The HPV-Automated Visual Evaluation (PAVE) Consortium is validating a cervical screening strategy enabling accurate cervical screening in resource-limited settings. A rapid, low-cost HPV assay permits sensitive HPV testing of self-collected vaginal specimens; HPV-negative women are reassured. Triage of positives combines HPV genotyping (four groups in order of cancer risk) and visual inspection assisted by automated cervical visual evaluation (AVE) that classifies cervical appearance as severe, indeterminate, or normal. Together, the combination predicts which women have precancer, permitting targeted management to those most needing treatment.

We analyzed CIN3+ yield for each PAVE risk level (HPV genotype crossed by AVE classification) from nine clinical sites (Brazil, Cambodia, Dominican Republic, El Salvador, Eswatini, Honduras, Malawi, Nigeria, and Tanzania). Data from 1832 HPV-positive participants confirmed that HPV genotype and AVE classification each strongly and independently predict risk of histologic CIN3+. The combination of these low-cost tests provided excellent risk stratification, warranting pre-implementation demonstration projects.

INTRODUCTION

MSF is providing cervical cancer screening in Blantyre and Chiradzulu districts in Southern Malawi in the catchment area of 10 health centres. Improved screening strategies under diverse recruitment models are introduced to increase HPV screening coverage at health centres and with outreach activities.

METHODS

Under PAVE study, self-collected vaginal swabs are tested by an isothermal amplification PCR assay followed byvisual inspection, imaging, and histological assessment for HPV +ve women. Women living <5km from health centers are recruited opportunistically during routine visits. After HPV test, they are advised either to wait onsite (test-and-wait model) or called back in two days’ time (test-and-call model) for triage and treatment visit.Women living>10km from health centers are offered HPV test, triage, and treatment in community settings by outreach teams (mobile-clinic model). A fourth model for women living 5-10km from a health center with HPV testing in their communities followed by a triage and treatment visit at respective health centers (mobile-lab model) is not yet implemented.

RESULTS

As of April 2024, over 2000 women have undergone HPV screening across all active sites. Key insights from the experience are focused at: i)streamlining patient flow during opportunistic recruitment at health centers,ii)improving HPV results communication, iii)effectively tracing women back for triage and treatment visits using phone and community based tracing, iv)ensuring provision of stable internet for effective and real time data collection and synchronization, v)reducing gaps in logistics and quality assurances at HPV lab particularly in mobile lab setup, vi)ensuring real-time quality histopathology review of cervical biopsies for case management,and vii)continuous monitoring of patients and data flow to ensure quality of screening, compliance, and effective case management.

CONCLUSIONS

Diverse HPV-based screening strategies are key to achieve good screening coverage, and subsequently reducethe cervical cancer morbidity and mortality in southern Malawi.