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Randomized Controlled Trial
. 2016 Feb 5;11(2):e0148488.
doi: 10.1371/journal.pone.0148488. eCollection 2016.

Direct Observation of Treatment Provided by a Family Member as Compared to Non-Family Member among Children with New Tuberculosis: A Pragmatic, Non-Inferiority, Cluster-Randomized Trial in Gujarat, India

Paresh Vamanrao Dave  1 , Amar Niranjan Shah  2 , Pankaj B Nimavat  1 , Bhavesh B Modi  1 , Kirit R Pujara  1 , Pradip Patel  1 , Keshabhai Mehariya  1 , Kiran Vaman Rade  2 , Soma Shekar  3 , Kuldeep S Sachdeva  4 , John E Oeltmann  5 , Ajay M V Kumar  6
Affiliations
Randomized Controlled Trial

Direct Observation of Treatment Provided by a Family Member as Compared to Non-Family Member among Children with New Tuberculosis: A Pragmatic, Non-Inferiority, Cluster-Randomized Trial in Gujarat, India

Paresh Vamanrao Dave et al. PLoS One. .

Abstract

Background: The World Health Organization recommends direct observation of treatment (DOT) to support patients with tuberculosis (TB) and to ensure treatment completion. As per national programme guidelines in India, a DOT provider can be anyone who is acceptable and accessible to the patient and accountable to the health system, except a family member. This poses challenges among children with TB who may be more comfortable receiving medicines from their parents or family members than from unfamiliar DOT providers. We conducted a non-inferiority trial to assess the effect of family DOT on treatment success rates among children with newly diagnosed TB registered for treatment during June-September 2012.

Methods: We randomly assigned all districts (n = 30) in Gujarat to the intervention (n = 15) or usual-practice group (n = 15). Adult family members in the intervention districts were given the choice to become their child's DOT provider. DOT was provided by a non-family member in the usual-practice districts. Using routinely collected clinic-based TB treatment cards, we compared treatment success rates (cured and treatment completed) between the two groups and the non-inferiority limit was kept at 5%.

Results: Of 624 children with newly diagnosed TB, 359 (58%) were from intervention districts and 265 (42%) were from usual-practice districts. The two groups were similar with respect to baseline characteristics including age, sex, type of TB, and initial body weight. The treatment success rates were 344 (95.8%) and 247 (93.2%) (p = 0.11) among the intervention and usual-practice groups respectively.

Conclusion: DOT provided by a family member is not inferior to DOT provided by a non-family member among new TB cases in children and can attain international targets for treatment success.

Trial registration: Clinical Trials Registry-India, National Institute of Medical Statistics (Indian Council of Medical Research) CTRI/2015/09/006229.

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Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist. The authors alone are responsible for the views expressed in this publication and they do not necessarily represent the decisions or policies of the World Health Organization and U.S. Centers for Disease Control and Prevention.

Figures

Fig 1
Fig 1. Flow diagram of study cohort of children with newly diagnosed TB registered in Gujarat State, India during June-September 2012.
See this image and copyright information in PMC

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