Preventing cervical cancer using HPV self-sampling: direct mailing of test-kits increases screening participation more than timely opt-in procedures - a randomized controlled trial

Abstract

BackgroundCervical cancer screening participation remains insufficient in most countries. Our aim was to evaluate whether offering a HPV self-sampling kit, either mailed directly to the woman’s home or using timely opt-in procedures for ordering the kit, increased screening participation compared with a standard second reminder.MethodsIn this randomized, controlled effectiveness trial, 9791 Danish women aged 30–64 who were due to receive the second reminder were equally randomized to either: 1) direct mailing of a second reminder and a self-sampling kit (directly mailed group); 2) mailing of a second reminder that offered a self-sampling kit to be ordered by e-mail, text message, phone, or webpage (opt-in group); or 3) mailing of a second reminder to attend regular cytology screening (control group). In an intention-to-treat analysis, we estimated the participation rate at 180 days post intervention, by returning a self-sample or attending regular cytology screening. We calculated the proportion of women with a positive HPV self-sample who attended for cervical cytology triage at the general practitioner within 90 days.ResultsParticipation was significantly higher in the directly mailed group (38.0%) and in the opt-in group (30.9%) than in the control group (25.2%) (participation difference (PD): 12.8%, 95% CI: 10.6–15.0% and PD: 5.7%, 95% CI: 3.5–7.9%, respectively). Within 90 days, 107 women (90.7%, 95% CI: 83.9–95.3%) with a HPV-positive self-sample attended follow-up.ConclusionsOffering the opportunity of HPV self-sampling as an alternative to regular cytology screening increased participation; the direct mailing strategy was the most effective invitation strategy. A high compliance with follow-up was seen.Trial registrationCurrent Controlled Trials NCT02680262. Registered 10 February 2016.

Increasing participation in cervical screening by targeting long‐term nonattenders: Randomized health services study

“…A proportion of women who ordered self-sampling kits, or were issued kits, instead participated via a regular screening cytology visit, a finding which has also been observed by others. 8,10 We may have reduced barriers to screening attendance in unknown ways, perhaps through an information or stronger reminder effect. The invitation letters in Arms 1-3 stated that women were contacted since they had not attended for more than 10 years, which may have catalyzed attendance.…”

“…7 Invitations to call a "nurse navigator" or offering a possibility to order HPV self-sampling kits online may be other options. [8][9][10] Such alternative strategies could lead to greater participation in long-term nonattenders, without substantial increases in health care resource use due to the limited size of this group. HPV testing on self-samples has similar accuracy for the detection of cervical precancer as HPV testing on clinician samples if a clinically validated PCR-based HPV assay is used.…”

Determinants for Participation in Human Papillomavirus Self-Sampling among Nonattenders to Cervical Cancer Screening in Denmark

“…Despite the promising results of studies in which self-sampling was offered to nonparticipants in routine screening, we have limited knowledge about which population groups are reached by this screening method and about the characteristics of women who do not accept the offer. Previous studies have found that sociodemographic characteristics, including ethnicity and educational level (14,(17)(18)(19), and previous screening behavior (12,16,(18)(19)(20)(21) are associated with self-sampling participation. To increase our knowledge of participation in self-sampling among nonattenders at routine cervical cancer screening, we conducted a registry-and questionnaire-based study among women invited for the Danish CSi study.…”

“…Recently, self-sampling, in which women collect a sample in their home and send it to a laboratory for HPV testing, was proposed as a method to overcome these barriers. There is growing evidence that this method appeals to women who would not otherwise be screened (12)(13)(14)(15)(16). In the Copenhagen Self-sampling initiative (CSi), a large-scale implementation study in which self-sampling was offered to 23,632 nonparticipants in the Danish routine screening program, 20% of the invited women participated in self-sampling (16).…”

Urine Collection in Cervical Cancer Screening – Comparison of Two HPV DNA Assays

“…The introduction of high-risk human papillomavirus (hrHPV) DNA testing in cervical cancer screening programs allows nonparticipating women to self-sample a cervico-vaginal sample in their own home using a device and return the sample to the laboratory for hrHPV testing by mail [1][2][3]. Home-based cervico-vaginal self-sampling is a well-accepted screening method, proven to increase screening participation signi cantly compared to mailed reminders to attend clinician-based screening [1,4]. Nevertheless, even with the cervico-vaginal self-sampling offer, some women are still not engaged in screening, possibly explained by the women's uncertainty about proper self-sampling including fear of injuries and discomfort touching oneself [5].…”