| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health and ICDS providers and beneficiaries |
|
|
Intervention / Comparator Agent
|
|
|
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. |