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CTRI Number  CTRI/2025/02/080863 [Registered on: 19/02/2025] Trial Registered Prospectively
Last Modified On: 18/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Assessment of the Effectiveness of a Behavior Change Communication Package on Knowledge, Attitude and Practice towards Cervical Cancer, it’s screening and HPV Vaccination among adolescent girls and women in East Singhbhum district 
Scientific Title of Study   Assessment of the Effectiveness of a Behavior Change Communication Package on Knowledge, Attitude and Practice towards Cervical Cancer, it’s screening and HPV Vaccination among adolescent girls (10-19 years) and women (20-65 years) in East Singhbhum district: A mixed method study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SOUMALYA GHOSH 
Designation  PhD Public Health Scholar 
Affiliation  Hamdard Institute of Medical Sciences and Research 
Address  Department of Community Medicine the Hamdard Institute of Medical Sciences and Research Guru Ravidas Marg Hamdard Nagar New Delhi

South
DELHI
110062
India 
Phone  6209020900  
Fax    
Email  soumalyaghosh1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR FARZANA ISLAM 
Designation  PROFESSOR AND HOD 
Affiliation  Hamdard Institute of Medical Sciences and Research 
Address  Department of Community Medicine the Hamdard Institute of Medical Sciences and Research Guru Ravidas Marg Hamdard Nagar New Delhi

South
DELHI
110062
India 
Phone  9560067059  
Fax    
Email  drfarzanaislam@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SOUMALYA GHOSH 
Designation  PhD Public Health Scholar 
Affiliation  Hamdard Institute of Medical Sciences and Research 
Address  Department of Community Medicine the Hamdard Institute of Medical Sciences and Research Guru Ravidas Marg Hamdard Nagar New Delhi


DELHI
110062
India 
Phone  6209020900  
Fax    
Email  soumalyaghosh1@gmail.com  
 
Source of Monetary or Material Support  
NUHM Jamshedpur, CS Office, Khasmahal, East Singhbhum, Jharkhand, India, 831002 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 Soumalya Ghosh  NUHM Jamshedpur, Jamshedpur Urban  NUHM Jamshedpur, Civil Surgeon Office, Khasmahal, Jamshedpur, East Singhbhum
Purbi Singhbhum
JHARKHAND 		 6209020900

soumalyaghosh1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Civil Surgeon East Singhbhum and NUHM Jamshedpur  Approved 
Institute Ethics Committee, HIMSR, New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adolescent girls (10-19 years) and women (20 – 65 years) have ability and willingness to provide informed consent or assent from the participants/caregivers  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Basic awareness materials   Basic awareness materials (e.g., a single pamphlet or verbal briefing) on the importance of cervical cancer screening and HPV vaccination will be provided for 1 month period after baseline assessment to the control group. These materials will not include the comprehensive strategies or interactive components featured in the BCC Package. 
Intervention  Behavior Change Communication BCC Package   BCC Package will be delivered to participants in the intervention group through interactive sessions conducted at Anganwadi Centers. Methods such as group discussions, role plays, visual aids, and distribution of pamphlets will be used to engage the participants effectively.After development of the final BCC Package small BCC sessions will be organized in each ward at a convenient time and place. The intervention will be provided for 1 month period after the baseline assessment. The components of the designed intervention, includes the following behavioral targets 1. Educate regarding Human Papilloma Virus 2. Creating awareness regarding Cervical Cancer and prevention strategies 3. Educate various risk factors for developing Cervical Cancer 4. Educate Cervical Cancer Screening Procedure and available diagnostics centers which conducts Cervical Cancer Screening 5. Creating awareness regarding HPV Vaccine and efficacy 6. Information regarding facilities available with HPV vaccine 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Adolescent girls (10-19 years) and women (20 – 65 years)
Ability and willingness to provide informed consent or assent from the participants/caregivers
 
 
ExclusionCriteria 
Details  Women already diagnosed with cervical cancer
The participant who will not be able to respond due to any severe illnesses.
The participants who will not be available for baseline data collection despite 2 times visit.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
the effectiveness of a Behavior Change Communication Package in changing the knowledge, attitude and practice towards Cervical Cancer, it’s screening and HPV Vaccination among the adolescent girls (10-19 years) and women (20 to 65 years).  Baseline Assessment: knowledge, attitude and practice towards Cervical Cancer, it’s screening and HPV Vaccination among the adolescent girls (10-19 years) and women (20 to 65 years). End Line assessment: After 8 weeks of baseline assessment and after 4 weeks of BCC sessions end line assessment will be done. 
 
Secondary Outcome  
Outcome  TimePoints 
the enabling factors & barriers regarding Cervical Cancer, it’s screening & HPV vaccination among the adolescent girls (10-19 years) & women (20 to 65 years).  at baseline assessment & end line assessment after 8 weeks 
 
Target Sample Size   Total Sample Size="256"
Sample Size from India="256" 
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   Phase 3 
Date of First Enrollment (India)   01/03/2025 
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="6"
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  

From each selected household study participant will be selected randomly.  Assent and consent will be taken as per the eligible criteria and ethical standards. After ensuring that participant has understood the purpose of the study. They will be interviewed face-to-face by the investigator. As the investigator is male, before conducting the face-to-face interview, the woman and guardian of the adolescent girl will be informed regarding the domains of the questionnaire. If the participant feels comfortable answering, then face to face interview will be conducted in a place where her privacy will be maintained. Socio-demographic information will be recorded. Relevant history of the any present illness, personal history comorbidity, substance use history will be collected. Participants will be interviewed on different aspect of knowledge, attitude and practice towards cervical cancer screening and HPV Vaccination.

 
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