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
|
|
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. |