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.

INTRODUCTION

Since November 2019, Medecins Sans Frontieres (MSF) and the Malawian Ministry of Health have provided a comprehensive range of cervical cancer care services. Initially, all consultations, pathological diagnoses, chemotherapy, surgery, and patient support activities were centralized at the tertiary hospital. To address the overwhelming surge in demand for these services, an innovative decentralisation approach was introduced to alleviate the workload and enhance patient care quality.

METHODS

The decentralization strategy involves triaging patients at the district level and categorizing them by type of lesion (Fig 1). Patients with early or locally advanced cancer, as well as those in need of palliative chemotherapy, are referred to the tertiary hospital for further evaluation and treatment. Those with premalignant lesions or advanced cancer are treated at the district level by trained surgical and palliative care teams. Quality is ensured through provision of medications, equipment and allowances, as well as monthly mentoring sessions for about 120 providers.

RESULTS

During the first months of comprehensive care provision, the number of palliative consultations at the tertiary hospital increased way above the threshold of 150 manageable consultations. Using the new decentralized system from August 2021, 818 palliative patients were referred to 45 palliative sites at district level, leading to a reduction in monthly consultations at central level from a high of 226 (2021) to a high of only 134 (2023) (Fig 2). Among the new patients presenting at the tertiary hospital, an average of 45% presented with benign or pre-malignant lesions. Therefore, from July 2023, 561 women started to be biopsied and managed at their district hospitals instead of the tertiary level.

CONCLUSIONS

It is feasible to provide a comprehensive package of cervical cancer care in low resource settings without overburdening services when a decentralization strategy is used to ensure manageable workload and high quality of care.