Impact of a tuberculosis treatment adherence intervention versus usual care on treatment completion rates: results of a

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(2020) 15:107

RESEARCH

Open Access

Impact of a tuberculosis treatment adherence intervention versus usual care on treatment completion rates: results of a pragmatic cluster randomized controlled trial Lisa M. Puchalski Ritchie1,2,3,4* , Monique van Lettow5,6, Austine Makwakwa7, Ester C. Kip5, Sharon E. Straus1,2, Harry Kawonga5, Jemila S. Hamid8, Gerald Lebovic2,4, Kevin E. Thorpe6,9, Merrick Zwarenstein10,11, Michael J. Schull1,12,13, Adrienne K. Chan1,4,5,6,12, Alexandra Martiniuk6,14,15 and Vanessa van Schoor5

Abstract Background: With the global shortage of skilled health workers estimated at 7.2 million, outpatient tuberculosis (TB) care is commonly task-shifted to lay health workers (LHWs) in many low- and middle-income countries where the shortages are greatest. While shown to improve access to care and some health outcomes including TB treatment outcomes, lack of training and supervision limit the effectiveness of LHW programs. Our objective was to refine and evaluate an intervention designed to address common causes of non-adherence to TB treatment and LHW knowledge and skills training needs. Methods: We employed a pragmatic cluster randomized controlled trial. Participants included 103 health centres (HCs) providing TB care in four districts in Malawi, randomized 1:1 stratified by district and HC funding (Ministry of Health, non-Ministry funded). At intervention HCs, a TB treatment adherence intervention was implemented using educational outreach, a point-of-care reminder tool, and a peer support network. Clusters in the control arm provided usual care. The primary outcome was the proportion of patients with successful TB treatment (i.e., cure or treatment completion). We used a generalized linear mixed model, with district as a fixed effect and HC as a random effect, to compare proportions of patients with treatment success, among the trial arms, with adjustment for baseline differences. (Continued on next page)

* Correspondence: [email protected] 1 Department of Medicine, University of Toronto, 6 Queen’s Park Crescent West, Third Floor, Toronto, ON M5S 3H2, Canada 2 Li Ka Shing Knowledge Institute, St. Michaels Hospital, St. Michael’s Hospital, 30 Bond St, Toronto, ON M5B 1W8, Canada Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain