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Early detection of cervical cancer in hard-to-reach populations of women through portable and point-of-care HPV testing

Periodic Reporting for period 1 - ELEVATE (Early detection of cervical cancer in hard-to-reach populations of women through portable and point-of-care HPV testing)

Reporting period: 2019-01-01 to 2020-06-30

ELEVATE: EarLy dEtection of cerVical cAncer in hard-to-reach populations of women through portable and point-of-care HPV TEsting

Cervical cancer, caused by the sexually transmittable Human Papillomavirus (HPV), is the fourth most prevalent cancer among women worldwide, even though it is detectable and preventable in pre-malignant stages through screening and early treatment. However, cervical cancer screening is often a time consuming and stressful event that requires a gynaecological examination. As a result, it is not adapted to women who are hard to reach due to social, geographical or other contextual barriers. A more accessible test, based on self-sampling, could increase cervical cancer screening in low-income or isolated populations, but also among women in general who for a variety of reasons do not attend regular screenings.

The ELEVATE consortium aims at developing a user-friendly portable, point-of-care HPV self-testing device that yields rapid, easy-to-understand results, and does not require any electrical outlets or specialized health personnel. The test will detect and identify both the human papilloma virus and cancer biomarker proteins to obtain a more complete and specific view on the risk of developing cervical cancer, so that a clear follow-up path can immediately be defined.

The new HPV self-testing tool will be piloted among hard-to-reach populations in a variety of countries (Belgium, Brazil, Ecuador and Portugal): by using a community-based participatory approach the study will test the user acceptability and the cost-effectiveness of the new screening tool. Ultimately, all acquired knowledge allows for optimised screening initiatives that will enhance participation among hard-to-reach women, and will feed into further refinement of national health strategies for cancer prevention in Latin-America and Europe.
Work performed by the Public Health Team:
During the first 18 months of ELEVATE protocols were developed for the collection of cervical samples among hard-to-reach women. These samples will be used for HPV DNA sequencing as well as for the development of the genetic and proteomic screening tests. Collaborations with clinical partners were set up in Belgium, Brazil, Ecuador and Portugal and ethical approval was obtained. The team in Brazil faced delay in acquiring ethical approval and was then hampered, just like the other study sites, by the COVID19 pandemic. In addition, the collection of samples of high-grade lesions is especially challenging since their low prevalence. The ELEVATE team has therefore adapted inclusion criteria and is looking for alternative sample collections methods, such as collecting leftovers from routine care or through biobanks. Due to the delay, the development of the HPV DNA test, more particularly the primers, will now rely on DNA sequencing results from the NCBI database and will then be adapted to the HPV DNA sequencing results obtained from the samples collected.
A literature review to identify hard-to-reach women in Belgium, Brazil, Ecuador and Portugal was conducted. Overall, factors related with low participation in cervical cancer screening include low education, low income, poor health literacy and lack of knowledge about cervical cancer. In Belgium and Portugal, older age, being unemployed and having a migrant background are negatively associated with screening participation. Distance to healthcare facilities and living in remote areas were factors found for Brazil and Ecuador, while in Belgium and Ecuador’s literature reviews, fear of the test and its result, negative experiences in health services and lack of time were mentioned.
Based on these results, protocols were developed to conduct focus group discussions with hard-to-reach women, health practitioners and community workers/stakeholders. The implementation of these discussions was interrupted by the COVID19 crisis; the remaining discussions will take place once the safety of participants and moderators can be guaranteed.
Another literature search was conducted to identify studies on cost and cost-effectiveness of HPV self-sampling detection programs. The data obtained through this literature review will be analysed in the upcoming months.

Work performed by the screening device Development Team:
The screening device consists of two main parts: the combined proteomic and genomic cartridge and the reading device.
The cartridges consist of three main parts: the proteomic biosensor, the genomic biosensor and the microfluidic manifold. These parts are being developed separately by UGENT, URV and IMM/Microliquid. When completed they are going to be merged with each other and tested as a single cartridge. The partners are keeping a close contact to be sure that their technologies are compatible with other partners.
In this regard, the first steps towards finalizing the substrate and design are taken. The biosensor development is going forward at both laboratories, while experiments to find an efficient lysis protocol for both tests is also underway. Both partners are testing their preliminary biosensors with real samples to test the accuracy of their results. Additional studies to determine the protein levels have also started.
The design of the microfluidic design for the combined cartridge has also started. This is performed in parallel with the PoCOsteo project and the findings and deliverables in that project are going to be used to speed up the progress ELEVATE.
As for the Portable HPV screening tool development (hardware and software), it should be noted that the PoCOsteo and ELEVATE projects are running in parallel though the physical deliverables for ELEVATE are scheduled after those of PoCOsteo, and not in this ELEVATE period.
Work carried out on the PoCOsteo project, however, during the reporting period has been entirely relevant and contributary to the ELEVATE enabling the project to benefit from a very high level of technology re-use.
During this period the first significant prototype of the screening device was delivered by Labman to IMM. This device enables testing the mechanical and pneumatic interfaces to the microfluding cartridge and also enables IMM to validate the design of the cartridge which, is very close to that that will be used in ELEVATE. This prototype also included the first major software release that provides the essential control system. Testing of the device is in progress.
Prototype designs for a multi-channel potentionstat were also been developed and tested, paving the way for a final design that will be physically integrated into the screening device.
The ELEVATE project expects to empower women to be screened and envisions an alternative for current standard practice, an alternative in which mobile health units can measure the self-obtained samples at or close to women’s homes and are able to provide immediate and clear personal feedback on the risk of cervical cancer and which actions best to take.

The impact of the ELEVATE project is not limited to countries involved in the study, as development of a common methodology to reach hard-to-reach populations is targeted. The conclusions of the project could hence be a first step towards a worldwide strategy for screening diverse hard-to-reach populations. This would play an important role in reaching the critical point where screening helps decrease in a similar extent the worldwide incidence and mortality of cervical cancer.