CTRI Number |
CTRI/2021/09/036130 [Registered on: 01/09/2021] Trial Registered Prospectively |
Last Modified On: |
31/08/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Preventive Screening Process of Care Changes Behavioral |
Study Design |
Single Arm Study |
Public Title of Study
|
Preventing cervical cancer through low-cost self-testing kit in low resource settings of India. |
Scientific Title of Study
|
Prevent cancer Foundation, US-2021 Global cancer Prevention Grant Preventing cervical cancer through low-cost HPV testing approaches in low resource settings of India |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Rita Isaac |
Designation |
Professor |
Affiliation |
Christian Medical College Vellore |
Address |
RUHSA Department,Christian Medical College, Vellore TAMIL NADU
632 209
India
Vellore TAMIL NADU 632 209 India |
Phone |
9489334910 |
Fax |
|
Email |
rita.isaac@cmcvellore.ac.in |
|
Details of Contact Person Scientific Query
|
Name |
Rita Isaac |
Designation |
Professor |
Affiliation |
Christian Medical College Vellore |
Address |
RUHSA Department,Christian Medical College, Vellore TAMIL NADU
632 209
India
Vellore TAMIL NADU 632 209 India |
Phone |
9489334910 |
Fax |
|
Email |
rita.isaac@cmcvellore.ac.in |
|
Details of Contact Person Public Query
|
Name |
Biswajit Paul |
Designation |
Professor |
Affiliation |
Christian Medical College Vellore |
Address |
RUHSA Department, Christian Medical College, Vellore Tamil Nadu 632209
Vellore TAMIL NADU 632209 India |
Phone |
8124034755 |
Fax |
|
Email |
drbpaul@cmcvellore.ac.in |
|
Source of Monetary or Material Support
|
Prevent Cancer Foundation, US-2021 Global Cancer Prevention Grant |
|
Primary Sponsor
|
Name |
Prevent Cancer Foundation |
Address |
1600 Duke Street
Suite 500
Alexandria, VA 22314 |
Type of Sponsor |
Other [Nonprofit Organisation ] |
|
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 Alexander |
CHAD Hospital (Tribal Site) |
Department of Community Health,
CMC Vellore, Bagayam
Vellore 632002 Vellore TAMIL NADU |
9486368796
anuoommen@cmcvellore.ac.in |
Mrs Rajeswari Siva |
College of Nursing (Urban Poor site) |
Community Health Nursing Department,
College of Nursing,
Kagithapatarai Campus,
CMC Vellore 632004 Vellore TAMIL NADU |
9944325317
rajeswari.siva@cmcvellore.ac.in |
Dr Prashanth |
RUHSA Hospital (Rural site) |
Consultant Room 2, Admin Block, RUHSA Department, RUHSA Campus PO,
Christian Medical College, Vellore
TAMIL NADU 632 209
India Vellore TAMIL NADU |
9443105071
drprashanth@cmcvellore.ac.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Review Board, Christian Medical College |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Men and Women aged 30 -60 years old |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Educational Intervention |
Health education on HPV self screening and cervical cancer through puppet shows, option grid, videos |
Comparator Agent |
Not applicable |
Not applicable |
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Inclusion criteria - Age 30-60 years
Sex - Both males and females |
|
ExclusionCriteria |
Details |
Exclusion criteria - Unwilling to participate |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Mean change in knowledge, attitude and practice in the community on HPV screening towards cervical cancer.
|
Oct 2021 to July 2022 |
|
Secondary Outcome
|
Outcome |
TimePoints |
To initiate policy decisions on national level scale up of cervical cancer services for poor women in India.
|
Oct 2021 to July 2022 |
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
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
|
Phase 2 |
Date of First Enrollment (India)
|
15/10/2021 |
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)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Plan to get a publication in a peer reviewed journal |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Cervical cancer poses a huge public health problem in India with one of the highest rates globally and contributing to one quarter of global burden. Women between 35-65 years of age are at increased risk for developing cervical cancer, especially the rates are high among women from rural, poor areas of the country. The disease has excellent prognosis if diagnosed at an early stage. Screening for cervical cancer is one of the methods for prevention and early diagnosis of the disease. HPV testing on self-collected samples by women is a low-cost screening technique for cervical cancer which may increase the scope of screening among women from rural, tribal and poor and low health literacy communities and improve outcomes. We outline plans to demonstrate a feasible cervical cancer screening in low-health-literacy regions of India - with HPV testing as a primary screening modality, emphasizing role of stakeholders’ engagement and capacity building of organizations that will inform national screening policy. We have chosen 3 areas (rural, urban slum and tribal) for study implementation. We propose to do it in three stands – First strand, will involve descriptive research and community engagement. We will conduct two workshops in the community inviting community leaders, local govt. officials and key community members. We will also conduct two focus group discussions with women and men groups, in each of the three areas and 10 key informant interviews, in each area to understand awareness, social, cultural, financial and health system barriers and facilitators to the disease and its screening. Second strand, involves educational activities, community participation and screening for cervical cancer. We will educate the community using different educational methods like option grid and puppet shows to improve awareness and acceptance to screening. We will invite the eligible women for participation in screening through self-collected samples and those found positive will be encouraged to visit hospital for further tests and treatment. Third strand, involves evaluation and stakeholder engagement activities. We will conduct semi-structured interviews with community health workers, health care providers and sample of screened women and their husbands; stakeholder workshops will be conducted to disseminate our findings. We will do a survey of 100 men and women from each of the three areas (300 in total) using a questionnaire before and after the intervention to determine change in knowledge, attitude and practice. We will collate the qualitative and quantitative findings and disseminate to policy makers and administrators to inform a national screening policy. |