HPV Screening for Cervical Cancer in Rural India
Abstract
BACKGROUND: In October 1999, we began to measure the effect of a single round of screening by testing for human papillomavirus (HPV), cytologic testing, or visual inspection of the cervix with acetic acid (VIA) on the incidence of cervical cancer and the associated rates of death in the Osmanabad district in India. METHODS: In this cluster-randomized trial, 52 clusters of villages, with a total of 131,746 healthy women between the ages of 30 and 59 years, were randomly assigned to four groups of 13 clusters each. The groups were randomly assigned to undergo screening by HPV testing (34,126 women), cytologic testing (32,058), or VIA (34,074) or to receive standard care (31,488, control group). Women who had positive results on screening underwent colposcopy and directed biopsies, and those with cervical precancerous lesions or cancer received appropriate treatment. RESULTS: In the HPV-testing group, cervical cancer was diagnosed in 127 subjects (of whom 39 had stage II or higher), as compared with 118 subjects (of whom 82 had advanced disease) in the control group (hazard ratio for the detection of advanced cancer in the HPV-testing group, 0.47; 95% confidence interval [CI], 0.32 to 0.69). There were 34 deaths from cancer in the HPV-testing group, as compared with 64 in the control group (hazard ratio, 0.52; 95% CI, 0.33 to 0.83). No significant reductions in the numbers of advanced cancers or deaths were observed in the cytologic-testing group or in the VIA group, as compared with the control group. Mild adverse events were reported in 0.1% of screened women. CONCLUSIONS: In a low-resource setting, a single round of HPV testing was associated with a significant reduction in the numbers of advanced cervical cancers and deaths from cervical cancer.
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The observed attrition is consistent with LMIC benchmarks where follow-up reaches a 50% plateau due to socio-logistical factors.
“This attrition is consistent with LMIC benchmarks where follow-up reaches a 50% plateau due to socio-logistical factors.9”
These results reinforce the findings of anchor trials (Sankaranarayanan et al) that established the superior sensitivity of HPV molecular testing over VIA or cytology.
“These results reinforce the findings of anchor trials (Sankaranarayanan et al) that established the superior sensitivity of HPV molecular testing over VIA or cytology.9,10,22”
Testing for HPV is a simple, low-cost technology that reduces cervical cancer incidence and related mortality when directly coupled with outpatient cryotherapy treatment for women testing HPV positive.
“Testing for HPV is a simple, low-cost technology that has been shown to reduce the cervical cancer incidence and related mortality when directly coupled with outpatient cryotherapy treatment for women testing HPV positive [2, 9, 10].”
In a cluster randomized trial in India, a single round of hrHPV testing was associated with a significant reduction in advanced cervical cancers and deaths due to cervical cancer.
“In a cluster randomized trial in India, a single round of hrHPV testing was associated with a significant reduction in the number of advanced cervical cancers and deaths due to cervical cancer [4].”
From A community‐based, cross‐sectional study of hr<scp>HPV DNA</scp> self‐sampling‐based cervical cancer screening in rural Karnataka, India (2019) · cites this paper as [4]
Assuming HPV prevalence among the women to be 7%-10% and concordance rate of 80%, at 95% confidence interval and power of 80%, around 1600 women were needed to undergo HPV testing by both methods.
“Sample size: Assuming HPV prevalence among the women to be 7%–10% based on the published reports, 19 , 20 and concordance rate of 80%, at 95% confidence interval (CI) and power of 80%, between samples collected by HCW and self‐collected samples, around 1600 women were needed to undergo HPV testing by both the methods.”
The only RCT on cervical cancer screening from India compared provider collected HPV-based screening to cytology and VIA-based screening, demonstrating the greater effectiveness of a single round of HPV screening in reducing mortality.
“The only RCT on cervical cancer screening from India compared provider collected HPV-based screening to cytology and VIA-based screening, demonstrating the greater effectiveness of a single round of HPV screening in reducing mortality.54”
Population-based cervical cancer screening is effective, as shown by sharp declines in age-standardised cervical cancer incidence in high-income countries following implementation of cytology-based screening.
“The effectiveness of population-based cervical cancer screening has also been shown, through the sharp declines in age-standardised cervical cancer incidence in high-income countries following the implementation of cytology-based screening.12, 13”
HPV-based tests are highly effective at detecting precancerous lesions.
“Randomised controlled trials have shown that HPV-based tests are highly effective at detecting precancerous lesions”
HPV-based tests are likely more effective at preventing cervical cancer than visual inspection with acetic acid or cytology.
“and are likely to be more effective at preventing cervical cancer than visual inspection with acetic acid or cytology.14, 15, 16”
HPV testing has practical advantages such as limited training requirements and the potential for self-sampling that ease the burden on healthcare resources, making it suitable for resource-limited settings.
“Furthermore, practical advantages such as limited training requirements and the potential for self-sampling ease the burden on healthcare resources, making it suitable for resource-limited settings [22, 24–26].”
From HPV Screening in Women Living with HIV (WLHIV) in Karnataka, India: Can it be Integrated into ART Centres? (2025) · cites this paper as [22]
HPV testing demonstrates superior sensitivity in detecting high-grade cervical lesions among WLHIV.
“HPV testing demonstrates superior sensitivity in detecting high-grade cervical lesions among women living with HIV (WLHIV).”
From HPV Screening in Women Living with HIV (WLHIV) in Karnataka, India: Can it be Integrated into ART Centres? (2025) · cites this paper as [22]
The increased sensitivity of HPV testing for cervical precancerous lesions is due to earlier detection rather than overdiagnosis.
“The increased sensitivity of HPV testing for cervical precancerous lesions has been shown to be due to earlier detection rather than overdiagnosis [22–25].”
From HPV Screening in Women Living with HIV (WLHIV) in Karnataka, India: Can it be Integrated into ART Centres? (2025) · cites this paper as [22]
HPV testing has high sensitivity for detecting precancerous lesions in WLHIV and inherent advantages of objectivity and reproducibility compared to visual inspection methods like VIA or subjective assessments like cytology.
“The rationale for this choice lies in HPV testing’s high sensitivity for detecting precancerous lesions in WLHIV and its inherent advantages of objectivity and reproducibility compared to visual inspection methods like VIA or subjective assessments like cytology [19–23].”
From HPV Screening in Women Living with HIV (WLHIV) in Karnataka, India: Can it be Integrated into ART Centres? (2025) · cites this paper as [22]
Pap smear missed a substantial proportion of HSIL+ lesions.
“Although Pap smear showed the highest specificity (94.5%), it missed a substantial proportion of HSIL+ lesions, emphasizing the clinical advantage of HPV testing in this population [21, 22, 24, 25, 27].”
From HPV Screening in Women Living with HIV (WLHIV) in Karnataka, India: Can it be Integrated into ART Centres? (2025) · cites this paper as [22]
Pap smear showed the highest specificity (94.5%) in that cohort.
“Although Pap smear showed the highest specificity (94.5%), it missed a substantial proportion of HSIL+ lesions, emphasizing the clinical advantage of HPV testing in this population [21, 22, 24, 25, 27].”
From HPV Screening in Women Living with HIV (WLHIV) in Karnataka, India: Can it be Integrated into ART Centres? (2025) · cites this paper as [22]
In a cohort of 1128 WLHIV, HPV testing achieved a sensitivity of 94.5% for detecting LSIL or worse, outperforming VIA (83.6%) and Pap smear (63.3%).
“In a cohort of 1128 WLHIV, HPV testing achieved a sensitivity of 94.5% for detecting LSIL or worse, outperforming VIA (83.6%) and Pap smear (63.3%).”
From HPV Screening in Women Living with HIV (WLHIV) in Karnataka, India: Can it be Integrated into ART Centres? (2025) · cites this paper as [22]
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Cervical Cancer Elimination in India: Progress, Gaps, and the Priorities
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- Authors
- Sankaranarayanan, R., Nene, B. M., Shastri, S. S., Jayant, K., Muwonge, R., Budukh, A. M., Hingmire, S., Malvi, S. G., Thorat, R., Kothari, A., Chinoy, R., Kelkar, R., Kane, S., Desai, S., Keskar, V. R., Rajeshwarkar, R., Panse, N., & Dinshaw, K. A.
- Affiliations
- Centre international de recherche sur le cancer (FR)
- Tata Memorial Hospital (IN)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2009-04-02
- Volume
- 360
- Issue
- 14
- Pages
- 1385-1394
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2130297731
- Semantic Scholar
- 3e5052b06aa9da6cf1ea906bc5af916b62041af4
- Cited by
- 1,278
- References
- 15
- Citations by year
- 2026: 38 · 2025: 56 · 2024: 48 · 2023: 53 · 2022: 46 · 2021: 67 · 2020: 61 · 2019: 68 · 2018: 64 · 2017: 76 · 2016: 66 · 2015: 93 · 2014: 80 · 2013: 93 · 2012: 113
- FWCI
- 75.43
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Women's cancer prevention and management
- Health Sciences › Medicine › Oncology › Global Cancer Incidence and Screening
- Keywords
- cervical cancer screening, HPV testing, visual inspection with acetic acid, cervical cancer incidence, cervical cancer mortality, cervical precancerous lesions, rural women, resource-limited settings, Osmanabad district
- MeSH terms
- Adult, Biopsy, Uterine Cervical Dysplasia, Uterine Cervical Neoplasms, Colposcopy, Cytological Techniques, Female, Humans, India, Mass Screening, Middle Aged, Predictive Value of Tests, Incidence, Acetic Acid, Papillomaviridae, Papillomavirus Infections
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