Sripriya Rao, Mayank Chhabra, Jagadish Kudkuli, Milan Toraskar, Aswathy G Nath, Devu Prakash, Shweta Srivastava, Wahengbam Imo Singh, Malini Chandrasekharan, Kunal Oswal, Jaganjeet Randhawa, Venkataramanan Ramachandran
Opportunistic hrHPV screening integrated with decentralized "see-and-treat" is a clinically robust strategy for LMICs. Significant regional heterogeneity requires tailored, state-specific policies and digital linkage-to-care frameworks to overcome compliance barriers and meet WHO 2030 cervical cancer elimination goals.
BACKGROUND: India lacks an organized national cervical cancer screening program, and while the World Health Organization (WHO) recommends human papillomavirus (HPV) deoxyribonucleic acid (DNA) testing as the primary modality, large-scale evidence on implementation via decentralized treatment pathways in India is limited. We evaluated the effectiveness of opportunistic high-risk HPV (hrHPV) DNA screening, assessing prevalence, genotype distribution, self-testing acceptance, and the diagnostic performance of a community-based "see-and-treat" approach.
OBJECTIVE: To evaluate the prevalence and genotype distribution of hrHPV and assess the diagnostic accuracy, treatment compliance, and clinical viability of a decentralized "see-and-treat" approach within a large-scale opportunistic screening program across 20 Indian states.
STUDY DESIGN: In this retrospective cross-sectional study (January 2022-December 2025), 62,868 women aged 25 to 65 years were enrolled across 20 Indian states via community outreach (75.1%) and hospital-based network (24.9%). Screening utilized clinician-collected or self-collected (10.5%) samples tested via the Cobas 6800 system. hrHPV-positive women were triaged by colposcopy and managed through a decentralized "see-and-treat" approach using thermal ablation (TA) or Large Loop Excision of the Transformation Zone (LLETZ). Primary outcomes included HPV prevalence, diagnostic accuracy (AUC), and treatment compliance.
RESULTS: Overall HPV prevalence was 8.5% (5,354/62,868), with significant regional variation (11.3% in Delhi NCR to 4.7% in Kerala). Non-16/18 high-risk genotypes accounted for 54.6% of infections. Positivity peaked at ages 26 to 30 years (10.1%) and had a minor peak at 51 to 55 years (8.4%). The see-and-treat modality demonstrated high diagnostic accuracy (AUC 0.95; sensitivity 0.98; specificity 0.91) with a program efficacy of 81.2% with 16.3% overtreatment and 21.1% undertreatment. Treatment compliance in the community sub-cohort was 51.3% (1,957/3,813). We identified five women with invasive cancers and 7.8% CIN III (28/357), 9.0% CIN II (32/357), and 26.3% CIN I (94/357) of the histopathology sub-group.
CONCLUSION: Opportunistic hrHPV screening integrated with decentralized "see-and-treat" is a clinically robust strategy for LMICs. Significant regional heterogeneity requires tailored, state-specific policies and digital linkage-to-care frameworks to overcome compliance barriers and meet WHO 2030 cervical cancer elimination goals.