A multicomponent diagnostic strategy was found to increase the number of patients being tested, diagnosed, and treated for confirmed tuberculosis (TB) infection, according to results of a cluster-randomized study published in The New England Journal of Medicine.
Researchers conducted a cluster-randomized trial at 20 centers in Uganda to compare the effects of a multicomponent diagnostic strategy vs routine care for diagnosing TB infection. Of the 20 centers included, 10 were assigned to the multicomponent diagnostic strategy and 10 were assigned to routine care. The multicomponent diagnostic strategy comprised on-site molecular testing for TB, guided restructuring of clinic workflows, and monthly feedback of quality metrics. Routine care comprised on-site sputum-smear microscopy and referral-based molecular testing for TB. The duration of the trial was 16 months, and the primary outcome was the number of adults treated for TB infection within 14 days of visiting a health center (XPEL-TB ClinicalTrials.gov number, NCT03044158). Completion of TB testing, same-day diagnosis, and same-day treatment were included as secondary outcomes.
Among a total of 10,644 eligible adults included in the trial, the mean age was 40 years, 60.1% were women, and 43.8% had HIV infection. The number of patients treated for confirmed TB infection within 14 days was increased among the centers that used the multicomponent diagnostic strategy vs those that used routine care (342 vs 220; adjusted rate ratio [aRR], 1.56; 95% CI, 1.21-2.01). Compared with clinics that used routine care, those that used the multicomponent diagnostic strategy had an increased number of patients who completed TB testing (aRR, 1.56; 95% CI, 1.21-2.01), received a same-day diagnosis (aRR, 1.89; 95% CI, 1.39-2.56), and received same-day treatment for TB infection (aRR, 2.38; 95% CI, 1.57-3.61). Among a total of 706 patients with confirmed TB infection, the proportion of patients who received same-day treatment or treatment within 14 days was increased among those at clinics that used the multicomponent diagnostic strategy (aRR, 2.29; 95% CI, 1.23-4.25) vs those at clinics that used routine care (aRR, 1.22; 95% CI, 1.06-1.40).
This study was limited by the small number of included health centers, and that the primary outcome was changed from the proportion of patients to the number of patients who were treated for TB infection within 14 days.
The researchers concluded, “as additional platforms for decentralized molecular testing become available, this trial provides strong evidence in support of their rapid implementation at community health centers in countries with a high prevalence of [TB infection], along with feasible strategies to promote quality improvement.”
Cattamanchi A, Reza TF, Nalugwa T, et al. Multicomponent strategy with decentralized molecular testing for tuberculosis. N Engl J Med. 2021;385(26):2441-2450. doi: 10.1056/NEJMoa2105470.