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

Gravitt PE, Paul P, Katki HA, Vendantham H, Ramakrishna G, Sudula M, Kalpana B, Ronnett BM, Vijayaraghavan K, Shah KV, CATCH Study Te - PLoS ONE (2010)

Bottom Line: 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.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.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America. pgravitt@jhsph.edu

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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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.
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pone-0013711-g001: 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.

Mentions: The degree of participation in the study and compliance with screening and diagnostic follow-up is summarized in Figure 1, stratified by immediate colposcopy arm and by overall screening test results. A total of 5603 women were determined to be eligible for screening and were invited to participate by at least one person-to-person contact. Of these, 2331 (41.6%) enrolled and completed the screening protocol; the remainder refused participation. As targeted in the study protocol, approximately 20% of consenting women were randomized to receive an immediate colposcopic examination following their screening tests at the enrollment visit (455/2331, immediate colposcopy arm). In addition, 582 women not randomized to immediate colposcopy but testing positive by any one or more of the three screening tests were referred back for a colposcopic examination at a second visit. Disease ascertainment was incomplete in both arms. In the randomized arm, a total of 114 women (25%) had a colposcopic abnormality where a biopsy was indicated; of these women, 61 (53.5%) refused biopsy. In the referred arm, 582 of the 1876 women (31%) were screen-positive and were referred for colposcopy; of these, 256 women (44.0%) did not return for the colposcopic follow-up. Among those who did come for the follow-up visit, 165 (50.6%) had a colposcopic abnormality indicating biopsy, with 45 (27.3%) refusing biopsy (significantly lower than biopsy refusal among women with immediate colposcopy (53.4%, p<0.001).


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

Gravitt PE, Paul P, Katki HA, Vendantham H, Ramakrishna G, Sudula M, Kalpana B, Ronnett BM, Vijayaraghavan K, Shah KV, CATCH Study Te - PLoS ONE (2010)

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.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2965656&req=5

pone-0013711-g001: 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.
Mentions: The degree of participation in the study and compliance with screening and diagnostic follow-up is summarized in Figure 1, stratified by immediate colposcopy arm and by overall screening test results. A total of 5603 women were determined to be eligible for screening and were invited to participate by at least one person-to-person contact. Of these, 2331 (41.6%) enrolled and completed the screening protocol; the remainder refused participation. As targeted in the study protocol, approximately 20% of consenting women were randomized to receive an immediate colposcopic examination following their screening tests at the enrollment visit (455/2331, immediate colposcopy arm). In addition, 582 women not randomized to immediate colposcopy but testing positive by any one or more of the three screening tests were referred back for a colposcopic examination at a second visit. Disease ascertainment was incomplete in both arms. In the randomized arm, a total of 114 women (25%) had a colposcopic abnormality where a biopsy was indicated; of these women, 61 (53.5%) refused biopsy. In the referred arm, 582 of the 1876 women (31%) were screen-positive and were referred for colposcopy; of these, 256 women (44.0%) did not return for the colposcopic follow-up. Among those who did come for the follow-up visit, 165 (50.6%) had a colposcopic abnormality indicating biopsy, with 45 (27.3%) refusing biopsy (significantly lower than biopsy refusal among women with immediate colposcopy (53.4%, p<0.001).

Bottom Line: 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.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.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America. pgravitt@jhsph.edu

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.

Show MeSH
Related in: MedlinePlus