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CTRI Number  CTRI/2024/03/063824 [Registered on: 08/03/2024] Trial Registered Prospectively
Last Modified On: 08/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A comprehensive health awareness Booklet for reproductive health schemes among the tribal women of Jharkhand.  
Scientific Title of Study   Development & Validation of a health awareness booklet: Reproductive Health Schemes for tribal women of Jharkhand 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ROHIT RAJ 
Designation  Ph.D. Scholar 
Affiliation  Manipal Tata Medical College Jamshedpur 
Address  First floor, left wing, room no 143, Department of Community Medicine, Manipal Tata Medical College, Kadani Road, East Singhbhum
First floor, left wing, room no 143, Department of Community Medicine, Manipal Tata Medical College, Kadani Road, East Singhbhum
Purbi Singhbhum
JHARKHAND
831017
India 
Phone  8235035808  
Fax    
Email  rohit1.mtmcjsr2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr. JARINA BEGUM 
Designation  HOD & PROFESSOR 
Affiliation  Manipal Tata Medical College Jamshedpur 
Address  First floor, left wing, room no 143, Department of Community Medicine, Manipal Tata Medical College, Kadani Road, East Singhbhum
First floor, left wing, room no 143, Department of Community Medicine, Manipal Tata Medical College, Kadani Road, East Singhbhum
Purbi Singhbhum
JHARKHAND
831017
India 
Phone  9618162611  
Fax    
Email  jarina.begum@manipal.edu  
 
Details of Contact Person
Public Query  
Name  ROHIT RAJ 
Designation  Ph.D. Scholar 
Affiliation  Manipal Tata Medical College Jamshedpur 
Address  First floor, left wing, room no 143, Department of Community Medicine, Manipal Tata Medical College, Kadani Road, East Singhbhum
First floor, left wing, room no 143, Department of Community Medicine, Manipal Tata Medical College, Kadani Road, East Singhbhum
Purbi Singhbhum
JHARKHAND
831017
India 
Phone  8235035808  
Fax    
Email  rohit1.mtmcjsr2022@learner.manipal.edu  
 
Source of Monetary or Material Support  
First floor, left-wing, room no 143, Department of Community Medicine, Manipal Tata Medical College, Kadani Road, East Singhbhum  
 
Primary Sponsor  
Name  Dr Rohit Raj 
Address  First floor, left wing, room no 143, Department of Community Medicine, Manipal Tata Medical College, Kadani Road, East Singhbhum 
Type of Sponsor  Other [Self] 
 
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 Rohit Raj  Manipal Tata Medical College  First floor, left wing, room no 143, Department of Community Medicine, Manipal Tata Medical College, Kadani Road, East Singhbhum
Purbi Singhbhum
JHARKHAND 		 8235035808

rohit1.mtmcjsr2022@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Manipal Tata Medical College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Reproductive age group tribal women (15 to 49 years) and adolescent girls 10 to 19 years. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  1. Adolescent girls (10-19years) & tribal women in the reproductive age group (15-49years), belonging to the following tribes: Santhal, Ho, Munda, Bhumiz, Kharia, and Sabar.
2. Who gave consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Migrant population and tribal women suffering from any mental illness. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Baseline data (KAP) of health care schemes utilization among tribal women of reproductive age group.
2. Identifying challenges in the utilization of services from different stakeholders.
3. Development of a Booklet covering the health schemes targeted for tribal women.

 		 For outcomes 1, 2, and 3 six months each will be given as a time period.  
 
Secondary Outcome  
Outcome  TimePoints 
1. Booklet can be copyrighted and can be used by others in larger study population.
 		 2 to 3 months 
 
Target Sample Size   Total Sample Size="745"
Sample Size from India="745" 
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)   19/03/2024 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

The Sustainable Development Goals and indigenous people are connected in various ways. Utilization of reproductive health services by tribal women and adolescent girls in Jharkhand is lagging behind. This research aims to evaluate the knowledge, attitude, and practices related to healthcare schemes among the tribal women along with the perspective of all stakeholders.  The objective of the study will be in two phase, phase 1: Need assessment-   1. To assess the knowledge, attitude, and practices of relevant healthcare schemes among tribal women in the reproductive age group. 2. To understand the challenges faced in the provision of tribal women healthcare schemes from different Stakeholder’s perspectives.  Phase 2: Implementation- To develop & validate the awareness booklet for the tribal women of reproductive age group and evaluate the perception of participants towards it.  This will be a cross-sectional study conducted in the field practice area of the Department of Community Medicine, as a part of an ongoing doctoral study. The total sample size for the pilot study was determined to be 475 for KAP and 50 to 60 in-depth interviews till the saturation of the data, to explore the challenges.  A self-administered, validated questionnaire tool was used to assess the Knowledge Attitude and Practices (KAP) of healthcare schemes among tribal women. The qualitative data was collected through in-depth interviews among stakeholders to evaluate their perspectives in terms of strengths, weaknesses, opportunities, and challenges. Data was analyzed using descriptive and thematic analysis. Based on the findings a Health awareness Booklet will be developed and it will be validated through subject experts and by piloting in the form of training in the study population.

 
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