Importance: Substance use is a major driver of the HIV epidemic and is 7 associated with poor HIV care outcomes. Patient navigation (care 8 coordination with case management) and the use of financial incentives for 9 achieving pre-determined outcomes are interventions increasingly promoted 10 to engage patients in substance use disorders treatment and HIV care, but 11 there is little evidence for their efficacy in improving HIV-1 viral 12 suppression rates.
Objective: To assess the effect of a structured patient navigation 14 intervention with or without financial incentives to improve HIV-1 viral 15 suppression rates among patients with elevated HIV-1 viral loads and 16 substance use recruited as hospital inpatients.
Design, Setting, and Participants: From July 2012 through January 2014, 18 801 patients with HIV infection and substance use from 11 hospitals across the United States were randomly assigned to receive either patient 1 navigation alone (n = 266), patient navigation plus financial incentives (n = 2 271), or treatment as usual (n = 264). The HIV-1 plasma viral load was 3 measured at baseline and at, 6 and 12 months.
Interventions: Patient navigation included up to 11 sessions of care 5 coordination with case management and motivational interviewing over 6 6 months. Financial incentives (up to $1160) were provided for achieving 7 targeted behaviors aimed at reducing substance use, increasing engagement 8 in HIV care, and improving HIV outcomes. Treatment as usual was the 9 standard practice at each hospital for linking hospitalized patients to 10 outpatient HIV care and substance use disorders treatment.
Main Outcome and Measures: The pre-specified primary outcome was HIV viral suppression (≤200 copies/mL) relative to viral non-suppression/all-cause mortality at 12-month follow-up.
Results: There were no differences in rates of HIV viral suppression among the three groups at 12-months (PN=89/249, 35.7%, PN+FI=98/254, 38.6%, TAU=85/249, 34.1%, χ2(2) = 0.78, p < .68). At 6-months 120/236 (46.2%) more participants in the PN+CM group were virally suppressed compared to 89/253 (35.2%) in the TAU group (p<.04).
Conclusion and Relevance: Time-limited patient navigation and contingency management had short-term effects but were not sufficient to achieve sustained post-intervention viral suppression among substance users with advanced HIV disease. More sustained individual-level interventions and broader-reaching approaches that address the social determinants of health may be needed for this population.