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

Details

• Alternative Title:
  PLoS One
• Personal Author:
  Dave, Paresh Vamanrao ; Shah, Amar Niranjan ; Nimavat, Pankaj B. ; Modi, Bhavesh B. ; Pujara, Kirit R. ; Patel, Pradip ; Mehariya, Keshabhai ; Rade, Kiran Vaman ; Shekar, Soma ; Sachdeva, Kuldeep S. ; Oeltmann, John E. ; Kumar, Ajay M. V.
• Description:
  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
  
  
• Subjects:
  Adolescent Antitubercular Agents Child Child, Preschool Directly Observed Therapy Family Female Humans Infant Male Patient Acceptance Of Health Care Treatment Outcome Tuberculosis

  More +
• Source:
  PLoS One. 11(2).
• Pubmed ID:
  26849442
• Pubmed Central ID:
  PMC4743945
• Document Type:
  Journal Article
• Place as Subject:
  India
• Volume:
  11
• Issue:
  2
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:014a0c180356b1d6dd8b1a23e7fc077a4ce474e0058128648b1af192b94eb312
• Download URL:
  https://stacks.cdc.gov/view/cdc/38207/cdc_38207_DS1.pdf
• File Type:
  [PDF - 707.66 KB ]