Program ROSE (Removing Obstacles to Cervical Screening): History
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Contributor:
Yin Ling Woo
,
Su Pei Khoo
,
Patti Gravitt
,
David Hawkes
,
Reena Rajasuriar
,
Marion Saville

Program ROSE (removing obstacles to cervical screening) is a primary HPV-based cervical screening program that incorporates self-sampling and digital technology, ensuring that women are linked to care. It was developed based on the principles of design thinking in the context of Malaysia. The program illustrates the importance of collaborative partnerships and addressing the multi-faceted barriers from policy changes, and infrastructure readiness to the implementation of a radically new cervical screening program in communities. The paradigm shift in cervical cancer requires a monumental and concerted effort in educating both the healthcare providers and the general public. 

  • self-sampling
  • cervical screening
  • ROSE

1. Tailoring the Global Roadmap towards Cervical Cancer Elimination to the Real-World Setting

Cervical cancer is a disease of inequity, with 85% of cases and deaths occurring in low and middle-income countries [1]. In 2019, the World Health Organization (WHO) made a call towards the elimination of cervical cancer as a public health problem by vaccinating 90% of female adolescents, screening 70% of eligible women with a high-performance test (HPV test) at least twice a lifetime and ensuring 90% of women who are screened positive will receive appropriate treatment [2]. It is estimated that the rapid scale-up of these interventions would result in most countries achieving the elimination goal of new cases of cervical cancer at less than 4 per 100,000 women by 2100 [3]. As of 2021, considerable disparities in the uptake of HPV vaccination are observed between countries; with more than 85% of high-income countries having introduced a national HPV immunization program while less than 25%, in lower-income countries. This is coupled with the lack of a national cervical cancer screening program and limited facilities available for diagnosis and treatment in the public sector of many lower-income countries [4]. Therefore, it will be incumbent on countries to pave the road to the elimination from pre-existing footpaths. Notwithstanding the impact of COVID-19 from which the world is recovering, many countries are experiencing the devastating effects of climate and humanitarian crises [5]. As an example, at the end of 2021, The UN Refugee Agency (UNHCR) reported that 89.3 million people worldwide were forcibly displaced because of persecution, conflict, human rights violations or events seriously disturbing public order [6]. Hunger has become a direct threat to the health and survival of millions [7].

2. Accelerating Innovation through Collaboration

Pilot Project ROSE started as a collaboration between the University of Malaya (UM), the Australian Centre for Prevention of Cervical Cancer (ACPCC), and independent experts. At its core, Pilot Project ROSE (later known as Program ROSE) integrates self-sampling, primary HPV testing and a digital registry, ensuring women who require follow-up are linked to care. Broadly, the UM team crowdsourced the resources required, contributed to the clinical care, and provided deep insights into the local communities while ACPCC brought technical support by way of laboratory and digital health expertise. As the pilot developed, collaborative partnerships became broader and included academics, implementors, institutions and individuals who shared the vision of making cervical cancer a rare disease in Malaysia.
The strategic roadmap provided by WHO was central in communicating the science and purpose behind the program to the public and policy makers. While many of the collaborator’s core expertise was not in healthcare, they embraced some level of uncertainty but believed that the goal was achievable. Throughout the process of designing Pilot Project ROSE, timely two-way communication was critical in building trust between all parties. Simultaneous discussions with telecommunication companies (TELCOs), computer programmers, legal departments, financiers, donors, doctors (gynaecologists, pathologists, primary care physicians), nurses, academics, policy makers and volunteers required a ‘different language’ to coordinate and convey the requirements for execution.
While it was important to have a bird’s eye view of the challenges faced with the current cervical screening program, a more detailed understanding of how the program was being delivered to the women in the primary care setting was vital. Stakeholder engagements were performed to explore the barriers from the implementor’s perspective (meetings and discussions with the ministry of health officers) and visits were made to the ministry of health primary care clinics (klinik kesihatan) to gain the perspectives of the healthcare providers and patients [8]. Structured interviews carried out among the different groups of health care providers (receptionists, nurses, doctors, attendants, and laboratory assistants in the clinics) provided an insight into the challenges encountered on a day-to-day basis. Moreover, the team explored how ready they were to accept a new modality of screening, in particular the introduction of self-sampling. Studies were simultaneously conducted to understand attitudes and acceptance of self-sampling among multi-ethnic Malaysian women [9]. The team sought a solution that would not disrupt the daily processes in these primary clinics that could be serving up to 1000 patients per day and to utilize existing resources (no need for new computers, printers, rooms or staffing), aligning it to the processes of the clinics and maximizing efficiency.
One of the initial benefits of the collaboration was getting the support of the manufacturers of HPV tests, and the related instrumentation. The budgets of many pilot studies are often diverted to the costs of the HPV tests (and instrumentation) and as such the most important features of a good program, such as engagement with the community, are conducted with minimal, or insufficient funding. The collaboration with a high-volume pathology laboratory (ACPCC) led to conversations with the HPV test manufacturers and the result was over 4000 tests donated by two different manufacturers (Cepheid for the point-of-care model and Roche for the centralized laboratory model). Furthermore, experts from the partner laboratory also provided subsequent technical support in relation to HPV testing. For instance, when approached by different manufacturers or their distributors with potentially new products, the team at ROSE have rapid access to experts for an independent and evidence-based perspective.
In February 2020, just as the COVID-19 pandemic was hitting, the ROSE Foundation Laboratory was officially launched. The partnership between the ROSE Foundation Laboratory and the collaborating pathology service continues today with clinical governance and scientific and technical support.

3. Acceptability of Self-Testing for HPV Testing in Malaysia

Organized population screening with conventional cytology in high-income countries has led to a reduction in cervical cancer mortality rates [10][11]. However, despite efforts to implement such costly cervical screening programs in less developed settings, these were met with limited success [12]. With the discovery that high-risk HPV is the necessary cause of cervical cancer [13], the scientific community consolidated their knowledge to develop effective vaccines and screening tools within a relatively short time, enabling the realization of eliminating a human cancer within the century [3]. The rapid development of HPV testing platforms that are validated for population screening supplemented by the ease of obtaining a sample through self-testing has nothing been short of revolutionary [14][15].
One of the biggest advantages of advocating for HPV testing as the primary screen is that a woman needs to only perform as few as two tests per lifetime with the option of self-testing. In the pilot phase, a survey of 1000 women found that more than 97% of women found the test acceptable and 99% would use this strategy rather than a physician-acquired sample. This information dispelled the myth that Malaysian women could not take their own samples and that it would lead to high invalid tests. In a recent Malaysian study, more than 80% of the participants perceived the self-sampling method as easy, convenient, not embarrassing, and confident in performing the test, indicating that self-sampling is highly acceptable. It was also the preferred choice of cervical screening compared to Pap smear and physician-sampling HPV test [16]. Over time the key messages to anyone asking about HPV testing became simple: Clinically validated, good support, and PCR-based for self-collection [15][17][18][19].
Program ROSE utilizes the COPAN 552C FLOQSwab® (COPAN Diagnostics Inc., Murrieta, CA, USA) for self-sampling. One of the major advantages is that these swabs can be stored in room temperature for up to 14 days before it is tested. Operationally, this means that community outreach programs can be conducted in rural or distant sites and only tested in the ROSE laboratory when the team returns with the swabs. The ease of transportation is a huge advantage particularly when community screens are not so accessible.

4. Success Measured by Linkage to Care

Any screening test without the appropriate follow-up does not save lives and is a waste of resources. One of the shortcomings in the Malaysian cervical screening program is the absence of information with regard to women requiring follow-up care. The norm for most women is the unstated rule that ‘no news is good news’.
Linkage to care was an important element built into Program ROSE with staff dedicated to ensuring women testing positive receive their results and are linked to care. This process is facilitated by a simplified algorithm that allows program staff, most of whom are non-medically trained, to engage with women, linking them to the nearest treatment centre. Researchers have learnt this is a critical step in facilitating linkage to care as many women expressed anxiety and fear of cancer following receipt of a positive test result but responded well when reassured by program staff.
For Pilot Project ROSE, the analysis of about 4000 screens found this effort translated to 90% of women with positive tests attending follow-up. Program ROSE has demonstrated that is possible to empower communities and train them to take on certain tasks with the support of professionals, thereby turning clinicians from being the do-ers to enablers. Women no longer need to attend their cervical screening in clinics or hospitals, relieving the stress in these facilities.
This linkage to care has been facilitated by the use of a digital registry powered by canSCREEN® (Australia); a digital health solution that securely records the participants identifying and contact information, and results of tests and follow-up visits, giving the ROSE team a clear view of participants that are overdue for follow-up care so that they can be contacted.

This entry is adapted from the peer-reviewed paper 10.3390/curroncol29100579

References

  1. Ferlay, J. Global Cancer Observatory: Cancer Today; International Agency for Research on Cancer: Lyon, France, 2020.
  2. World Health Organization. Global Strategy to Accelerate the Elimination of Cervical Cancer as a Public Health Problem; World Health Organization: Geneva, Switzerland, 2020.
  3. Canfell, K. Towards the global elimination of cervical cancer. Papillomavirus Res. 2019, 8, 100170.
  4. Dorji, T.; Nopsopon, T.; Tamang, S.T.; Pongpirul, K. Human papillomavirus vaccination uptake in low-and middle-income countries: A meta-analysis. eClinicalMedicine 2021, 34, 100863.
  5. World Health Organization. Health Emergencies List; World Health Organization: Geneva, Switzerland, 2022.
  6. UNHCR. Global Trends Forced Displacement in 2021; The UN Refugee Agency: Copenhagen, Denmark, 2022.
  7. World Health Organization. WHO Launches Appeal to Respond to Urgent Health Needs in the Greater Horn of Africa. Available online: https://www.who.int/news/item/02-08-2022-who-launches-appeal-to-respond-to-urgent-health-needs-in-the-greater-horn-of-africa (accessed on 23 August 2022).
  8. Yong, C.; Hong, L.; Lee, K.; Krishnasamy, I.; Nasir, N.B.; Gravitt, P.; Lee, Y.; Woo, Y. Healthcare Providers’ Views on Cervical Screening: A Qualitative Study of Barriers to Cervical Screening in Malaysia. J. Glob. Oncol. 2018, 4, 214s.
  9. Ma’Som, M.; Bhoo-Pathy, N.; Nasir, N.H.; Bellinson, J.; Subramaniam, S.; Ma, Y.; Yap, S.-H.; Goh, P.-P.; Gravitt, P.; Woo, Y.L. Attitudes and factors affecting acceptability of self-administered cervicovaginal sampling for human papillomavirus (HPV) genotyping as an alternative to Pap testing among multiethnic Malaysian women. BMJ Open 2016, 6, e011022.
  10. Arbyn, M.; Raifu, A.O.; Weiderpass, E.; Bray, F.; Anttila, A. Trends of cervical cancer mortality in the member states of the European Union. Eur. J. Cancer 2009, 45, 2640–2648.
  11. Smith, M.; Canfell, K. Impact of the Australian National Cervical Screening Program in women of different ages. Med. J. Aust. 2016, 205, 359–364.
  12. Alfaro, K.; Maza, M.; Cremer, M.; Masch, R.; Soler, M. Removing global barriers to cervical cancer prevention and moving towards elimination. Nat. Rev. Cancer 2021, 21, 607–608.
  13. Burd, E.M. Human papillomavirus and cervical cancer. Clin. Microbiol. Rev. 2003, 16, 1–17.
  14. Stanczuk, G.; Baxter, G.; Currie, H.; Lawrence, J.; Cuschieri, K.; Wilson, A.; Arbyn, M. Clinical validation of hrHPV testing on vaginal and urine self-samples in primary cervical screening (cross-sectional results from the Papillomavirus Dumfries and Galloway—PaVDaG study). BMJ Open 2016, 6, e010660.
  15. Arbyn, M.; Smith, S.B.; Temin, S.; Sultana, F.; Castle, P. Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: Updated meta-analyses. BMJ 2018, 363, k4823.
  16. Khoo, S.P.; Lim, W.T.; Rajasuriar, R.; Nasir, N.H.; Gravitt, P.; Woo, Y.L. The Acceptability and Preference of Vaginal Self-sampling for Human Papillomavirus (HPV) Testing among a Multi-ethnic Asian Female Population. Cancer Prev. Res. 2020, 14, 105–112.
  17. Meijer, C.J.; Berkhof, J.; Castle, P.E.; Hesselink, A.T.; Franco, E.L.; Ronco, G.; Arbyn, M.; Bosch, F.X.; Cuzick, J.; Dillner, J.; et al. Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older. Int. J. Cancer 2009, 124, 516–520.
  18. Arbyn, M.; Depuydt, C.; Benoy, I.; Bogers, J.; Cuschieri, K.; Schmitt, M.; Pawlita, M.; Geraets, D.; Heard, I.; Gheit, T.; et al. VALGENT: A protocol for clinical validation of human papillomavirus assays. J. Clin. Virol. 2016, 76 (Suppl. 1), S14–S21.
  19. Arbyn, M.; Simon, M.; Peeters, E.; Xu, L.; Meijer, C.J.; Berkhof, J.; Cuschieri, K.; Bonde, J.; Vanlencak, A.O.; Zhao, F.-H.; et al. 2020 list of human papillomavirus assays suitable for primary cervical cancer screening. Clin. Microbiol. Infect. 2021, 27, 1083–1095.
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