Brian W Pence1, Bradley N Gaynes, Julie L Adams, Nathan M Thielman, Amy D Heine, Michael J Mugavero, Teena McGuinness, James L Raper, James H Willig, Kristen G Shirey, Michelle Ogle, Elizabeth L Turner, E Byrd Quinlivan. 1. aDepartment of Epidemiology, Gillings School of Global Public Health bDepartment of Psychiatry, School of Medicine, UNC-Chapel Hill cPharmaceutical Product Development of Wilmington dDivision of Infectious Diseases, School of Medicine, Duke University, Durham eDivision of Infectious Diseases, School of Medicine, UNC-Chapel Hill, North Carolina fDivision of Infectious Diseases gDepartment of Psychiatry, School of Medicine, University of Alabama-Birmingham, Birmingham, Alabama hDepartment of Psychiatry, School of Medicine, Duke University, Durham iWarren-Vance Community Health Center Inc., Henderson jDepartment of Biostatistics and Bioinformatics and Duke Global Health Institute, Duke University, Durham kInstitute for Global Health and Division of Infectious Diseases, School of Medicine, UNC-Chapel Hill, North Carolina, USA.
Abstract
BACKGROUND: Depression is a major barrier to HIV treatment outcomes. OBJECTIVE: To test whether antidepressant management decision support integrated into HIV care improves antiretroviral adherence and depression morbidity. DESIGN: Pseudo-cluster randomized trial. SETTING: Four US infectious diseases clinics. PARTICIPANTS: HIV-infected adults with major depressive disorder. INTERVENTION: Measurement-based care (MBC) - depression care managers used systematic metrics to give HIV primary-care clinicians standardized antidepressant treatment recommendations. MEASUREMENTS: Primary - antiretroviral medication adherence (monthly unannounced telephone-based pill counts for 12 months). Primary time-point - 6 months. Secondary - depressive severity, depression remission, depression-free days, measured quarterly for 12 months. RESULTS:From 2010 to 2013, 149 participants were randomized to intervention and 155 to usual care. Participants were mostly men, Black, non-Hispanic, unemployed, and virally suppressed with high baseline self-reported antiretroviral adherence and depressive severity. Over follow-up, no differences between arms in antiretroviral adherence or other HIV outcomes were apparent. At 6 months, depressive severity was lower among intervention participants than usual care [mean difference -3.7, 95% confidence interval (CI) -5.6, -1.7], probability of depression remission was higher [risk difference 13%, 95% CI 1%, 25%), and suicidal ideation was lower (risk difference -18%, 95% CI -30%, -6%). By 12 months, the arms had comparable mental health outcomes. Intervention arm participants experienced an average of 29 (95% CI: 1-57) more depression-free days over 12 months. CONCLUSION: In the largest trial of its kind among HIV-infected adults, MBC did not improve HIV outcomes, possibly because of high baseline adherence, but achieved clinically significant depression improvements and increased depression-free days. MBC may be an effective, resource-efficient approach to reducing depression morbidity among HIV patients.
RCT Entities:
BACKGROUND:Depression is a major barrier to HIV treatment outcomes. OBJECTIVE: To test whether antidepressant management decision support integrated into HIV care improves antiretroviral adherence and depression morbidity. DESIGN: Pseudo-cluster randomized trial. SETTING: Four US infectious diseases clinics. PARTICIPANTS: HIV-infected adults with major depressive disorder. INTERVENTION: Measurement-based care (MBC) - depression care managers used systematic metrics to give HIV primary-care clinicians standardized antidepressant treatment recommendations. MEASUREMENTS: Primary - antiretroviral medication adherence (monthly unannounced telephone-based pill counts for 12 months). Primary time-point - 6 months. Secondary - depressive severity, depression remission, depression-free days, measured quarterly for 12 months. RESULTS: From 2010 to 2013, 149 participants were randomized to intervention and 155 to usual care. Participants were mostly men, Black, non-Hispanic, unemployed, and virally suppressed with high baseline self-reported antiretroviral adherence and depressive severity. Over follow-up, no differences between arms in antiretroviral adherence or other HIV outcomes were apparent. At 6 months, depressive severity was lower among intervention participants than usual care [mean difference -3.7, 95% confidence interval (CI) -5.6, -1.7], probability of depression remission was higher [risk difference 13%, 95% CI 1%, 25%), and suicidal ideation was lower (risk difference -18%, 95% CI -30%, -6%). By 12 months, the arms had comparable mental health outcomes. Intervention arm participants experienced an average of 29 (95% CI: 1-57) more depression-free days over 12 months. CONCLUSION: In the largest trial of its kind among HIV-infected adults, MBC did not improve HIV outcomes, possibly because of high baseline adherence, but achieved clinically significant depression improvements and increased depression-free days. MBC may be an effective, resource-efficient approach to reducing depression morbidity among HIV patients.
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