Abstract
Introduction:
As HPV self-collection for cervical cancer screening is introduced into clinical practice, it is critical to understand factors that may potentially impact adoption. This article aims to describe clinicians’ attitudes toward self-collection guided by the Cabana Guideline Based Practice Improvement Framework.
Methods:
This study is a secondary analysis of a survey of clinicians at federally qualified health centers (n = 147). The survey, distributed to clinicians practicing in safety net settings in 2021–2022, explored the potential benefits and concerns of HPV self-collection, and how helpful self-collection would be in catching up patients overdue for screening. Clinicians’ anticipated practices were evaluated by asking to which patients and in what location they would recommend self-collection. Descriptive frequencies were obtained for quantitative items. Qualitative comments were coded using thematic analysis.
Results:
Most participants were female (84%), White (69%), and non-Hispanic/non-Latinx (86%). Responses indicated a lack of awareness that primary HPV testing is a recommended form of screening and the management of positive HPV test results. The main benefits identified were convenience and increased access to care. Participants’ concerns included patients incorrectly conducting the test or obtaining an inadequate sample, fewer appointments with clinicians, and patients not returning the test or attending follow-up appointments.
Conclusion:
This study provides important baseline information for clinicians’ perceptions of self-collection prior to FDA approval. Now that HPV self-collection has received regulatory approval for routine use, further research is needed to address concerns and guide its adoption into clinical practice.
Keywords
Introduction
In recent years, cervical cancer incidence rates in the United States have increased by 1.7% annually from 2012 to 2019 among women ages 30–44, and the rate of distant-stage cervical cancer has increased for all women by 1.3% annually from 2001 to 2018.1,2 Specific subpopulations experienced a higher increase in distant-stage cervical cancer.2,3 While the United States has experienced these increases, other countries (e.g., Australia, Scotland, and Norway) are reporting declines in cervical cancer and planning for the elimination as a public health problem in the near future.4–6 Likely contributing to these increases in the United States, cervical cancer screening rates are declining; from 2005 to 2019, the percentage of women 21–65 years old overdue for screening increased from 14.4% to 23.0%. 7 Those without insurance have significantly higher rates of being overdue for screening than those with insurance.7,8 In 2020, only 51% of patients in federally qualified health centers (FQHCs) were up to date on cervical cancer screening, compared to 82.9% of the general U.S. population. 9 In a study at a safety-net setting, the majority of women diagnosed with cervical cancer had no prior health care system contact (69%) and were not previously screened (63%). 10 Additionally, 21% of those screened did not follow up after a positive screening test. 10
Cervical cancer screening recommendations are shifting from cytology-based (i.e., Pap smears) to HPV-based testing (i.e., cotesting or primary HPV testing) as reflected in current screening guidelines from the American Cancer Society (ACS) 11 and the United States Preventive Services Task Force.12,13 In May 2024, the Food and Drug Administration (FDA) approved the use of in-clinic HPV self-collection, and a home-based test was approved in 2025.14,15 HPV self-collection can expand access to cervical cancer screening by increasing screening options and addressing patient preferences, reducing the need for a speculum exam, and potentially decreasing provider burden. 16 Several countries have introduced self-collection in their national screening programs and observed an increase in women opting for self-collection over clinician-collected samples.17,18
As new techniques such as self-collection for cervical cancer screening are introduced, clinicians’ attitudes toward these techniques should be evaluated to understand potential factors that impact adoption. The Cabana Guideline Based Practice Improvement Framework provides an excellent guide to examine clinicians’ adoption of practice guidelines. 19 The factors described in the Framework include knowledge (i.e., lack of familiarity and awareness), attitudes (i.e., lack of agreement with specific and general guidelines, outcome expectancy, self-efficacy, and motivation), and external barriers (e.g., time, resources, patient perceptions of new guidelines), and the impact on clinician’s subsequent behavior. 19
While HPV self-collection is a promising method for increasing screening opportunities for underserved communities, it is unclear how clinicians perceive self-collection and its utility in their patient population. This article describes attitudes toward HPV self-collection among clinicians practicing in FQHCs, guided by the Cabana Guideline Based Practice Improvement Framework.
Methods
Sample
This study is a secondary analysis of a study examining cervical cancer screening, guideline adoption, and HPV vaccine recommendations among clinicians practicing in FQHCs.20,21 Study details are published elsewhere.20,21 Briefly, clinicians were recruited through the ACS Vaccinating Adolescents Against Cancer program and professional networks of the PIs (S.T.V., R.B.P., H.F.). Clinicians were eligible to participate if they: (1) performed cervical cancer screening, (2) were either a physician or other advanced practice provider, and (3) practiced in an FQHC or safety net facility. Data were collected from October 2021 to July 2022. This study was approved by the institution’s Scientific Review Committee and Institutional Review Board (Advarra).
Survey measures
The survey included items assessing HPV vaccination practices, cervical cancer screening practices including HPV self-collection, and the impact of the COVID-19 pandemic on health care services and was guided by the Guideline Based Practice Improvement Framework. 19 The quantitative data presented in the current study were previously reported. 20 This article analyzes the data through the lens of the Guideline Based Practice Improvement Framework 19 and additional qualitative write-in results. The current analysis focuses on HPV self-collection items. Participants were asked, “If FDA approved, to what extent would you, as a clinician, view the following as potential benefits/advantages of self-collected HPV testing?” and “If FDA approved, to what extent would you, as a clinician, view the following as potential concerns about recommending self-collected HPV testing to your patients?” Potential benefits included screening patients who have difficulty accessing screening, screening patients via telemedicine, and screening patients who prefer not to have speculum exams; response options ranged from 1 = not a benefit to 4 = a large benefit. The potential concerns evaluated included a belief that a pelvic exam by a clinician should be part of cervical cancer screening, patients may not collect adequate specimens, patients may not return specimen in a timely manner, and if performed at home, patients may not present for routine primary care or follow-up for abnormal results; response options ranged from 1 = not a concern to 4 = large concern. Clinicians were also asked, “If FDA approved, how helpful would HPV self-collection be to catch up patients who may be overdue for screening due to the COVID-19 pandemic?” (1 = not helpful to 3 = very helpful). An open-ended item asked why they think HPV self-collection would or would not be helpful in catching up patients who are overdue for cervical cancer screening.
The survey was performed prior to FDA approval of HPV self-collection. Two items were used to evaluate clinicians’ anticipated behavior related to HPV self-collection if FDA approved: (1) For which patients would they recommend HPV self-collection instead of a clinician-collected sample? Response options included all patients, any patient who preferred a self-sample over a clinician-collected sample, only patients who could not have clinician-collection screening in the clinic, N/A I would not offer HPV self-collection, and other. (2) What location would they recommend patients perform their self-sample HPV tests? Location options included in the clinic, at home, either in a clinic or at home, depending on patient preference, and other.
Participant demographics collected included age, gender identity, race and ethnicity, medical training, specialty, and state of residence. Training was categorized as either physician (i.e., MD, DO) or other advanced practice provider (APPs; i.e., physician assistant, nurse practitioners, certified nurse midwives). Specialty was categorized as (1) obstetrics and gynecology and women’s health, (2) family medicine, and (3) internal medicine, pediatric/adolescent medicine, and other. Using the Healthy People 2030 goal of 72.9%, 22 state of residence was recoded to group those at or above the goal and those below the goal.
Data analysis
Descriptive frequencies were obtained using SPSS. Qualitative comments from the open-ended survey items were exported to MAXQDA, and a codebook based on a priori and inductive themes was developed. Deductive analysis was guided by the Guideline Based Practice Improvement Framework, where open-ended responses were coded according to constructs within the framework (i.e., Knowledge, Attitudes, and External Barriers). Inductive analysis allowed for relevant subthemes to emerge (e.g., perceptions of feasibility of self-sampling for patients, clinician belief in the importance of patient education on self-sample collection) within broad constructs. Two members of the study team (H.N.O. and P.L.) coded the comments using thematic analysis.
Results
Sample characteristics
A total of 159 participants completed the survey. Twelve were excluded due to ineligible clinical training (n = 5), not conducting screening (n = 6), or missing responses to self-collection benefits and concerns items (n = 1), leaving a final sample size of 147 participants and 142 write-in responses in this analysis. The majority were female (84%), White (69%), and non-Hispanic (86%). Respondents were equally split between physicians and APPs (46% and 54%, respectively), and 70% worked in family medicine. Approximately 65% of participants resided in states with screening rates below the Healthy People 2030 goal of 79.2% (Table 1).
Demographic Characteristics (n = 147) a
Data previously reported in Fuzzell et al. (2023).
Does not add to 147 because they are select all that apply.
The guideline-based practice improvement framework
Survey items and open-ended responses were categorized into themes based on the Guideline Based Practice Improvement Framework: Knowledge, Attitudes, External Barriers, and Anticipated Clinician Behavior. The sections below discuss the broader themes and example-related subthemes. The themes, quantitative results, 20 all subthemes, and example quotes for open-ended responses are shown in Table 2.
Quantitative and Qualitative Results with Associated Quotes
Data previously reported in Fuzzell et al. (2023).
Quantitative results (previously reported in Fuzzell et al. (2023))
Potential perceived benefits and barriers to HPV self-collection
Participants reported the ability to screen patients who have difficulty accessing screening and screening patients who prefer not to have speculum exams as large benefits to HPV self-collection (40% and 57%, respectively; Table 2). Approximately 29% of participants reported the ability to screen via telemedicine as a large benefit of self-collection, while most reported it as a moderate (34%) or small benefit (34%). Participants reported that patients not collecting adequate samples or not returning samples in a timely manner were large concerns of HPV self-collection (33% and 38%, respectively; Table 2). Approximately 47% believed that pelvic exams should be part of screening, and 64% reported patients not coming for routine primary care or follow-up of abnormal results as a moderate or large concern (Table 2).
Anticipated clinician behavior
Participants were asked which patients they would recommend HPV self-collection for and which location they would recommend performing self-sampled tests. Only 6% of participants said they would recommend self-collection for all patients, while the majority would only recommend it for those who could not have screening in a clinic due to other issues (i.e., transportation issues, fear of coming to the clinic, difficulty with speculum exams; Table 3). Most said they would recommend patients perform self-sampled HPV tests either in the clinic or at home, depending on the patient’s preference (86%; Table 3). Sixty percent believe that HPV self-collection would be somewhat helpful in catching up patients who may be overdue for screening due to the COVID-19 pandemic.
Clinicians’ Anticipated HPV Self-Collection Behaviors a
Data previously reported in Fuzzell et al. (2023).
Qualitative results
Knowledge
Clinician awareness of the option of primary HPV testing for cervical cancer screening
Participants’ responses indicated a lack of awareness that primary HPV testing (i.e., without a concurrent Pap test) is a recommended form of cervical cancer screening: “HPV alone is not yet the standard? So until deemed equal to Pap plus HPV, I feel we are missing something without Pap. Now if it is equal…… I’m all in!” One indicated that patients do not perform test properly and “as far as we know the cervix should be sampled not only the vaginal area.”
Clinician lack of understanding regarding management of positive HPV test results
Additionally, there was a lack of understanding regarding management of positive HPV test results. For patients testing HPV positive, cytology (Pap tests) are needed to determine the next steps in management. Participants were not aware of this workflow: “Lack of cytology; management and treatment algorithms are not based on HPV testing alone?” Another participant stated, “ASCCP needs to help us know what to do with HPV only tests results. My training is cytology based, hard to know how only HPV will work.”
Attitudes
Clinician perceptions of overall helpfulness of self-collection as a screening method
Overall, self-collection was seen as a helpful screening method for a variety of reasons, including increasing access, patient convenience, and decreasing barriers. Many participants expressed that self-collection was “better than nothing” and “anything that increases the number of patients screened.” One responded, “This method would certainly be better than no screening at all. While it may not be perfect, we are not in perfect times and we must adapt.”
Clinician belief in the importance of patient education on self-collection collection
Several participants emphasized the importance of educating patients on how to collect an adequate sample. For example, one indicated “there would need to be a lot of [patient] education on how to perform the sample and submit it,” while another participant mentioned the potential benefits in increasing early detection if proper patient education is provided, indicating, “this screening, provided with adequate counseling and understanding how to follow up abnormal results, could improve cervical cancer screening and early detection rates.” Some participants described patient “lack of knowledge” as a possible barrier to self-collection and further indicated that patients will “need more details on how they will do the test correctly.”
Clinician perception that self-collection could help with identifying underscreened patients or reach more patients overall
HPV self-collection may be a useful tool to overcome barriers to screening. This adds an option for screening for those who are reluctant to screen and might be a more acceptable option. One participant said, “… Add another option [type of screening test] available, which is always good.” Self-collection was perceived by several participants as a beneficial way to facilitate access to care among those who may not receive frequent screenings for various reasons, such as transportation difficulties, lack of patient engagement, and trauma or anxiety. Self-collection can be used to catch up patients at average risk who are behind on screening, as it can be performed in the clinical setting without a provider exam and in the home setting, if FDA-approved. Participants believed that self-collection is a feasible option for many patients. One described that self-sampling “may help re-engage patients in general by making part of the screen more accessible,” while another explained that self-sampling “may catch more individuals who are ambivalent or otherwise have trauma/anxiety related hesitation with pelvic exams.” A few participants specifically mentioned the benefit of self-collection during the COVID-19 pandemic, including “this would have been a nice option to have the patients self-swab” and “so behind on screening due to COVID that I want to do whatever it takes to get people caught up.”
Clinician motivation: Concerns
Many participants expressed concerns related to self-collection. A few responses indicated that patients will still have to come to the clinic to either pick up the test or due to inadequate sampling, with one saying this “would be wasting resources.” Other concerns included expected low uptake, not trusting self-collection, and patients not following through with either completing the original self-collection or the follow-up testing if the screening was positive.
Lack of outcome expectancy: Self-collection resulting in missing abnormalities in clinic
The possibility of missing abnormalities and other issues without a clinic appointment was a concern of self-collection. Many participants stated the importance of pelvic exams and delaying diagnosis and treatment of other abnormalities. One said that self-collection “should not replace in-person visits and pelvic exams” because vital things happen during those appointments, while another said that “pelvic exams have importance beyond just HPV testing.”
External barriers
Patient motivation: Belief that patients may not remember to return sample, self-collection issues, or create lack of follow-up
In line with the quantitative results, a large concern for self-collection is not returning the sample, inadequate sampling, and a lack of follow-up of positive results. Related to not returning the test, a few participants compared HPV self-collection to low uptake of FIT testing in their practice, with one noting that “FIT testing should improve screening rates but a very high portion of my patients never perform/return the specimen… I anticipate a similar challenge with HPV self-sampling.” In addition to patient-related concerns, there were concerns around the validity of HPV self-collection and the possibility of false negatives. Other participants were concerned that patients who already experience disparities, for example, those with limited health literacy or limited English language proficiency, would be further disadvantaged by requiring a self-collected test. One participant stated, “they can’t do this.”
Discussion
This article describes clinicians’ perceptions of HPV self-collection guided by the Cabana Guideline Based Practice Improvement Framework. Attitudes toward HPV self-collection varied, with clinicians reporting positive and negative attitudes. The main benefits of HPV self-collection included being more convenient for patients and increasing access to care. The main concerns included patients incorrectly completing the test or obtaining an inadequate sample, a reduction in patients coming to appointments with providers, and patients not returning the test or attending follow-up appointments. This is consistent with other literature exploring the barriers and facilitators to self-collection. 23
As reported in Fuzzell et al. (2023), compared to previous research with clinicians in the general population, 24 clinicians in the current study practicing in safety-net settings were more willing to offer self-collection in either the office or at home. However, they were less likely to recommend self-collection for all patients (6%) compared to general clinicians (43%). 24 Approximately 5% of clinicians in the current study said they would not offer self-collection to any patient, compared to 21% of the general population clinicians. 24 The concerns related to HPV self-collection were similar between the groups, with the largest concerns being patients not collecting adequate samples, not returning the sample, and not presenting for routine care or follow up. In the current study, the largest benefit of self-collection was screening patients who prefer not to have a speculum exam. In the general population clinicians, the main benefits were screening patients who have limited access or ability to travel to clinic and those with other logistical barriers. 24
Some clinicians in the current study expressed concerns about HPV self-collection based on incorrect information, as shown in the open-ended item responses. First, cytology was assumed to be either a more effective screening test or a necessary part of cervical cancer screening. Guidelines since 2018 have recommended HPV testing alone (primary HPV) as an option.11,12 However, uptake in the United States has been very low (<1% of clinics offer HPV alone). 25 Second, confusion relates to the management of a positive result on a primary HPV test. Because HPV testing is very sensitive but not very specific, a second test (usually a Pap test) is needed to determine the follow-up steps after a positive result on primary HPV screening. 26 Third, while clinicians correctly noted that patients could not reach the cervix on a self-collection, they did not understand that self-collected HPV testing is intended to be a vaginal sample. 27 Because of PCR amplification techniques, reaching the cervix is not required for accurate results on these tests. Consistent with other literature, 24 these concerns reflect the need to educate clinicians about HPV testing and self-collection, including the benefits of HPV testing, updates to screening and management guidelines, and the logistics of HPV self-collection. An example of educational materials for clinicians is the Clinician Communication Guide from the National Roundtable on Cervical Cancer, which explores the approved devices, patient eligibility, and discussion points. 28
This study has both limitations and strengths. The first limitation is a small sample size (n = 147). Approximately 85% of participants were female, and 70% were White, which may not be representative of clinicians throughout the United States and limits the generalizability of study results. As the qualitative data are based on write-in responses, the study team did not have the opportunity to explore and expand on the participants’ responses. A strength of this study is that the sample is composed of FQHC/safety-net clinicians. While this may limit the generalizability of the results and potentially influence their attitudes and perceptions of self-collection, these settings also offer a promising opportunity to have patients complete self-collection, given that cervical cancer screening rates tend to be lower in these practices. Additionally, the use of the Cabana Guideline Based Practice Improvement Framework to guide the survey development and data analysis is a strength of the study design and analysis. While this study includes previously published quantitative data, 20 it builds upon this work by analyzing responses to an additional open-ended survey item and mapping the responses to the Framework, which provides more context for the quantitative responses reported in Fuzzell et al. (2023). This study was conducted prior to the FDA approval of HPV self-collection, which provides important baseline information for clinicians’ perceptions of self-collection. Since HPV self-collection has been approved, clinician attitudes and perception of barriers might change with formal recognition of the value of self-collection that would not be represented in the current study. This study can help guide the adoption of self-collection by informing future interventions to: (1) provide clinician-focused educational about HPV self-collection and (2) address clinicians’ concerns and barriers to offering self-collection to their patients.
Conclusion
HPV self-collection has the potential to increase cervical cancer screening access, especially among underserved populations. Clinicians practicing in safety-net settings support HPV self-collection for patients who otherwise would not complete screening due to other barriers (e.g., transportation, difficulty with speculum exams); however, many clinicians still have reservations about the reliability of self-collection, their patients’ ability to collect an adequate sample, and the reduction in pelvic exams potentially leading to delays in identifying health concerns. With the potential for reaching under-screened populations and the recent approval of HPV self-collection in a clinical setting, further research with providers addressing these concerns is needed.
Authors’ Contributions
H.N.O.: Formal analysis, writing—original draft, writing—review and editing, visualization; P.L.: Formal analysis, investigation, writing—review and editing; L.F.: Investigation, writing—review and editing; N.C.B.: Formal analysis, investigation, writing—review and editing; M.C.: Writing—review and editing; H.B.F.: Conceptualization, methodology, investigation, writing—review and editing; R.B.P.: Conceptualization, methodology, investigation, resources, writing—review and editing, funding acquisition; S.T.V.: Conceptualization, methodology, investigation, resources, writing—review and editing, supervision, funding acquisition.
Footnotes
Author Disclosure Statement
No competing financial interests exist.
Funding Information
This study was funded by the American Cancer Society (TLC-21-002-01-TLC; PIs: Vadaparampil and Perkins). Dr. Owens’s work was funded by the National Cancer Institute while she was a postdoctoral fellow at H. Lee Moffitt Cancer Center and Research Institute (T32CA090314; MPIs: S.T. Vadaparampil and V.N. Simmons). Dr. Brownstein received support from the South Carolina Translational Research Institute (1UL1TR00145) as well as previous support from the Moffitt Cancer Center’s Biostatistics and Bioinformatics Shared Resource (BBSR) and Cancer Center Support Grant (P30CA076292). The funders had no role in the study design, conduct, or reporting.