CTRI Number	CTRI/2015/09/006229 [Registered on: 30/09/2015] Trial Registered Retrospectively
Last Modified On:	30/09/2015
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Process of Care Changes
Study Design	Cluster Randomized Trial
Public Title of Study	Direct observation of treatment provided by a family member for children with tuberculosis compared with treatment observation by non-family member in Gujarat, India
Scientific Title of Study Modification(s)	Prospective study on inclusion of the family member as a DOT provider for pediatric patients in state of Gujarat
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr Paresh Dave  Address  Block No 5 Dr Jivraj Mehta Bhavan Sector 10 Gandhinagar Gandhinagar GUJARAT 382010 India  Phone  07923253330   Fax     Email  stogu@rntcp.org
Details Contact Person Scientific Query Modification(s)	Name  Dr Amar Shah  Address  Central TB Division Room No 523 C 5th Floor Nirman Bhavan Moulana Azad Road New Delhi New Delhi DELHI 110011 India  Phone  8130424211   Fax     Email  shaha@rntcp.org
Details Contact Person Public Query Modification(s)	Name  Dr Amar Shah  Address  Central TB Division Room No 523 C 5th Floor Nirman Bhavan Moulana Azad Road New Delhi New Delhi DELHI 110011 India  Phone  8130424211   Fax     Email  shaha@rntcp.org
Source of Monetary or Material Support Modification(s)	Study cost regarding data collection supervision & monitoring was borne by Government Revised National Tuberculosis Control Program Gujarat India at Following Address State Tuberculosis Cell Block Number 5 Jivraj Mehta Bhawan Sector 10 Gandhinagar PIN CODE 382010 Gujarat
Primary Sponsor Modification(s)	Name  Revised National Tuberculosis Control Program  Address  TB Division Commissionerate of Health Medical Services & Medical Education Block No 5 Dr Jivraj Mehta Bhavan Gandhinagar-382010 Gujarat   Type of Sponsor  Government funding agency
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Paresh Dave  Commissionerate of Health Medical Service & Medical Education   Block 5 Jivraj Mehta Bhawan Gandhingar Gujarat Gandhinagar   07923253330 079-23253559 stogu@rntcp.org
Details of Ethics Committee Modification(s)	No of Ethics Committees= 2   Name of Committee  Approval Status  The institutional ethics committee B J Medical College & Civil Hospital Ahmedabad Gujarat  Approved  Ethics Advisory Committee the UNION  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Tuberculosis
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Intervention  Family Member as a DOT provider  Family DOT is a strategy in which anti-TB medications are administered under the supervision of an adult household member. For treatment of child (0 to 14 years) TB patient, Standard RNTCP pediatric Patient wise Box (PWB) will be used which contains 2 months of Intensive Therapy of four drugs Isoniazid, Rifampicin, Pyrazinamide and Ethambutol on alternated days orally. This will be followed by two drugs Isoniazid and Rifampicin for four months on alternate day basis. Total duration of therapy will be 6 months. The difference between the comparator agent is only who is providing the drugs. In intervention arm family member will provide the drugs to pediatric TB patient  Comparator Agent  Non Family Member as a DOT provider  Non Family DOT is a strategy in which anti-TB medications are administered under the supervision of person other than a family member. For treatment of child (0 to 14 years) TB patient, Standard RNTCP pediatric Patient wise Box (PWB) will be used which contains 2 months of Intensive Therapy of four drugs Isoniazid, Rifampicin, Pyrazinamide and Ethambutol on alternated days orally. This will be followed by two drugs Isoniazid and Rifampicin for four months on alternate day basis. Total duration of therapy will be 6 months.
Inclusion Criteria	Age From  0.00 Day(s) Age To  14.00 Year(s) Gender  Both  Details  all children with newly diagnosed TB registered for treatment in Gujarat from June to September of 2012 under Revised National Tuberculosis Control Program
ExclusionCriteria	Details  Children requiring hospital admission during TB treatment
Method of Generating Random Sequence	Stratified randomization
Method of Concealment	Not Applicable
Blinding/Masking	Not Applicable
Primary Outcome Modification(s)	Outcome  TimePoints  Tuberculosis Treatment Success Rate   Six Months
Secondary Outcome Modification(s)	Outcome  TimePoints  Weight Gain at the End of TB Treatment among Children Successfully Treated for Tuberculosis  Six Months
Target Sample Size	Total Sample Size="566" Sample Size from India="566"
Phase of Trial	N/A
Date of First Enrollment (India)	01/06/2012
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="1" Months="6" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details
Brief Summary	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. 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%.