title: 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.
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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinical Trials Registry-India, National Institute of Medical Statistics (Indian Council of Medical Research) CTRI/2015/09/006229.
authors: Department of Health and Family Welfare, Government of Gujarat, Gandhinagar, Gujarat, India.
authors: Paresh Vamanrao
authors: PV
authors: Dave
authors: WHO country office for India, New Delhi, India.
authors: Amar Niranjan
authors: AN
authors: Shah
authors: Department of Health and Family Welfare, Government of Gujarat, Gandhinagar, Gujarat, India.
authors: Pankaj B
authors: PB
authors: Nimavat
authors: Department of Health and Family Welfare, Government of Gujarat, Gandhinagar, Gujarat, India.
authors: Bhavesh B
authors: BB
authors: Modi
authors: Department of Health and Family Welfare, Government of Gujarat, Gandhinagar, Gujarat, India.
authors: Kirit R
authors: KR
authors: Pujara
authors: Department of Health and Family Welfare, Government of Gujarat, Gandhinagar, Gujarat, India.
authors: Pradip
authors: P
authors: Patel
authors: Department of Health and Family Welfare, Government of Gujarat, Gandhinagar, Gujarat, India.
authors: Keshabhai
authors: K
authors: Mehariya
authors: WHO country office for India, New Delhi, India.
authors: Kiran Vaman
authors: KV
authors: Rade
authors: National Tuberculosis Institute, Government of India, Bangalore, India.
authors: Soma
authors: S
authors: Shekar
authors: Central TB Division, Ministry of Health and Family Welfare, Government of India, New Delhi, India.
authors: Kuldeep S
authors: KS
authors: Sachdeva
authors: U.S. Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
authors: John E
authors: JE
authors: Oeltmann
authors: International Union Against Tuberculosis and Lung Disease, South-East Asia Regional Office, New Delhi, India.
authors: Ajay M V
authors: AM
authors: Kumar
mesh_terms: D000293:Adolescent; D000995:Antitubercular Agents / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D023801:Directly Observed Therapy / Q000379:methods* / Q000523:psychology; D005190:Family; D005260:Female; D006801:Humans; D007194:India; D007223:Infant; D008297:Male; D010342:Patient Acceptance of Health Care; D016896:Treatment Outcome; D014376:Tuberculosis / Q000188:drug therapy*
chemical_list: D000995:Antitubercular Agents