Effectiveness and Cost-Effectiveness of Group Support Psychotherapy Delivered by Trained Lay Health Workers for Depression Treatment Among People with HIV in Uganda: A Cluster Randomized Trial

Abstract

Background: There is a scarcity of data on integrating and scaling up mental health interventions for people living with HIV in sub-Saharan Africa. Methods: Thirty primary care health centres (PHCs) were randomized 1:1 to offer Group Support Psychotherapy (GSP) or Group HIV Education (GHE). Participants were followed up at 6 and 12 months thereafter. Primary outcomes were change in depression and function scores, analysed by intention-to-treat using multilevel random effects regression analyses adjusting for clustering in PHCs. Secondary outcomes were post-traumatic stress symptoms, hazardous alcohol use, suicide risk, adherence to antiretroviral therapy (ART), viral loads (VLs) and cost-effectiveness data. This trial is registered with The Pan African Clinical Trials Registry, numberPACTR201608001738234. Findings: Between September 13, and December 15, 2016, we assessed 1,473 individuals, of whom 1,140 were recruited from PHCs offering GSP (n=578) or GHE (n=562). At 6 months post- treatment, we observed a greater reduction in depression symptoms among GSP than GHE participants [β = -5·28; 95% CI -5·85 to -4·72, p= < 0·001; effect size=1·28]. This effect was greater at 12 months post-treatment [β= -7·31; 95% CI -7·89 to -6·72, p=< 0·001]. Additionally, function scores were higher among GSP than GHE participants at 6 months [β= 4·12; 95% CI 3·75 to 4·49, p= < 0·001; effect size=1·44] and 12 months post-treatment [β= 5·07; 95% CI 4·72 to 5·42; p= < 0·001]. Significantly more GSP than GHE participants reported reduced post-traumatic stress symptoms; lower suicide risk, less use of alcohol and better adherence to ART in the long-term. The improvement in VL suppression was comparable between both groups. The incremental cost per disability adjusted life year averted was US$11·4. A total of 36 participants experienced 63 serious adverse events. Interpretation: GSP delivered by lay health workers is a more cost-effective psychological treatment for HIV related depression compared to GHE. Trial Registration Number: This trial is registered with The Pan African Clinical Trials Registry, numberPACTR201608001738234. Funding: This study was funded by Grand Challenges Canada, Grant #0770-05. EN-M is supported by the MQ Mental Health Fellowship Award, Grant #MQ15FIP100024. Declaration of Interest: None declared. Ethical Approval: The study was submitted to and approved by the Makerere University College of Health Sciences Research Ethics Committee, The AIDS Support Organization Research Ethics Committee, and the Uganda National Council of Science and Technology. All study participants were required to provide written informed consent.