Periodic Reporting for period 1 - CHILI (A Community-based HPV screening implementation in Low-Income countries)
Reporting period: 2021-09-01 to 2023-02-28
The CHILI consortium envisions to optimize a cervical cancer screening strategy in compliance with the most recent WHO guidelines and tailored to the context and needs of four low- and middle-income countries (LMICs): Ethiopia, Uganda, Mozambique and Cambodia. The strategy includes a new cervical cancer screening test which is currently being developed in ELEVATE, another Horizon 2020 project, and which combines self-sampling with a low-cost, portable measurement device, detecting both the human papilloma virus – the main cause of cervical cancer – and cancer biomarker proteins. The test will be adapted to ensure its applicability and affordability on a large scale in these four countries.
The simultaneous and nearly real-time detection of HPV DNA and the proteomic markers allows for the detection of those cervical HPV infections associated with progression towards cervical cancer. Therefore, the test detects patients who need referral for close follow-up and/or treatment, and thereby has the potential to reduce drastically the cancer burden in LMICs. The acceptability and uptake of the ELEVATE test among women will be compared with that of different, more conventional screening strategies. In addition, the cost-effectiveness will be estimated by economic modelling.
Indeed, cervical cancer is the 4th most common cancer in women worldwide. Early detection of precancer has shown to be successful in reducing cancer incidence and mortality. However, there are substantial inequalities in terms of cervical cancer burden with up to nine in ten women who die from cervical cancer living in low- and middle-income countries. A global implementation of screening services is hampered by differences between countries with regard to resources, availability and quality of preventive strategies.
Our vision is a world where all women receive equal opportunities to protect themselves against preventable diseases. The CHILI consortium aims to comprehend current screening practices and challenges to define and implement new strategies, including the ELEVATE screening test, that meet the conditions of the local context and the preferences of the local women. We aim to assure sustainability and integration within the local health system while implementing and evaluating the new screening strategy in order to support the countries to move towards universal screening.
The simultaneous and nearly real-time detection of HPV DNA and the proteomic markers allows for the detection of those cervical HPV infections associated with progression towards cervical cancer. Therefore, the test detects patients who need referral for close follow-up and/or treatment, and thereby has the potential to reduce drastically the cancer burden in LMICs. The acceptability and uptake of the ELEVATE test among women will be compared with that of different, more conventional screening strategies. In addition, the cost-effectiveness will be estimated by economic modelling.
Indeed, cervical cancer is the 4th most common cancer in women worldwide. Early detection of precancer has shown to be successful in reducing cancer incidence and mortality. However, there are substantial inequalities in terms of cervical cancer burden with up to nine in ten women who die from cervical cancer living in low- and middle-income countries. A global implementation of screening services is hampered by differences between countries with regard to resources, availability and quality of preventive strategies.
Our vision is a world where all women receive equal opportunities to protect themselves against preventable diseases. The CHILI consortium aims to comprehend current screening practices and challenges to define and implement new strategies, including the ELEVATE screening test, that meet the conditions of the local context and the preferences of the local women. We aim to assure sustainability and integration within the local health system while implementing and evaluating the new screening strategy in order to support the countries to move towards universal screening.
For all of the four LMICs involved in CHILI, we have been able to determine the majority of the key parameters and indicators with regard to cervical cancer by conducting a literature review and performing formative research. In some of these countries the available literature on cervical cancer is scarce. However, we were able to complement these gaps by performing focus group discussions and interviews with key stakeholders. During this formative research, the cervical cancer experts were able to advise us on the quality of the data available in the country and on how to access additional sources of information such as national or local cancer registries and anonymized patient registries. In addition, the members of the installed implementation boards in each of the countries were able to supplement important information.
All involved implementation countries have also gathered a large volume of data regarding the barriers and facilitators to attend conventional cervical screening from different perspectives: women, community representatives, primary healthcare providers, local medical specialists and cervical cancer experts and policymakers. Similarly, alternative strategies such as self-sampling were discussed with these stakeholders. This information will be combined with the services preferences that will be investigated in the upcoming survey with discrete choice experiment, scheduled in Period 2.
The preliminary specifications for the targeted CHILI proteomic/genomic sensor tool platform have been updated in view of the situation in the targeted LMIC countries in CHILI.
Approaches have been evaluated for the manufacture of electrode arrays compatible with biofunctionalization that could be used as a more cost-effective alternative compared to the use of screen-printing of high-temperature cure gold on ceramic substrate currently employed in the ELEVATE project. Within CHILI, a more cost-effective design employing silver conducting tracks will be employed. Furthermore, other possibilities for lowering the system costs for ELEVATE were explored, specifically the use of a common process for the biofunctionalization of the electrodes of the array, as well as a reduced number of blisters and inherently fluidic channels in the microsystem.
Key activities have been the development of the cartridge and the further development of the PoC screening tool. The cartridge combines both proteomic and genomic assays and this area has seen the most radical change. The revised sensor design required independent excitation from the potentiostat. The revised cartridge design is now complete, a prototype screening tool is built and tested and the revised potentiostat is built, tested and characterised.
The collection of self-samples among women with and without cervical lesions by the 4 LMIC partners, required for the test and validation phase of the adapted screening tests and screening tool, has been initiated in Cambodia. The teams in Ethiopia, Uganda and Mozambique will start collecting samples in the next months.
All involved implementation countries have also gathered a large volume of data regarding the barriers and facilitators to attend conventional cervical screening from different perspectives: women, community representatives, primary healthcare providers, local medical specialists and cervical cancer experts and policymakers. Similarly, alternative strategies such as self-sampling were discussed with these stakeholders. This information will be combined with the services preferences that will be investigated in the upcoming survey with discrete choice experiment, scheduled in Period 2.
The preliminary specifications for the targeted CHILI proteomic/genomic sensor tool platform have been updated in view of the situation in the targeted LMIC countries in CHILI.
Approaches have been evaluated for the manufacture of electrode arrays compatible with biofunctionalization that could be used as a more cost-effective alternative compared to the use of screen-printing of high-temperature cure gold on ceramic substrate currently employed in the ELEVATE project. Within CHILI, a more cost-effective design employing silver conducting tracks will be employed. Furthermore, other possibilities for lowering the system costs for ELEVATE were explored, specifically the use of a common process for the biofunctionalization of the electrodes of the array, as well as a reduced number of blisters and inherently fluidic channels in the microsystem.
Key activities have been the development of the cartridge and the further development of the PoC screening tool. The cartridge combines both proteomic and genomic assays and this area has seen the most radical change. The revised sensor design required independent excitation from the potentiostat. The revised cartridge design is now complete, a prototype screening tool is built and tested and the revised potentiostat is built, tested and characterised.
The collection of self-samples among women with and without cervical lesions by the 4 LMIC partners, required for the test and validation phase of the adapted screening tests and screening tool, has been initiated in Cambodia. The teams in Ethiopia, Uganda and Mozambique will start collecting samples in the next months.
It is the intention of the CHILI consortium to make cervical cancer screening accessible, acceptable and affordable for every women in a low-income country with the aim to reach a breakthrough and significantly increase the number of women that are regularly screened and therefore, further reduce the burden of cervical cancer in the world. In this way, the CHILI project will contribute to the United Nations’ Sustainable Development Goal 3.4. A key enabler for this novel approach is the ELEVATE self-sampling test which can simultaneously detect oncogenic human papillomavirus (HPV) DNA and the proteomic p16/ki67 cervical cancer biomarkers, which is being developed in the ELEVATE project.
The CHILI project expects to empower women to be screened and envisions an alternative for current standard practices, an alternative in which small, local health units can analyse 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. Maximum impact and innovation will be achieved through collaboration between academic researchers and national and local stakeholders, who will identify current screening practices and define new strategies. Through formative research and quantitative data collection the cervical cancer screening cascade (awareness creation, pre- and post-counseling, offering a test and ensuring referral of positive cases) will be evaluated. Based on these results, (training) activities and if necessary, materials will be developed (brochure, guidelines, etc.) to help strengthening screening practices. During the scheduled pilot study this improved screening strategy will be implemented in combination with the point-of-care ELEVATE test. The results of this pilot study will be translated into evidence-based guidelines and policy recommendations.
The CHILI project expects to empower women to be screened and envisions an alternative for current standard practices, an alternative in which small, local health units can analyse 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. Maximum impact and innovation will be achieved through collaboration between academic researchers and national and local stakeholders, who will identify current screening practices and define new strategies. Through formative research and quantitative data collection the cervical cancer screening cascade (awareness creation, pre- and post-counseling, offering a test and ensuring referral of positive cases) will be evaluated. Based on these results, (training) activities and if necessary, materials will be developed (brochure, guidelines, etc.) to help strengthening screening practices. During the scheduled pilot study this improved screening strategy will be implemented in combination with the point-of-care ELEVATE test. The results of this pilot study will be translated into evidence-based guidelines and policy recommendations.