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CTRI Number  CTRI/2025/02/079915 [Registered on: 03/02/2025] Trial Registered Prospectively
Last Modified On: 27/01/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Acceptability and Feasibility of HPV Self-Sampling as an Alternative Primary Cervical Cancer Screening in Under-Screened, Hard to reach Tribal Women population in Maharashtra: A Cross-Sectional Study. 
Scientific Title of Study   Prevalence of Human Papilloma Virus [HPV] Infection & Acceptability, Feasibility of HPV Self-Sampling as an Alternative Primary Cervical Cancer Screening in Under-Screened, Hard to reach Tribal Women population in Maharashtra: A Cross-Sectional Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sharmila Pimple 
Designation  Professor and Head 
Affiliation  Tata Memorial Hospital 
Address  Department of Preventive Oncology 3rd floor, Service block Tata Memorial Hospital Dr Ernest Borges road Parel, Mumbai Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9223207939  
Fax    
Email  pimplesharmila@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sharmila Pimple 
Designation  Professor and Head 
Affiliation  Tata Memorial Hospital 
Address  Department of Preventive Oncology 3rd floor, Service block Tata Memorial Hospital Dr Ernest Borges road Parel, Mumbai Mumbai MAHARASHTRA 400012 India


MAHARASHTRA
400012
India 
Phone  9223207939  
Fax    
Email  pimplesharmila@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sharmila Pimple 
Designation  Professor and Head 
Affiliation  Tata Memorial Hospital 
Address  Department of Preventive Oncology 3rd floor, Service block Tata Memorial Hospital Dr Ernest Borges road Parel, Mumbai Mumbai MAHARASHTRA 400012 India


MAHARASHTRA
400012
India 
Phone  9223207939  
Fax    
Email  pimplesharmila@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital Department of Preventive Oncology 3rd floor, Service block Tata Memorial Hospital Dr Ernest Borges road Parel, Mumbai400012, Maharashtra, India 
 
Primary Sponsor  
Name  Dr Sharmila Pimple 
Address  Tata Memorial Hospital 3rd floor, Service block building, Dr. Ernest Borges road, Parel, Mumbai 400012, Maharshtra 
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 Sharmila Pimple  Tata Memorial Hospital  Room No:106, 1st Floor, Preventive Oncology Services, Khopoli Dr. Babasaheb Ambedkar Hospital Khopoli, Tal Khalapur, Dist Raigad
Raigarh
MAHARASHTRA 		 9223207939

pimplesa@tmc.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committees- II Tata Memorial Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Prevention from Cervical Cancer 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Women between the age group of 25-60 years,
Non-pregnant
With an intact uterus and,
No past history of cervical neoplasia.
 
 
ExclusionCriteria 
Details  Unmarried
Have had a total hysterectomy
Have a history of cervical cancer
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Percentage of eligible women aware of cervical cancer screening programs.
Percentage of eligible women screened using hrHPV self-sampling.

Percentage of hrHPV-positive women adhering to follow-up recommendations
Percentage of women receiving appropriate treatment following cervical cancer screening.

Operational Feasibility:
Coverage of self-sample HPV/DNA screening among the target population.
Number and percentage of invalid test results.
Compliance rates of screen-positive cases undergoing reference diagnostic procedures:
Conventional cytology.
Colposcopy-guided biopsy or Endocervical Curettage (ECC).

Technical Feasibility:
Duration from sample collection to laboratory transport.
Duration from sample collection to report delivery. 		 24 months. 
 
Secondary Outcome  
Outcome  TimePoints 
To identify the sociocultural barriers, preferences, and facilitators influencing the adoption of HPV self-sampling among under-screened tribal women in Maharashtra.
To evaluate the acceptability of HPV self-sampling as a screening method in the tribal population.
To assess the operational feasibility of implementing HPV self-sampling as a screening strategy. 		 24 months. 
 
Target Sample Size   Total Sample Size="4941"
Sample Size from India="4941" 
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)   02/02/2026 
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="0"
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  

Cervical cancer is a significant health issue for women in India, particularly those in remote tribal areas who face barriers like cultural, social, low literacy, poverty, and limited access to healthcare. This study aims to introduce HPV self-sampling as an easier way for these women to screen for cervical cancer.

HPV (Human Papillomavirus) can cause cervical cancer. Unlike traditional Pap tests that require a clinic visit, HPV self-sampling allows women to collect their own samples at home or at local health camps. This method is more accessible and comfortable for women in remote areas.

The study will be conducted over two years in the tribal regions of Raigad District, Maharashtra. Eligible women aged 25-60 will be educated by community health workers on cervical cancer and will be trained on using the self-sampling kits. They will then collect and return their samples for testing.

Women who test positive for HPV will receive further evaluation, while those who test negative will be advised to screen again after five years. The study aims to demonstrate that HPV self-sampling is a feasible and acceptable method for cervical cancer screening. It also aims to enumerate all the socio-cultural barriers and challenges faced by tribal women for getting themselves tested for cervical cancer screening. By increasing screening rates, the study hopes to enable earlier detection and better health outcomes for tribal women, leading to improved cancer prevention strategies in India.

 
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