Objectives

To evaluate experiences and reactions after receiving a mailed, unsolicited human papillomavirus self-sampling kit and identify psychosocial correlates of using kits.

Methods

Survey participants were underscreened women aged 30-64 who were mailed human papillomavirus kits as part of a pragmatic trial at Kaiser Permanente Washington, a United States integrated health care system. Six months after the mailing, we invited kit returners and non-returners to complete a web survey that measured psychosocial factors (e.g. cervical cancer/human papillomavirus knowledge, attitudes toward screening), experiences, and reactions to kits. We compared responses between kit returners and non-returners.

Results

Comparing 116 kit returners (272 invited) and 119 non-returners (1083 invited), we found no clinically significant differences in psychosocial factors. Overall, survey respondents showed knowledge gaps in human papillomavirus natural history (82% did not know human papillomavirus infection can clear on its own) and interpreting human papillomavirus test results (37% did not know a human papillomavirus-negative result indicates low cancer risk). Kit returners found kits convenient and easy to use (>90%). The most common reason for non-return was low confidence in ability to correctly use a kit, although many non-returners (49%) indicated that they would consider future use. Women reported low trust in human papillomavirus testing to identify women at high risk for cervical cancer (52% in returners, 42% in non-returners).

Conclusions

Screening programs could improve uptake and acceptability of human papillomavirus self-sampling through outreach materials that emphasize the high efficacy of human papillomavirus testing for cervical cancer screening and educate patients about how to interpret results.

Women who delay or do not attend Papanicolaou (Pap) screening are at increased risk for cervical cancer. Trials in countries with organized screening programs have demonstrated that mailing high-risk (hr) human papillomavirus (HPV) self-sampling kits to under-screened women increases participation, but U.S. data are lacking. HOME is a pragmatic randomized controlled trial set within a U.S. integrated healthcare delivery system to compare two programmatic approaches for increasing cervical cancer screening uptake and effectiveness in under-screened women (>3.4years since last Pap) aged 30-64years: 1) usual care (annual patient reminders and ad hoc outreach by clinics) and 2) usual care plus mailed hrHPV self-screening kits. Over 2.5years, eligible women were identified through electronic medical record (EMR) data and randomized 1:1 to the intervention or control arm. Women in the intervention arm were mailed kits with pre-paid envelopes to return samples to the central clinical laboratory for hrHPV testing. Results were documented in the EMR to notify women's primary care providers of appropriate follow-up. Primary outcomes are detection and treatment of cervical neoplasia. Secondary outcomes are cervical cancer screening uptake, abnormal screening results, and women's experiences and attitudes towards hrHPV self-sampling and follow-up of hrHPV-positive results (measured through surveys and interviews). The trial was designed to evaluate whether a programmatic strategy incorporating hrHPV self-sampling is effective in promoting adherence to the complete screening process (including follow-up of abnormal screening results and treatment). The objective of this report is to describe the rationale and design of this pragmatic trial.

Objective

We explored patient perspectives after a positive human papillomavirus (HPV) self-sampling result to describe experiences and information needs for this home-based screening modality.

Materials and methods

We recruited women who tested high-risk (hr) HPV positive during a pragmatic trial evaluating mailed hrHPV self-sampling kits as an outreach strategy for women overdue for Pap screening in a U.S. integrated health care system. Telephone interviews were conducted from 2014 to 2017. Five independent coders analyzed transcripts using iterative content analysis.

Results

Forty-six women (61% of invited; median age 55.5 years) completed a semistructured interview. Six themes emerged: (1) convenience of home-based screening, (2) intense feelings and emotions after receiving positive kit results, (3) importance of seeing provider and discussing kit results, (4) information seeking from various sources, (5) confusion about purpose and meaning of HPV versus Pap tests, and (6) concern that HPV self-sampling is inaccurate when the subsequent Pap test is normal.

Conclusions

Although women liked the kit's convenience, discussion about discordant home HPV and in-clinic Pap results led them to question the accuracy of HPV self-sampling. Patient-provider communication around home HPV kits is more complex than for reflex or cotesting because clinician-collected Pap results are unknown at the time of the positive kit result. Patients need education about differences between HPV and Pap tests and how they are used for screening and follow-up. To reassure patients and keep them interested in self-sampling, education should be provided at multiple time points during the screening process.