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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  
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 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  
Status 
Not Applicable 
 
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.

 
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