Abstract
BackgroundWhile 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 FindingsA 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.ConclusionsWe 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.
Highlights
Broad adoption of effective Pap smear screening programs is credited with a substantial reduction in cervical cancer incidence in many countries, but it has not been possible to implement this strategy in the developing world, which bears 80% of the global burden of cervical cancer
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
In order to provide a bridge between well-controlled research studies and programmatic implementation, we addressed the following aims in women age 25 years and older in a population-based study in Medchal Mandal, a peri-urban rural community in the state of Andhra Pradesh, India: (1) evaluate the effectiveness of using visual inspection with acetic acid (VIA), PAP, and human papillomavirus (HPV) DNA testing to detect CIN2+ and (2) evaluate the implementation of cervical cancer screening within the local health care system
Summary
Broad adoption of effective Pap smear screening programs is credited with a substantial reduction in cervical cancer incidence in many countries, but it has not been possible to implement this strategy in the developing world, which bears 80% of the global burden of cervical cancer The reasons for this failure include a lack of infrastructure, requirement of specialized training, requirement of multiple visits by the woman for follow-up and treatment, the difficulties in implementing quality controls for the procedures, and lack of facilities to provide the needed treatment. Over the last decade, efforts to reduce the global cervical cancer burden through screening have focused on development and evaluation of alternative screening assays to the Pap smear Two such assays have been widely promoted: visual inspection of the cervix following acetic acid application (VIA) and molecular tests for the presence of high risk human papillomavirus (HR-HPV) infection [1,2]. 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
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