The effect of self-sampled HPV testing on participation to cervical cancer screening in Italy: a randomised controlled trial (ISRCTN96071600)

Abstract

Background:In Italy, cervical cancer screening programmes actively invite women aged 25–64 years. Programmes are hindered by low participation.Methods:A sample of non-responder women aged 35–64 years, belonging to three different programmes (in Rome, Florence and Teramo), was randomly split into four arms: two control groups received standard recall letters to perform either Pap-test (first group) or human papillomavirus (HPV) test (second group) at the clinic. A third arm was sent letters offering a self-sampler for HPV testing, to be requested by phone, whereas a fourth group was directly sent the self-samplers home.Results:Compliance with standard recall was 13.9% (N619). Offering HPV test at the clinic had a nonsignificant effect on compliance (N616, relative risk (RR)=1.08; 95% CI=0.82–1.41). Self-sampler at request had the poorest performance, 8.7% (N622, RR=0.62; 95% CI=0.45–0.86), whereas direct mailing of the self-sampler registered the highest compliance: 19.6% (N616, RR=1.41; 95% CI=1.10–1.82). This effect on compliance was observed only in urban areas, Florence and Rome (N438, RR=1.69; 95% CI=1.24–2.30), but not in Abruzzo (N178, RR=0.95; 95% CI=0.61–1.50), a prevalently rural area.Conclusions:Mailing self-samplers to non-responders may increase compliance as compared with delivering standard recall letters. Nevertheless, effectiveness is context specific and the strategy costs should be carefully considered.

Human papillomavirus self-sampling for screening nonattenders: Opt-in pilot implementation with electronic communication platforms

“…Giorgi‐Rossi et al . invited Italian women for opt‐in self‐sampling if they had not responded to a routine invitation for 3–5 months 13, 14. Here, 20% women participated when offered to have the kit sent to home and 9–11% when they could pick it up from a local pharmacy.…”

“…An alternative approach is to have nonattenders actively “opt in,” that is, order the self‐sampling kits if interested after receiving an invitation from the screening program. Only few studies11, 12, 13, 14, 15, 16 have used the opt‐in approach so far, with a reported return rate of 9–39%. A general concern is that by requiring additional effort from women to confirm their willingness to participate, this approach is vulnerable to low participation rates 13, 14…”

Offering Self-Sampling Kits for HPV Testing to Reach Women Who Do Not Attend in the Regular Cervical Cancer Screening Program

“…In trials, the response rate among underscreened women who received invitations, including self-samplers, varied widely between settings ranging from 6% (8) to 31% (9), which was on average 2.1 times higher (95% CI, 1.3-3.5) than in the control groups who received a conventional reminder letter (4). In two trials, conducted in Italy and Sweden, women were sent a self-sampler if they confirmed their wish to receive one (10,11). The pooled difference in participation rates between the opt-in self-sampling arm and the control arm of conventional reminder letter was not significantly different from zero (1%; 95% CI, À4% to 5%; pooled from refs.…”

Preference for Human Papillomavirus–Based Cervical Cancer Screening

“…14 However, further evaluation of this approach is needed as past studies suggest that women's preference for self-sampling at home or at the clinic might vary across settings. 18-20 For instance, in a Uganda study, lack of privacy at home was cited as a barrier to self-sampling. 19 In Italy, direct mailing of a self-sampling kit to women who failed to respond to a screening invitation increased screening coverage in urban areas, but not in rural areas.…”