Adithya Cattamanchi1, Tania F Reza1, Talemwa Nalugwa1, Katherine Adams1, Mariam Nantale1, Denis Oyuku1, Sarah Nabwire1, Diana Babirye1, Stavia Turyahabwe1, Austin Tucker1, Hojoon Sohn1, Olivia Ferguson1, Ryan Thompson1, Priya B Shete1, Margaret A Handley1, Sara Ackerman1, Moses Joloba1, David A J Moore1, J Lucian Davis1, David W Dowdy1, Katherine Fielding1, Achilles Katamba1. 1. From the Division of Pulmonary and Critical Care Medicine and the Center for Tuberculosis, San Francisco General Hospital (A.C., T.F.R., P.B.S.), the Partnerships for Research in Implementation Science for Equity Center (A.C., P.B.S., M.A.H.), and the Departments of Epidemiology and Biostatistics (M.A.H.) and Social and Behavioral Sciences (S.A.), University of California, San Francisco, San Francisco; the Uganda Tuberculosis Implementation Research Consortium (A.C., T.N., M.N., D.O., S.N., D.B., S.T., P.B.S., D.A.J.M., J.L.D., D.W.D., A.K.), National Tuberculosis and Leprosy Program, Uganda Ministry of Health (S.T.), and the Schools of Biomedical Sciences (M.J.) and Medicine (A.K.), Makerere University College of Health Sciences - all in Kampala, Uganda; the Implementation Science Program (K.A.) and the Department of Epidemiology (A.T., H.S., O.F., R.T., D.W.D.), Johns Hopkins Bloomberg School of Public Health, Baltimore; the Faculties of Infectious and Tropical Diseases (D.A.J.M.) and Epidemiology and Population Health (K.F.) and the TB Centre (D.A.J.M., K.F.), London School of Hygiene and Tropical Medicine, London; the Department of Epidemiology of Microbial Diseases and the Center for Methods in Implementation and Prevention Sciences, Yale School of Public Health, and the Section of Pulmonary, Critical Care, and Sleep Medicine, Yale School of Medicine - both in New Haven, CT (J.L.D.).
Abstract
BACKGROUND: Effective strategies are needed to facilitate the prompt diagnosis and treatment of tuberculosis in countries with a high burden of the disease. METHODS: We conducted a cluster-randomized trial in which Ugandan community health centers were assigned to a multicomponent diagnostic strategy (on-site molecular testing for tuberculosis, guided restructuring of clinic workflows, and monthly feedback of quality metrics) or routine care (on-site sputum-smear microscopy and referral-based molecular testing). The primary outcome was the number of adults treated for confirmed tuberculosis within 14 days after presenting to the health center for evaluation during the 16-month intervention period. Secondary outcomes included completion of tuberculosis testing, same-day diagnosis, and same-day treatment. Outcomes were also assessed on the basis of proportions. RESULTS: A total of 20 health centers underwent randomization, with 10 assigned to each group. Of 10,644 eligible adults (median age, 40 years) whose data were evaluated, 60.1% were women and 43.8% had human immunodeficiency virus infection. The intervention strategy led to a greater number of patients being treated for confirmed tuberculosis within 14 days after presentation (342 patients across 10 intervention health centers vs. 220 across 10 control health centers; adjusted rate ratio, 1.56; 95% confidence interval [CI], 1.21 to 2.01). More patients at intervention centers than at control centers completed tuberculosis testing (adjusted rate ratio, 1.85; 95% CI, 1.21 to 2.82), received a same-day diagnosis (adjusted rate ratio, 1.89; 95% CI, 1.39 to 2.56), and received same-day treatment for confirmed tuberculosis (adjusted rate ratio, 2.38; 95% CI, 1.57 to 3.61). Among 706 patients with confirmed tuberculosis, a higher proportion in the intervention group than in the control group were treated on the same day (adjusted rate ratio, 2.29; 95% CI, 1.23 to 4.25) or within 14 days after presentation (adjusted rate ratio, 1.22; 95% CI, 1.06 to 1.40). CONCLUSIONS: A multicomponent diagnostic strategy that included on-site molecular testing plus implementation supports to address barriers to delivery of high-quality tuberculosis evaluation services led to greater numbers of patients being tested, receiving a diagnosis, and being treated for confirmed tuberculosis. (Funded by the National Heart, Lung, and Blood Institute; XPEL-TB ClinicalTrials.gov number, NCT03044158.).
BACKGROUND: Effective strategies are needed to facilitate the prompt diagnosis and treatment of tuberculosis in countries with a high burden of the disease. METHODS: We conducted a cluster-randomized trial in which Ugandan community health centers were assigned to a multicomponent diagnostic strategy (on-site molecular testing for tuberculosis, guided restructuring of clinic workflows, and monthly feedback of quality metrics) or routine care (on-site sputum-smear microscopy and referral-based molecular testing). The primary outcome was the number of adults treated for confirmed tuberculosis within 14 days after presenting to the health center for evaluation during the 16-month intervention period. Secondary outcomes included completion of tuberculosis testing, same-day diagnosis, and same-day treatment. Outcomes were also assessed on the basis of proportions. RESULTS: A total of 20 health centers underwent randomization, with 10 assigned to each group. Of 10,644 eligible adults (median age, 40 years) whose data were evaluated, 60.1% were women and 43.8% had human immunodeficiency virus infection. The intervention strategy led to a greater number of patients being treated for confirmed tuberculosis within 14 days after presentation (342 patients across 10 intervention health centers vs. 220 across 10 control health centers; adjusted rate ratio, 1.56; 95% confidence interval [CI], 1.21 to 2.01). More patients at intervention centers than at control centers completed tuberculosis testing (adjusted rate ratio, 1.85; 95% CI, 1.21 to 2.82), received a same-day diagnosis (adjusted rate ratio, 1.89; 95% CI, 1.39 to 2.56), and received same-day treatment for confirmed tuberculosis (adjusted rate ratio, 2.38; 95% CI, 1.57 to 3.61). Among 706 patients with confirmed tuberculosis, a higher proportion in the intervention group than in the control group were treated on the same day (adjusted rate ratio, 2.29; 95% CI, 1.23 to 4.25) or within 14 days after presentation (adjusted rate ratio, 1.22; 95% CI, 1.06 to 1.40). CONCLUSIONS: A multicomponent diagnostic strategy that included on-site molecular testing plus implementation supports to address barriers to delivery of high-quality tuberculosis evaluation services led to greater numbers of patients being tested, receiving a diagnosis, and being treated for confirmed tuberculosis. (Funded by the National Heart, Lung, and Blood Institute; XPEL-TB ClinicalTrials.gov number, NCT03044158.).
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