Lisa R Metsch1, Daniel J Feaster2, Lauren Gooden1, Tim Matheson3, Maxine Stitzer4, Moupali Das5, Mamta K Jain6, Allan E Rodriguez7, Wendy S Armstrong8, Gregory M Lucas9, Ank E Nijhawan10, Mari-Lynn Drainoni11, Patricia Herrera12, Pamela Vergara-Rodriguez12, Jeffrey M Jacobson13, Michael J Mugavero14, Meg Sullivan15, Eric S Daar16, Deborah K McMahon17, David C Ferris18, Robert Lindblad19, Paul VanVeldhuisen19, Neal Oden19, Pedro C Castellón1, Susan Tross20, Louise F Haynes21, Antoine Douaihy22, James L Sorensen23, David S Metzger24, Raul N Mandler25, Grant N Colfax3, Carlos del Rio26. 1. Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, New York. 2. Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida. 3. San Francisco Department of Public Health, San Francisco, California. 4. Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland. 5. San Francisco Department of Public Health, San Francisco, California5San Francisco General Hospital, San Francisco, California6University of California, San Francisco. 6. Division of Infectious Diseases, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas8Parkland Health and Hospital System, Dallas, Texas. 7. Division of Infectious Diseases, Department of Medicine, Miller School of Medicine, University of Miami, Miami, Florida. 8. Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia. 9. Johns Hopkins University School of Medicine, Baltimore, Maryland. 10. Division of Infectious Diseases, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas. 11. 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. 12. Ruth M. Rothstein CORE Center, John H. Stroger, Jr, Hospital of Cook County, Chicago, Illinois. 13. 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. 14. Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham. 15. Section of Infectious Diseases, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts. 16. Los Angeles Biomedical Research Institute at Harbor-University of California Los Angeles Medical Center, Torrance. 17. University of Pittsburgh, Pittsburgh, Pennsylvania. 18. Mount Sinai St Luke's and Mount Sinai West Hospitals, New York, New York23Icahn School of Medicine at Mount Sinai, New York, New York. 19. The Emmes Corporation, Rockville, Maryland. 20. 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. 21. Division of Addiction Sciences, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina. 22. University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. 23. Western States Node, National Drug Abuse Treatment Clinical Trials Network, Department of Psychiatry, University of California, San Francisco. 24. Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia31Treatment Research Institute, Philadelphia, Pennsylvania. 25. Center for the Clinical Trials Network, National Institute on Drug Abuse, National Institutes of Health, Bethesda, Maryland. 26. 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.
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.
RCT Entities:
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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