Horizon 2020 EarLy dEtection of cerVical cAncer in hard-to-reach populations: development and implementation of a new HPV test combining self-sampling with a low-cost, portable and point-of-care device (ELEVATE) Sónia Dias, Ana Gama, Ines Keygnaert, Katrina Perehudoff, Heleen Vermandere, Olivier Degomme This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant No 825747

Cervical cancer screening coverage Cervical cancer is the fourth most common cancer in women in the world. Human Papillomavirus (HPV) is the main cause > 150 HPV types (high-risk types, low-risk types) Early detection through cancer screening can improve survival. Cervical cancer screening coverage Brazil: 71% Portugal: 71% Belgium: 62% Ecuador: 9% Screening rates tend to be much lower among women in rural areas, from low socio-economic backgrounds or from ethnic minorities

Challenges for cervical cancer screening Cervical cytology continues to be the primary screening method (sampling cells from the cervix by a specialized gynecologist and evaluating the presence of potential cell abnormalities related to cervical cancer under a microscope) - low sensitivity. HPV DNA testing has been endorsed as an effective and low-cost primary screening method (higher sensitivity), however: Current HPV DNA tests can only discriminate between some high-risk HPV infections and cannot determine HPV infection with multiple HPV genotypes; Current cervical cancer screening tools are not available, acceptable, and/or cost-effective for hard-to-reach women, resulting in under-screening.

Objectives To identify hard-to-reach women and define a strategy to increase their participation in Belgium, Brazil, Ecuador, Portugal Target population To improve detection of infections by designing a HPV genotyping test with detection of 2 protein cervical cancer biomarkers Test design To develop a portable genomic/proteomic testing device using the now test for detection at point-of-care in low-resource settings Device development To determine the user-acceptability and cost-effectiveness of the new screening intervention in Belgium, Brazil, Ecuador, Portugal Societal impact

How to reach hard-to-reach women

Identify hard-to-reach populations Goal - To identify hard-to-reach women for cervical cancer screening in the study countries. Methodology - Triangulation of sources: Academic literature, government and NGO reports (grey literature), policy documents – accessed through systematic online search; Anonymised patient registries and/or insurance databases that permit the characterisation of under- or never-screened women. Focus group discussions Goal – To understand barriers and facilitators of hard-to-reach women’s participation in conventional cervical screening and to explore alternative strategies to enhance their participation, including self-sampling. Methodology – 12 focus groups (3 FG in each study country): 8 FG with women from hard-to-reach populations 4 FGs with screening/health professionals

Design strategies to pilot the HPV detection device in hard-to-reach populations Goal – To develop country-specific strategies to inform the study design of the pilot intervention Methodology Target group: women from socially vulnerable hard-to-reach populations. The strategy will include: approaches to build rapport with the target women (based on partners’ experience and expertise of working with these populations) Design of the screening intervention to test the HPV detection device in an acceptable manner for the target women

HPV genetic variability analysis

Collect cervical specimens Goal – To collect cervical specimens in the study countries for HPV sequencing and test validation Methodology – collection of 250 samples among women > 30 years old who have not been screened during the last 5 years and belong to an identified subgroup of hard-to-reach women 150 samples with high prevalence of high risk HPV 50 samples with low prevalence of high risk HPV 50 samples - normal cytology

Design of HPV detection test Proteomic and genomic HPV screening sensor development Microfluidic cartridge and screening tools development

Pilot the HPV testing intervention in hard-to-reach communities

Piloting the new testing device Goal – to estimate user take-up of new screening strategy and assess the user take-up and acceptability of a HPV self-sampling and testing Methodology Recruiting and training community based researchers 3-arm prospective intervention study: Group 1 (control): local coverage of screening Group 2: 125 women receive info about cervix cancer and are referred to local clinics for screening Group 3: 125 women receive information about cervix cancer and are offered on-site HPV testing and results Interviews with participants of Group 3 to understand the users’ perspective and satisfaction Interviews with health care providers about their beliefs and attitudes towards the self-screening device

Economic analysis of the intervention

Horizon 2020 EarLy dEtection of cerVical cAncer in hard-to-reach populations: development and implementation of a new HPV test combining self-sampling with a low-cost, portable and point-of-care device (ELEVATE) THANK YOU sonia.dias@ensp.unl.pt ana.gama@ensp.unl.pt This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant No 825747