(114) HPV-AUTOMATED VISUAL EVALUATION (PAVE) STUDY: VALIDATING A NOVEL CERVICAL SCREENING STRATEGY. PRELIMINARY RESULTS OF PHASE 1 FROM CAMBODIA

Abstract

Abstract Introduction The HPV-Automated Visual Evaluation (PAVE) Study is an international, multi-centric study designed to evaluate a novel cervical screen-triage-treat strategy for resource-limited settings as part of a global strategy to reduce cervical cancer burden as part of the National Cancer Institute’s Cancer Cures Moonshot Initiative. The PAVE strategy involves: 1) screening with self-sampled HPV testing; 2) triage of HPV-positive participants with a combination of extended genotyping and visual evaluation of the cervix assisted by deep-learning-based automated visual evaluation (AVE); and 3) treatment with thermal ablation or excision (LLETZ). The PAVE study has two phases: efficacy (2023-2024) and effectiveness (planned to begin in 2024-2025). The efficacy phase aims to refine and validate the screen-triage portion of the protocol. The effectiveness phase will examine implementation of the PAVE strategy into clinical practice, cost-effectiveness, and health communication. The study will enroll a total 100,000 women in 9 different countries. Objective The Cambodia section of the study will enroll a total of 10,000 women 25 to 49 years of age. Two different cohorts are being studied: lower-risk women who are employed (and screened) at garment factories, and higher-risk women living with HIV (WLWH) who are enrolled in the Cambodian National Centre for HIV/AIDS Dermatology and STDS (NCHADS) clinics. Very few women in either cohort have ever been screened for cervical cancer. Methods After an initial educational campaign including videos and written literature, eligible women were consented and performed HPV self-sampling. HPV testing was performed with the modified AmpFire HPV isothermal testing system (Atila Biosystems, California) which provides genotyping information in following groups: 16, 18/45, 31/33/35/52/58, 39/59/68/51/56/59. All women were informed of the HPV status via SMS. All HPV positive women had digital colposcopy with 5% acetic acid using an IRIS digital colposcope (Liger, Utah) and digital images were obtained. All women hrHPV+ had ectocervical and/or endocervical biopsies with SoftBiopsy or SoftECC brush (Histologics, California). Women with CIN2+ lesions then had LEEP. Results As of October 31st, 2023, 2097 Garment workers and 530 WLWH have been enrolled. From 259 of 2097 garment workers were hrHPV+ (12.4%). 10 of the 259 (3.9%) had biopsy confirmed CIN2+ lesions. Only 9 (3.4%) of the garment workers were lost to follow up after testing positive for hrHPV. 128 of 530 WLWH were hrHPV+ (24.15%), 101 of these 128 women presented for visual evaluation of their Cervices and 21 had a CIN2+ lesions and 11 had invasive cancer. Currently, 27 of the hrHPV+ WLWH have been lost-to-follow-up, though efforts continue to reach these women. Conclusions Women in low resource settings often have great socioeconomic barriers to cervical cancer screening. Screening and treating in garment factories appears to be a very successful strategy as high numbers of women can be screened in a short period of time. Additionally, there has been very minimal loss-to-follow-up even though HPV testing was performed up to one month prior to the visual inspection of hrHPV+ women. Screening WLWH, however, is a greater challenge as they often have to travel greater distances to get screened and frequently face greater economic burdens. Strategies such as arranging and paying for all transportation and compensation for lost wages will be used in the future to limit loss-to-follow-up. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Dare Bioscience.