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. 2010 Oct 28;5(10):e13711.
doi: 10.1371/journal.pone.0013711.

Effectiveness of VIA, Pap, and HPV DNA testing in a cervical cancer screening program in a peri-urban community in Andhra Pradesh, India

Patti E Gravitt  1 , Proma Paul, Hormuzd A Katki, Haripriya Vendantham, Gayatri Ramakrishna, Mrudula Sudula, Basany Kalpana, Brigitte M Ronnett, K Vijayaraghavan, Keerti V Shah; CATCH Study Team
Collaborators, Affiliations

Effectiveness of VIA, Pap, and HPV DNA testing in a cervical cancer screening program in a peri-urban community in Andhra Pradesh, India

Patti E Gravitt et al. PLoS One. .

Abstract

Background: While many studies have compared the efficacy of Pap cytology, visual inspection with acetic acid (VIA) and human papillomavirus (HPV) DNA assays for the detection cervical intraepithelial neoplasia and cancer, few have evaluated the program effectiveness.

Methods and findings: A population-based sample of 5603 women from Medchal Mandal in Andhra Pradesh, India were invited to participate in a study comparing Pap cytology, VIA, and HPV DNA screening for the detection of CIN3+. Participation in primary screening and all subsequent follow-up visits was rigorously tracked. A 20% random sample of all women screened, in addition to all women with a positive screening test result underwent colposcopy with directed biopsy for final diagnosis. Sensitivity, specificity, positive and negative predictive values were adjusted for verification bias. HPV testing had a higher sensitivity (100%) and specificity (90.6%) compared to Pap cytology (sensitivity = 78.2%; specificity = 86.0%) and VIA (sensitivity = 31.6%; specificity = 87.5%). Since 58% of the sample refused involvement and another 28% refused colposcopy or biopsy, we estimated that potentially 87.6% of the total underlying cases of CIN3 and cancer may have been missed due to program failures.

Conclusions: We conclude that despite our use of available resources, infrastructure, and guidelines for cervical cancer screening implementation in resource limited areas, community participation and non-compliance remain the major obstacles to successful reduction in cervical cancer mortality in this Indian population. HPV DNA testing was both more sensitive and specific than Pap cytology and VIA. The use of a less invasive and more user-friendly primary screening strategy (such as self-collected swabs for HPV DNA testing) may be required to achieve the coverage necessary for effective reduction in cervical cancer mortality.

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Conflict of interest statement

Competing Interests: PE Gravitt has received research funding from Roche Molecular Systems and serves on the Scientific Advisory Board of Qiagen Corp. Both companies manufacture HPV DNA diagnostic tests. This does not alter the authors' adherence to all the PLoS ONE policies on sharing data and materials.

Figures

Figure 1
Figure 1. Participation in screening and follow-up (colposcopy and biopsy where recommended) by randomization arm and screening result.
Screen positive indicates positive result on VIA, Pap, and/or HPV DNA testing. Colposcopy normal indicates no area of abnormality identified, no biopsy recommended. Colposcopy abnormal-biopsy taken indicates that a biopsy was successfully obtained from all visually identified areas of abnormality. Colposcopically abnormal-biopsy refused indicates that a lesion was visualized and biopsy recommended, but the patient refused.
Figure 2
Figure 2. Estimated proportion of cases of CIN2+ observed and estimated via population weighting for verification bias adjustment.
Screen detected indicates proportion of cases of CIN2+ detected by hc2, and screen undetected indicates the proportion of CIN2+ cases detected through the screening program, but missed by hc2. Refused biopsy indicates the proportion of CIN2+ cases estimated among those who refused biopsy, refused colposcopy indicates the proportion of CIN2+ cases estimated among those who screened positive, but refused colposcopic exam, and refused involvement indicates the proportion of CIN2+ cases estimated among those who refused participation in the program (i.e., not screened).
See this image and copyright information in PMC

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