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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%.

 

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