Multicomponent Strategy with Decentralized Molecular Testing for Tuberculosis
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Date
2021
Journal Title
Journal ISSN
Volume Title
Publisher
New England Journal of Medicine
Abstract
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 sameday
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.)
Description
Keywords
Multicomponent Strategy, Molecular Testing, Tuberculosis
Citation
Cattamanchi, A., Reza, T. F., Nalugwa, T., Adams, K., Nantale, M., Oyuku, D., ... & Katamba, A. (2021). Multicomponent Strategy with Decentralized Molecular Testing for Tuberculosis. New England Journal of Medicine, 385(26), 2441-2450. DOI: 10.1056/NEJMoa2105470