Adults with Preventive Care Needs Guide

KEY ACTIVITY #17:

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 cervical cancer screening. Studies have demonstrated that self-sampling has the potential to increase participation of underscreened women. In the 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.

Currently, two self-collection tests have received FDA approval for use within clinical settings: Onclarity HPV, manufactured by Becton, Dickinson and Company (BD), and cobas HPV, produced by Roche Molecular Systems. Additionally, one FDA-approved home testing kit is available; however, access to this kit is limited, as patients must utilize TEAL Health services to obtain and use the test. ​ ​

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. Most cervical cancers develop in women who have not participated in screening, making the detection of precancerous cells through regular screening a potentially lifesaving measure. 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. There are two self-collection tests approved by the FDA for use within clinical settings and one FDA-approved ​​home test. 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

Now that the FDA has approved two self-sampling tests, health centers can use the guide, Primary HPV Testing and HPV Self-Collection: A Guide to Implementing HPV Self-Collection in Clinics, and the companion presentation decks to help them decide whether to incorporate these tools into their cervical cancer screening protocols. There are two companion presentation decks:

• Primary HPV Testing and HPV Self-Collection: A Guide to Implementing HPV Self-Collection in Clinics
• For Providers: Primary HPV Testing and HPV Self-collected Testing
• For Back Office Staff: Primary HPV Testing and HPV Self-collected Testing

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.
• Centers for Disease Control and Prevention. (2023a, June 1). Self testing. Centers for Disease Control and Prevention. 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.
• NCI Cervical Cancer “last mile” initiative. Division of Cancer Prevention. (n.d.) 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.