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CTRI Number  CTRI/2021/11/038129 [Registered on: 18/11/2021] Trial Registered Prospectively
Last Modified On: 10/11/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Behavioral 
Study Design  Other 
Public Title of Study   Preventing Cervical Cancer through HPV self-sampling 
Scientific Title of Study   Preventing Cervical Cancer in India through self-sampling  
Trial Acronym  PCCIS 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gauravi Mishra 
Designation  Professor and Physician 
Affiliation  Tata Memorial Hospital 
Address  Department of Preventive Oncology Centre for Cancer Epidemiology 3rd Floor Service Block Tata Memorial Hospital Dr E Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177000  
Fax    
Email  gauravi2005@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gauravi Mishra 
Designation  Professor and Physician 
Affiliation  Tata Memorial Hospital 
Address  Department of Preventive Oncology Centre for Cancer Epidemiology 3rd Floor Service Block Tata Memorial Hospital Dr E Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177000  
Fax    
Email  gauravi2005@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Gauravi Mishra 
Designation  Professor and Physician 
Affiliation  Tata Memorial Hospital 
Address  Department of Preventive Oncology Centre for Cancer Epidemiology 3rd Floor Service Block Tata Memorial Hospital Dr E Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177000  
Fax    
Email  gauravi2005@yahoo.co.in  
 
Source of Monetary or Material Support  
Fund for Innovation and Transformation, Program of the Inter-Council Network of Provincial and Regional Councils (ICN), Global Affairs Canada. 
 
Primary Sponsor  
Name  Fund for Innovation and Transformation ICN Global Affairs Canada 
Address  Richard McCulloch, Executive Director, Research Services, Email- Richard.McCulloch@ryerson.ca Phone no- (416) 979-5000 x556521 Fax no. - (416) 979-5233 
Type of Sponsor  Other [Foreign funding] 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gauravi Mishra  Tata Memorial Hospital  Department of Preventive Oncology, Centre for Cancer Epidemiology, 3rd Floor,Room No.314, Service Block, Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA 
02224177000

gauravi2005@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
TMH, IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  120 women, who are under or never screened (UNS) for cervical cancer and 120 male partners (supportive partners)  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Innovative health education material  Development of innovative sexual health education materials under the study to engage women and communities to: (1) Increased HPV self-sampling among UNS women. (2) Increased awareness and knowledge of HPV and cervical cancer among women and men in their families. (3) Increased sexual health literacy/knowledge among women and men in villages. (4) Increased capacity among local community health professionals / workers and graduate students to carry out similar initiatives (5) Evidence of changes in gender norms to support gender and health equity. (6) New evidence available to inform local and regional public health policies to advance HPV and cervical cancer screening in rural India. 
Comparator Agent  not applicable  The proposed study is not a drug trial and hence does NOT involve dose, frequency, route of administration or duration of therapy. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  69.00 Year(s)
Gender  Both 
Details  A. Female Participants’ eligibility criteria include:
1.Under or Never screened (UNS) women (i.e. self-report of >4 years since last Pap test/VIA test, including no history of Pap test or VIA test in past).
2.Sexually active women aged 30-69 years.
3.No history of hysterectomy or past history of precancerous or cancerous lesions.
4.Willing to share contact information with the study team.

B. Eligibility criteria for men Participants include:
Male family members (husbands, fathers, brothers, sons, cousins, friends) identified and referred by UNS women participants shall be above age of 18 years.

C. The service providers eligibility criteria for focus group discussion include:
Shall be from the villages identified for implementation of the study and having a fair knowledge of cervical cancer screening.

 
 
ExclusionCriteria 
Details  1. Pregnant women
2. Women with past history of cervical cancer
3. Women who have undergone hysterectomy
4. Individuals not willing to participate 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Quantify the screening outcomes and referrals for diagnostic test
2.Acceptability / Preference outcome for HPV Self sampling kits.
3.Quantifying educational outcomes for knowledge and attitude about cervical cancer risk factors and screening( overall and by gender) in the community 
15 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NA 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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)   01/01/2022 
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="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Cervical cancer is the 2nd leading cause of cancer death in Indian women. Screening for Human Papilloma Virus (HPV), which causes cervical cancer, is effective for early diagnosis and prevention of the disease. Cervical cancer screening rates in low- and middle-income countries (LMIC) are very low (19%) as compared to High-income countries (69%). In India, limited screening resources, low knowledge and stigma around cervical cancers are the recognized barriers for screening among women. HPV self-sampling allows women to self-sample in the privacy of their home and at a time that is convenient for them.  It has proven to be effective in engaging under/never screened (UNS) women in cervical cancer screening, which results in early detection, reduced mortality and morbidity, and improved overall quality of life for a woman.

The overall goal of our proposed pilot study is to improve the sexual health of women in rural India by reducing avoidable health disparities associated with HPV and cervical cancer. The intended target shall be 120 under/never screened rural Indian women and 120 male partners in Palghar district of Maharashtra.

The objective of the study is development of innovative art based sexual health education materials (Videos, story telling, Graphic novels, family centred activities) to engage women and their male partners for two main objectives under the study-

(1) to increase awareness and knowledge of sexual health education including HPV and cervical cancer among women and men in the families. (Primary cervical cancer prevention)

(2) to increase cervical cancer screening uptake by enabling women to self-sample using an HPV kit in their homes. (Secondary cervical cancer prevention)

The anticipated outcome of the study are

1.There will be an increase in sexual health literacy (knowledge) and reduction in sexual heath stigma (attitudes) related to cervical cancer and increase uptake of screening after participating in the study.

2. There will be a higher uptake of HPV self-sampling compared to traditional method of screening (Pap-test/ VIA test) among under and never screened women.

 

Contribution of the study for National health priority

Study shall contribute to primary and secondary awareness for cervical cancer which is the common cancer among Indian women. The study would lead to increased awareness and knowledge of sexual health, HPV and cervical cancer among women and men in their families and communities (primary prevention) and increased cervical cancer screening uptake practice of HPV self-sampling among women who have been unscreened or never screened for cervical cancer (secondary prevention).The study has a capacity building component for ASHA workers/ Community health volunteers and graduate nursing students by appointing them as a part of study team and training them with the goal of transferrable skills that will in long run contribute to increase awareness towards cervical cancer.This shall also contribute to increased local capacity in promoting cervical cancer screening and follow-up. The engagement of men as a secondary target population from the community in this study will ensure their direct support to the women in undertaking the test and further referrals, if necessary. This shall indirectly contribute to positive parenting, which will also in turn lead to improved wellbeing among girls and possibly support boys to grow up with less gender biases.

The study shall highly contribute to WHO’s global effort to eliminate cervical cancer worldwide.The Project Advisory Committee formed under the study shall critically review the sexual health material developed under the project so that the communication materials are culturally and linguistically appropriate. These materials can be utilized during and after the project’s conclusion by other Indian States to promote awareness about cervical cancer screening and sexual health literacy. This intervention has a high likelihood of success and will provide new concept to scale up implementation of cervical cancer screening in rural India, if proven successful.

 
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