Early detection, referral and treatment for breast and cervical cancer among women - A population-based study in Udupi district, Karnataka

This is a prospective cross-sectional study to be conducted among women in the age group of 30-55 years within Udupi district.

Objectives of the study:

1.Screening rural women for breast and cervical cancers, anemia, hypertension and type II diabetes in Udupi district.

2.Establishing a referral pathway and follow-up mechanism for the management of women with positive findings with the screening procedures.

3.Assessing the usefulness of Validation of the AI-enabled cervical cancer screening tool -Sakhi Manipal, in terms of image quality, user-friendliness and accuracy

Sample size: Complete enumeration of all participants who come forward for screening during the study period (approximately 4000 within the study period).

Methodology:

Tool for data Collection:

Semi-structured interview-based questionnaire on Epicollect5 to collect study participant information and document the findings of the screening tests and referral details.

Tool for Breast cancer screening -  iBE ( iBreast Exam) - The iBE is an FDA 510(k) cleared non-invasive and low-cost technique for early detection of clinically relevant breast lesions using a handheld point-of-care medical device. iBE utilizes an array of dynamic capacitive pressure sensors to perform electronic palpation for breast abnormalities (Sensitivity = 84 %; Specificity = 94 %; PPV = 60 %; NPV = 98 %.)

Tool for cervical cancer screening : Visual inspection after acetic acid test using an indigenously designed, AI-enabled image capture device called SAKHI-Manipal (VIA-AI). SAKHI-Manipal has a sensitivity and specificity of 86.75% and 87.65% respectively. VIA will be reported by the healthcare workers and by the AI. When there is disagreement in reports, an expert will evaluate the respective images and will provide the final decision.  Additionally, a Pap smear also will be obtained.

BP measurement (using a digital BP apparatus), RBS estimation (using a glucometer), and HB estimation (finger prick method using a portable hemoglobinometer) will also be done as part of this screening activity

Written informed consent will be taken from all the participants of the study. Privacy, anonymity  and data confidentiality will be maintained throughout the study.

Screening will be in two settings:

Awareness sessions will be held for 30 minutes prior to screening.

1.            At community level, for the women who report for well women screening after the community mobilization.

2.            At KH Manipal for the women workforce and the spouses/ family members of men workforce, both belonging to below poverty line economic groups. The HR department of the hospital will help in mobilizing the women for awareness activity as well as screening.