Skip to main content
European Commission logo print header

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

Periodic Reporting for period 2 - ELEVATE (Early detection of cervical cancer in hard-to-reach populations of women through portable and point-of-care HPV testing)

Periodo di rendicontazione: 2020-07-01 al 2021-12-31

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 this period, in total 24 focus group discussions (FGDs) were performed in Belgium, Portugal, Ecuador and Brazil to understand the barriers and facilitators faced by hard-to-reach women to attend cervical cancer screening (CCS) and explore alternative strategies to reach these populations. All countries managed to conduct FGDs with healthcare providers and community workers. However, the COVID 19 pandemic hampered the implementation of FGDs with hard-to-reach women in Belgium and Brazil.
Multiple barriers to cervical cancer screening were identified in the 4 countries. A low awareness about CCS and having other priorities were (indirectly) reported by all countries. Some barriers were more specific for the context of the respective country. In Belgium, a lack of focus on prevention is the most commonly reported barrier. In Ecuador, an important additional barrier was embarrassment, especially if screening was performed by a male doctor. On the healthcare system level, difficulty in accessing health services and delay in care were identified. In Brazil, factors related to a low income, shame and a healthcare system that is difficult to access for screening, were most commonly reported next to the lack of information which is a general finding in all countries. In Portugal, where the focus groups were focused on (participants working with) migrant women, barriers also included lack of information and low health literacy, next to uneasiness with the cervical cancer screening test, and family dynamics, legal issues regarding migration status and a poor relationship between women and the healthcare providers. The anticipated acceptability of self-sampling is generally high in the four countries.

Subsequently, based on the results from the literature review (PTR1) and the FGDs, country-specific strategies to reach hard-to-reach women in the pilot study were prepared. There were several discussions with partners to explore approaches to reach hard-to-reach women and recruit them to the pilot study, and potential options to ensure that the country-specific strategies designed would not only be tailored and adapted to the local contexts and acceptable to the study populations, but also compatible with the newly developed device. In the coming months, the protocols for the interventions will be finalized.

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.
Regarding the cartridges, they consist of three parts: the proteomic and the genomic biosensor and the microfluidic manifold. When completed they are going to be merged with each other on a single cartridge.
In this regard, the first steps towards finalizing the substrate and design are taken. The biosensor development is going forward at both laboratories, while the establishment of a protocol for lysis to enable the co-extraction for simultaneous proteomic and genomic detection of targets has been successful. Both partners are testing their preliminary biosensors with real samples to determine the accuracy of their results. Primers for the genomic sensor and the detection of various HPV genes have been validated. For the proteomic sensor concentrations of the crosslinker, antibodies and blocking solutions have been optimized and a LOD down to 50 pg/µL for the detection of one biomarker has been reached. The optimization of the detection of the other is still ongoing as well as the tests on real samples using the in-house ELISA kit to determine the reference range for the proteins. The design of the microfluidic design for the combined cartridge is finished and final cartridge components are tested. Discussions were held to ensure that the cartridge design will be compatible with the mold injection process. Some modifications to the cartridge were introduced, particularly concerning the injection inlet.

Regarding the reading device the aim is to develop prototype HPV screening tools (Labman) capable of processing the assays that are implemented on the ‘lab on a chip’ microfluidic cartridges. Development during this period has followed three parallel activities: screening tool hardware, screening tool software and potentiostat development. Two screening tool prototype devices including software have been built and tested. This version of the device is specified for testing in laboratory conditions by university partners UGent and URV. The potentiostat has been developed in parallel with the device hardware and software. Characterisation testing is currently in progress and the results thus far are promising.
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.
ELEVATE logo as part of the branding