| 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
|
|
|
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
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anuoommen@cmcvellore.ac.in].
- 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.
- 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. |