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CTRI Number  CTRI/2023/07/054817 [Registered on: 05/07/2023] Trial Registered Prospectively
Last Modified On: 28/06/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Rapid assessment of health and nutrition services of district Una, Himachal Pradesh 
Scientific Title of Study   Formative Research: Rapid Assessment of Una District, Himachal Pradesh 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sarmila Mazumder 
Designation  Senior Deputy Director and Senior Scientist 
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  45 Kalu Sarai, New Delhi

South
DELHI
110016
India 
Phone  011-46043751-55  
Fax  011-46043756  
Email  sarmila.mazumder@sas.org.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sarmila Mazumder 
Designation  Senior Deputy Director and Senior Scientist 
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  45 Kalu Sarai, New Delhi

South
DELHI
110016
India 
Phone  011-46043751-55  
Fax  011-46043756  
Email  sarmila.mazumder@sas.org.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sarmila Mazumder 
Designation  Senior Deputy Director and Senior Scientist 
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  45 Kalu Sarai, New Delhi

South
DELHI
110016
India 
Phone  011-46043751-55  
Fax  011-46043756  
Email  sarmila.mazumder@sas.org.in  
 
Source of Monetary or Material Support  
The project will be funded by the Bill & Melinda Gates Foundation (BMGF) routed through the Department of Biotechnology, BIRAC Grand Challenges-platform. 
 
Primary Sponsor  
Name  Centre for Health Research and Development Society for Applied Studies 
Address  45, Kalu Sarai, New Delhi 
Type of Sponsor  Other [Not for profit research organization] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sarmila Mazumder  District Hospital, Una, Himachal Pradesh  District Hospital, Una, Himachal Pradesh Department of Women and Child Health, Himachal Pradesh
Una
HIMACHAL PRADESH 
011-46043751-55
011-46043756
sarmila.mazumder@sas.org.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Review Committee, Centre for Health Research and Development, Society for Applied Studies  Approved 
Himachal Pradesh State Govt. Approval   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Health and ICDS providers and beneficiaries  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Preconception women in reproductive age group with no or one child, pregnant women , children less than 2 years of age and their family members. Government health care providers, community health workers and ICDS workers residing in the district Una.  
 
ExclusionCriteria 
Details  This is a formative research for rapid assessment with no exclusion criteria for the target population unless someone is mentally challenged or not in a position to respond or refuse to participate.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To make a quick assessment of the district and identify the barriers, challenges and facilitators of implementing the WINGS integrated interventions. We will explore possible solutions for the mandatory prerequisites to initiate implementation of WINGS.
The HP government has selected Una as the study district.
 
8 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable  
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

In the rapid assessment of Una, we will obtain information on key baseline health indicators, health and ICDS facilities in the area, available services in health facilities and community,  referral facilities and availability of transport in the area, current practices and utilization of services and implementation status of national programs in maternal and child health. In addition to understanding the overall population and population distribution, we will focus on the preconception women and services available for them. We will explore the use of mHealth, Health Management Information System (HMIS), existing Social Behavioral Change Communication (SBCC) activities and awareness and utilization of various government schemes. We will identify any local non-government organizations or other organizations working in the district.

We will do an initial desk review and list areas in which adequate information is not available. Field activities will follow the desk review to obtain deeper insights into the areas listed. We will assess facilities. We will use qualitative research methods to ascertain knowledge, attitude and practices of providers and beneficiaries.

 
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