In case you missed it, here are Part One and Part Two of the series. In Part Two, “How the Primary HPV Test Can Help End Cervical Cancer,” we covered why primary HPV tests are an effective screening for cervical cancer. We discussed how HPV tests are especially important because they allow for self-collection, which is proving to be as accurate as clinician-collected HPV samples. 

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This is Part Three, the final piece in this research series, where we delve into how self-collected HPV samples can end cervical cancer. We discuss the critical need to expand the options people have for how they can engage in cervical cancer screening, and underscore why self-collection presents an effective and equitable screening option. Seeing the success of self-collection around the world, the United States could benefit greatly from its potential as well. 

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Self-Collection Encourages Routine Screening and Prevents Deaths

To end cervical cancer (typically defined as fewer than 4 cases per 100,000 women), we need to improve screening uptake among never-screened and underscreened individuals. We know that providing adequate choice and control around cancer screenings improves both screening engagement and resulting health outcomes. Here, self-collection stands out as an important and necessary cervical cancer screening option. 

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Many people avoid their cervical cancer screenings because they cannot access a clinic, are uncomfortable with a provider conducting an intimate (and often painful) cervical exam, or because they have survived sexual trauma or violence that is triggered during a speculum exam required for traditional clinic-based cervical cancer screening. If we are to improve screening consistency and expand access for these hard-to-reach populations, it is imperative that healthcare systems implement HPV self-collection as an equitable and accurate screening option (proving to be just as sensitive as clinician-collection). 

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Providing people more screening choices using self-collection can improve screening engagement and eliminate cervical cancer, avoiding 62 million deaths worldwide in the coming 100 years. In the United States, 93% of the average 12,000+ cases each year can be prevented through more accessible screening measures. Research also highlights that increasing screening rates is the most effective way to eliminate cancer in the United States. Scaling up screening access and engagement will both expedite elimination of cervical cancer (by 10-13 years) in the United States while also averting 1,400-2,088 cases per year over 2020-2100. 

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Using self-collected HPV tests is not a novel idea. Several countries have adopted this strategy for cervical cancer screenings. As of 2022, 17 countries (ranging from low- to high-resource settings) recommend self-collecting either as a primary cervical cancer screening option or as a strategy to reach underscreened populations. In particular Australia – which extended self-collected HPV tests as a primary screening option in July 2022 – is well on its way to meeting the WHO’s target for eliminating cervical cancer by 2035. Each of these countries has recognized the consequentiality of expanding screening options to promote engagement and enable timely care that minimizes cervical cancer cases and deaths. 

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In the United States, the FDA approved in-clinic (including mobile clinics) self-collection in 2024. Self-collection could notably reduce cervical cancer deaths among underscreened and never-screened women. For this reason, international bodies such as the WHO and European Commission recommend that providers offer the self-collection option to patients who are overdue for screening. Similarly, in the U.S. at-home HPV self-collection presents a promising prospect for ending cervical cancer. We at Teal Health are among those leading clinical studies towards an FDA approval for HPV at-home self-collection using our Wand and telehealth platform.  

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Self-collection Recognizes Lived Experiences and Addresses Barriers 

Research highlights several barriers to cervical screening within clinic settings. These include:

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In addition to addressing these barriers and negative experiences, self-collected HPV testing would also help maintain screening in unpredictable circumstances (e.g., healthcare shutdowns during COVID-19 pandemic). 

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We saw the potential of at-home self-collection unfold during the pandemic, with colorectal cancer screenings. For decades colorectal cancer screening lagged due to similar issues as cervical screening: inconvenience around clinic access and fear of a colonoscopy. However, leveraging at-home self-collected colorectal cancer tests has helped address these barriers and optimize screening participation. So much so that colorectal cancer screening was one of the only cancer screenings that did not decline during the pandemic due to at-home options. 

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Similarly, at-home self-collection could improve cervical cancer screening and follow-up care, particularly among hard-to-reach and underscreened populations. Programmatic and implementation research has found that mailing women at-home self-collection kits, rather than reminding them to come into a clinic for screening, generated higher screening rates. Higher screening engagement using at-home self-collection has been consistent in US-based studies, particularly among low-income and underscreened women. Together, these findings bolster the idea that at-home self-collection enables convenience and greater access to effective cervical cancer screening, thereby heightening screening participation and public health benefits. 

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Extending a self-collection option also critically enables access for those who cannot readily access clinics or have trauma or mistrust around traditional clinician-conducted speculum exams and screenings. This is significant considering that experiences of violence and sexual trauma – which are more common among women and non-binary individuals – are notable risk factors for cervical cancer and often cited as deterrents to traditional clinic-based screenings. By affording people more choice and control over how they can complete their cervical screening, self-collection can create more equity in the gender health gap. 

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Self-collection is highly acceptable among people worldwide and preferred over clinician-collection (in an analysis of 7 studies, totalling 1470 women, 97% found self-collection acceptable). In Australia, women reported “pleasant” and “positive” experiences with self-collection, highlighting greater control over their screening. Several noted that they would not complete their cervical cancer screening without a self-collection option, saying they would have remained up-to-date on regular screenings had self-collection been made available earlier. Practitioners, too, underscored self-collection as a “progressive’ change, noting that this option helped them convince many (especially hesitant) patients to complete their cervical cancer screening.

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Self-collection is Cost-Effective and Supports Broad Healthcare Engagement 

At-home HPV self-collection presents other benefits that reduce health disparities. Because HPV DNA tests are more cost effective than other cervical screenings, at home HPV self-collection could further reduce screening expenses and save healthcare dollars. In the U.S., evidence suggests at-home self-collection could improve cost effectiveness not only because it drives screening uptake, but moreover increases adherence to follow-up care which decreases the lifetime risk of cervical cancers.

While some worry that at-home self-collection for cervical screening will compromise patients' likelihood of attending to necessary follow-up care, research suggests otherwise. Evidence shows that with appropriate information and education, follow-up care after self-collection is typically pursued. In some studies, adherence to follow-up consultations, procedures, and examinations was as high as 85-95% for women who tested positive for HPV via self-collection, many of whom were previously underscreened. The high compliance with follow-up care is represented in studies worldwide, which show that women are typically motivated to seek further clinical care if they test positive for HPV and they understand the importance of follow-up for positive screen (e.g. anticipatory guidance). 

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This high attendance to follow-up care among those who test positive for HPV after self-collecting helps ensure cervical disease does not progress. As such, strategies to encourage participation in follow-up care need to be an integral consideration in any cervical cancer screening program. 

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Self-Collection for Cervical Cancer Screening in the United States 

Data from countries that have rolled out self-collection for cervical cancer screening tells us that awareness and support among healthcare providers is essential to realizing the potential of this cancer prevention approach. For instance, Australia gained widespread support from primary providers who were willing to implement self-collection. This required equipping practitioners with more resources to integrate self-collection into routine practice and maximize the benefits of this strategy. Similarly, in other countries, clinicians’ acceptability and endorsement of self-collection played an important role in improving screening engagement, especially among underscreened populations. 

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Following this lead, providers in the United States should stay abreast of evidence around primary HPV testing and self-collection (including at-home self-collection), positioning themselves to carry out equitable and accessible cervical screening measures now that self-collection is FDA-approved for in-clinic use. ACOG has expressed that self-collected HPV samples could be a valuable strategy to increase cervical screening access and participation, a nod towards the mounting evidence in favor of the accuracy of self-collection and importance as a health equity measure. 

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Despite the well-evidenced efficacy of primary HPV testing, as well as the recommendations to use HPV screening (phasing out cytology-based Pap smears), practice has not shifted in the United States with many doctors still preferring co-testing. It has been suggested that healthcare infrastructure is not well-equipped to handle an influx of HPV DNA tests and ensure result delivery and triage to appropriate follow-up care. 

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However, infrastructural capacities develop over time; as clinical practices shift to incorporating new, scientifically-sound approaches so too will the system adapt (as we are currently seeing with recommendations for laboratories to accommodate colorectal cancer self-collection). Shifting toward primary HPV tests will also likely not require as much of an infrastructural transformation as some anticipate. The increase in colposcopies should be rather minimal, even among the underscreened, given that only  around 5% of people will have a positive test. Further, given partial genotyping (ability to report high-risk HPV types 16 and 18 separately from other high-risk HPV types) as well as effective triage pathways through Pap smears (for which the infrastructure already exists), the increased capacity needs for colposcopy should be rather manageable. 

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Physicians in the United States also reported they would be more likely to implement primary HPV DNA testing given more support from medical organizations and availability of the tests, which in turn could persuade broader healthcare practice changes. Overall, there is a need for more awareness in the United States surrounding the proven efficacy of primary HPV testing for cervical cancer screening. 

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The United States is committed to ending cervical cancer, and self-collection is a crucial public health measure toward this end. There are several efforts, including major public-private partnerships and innovative private endeavors, to secure FDA approval of additional self-collection approaches (e.g., at-home testing) and increase the uptake of HPV self-collection for cervical cancer screening. This process will undoubtedly be rigorous and require adequate proven metrics around Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) for self-collection as compared to clinician-collection. Still, evidence suggesting sample equivalency as well as the successful implementation of self-collection in other countries’ offers optimism for the United States to feasibly eliminate cervical cancer. 

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That’s all we have, for now. We hope this research series was helpful, and that it speaks to why Teal is working so hard to bring an FDA-approved self-collection for cervical cancer screening to the United States. If you want to share your thoughts, please reach out to us. 

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