The CryoPop study: Screening for high‐grade cervical dysplasia in Karnataka, India

Objective To describe our experience of screening with visual inspection with acetic acid (VIA) and colposcopy to identify women with high‐grade precancerous cervical lesions who were candidates for cryotherapy. Women were screened to determine eligibility for a clinical trial testing the safety and efficacy of a new, simple and inexpensive cryotherapy device (CryoPop®) targeted for use in low and middle‐income countries (LMICs). Design Prospective cohort study. Setting Primary and urban health centres in Belagavi, Hubballi and Vijayapur, India. Population Women in the age‐group 30–49 years, premenopausal, with no prior hysterectomy and no known HIV infection were eligible for screening. Methods Visual inspection with acetic acid was performed on eligible women following informed consent. VIA‐positive women were referred for colposcopy and biopsy. Biopsies were read by two pathologists independently, with a third pathologist acting as tie‐breaker if needed. Main outcome measures The primary outcome measures were the number/proportion of women screening positive by VIA and the number/proportion of those women screening VIA‐positive found to have high‐grade cervical lesions on biopsy (cervical intraepithelial neoplasia 2/3 [CIN 2/3]). Demographic variables were compared between women who screened VIA‐positive and those who screened VIA‐negative; a separate comparison of demographic and limited reproductive variables was performed between women who had CIN 2/3 on biopsy and those without CIN 2/3 on biopsy. Chi‐square or Fisher's exact tests for categorical data and t‐tests or analysis of variance for numeric data were used with all tests two‐sided and performed at an alpha 0.05 level of statistical significance. Results A total of 9130 women were screened with VIA between 4 July 2020 and 31 March 2021. The mean age of all women screened was 37 years (standard deviation = 5.6 years) with 6073 of the women (66.5%) in the 30–39 year range. Only 1% of women reported prior cervical cancer screening. A total of 501 women (5.5%) were VIA‐positive; of these, 401 women underwent colposcopy. Of those who had colposcopy, 17 (4.2%) had high‐grade lesions on biopsy, an additional 164 (40.9%) had low‐grade cervical lesions on biopsy or endocervical curettage and one woman (0.2%) was found to have invasive cancer. VIA‐positive women were younger and had higher levels of education and income; however, women who were VIA‐positive and found to have CIN 2/3 were older, were mor