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CTRI Number  CTRI/2015/03/005640 [Registered on: 17/03/2015] Trial Registered Retrospectively
Last Modified On: 04/08/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Cluster Randomized Trial 
Public Title of Study   Improving access to medicines for rural poor in Tumkur, India 
Scientific Title of Study   Improving equitable access to quality generic medicines for patients with non-communicable diseases in Tumkur, India 
Trial Acronym  IPH ATM study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prashanth Nuggehalli Srinivas 
Designation  Faculty 
Affiliation  Institute of Public Health Bangalore 
Address  250, 2 C Main, 2 C Cross, Girinagar I Phase, Bangalore

Bangalore
KARNATAKA
560085
India 
Phone  918026421929  
Fax    
Email  prashanthns@iphindia.org  
 
Details of Contact Person
Scientific Query  
Name  Prashanth Nuggehalli Srinivas 
Designation  Faculty 
Affiliation  Institute of Public Health Bangalore 
Address  250, 2 C Main, 2 C Cross, Girinagar I Phase, Bangalore


KARNATAKA
560085
India 
Phone  918026421929  
Fax    
Email  prashanthns@iphindia.org  
 
Details of Contact Person
Public Query  
Name  Prashanth Nuggehalli Srinivas 
Designation  Faculty 
Affiliation  Institute of Public Health Bangalore 
Address  250, 2 C Main, 2 C Cross, Girinagar I Phase, Bangalore


KARNATAKA
560085
India 
Phone  918026421929  
Fax    
Email  prashanthns@iphindia.org  
 
Source of Monetary or Material Support  
Alliance for Health Policy and Systems Research, World Health Organization, Geneva 
 
Primary Sponsor  
Name  Institute of Public Health 
Address  250, 2 C Main, 2 C Cross, Girinaar I Phase, Bangalore-560085. Phone : 08026421929 Email : mail@iphindia.org 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Narayana Devadasan  Koratagere  Primary health centres of Koratagere, Department of Health and Family Welfare, Tumkur.
Tumkur
KARNATAKA 		 918026421929

deva@iphindia.org 
Dr Narayanan Devadasan  Sira  Primary health centres of Sira and Health and Family Welfare department, Tumkur.
Tumkur
KARNATAKA 		 918026421929

deva@iphindia.org 
Dr Narayana Devadasan  Turuvekere  Primary health centres of Turuvekere, Department of health and family welfare, Tumkur.
Tumkur
KARNATAKA 		 918026421929

deva@iphindia.org 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
IPH Institutional Ethics Committee  Approved 
WHO Ethics Review Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Households with self-reported patients with Diabetes and/or Hypertension 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Community platforms strengthening  This group will be offered a package of interventions including health services optimisation and material to strengthen existing community participation platforms. The training for ANMs and ASHAs for counselling of NCD patients and ensuring their continuous visit to PHCs for care will happen once followed by a refresher in 10-12 months interval. Organisation of NCD patient group meeting for discussion on improvement of NCD care at PHCs will occur at these PHCs belonging to intervention II arm.The maximum number of time a patient group meeting will occur at a given intervention II PHC is two. Overall intervention period is 18 months. 
Comparator Agent  Control  This group of PHCs will receive visits from the study team and observation will be recorded for existing government program for NCD control at these PHCs.  
Intervention  Health services optimisation in PHCs  Intervention PHCs will be offered a package consisting of training and technical support to health staffs (PHC Medical officers, pharmacists and ANMs) to implement continuous care for patients with non-communicable diseases. There will be one such training followed by a refresher training in 10-12 months interval. The overall intervention period is 18 months. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Any household who self-report a household member with Diabetes and/or Hypertension, who consent to participate in the study after going through the information package provided in local language 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence    
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Total health expenditure, out-of-pocket expenditure on medicines by patients with NCDs, proportion of NCD patients registered in PHC, outpatient consultation for NCDs and improved compliance and repeat visits by patients with NCDs  Total health expenditure, out-of-pocket expenditure on medicines by patients with NCDs, proportion of NCD patients registered in PHC, outpatient consultation for NCDs and improved compliance and repeat visits by patients with NCDs 
 
Secondary Outcome  
Outcome  TimePoints 
Average consultation time for NCDs at PHCs, Average duration of stock-outs of medicines at PHC, Proportion of NCD medicines of acceptable (IP) quality at PHC and private pharmacies  2013, 2015 
 
Target Sample Size   Total Sample Size="1069"
Sample Size from India="1069" 
Final Enrollment numbers achieved (Total)= "1187"
Final Enrollment numbers achieved (India)="1187" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/03/2014 
Date of Study Completion (India) 01/12/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
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
Modification(s)  		 1. Prashanth NS, Elias MA, Pati MK, Aivalli P, Munegowda CMM, Bhanuprakash S, et al. Improving access to medicines for non-communicable diseases in rural India: a mixed methods study protocol using quasi-experimental design. BMC Health Serv Res [Internet]. 2016 Dec 22;16(1):421. 2. Elias MA, Pati MK, Aivalli P, Srinath B, Munegowda C, Shroff ZC, et al. Preparedness for delivering noncommunicable disease services in primary care: Access to medicines for diabetes and hypertension in a district in south India. BMJ Glob Heal. 2017; 3. Aivalli PK, Elias MA, Pati MK, Bhanuprakash S, Munegowda C, Shroff ZC, et al. Perceptions of the quality of generic medicines: implications for trust in public services within the local health system in Tumkur, India. BMJ Glob Heal. 2018;  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is a health systems research study in which we have enrolled 39 primary health centres in three talukas of Tumkur district into one of three arms of the study (two intervention and one control). No patients or human subjects are being enrolled in the study. However, the primary outcomes of interest are related to non-communicable disease outcomes in the community, which is being measured before and after the intervention using a cluster-randomised sampling design in each of these facilities. The intervention includes a package of activities provided to health workers.  
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