HPV testing on self collected cervicovaginal lavage specimens as screening method for women who do not attend cervical screening: cohort study

Gök and colleagues (1) in their cohort study showed a higher response
rate to the mailing of a self sampler device for HPV test, compared to the
standard recall letters in women non attending to regular cervical cancers
screening program (RR 1.66). This higher response leads to an increase of
compliance to the program of 5%. The authors admit that this could be an
over-estimation, because they do not know if part of the newly compliant
women were already covered by a Pap-test performed privately outside the
screening program.

We found similar results using a similar approach in three Italian
screening programs (Florence, Rome, and Abruzzo) measuring the effect on
women’s participation of a self-sampler device using different strategies
of mailing. 2479 randomly selected women, aged 35-64, who did not attend
to screening programs, were randomly divided in 4 arms: 2 intervention
arms and 2 control arms.

Here we report the results of the standard recall letter arm and those of
the direct mailing of the HPV self-sampler devices arm. These two arms are
almost identical to the Gök and colleagues’ protocol (1), including the
same device. Women in the self-sampler arm were asked to answer a short
questionnaire that included also information on the latest Pap-test date.
Overall the compliance to standard recall was 13.9% (N=619), while the
direct mailing of the self-sampler had a compliance of 19.5% (N=616)
(RR=1.4, 95% CI 1.1-1.8). The results found in the metropolitan areas were
different from those found in the rural areas. In Florence and Rome the RR
was 1.7 (95% CI=1.2-2.3), while in Abruzzo it was 0.95 (95% CI 0.61-1.50),
the heterogeneity was border-line significant (p=0.046).

The information regarding the latest Pap-test date gathered from the
questionnaires allowed to investigate the impact on population coverage
including also the contribution of private screening, as reported by
women. The analysis has been performed only in Florence and Rome, the only
place where an increase in compliance was observed and, consequently an
effect on coverage can be expected.

The analysis of the impact on Pap-test coverage showed that out of 90
women responding to the direct mailing in Florence and Rome, 4 never had a
Pap-test before and 30 were poorly covered (latest test more than 3 years
before, according to the Italian guidelines recommendations). Considering
a compliance to first call of 40%, the increase in total coverage would be
+4% (95% CI 2.8-5.6). If we consider not covered only women who performed
a Pap-test over 5 years before, those are only 14, consequently the impact
on total coverage would be less than 2%. This may appear a small increase,
but, considering the high baseline coverage in Central-Italy metropolitan
areas (more than 80%)(2), we are currently taking care the very last part
of the uncovered population.

In conclusion, surprisingly two studies, one in Holland and one in Italy,
found similar results for what concerns behavioural aspects such as
screening attendance, but we have evidence that difference may exist in
different (rural vs metropolitan) context.

References

1. Gök M, Heideman DA, van Kemenade FJ, Berkhof J, Rozendaal L, Spruyt JW,
Voorhorst F, Beliën JA, Babovic M, Snijders PJ, Meijer CJ. HPV testing on
self collected cervicovaginal lavage specimens as screening method for
women who do not attend cervical screening: cohort study. BMJ. 2010 Mar
11;340:c1040. doi: 10.1136/bmj.c1040.

2. Progressi delle Aziende Sanitarie per la Salute in Italia.
Available on the web at (last access 26/03/2010):
http://www.epicentro.iss.it/passi/report_2008.asp

Members of the Self-Sampling Study working group:
Rome: Paolo Giorgi Rossi, Alessandra Sperati, Laura Camilloni, Laila Maria
Marsili, Paola Capparucci, Concetta Bellanova; Abruzzo: Claudio Angeloni,
Amedeo Lattanzi, Tatiana Reggi, Patrizia Bruni, Clara Monaco; Florence:
Anna Iossa, Massimo Confortini, Francesca Maria Carozzi, Carmen Beatriz
Visioli, Cristina Sani, Carmelina di Pierro, Elisa Sereno.

Competing interests:
Francesca M Carozzi is occasional advisor to Gen-Probe, Abbot, Sanofi and Glaxo Smith Kline; Laziosanità received a Grant from Sanofi Pasteur MSD for a research on HPV burden of disease; Paolo Giorgi Rossi received travel reimbursement for presenting results in two conferences from Sanofi Pasteur MSD and in one from Glaxo Smith Kline. Laziosantà, ISPO and Coordinamento Screening Abruzzo are responsible for coordination and implementation of cervical cancer screening in their competence area.