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

Abstract

ObjectiveTo 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).DesignProspective cohort study.SettingPrimary and urban health centres in Belagavi, Hubballi and Vijayapur, India.PopulationWomen in the age‐group 30–49 years, premenopausal, with no prior hysterectomy and no known HIV infection were eligible for screening.MethodsVisual 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 measuresThe 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.ResultsA 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 more likely to be housewives and had higher household income than those without CIN 2/3.ConclusionDespite the COVID‐19 pandemic, over 9100 women were screened with VIA for precancerous lesions. However, only 17 (4.2%) were found to have biopsy‐proven high‐grade cervical lesions, underscoring the subjective performance of VIA as a screening method. Given that this is significantly lower than rates reported in the literature, it is possible that the prevalence of high‐grade lesions in this population was impacted by screening a younger and more rural population. This study demonstrates that screening is feasible in an organised fashion and can be scaled up rapidly. However, while inexpensive and allowing for same‐day treatment, VIA may be too subjective and have insufficient accuracy clearly to identify lesions requiring treatment, particularly in low‐prevalence and low‐risk populations, calling into question its overall cost‐effectiveness.

Improving maternal, neonatal and child health outcomes in low‐resource settings: Translating research evidence to practice – report from The Third International Conference on Maternal, Newborn and Child Health

“…An article in this supplement on screening and treatment for high‐grade cervical dysplasia, at first consideration, might seem like an outlier in this issue with the other articles mostly focusing on pregnancy outcome. However, the expansion of research topics covered by the JNMC Research Unit is an indication that the unit leadership wants to be involved in women's health research beyond pregnancy 24 …”

“…However, the expansion of research topics covered by the JNMC Research Unit is an indication that the unit leadership wants to be involved in women’s health research beyond pregnancy. 24 …”