Preventive Care - Key Activity 19

KEY ACTIVITY #19:

Explore the Development of Self-Sampling Techniques for Human Papillomavirus (HPV) Screening

 

This activity involves the following elements of person-centered population-based care: operationalize clinical guidelines; proactive patient outreach and engagement; pre-visit planning and care gap reduction; address social needs.

Overview

This activity offers guidance to practices exploring the development of self-sampling techniques that screen for the presence of human papillomavirus (HPV) as an alternative to a clinician-obtained Pap smear. Studies have demonstrated that self-sampling has the potential to increase participation of underscreened women. In the limited nations where it has been used, self-sampling for HPV has shown high levels of satisfaction among patients.1,6 In the United States, HIV self-testing has been demonstrated to decrease barriers to HIV screening and is supported by the CDC.2 Additionally, self-sampling for detection of chlamydia and gonorrhea has demonstrated both high performance and high patient acceptance. The National Cancer Institute is currently supporting a public-private partnership to bring together federal agencies, industry partners and professional societies to contribute evidence about the accuracy and clinical effectiveness of self-sampling based on HPV testing for cervical cancer screening. This partnership is called the Last Mile Initiative and is designed to evaluate the usability, acceptability and accuracy of multiple self-sampling device-assay combinations and is expected to inform future utility of self-sampling for HPV as an effective tool.

Self-sampling is not yet approved by the FDA in the United States, and it is unclear if or when self-sampling will be approved by the Health Resources and Services Administration (HRSA). However, given World Health Organization (WHO) support for self-sampling techniques and the expansion of technology, this is an option whose development is worth following.

 

Why this matters

Cervical cancer is a common disease caused by the human papillomavirus (HPV), and the presence of certain HPV subtypes on cervical cancer screening is understood to be a marker that may lead to cancer. Thus, screening for these precancerous cells can be lifesaving. Yet many eligible women do not undergo screening for cervical cancer due to barriers, such as transportation, time and fear of undergoing a pelvic exam. A new method of HPV testing can be performed on vaginal samples collected by the patient through self-sampling techniques. These techniques and materials are under evaluation in the United States and may prove to be effective tools for HPV detection among women at risk. In countries where self-sampling is used, the technique has demonstrated high levels of patient acceptance. A randomized controlled study of over 31,000 individuals enrolled in a U.S. healthcare system demonstrated that direct mail self-sampling increased fulfillment of cervical cancer screening by more than 14% among those who were due or overdue for cervical cancer screening.

 

Action steps and roles

Because HPV self-sampling techniques are not yet licensed by the FDA or approved by HRSA for use in federally qualified health centers (FQHCs), the technique is not available for health centers at this time. However, practices are encouraged to follow the development of these technologies and continue to evaluate them for possible use in patient populations. In the event self-sampling tools are approved by the FDA and approved for use in health centers, suggested action steps are provided.

To follow are potential steps for developing self-sampling techniques for human papillomavirus (HPV) screening:

  1. Establish a protocol for self-sampling for HPV that adheres to evidence-based guidance and risk and benefit assessment and adheres to effective sample handling and processing.
  2. Educate clinicians and support personnel about self-sampling options so that they are able to discuss the options with patients and process materials effectively. See the CDC self-sampling education program under resources for this activity.
  3. Identify patients who are eligible for self-sampling, inform them of the option, and discuss the risks and benefits of self-sampling for HPV.
  4. Inform patients about the risks and benefits of self-sampling, discuss the sampling technique, respond to questions, and provide materials and guidance for returning the sample.
  5. Identify workflows that enable patient education, timely return of the specimen, specimen processing, communication of test results, and appropriate patient follow-up based on test results.
  6. Send patients reminders about the timing of sampling and sampling technique.
  7. Process self-samples that are returned to the practice.

This technique is still under scientific study and global use is limited.

Should this method be approved by HRSA, PHMI will provide more detailed guidance for practices.

Evidence base for this activity

  • Di Gennaro G, Licata F, Trovato A, Bianco A. Does self-sampling for human papillomavirus testing have the potential to increase cervical cancer screening? An updated meta-analysis of observational studies and randomized clinical trials. Front Public Health. 2022 Dec 8;10:1003461. doi: 10.3389/fpubh.2022.1003461. PMID: 36568753; PMCID: PMC9773849.
  • https://www.cdc.gov/stophivtogether/hiv-testing/self-testing.html
  • Van Der Pol B, Taylor SN, Mena L, Lebed J, McNeil CJ, Crane L, Ermel A, Sukhija-Cohen A, Gaydos CA. Evaluation of the Performance of a Point-of-Care Test for Chlamydia and Gonorrhea. JAMA Netw Open. 2020 May 1;3(5):e204819. doi: 10.1001/jamanetworkopen.2020.4819. PMID: 32407506; PMCID: PMC7225902.
  • https://prevention.cancer.gov/major-programs/nci-cervical-cancer-last-mile-initiative
  • Madzima TR, Vahabi M, Lofters A. Emerging role of HPV self-sampling in cervical cancer screening for hard-to-reach women: Focused literature review. Can Fam Physician. 2017 Aug;63(8):597-601. PMID: 28807952; PMCID: PMC5555324.
  • Wong EL, Cheung AW, Wong AY, Chan PK. Acceptability and Feasibility of HPV Self-Sampling as an Alternative Primary Cervical Cancer Screening in Under-Screened Population Groups: A Cross-Sectional Study. Int J Environ Res Public Health. 2020 Aug 27;17(17):6245. doi: 10.3390/ijerph17176245. PMID: 32867315; PMCID: PMC7503998.
  • Winer RL, Lin J, Anderson ML, et al. Strategies to Increase Cervical Cancer Screening With Mailed Human Papillomavirus Self-Sampling Kits: A Randomized Clinical Trial. JAMA. 2023;330(20):1971–1981. doi:10.1001/jama.2023.21471.
  • Serrano B, Ibáñez R, Robles C, Peremiquel-Trillas P, de Sanjosé S, Bruni L. Worldwide use of HPV self-sampling for cervical cancer screening. Prev Med. 2022 Jan;154:106900. doi: 10.1016/j.ypmed.2021.106900. Epub 2021 Nov 30. PMID: 34861338.