FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/04/042327 [Registered on: 29/04/2022] Trial Registered Prospectively
Last Modified On: 14/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Cluster Randomized Trial 
Public Title of Study   Finding ways to improve cervical cancer screening programs for women (SHE-CAN study).  
Scientific Title of Study   Developing a scalable, woman-centred model for cervical cancer screening in vulnerable women in India, the SHE-CAN study (Self-collected HPV Evaluation for the Prevention of Cervical CANcer). 
Trial Acronym  SHE-CAN 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anu Mary Oommen 
Designation  Professor of Community Medicine 
Affiliation  Christian Medical College Vellore 
Address  Community Health Department, Christian Medical College Vellore, Bagayam, Vellore

Vellore
TAMIL NADU
632002
India 
Phone  9486368796  
Fax    
Email  anuoommen@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anu Mary Oommen 
Designation  Professor of Community Medicine 
Affiliation  Christian Medical College Vellore 
Address  Community Health Department, Christian Medical College Vellore, Bagayam, Vellore

Vellore
TAMIL NADU
632002
India 
Phone  9486368796  
Fax    
Email  anuoommen@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Anu Mary Oommen 
Designation  Professor of Community Medicine 
Affiliation  Christian Medical College Vellore 
Address  Community Health Department, Christian Medical College Vellore, Bagayam, Vellore

Vellore
TAMIL NADU
632002
India 
Phone  9486368796  
Fax    
Email  anuoommen@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
National Health and Medical Research Council, Australia and GACD - Global Alliance for Chronic Diseases 
 
Primary Sponsor  
Name  Australian Centre for the Prevention of Cervical Cancer ACPCC 
Address  Australian Centre for the Prevention of Cervical Cancer, Level 6, 176 Wellington Parade, East Melbourne VIC, 3002, Australia 
Type of Sponsor  Other [International not-for-profit] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anu Mary Oommen  Christian Medical College Vellore   Community Health Department, Christian Medical College Vellore,
Vellore
TAMIL NADU 
9486368796

anuoommen@cmcvellore.ac.in 
Dr Eric Zomawia  National Health Mission Mizoram  National Health Mission, PBCR, Department of Health and Family Welfare, Aizawl, 796001, Mizoram Civil Hospital, Aizawl
Mamit
MIZORAM 
9436140807

ezomawia@gmail.com 
Dr Ravikumar  Tribal Health Initiative hospital (THI)  Tribal Health Initiative, Sittilingi, Harur PO, 636 906,
Dharmapuri
TAMIL NADU 
9677956752

mravi13@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics Committee, THI  Approved 
Institutional Ethics Committee and Institutional Review Board Christian Medical College Vellore  Approved 
Institutional Ethics Committee, Civil hospital, Aizawl  Approved 
Institutional Review Board and Ethics Committee of the Christian Medical College Vellore  Approved 
Institutional Review Board and Ethics Committee of the Christian Medical College Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  R 87.810  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HPV self collection at home  Eligible women aged 30-49 years will be given education and HPV kits to self collect vaginal samples which will be tested for HPV. Those who are screen positive will be referred for further evaluation.  
Comparator Agent  HPV testing at a facility  Eligible women aged 30-49 years will be offered HPV testing which can be either self-collected or collected by a health care provider (based on the womans choice), with screen positives referred for further evaluation. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  All women in the selected clusters, aged 30-49 years, married, with no previous
history of cervical cancer, with an intact uterus 
 
ExclusionCriteria 
Details  Clusters where a recent HPV based screening trial has been done
History of cervical cancer/hysterectomy
Pregnancy
Women with abnormal inter-menstrual or post-menopausal bleeding
Menstruation or within 12 weeks of delivery/abortion.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
percent well managed (Completed a valid screening test (sample processed successfully to positive or negative result, including recollection of invalid samples) AND i) for HPV negative women, woman advised of negative result or ii) for HPV positive women, completed assessment and, if needed, treatment]  12 months (end of trial) 
 
Secondary Outcome  
Outcome  TimePoints 
Representativeness of screened participants out of eligible women  12 months (end of trial) 
Acceptability of HPV self sampling  12 months (end of trial) 
Cost effectiveness in terms of incremental costs per QALY gained, cost per case screened and treated  12 months (end of trial) 
 
Target Sample Size   Total Sample Size="6600"
Sample Size from India="6600" 
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)   01/06/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [anuoommen@cmcvellore.ac.in].

  6. For how long will this data be available start date provided 01-02-2027 and end date provided 31-01-2037?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

In the context of WHO’s call for the elimination of cervical cancer as a major global health challenge, policy makers are faced with an urgent need for evidence on how to effectively implement cervical screening to achieve population level coverage.

While India’s current policy of Visual Inspection of the cervix with Acetic acid (VIA) is largely based on affordability, it has suboptimal effectiveness and has never been demonstrated to be scalable to a country level or sustainable, due to the critical need for quality assurance and ongoing training. While researchers in India have advanced recent global evidence regarding a more effective and scalable approach to cervical screening, implementation has not yet occurred at scale.

We will co-design scalable HPV based cervical screening approaches with stakeholders and others, following an initial assessment of current implementation status of screening, women’s experiences,  health providers’ and community perspectives in vulnerable communities (e.g. tribal, rural and urban poor). We will evaluate its implementation through a cluster randomised screening program trial in rural, urban poor and tribal populations in Tamil Nadu and Mizoram, that have different vulnerable populations, disease profiles and health care settings. As demonstrated recently in other low-middle income countries, we aim to demonstrate that a strategy including HPV-based screening is likely to be the most effective, practical, affordable and acceptable method for wide scale adoption by women living in some of the most underserved areas of India.

 
Close