Validation of a Lab-free Low-cost Screening Test for Prevention of Cervical Cancer

BACKGROUND:

Cervical cancer, caused by persistent infection of carcinogenic types of the human papillomavirus (HPV), is the second leading cause of female cancer in El Salvador. Effective screening and treatment of precancerous lesions have lowered cervical cancer rates in high-income countries, but the disease remains a leading cause of death in low-and middle-income countries (LMICs). Currently, up to 80% of the disease burden and 90% of global deaths occur in LMICs primarily due to lack of resources and poor infrastructure. A new test, Automated Visual Evaluation (AVE), is a point-of-care screening and triage diagnostic tool based on the assessment of digital images through artificial intelligence.

The purpose of this study is to validate Automated Visual Evaluation (AVE), specifically the CINFinder version developed by DL Analytics, a point-of-care screening and triage diagnostic tool based on the assessment of digital images through artificial intelligence. AVE has been in development since 2021. The current study will consist of a clinical trial to compare the sensitivity of AVE (CINFinder version) with traditional screening and triage tests.

STUDY DESIGN:

This is a prospective paired interventional study of 10,000 women in San Salvador, El Salvador, to test the difference in sensitivities between AVE (CINFinder) and with other screening and triage tests, including HPV tests and unaided visual inspection with acetic acid (VIA) to detect CIN2+ as a primary screening method. As a secondary aim, investigators will also validate the use of AVE as a triage test in patients with positive HPV results. Histopathology diagnosis will be used as the reference to determine true disease status.

STUDY PROCEDURES:

The design includes a screening visit, a colposcopy visit, and a result delivery and treatment visit. During the screening visit, participants will undergo routine HPV sample collection, VIA, AVE with the EVA System (digital colposcope), and an additional cervical image capture with an Android smartphone. Women with a positive screening result on any of the three main screening tests (HPV test, VIA, or AVE with the EVA System) will be referred to a second study visit to undergo HPV testing with a genotyping test, AVE with the EVA System for the second time, and colposcopy with biopsy. In addition, 5% of screen-negative women will undergo the same procedures. Results from VIA and AVE with the EVA System during the first and the second visit will be compared to determine AVE performance as a screening and triage test, respectively. Histopathology findings will serve as the reference to establish the true diagnosis of each case. Women will receive their histopathology results during the third visit and, if eligible, will be offered ablation treatment the same day. Women ineligible for ablation will be referred to LEEP or other care as appropriate.