10; Gregory M. Lucas, MD, PhD11; Ank E. Nijhawan, MD7; Mari-Lynn Drainoni, PhD12,13; Patricia Herrera, MD14; Pamela Vergara-Rodriguez, MD14; Jeffrey M. Jacobson, MD15,16,17,18; Michael J. Mugavero, MD19; Meg Sullivan, MD13; Eric S. Daar, MD20; Deborah K. McMahon, MD21; David C. Ferris, MD22,23; Robert Lindblad, MD24; Paul VanVeldhuisen, PhD24; Neal Oden, PhD24; Pedro C. Castellón, MPH1; Susan Tross, PhD25,26; Louise F. Haynes, MSW27; Antoine Douaihy, MD28; James L. Sorensen, PhD29; David S. Metzger, PhD30,31; Raul N. Mandler, MD32; Grant N. Colfax, MD3; Carlos del Rio, MD10,33
[+] 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.
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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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Figure.
Flow of Patients Through the Project HOPE Trial

CAPI indicates computer-assisted personal interview.

aConsent was not required for prescreening.

bInformal tallies showed that refusal, being too ill and discharged before screening were equivalent reasons for not being screened.

cPhysical functioning criteria included 26 with Karnofsky score < 60; 10 too sick to participate, and 6 cognitive functioning precluded involvement.

dParticipants in the usual-treatment group received treatment as usual which was not tracked by the study.

eA patient who died in the 12 month period but was counted as lost to follow-up at 6 months.

fVirally suppression as treatment success includes participants with viral >200 copies/mL and treatment failure as death. This analysis includes those lost to follow-up for whom medical records of viral load were available.

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