A randomized, controlled trial of two strategies of offering the home‐based HPV self‐sampling test to non‐ participants in the Flemish cervical cancer screening program

Abstract

We conducted a randomized, controlled trial to evaluate different strategies of offering an HPV-self sampling program, and compared this with two control groups. All total of 35,354 women who did not participate in the Flemish cancer screening program were included in the study: 9,118 received a HPV self-collection brush (RIATOL qPCR HPV genotyping test (qPCR [E6/E7]); 9,098 were offered the opportunity to order an HPV-selfsampling brush, 8,830 received the recall letter; 8,849 received no intervention. Within 12 months after the mailing, 18.7% of the women who had received the brush, participated by returning a self-sample sample, while 10.6% women allocated to the opt- in group did so. 10.5% women who received the standard recall letter, had a PAP smear taken within a period of 12 months; while 8% women did so without receiving an intervention at all. Participation in postmenopausal women was higher than in women younger than 50 in both self-sampling arms. Screening by means of the self-sample kit increased by age, contradictory when screening is performed by a PAP smear. Of those testing hrHPV positive (9.5%), 88.9% attended for follow up cytology. The mean DNA concentration, found in the self-sampler, decreased by age, causing a higher number of inconclusive results. Our results support the efficacy of a self-sampling strategy to increase participation in the Flemish screening program. Self-sampling seems particularly acceptable to postmenopausal non-responders. Future research should focus on the performance of different self-sampling devices in post-menopausal women as low DNA concentrations exponentially increased over age.

Self-sampling for human papillomavirus (HPV) testing: a systematic review and meta-analysis

“…After two independent reviewers screened in duplicate and gained consensus, 149 articles were pulled for full-text review. Of these, 33 studies (reported in 34 articles) were included in the review 21–54…”

“…Substantial heterogeneity was present in all meta-analyses of screening uptake. Combining all self-sampling kit dissemination methods, meta-analysis of the 29 reported effect sizes from RCTs21–25 27 29–36 38–47 50–54 found that women were twice as likely to use cervical cancer screening services through self-sampling compared with standard-of-care screening practices (RR: 2.13, 95% CI 1.89 to 2.40, I-squared: 99.34) (figure 2).…”

“…In the 23 RCTs comparing opt-out HPV self-sampling (kit directly mailed to home address) with control,22–24 27 29–36 39 42 43 45–47 51–54 meta-analysis found that HPV self-sampling was associated with twice the likelihood of attending screening compared with control (RR: 2.27, 95% CI 1.89 to 2.71, I-squared: 99.27) (figure 3). These RCTs all took place in Europe, except for two in Canada and one in Nigeria.…”

“…Meta-analysis of five RCTs29 30 35 36 47 found a non-significant increase in likelihood of HPV screening participation for opt-in HPV self-sampling where participants requested or picked up self-sampling kits compared with control (RR: 1.28, 95% CI 0.90 to 1.82, I-squared: 98.36) (figure 5). These RCTs all took place in Europe among women aged 30–65 who were hard to reach through conventional cervical cancer screening programmes.…”

DNA concentration from self samples for HPV testing

“…

Dear Editor, We read with interest the article of Kellen et al 1 We are encouraged by the positive response to self-sampling, particularly among postmenopausal women. However, we were struck by the findings that DNA concentration decreased as a function of age.

…”