The effect of a self-sampling device for human papillomavirus (HPV) test on the women's participation to cervical cancer screening in Italy

ISRCTN ISRCTN96071600
DOI https://doi.org/10.1186/ISRCTN96071600
Secondary identifying numbers N/A
Submission date
24/08/2009
Registration date
18/05/2010
Last edited
24/02/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Paolo Giorgi Rossi
Scientific

Laziosanità - Agenzia di Sanità Pubblica, Regione Lazio
via di S. Costanza 53
Rome
00198
Italy

giorgirossi@asplazio.it

Study information

Study designFour-arm randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a participant information sheet
Scientific titleThe effect of a self-sampling device for human papillomavirus (HPV) test on the women's participation to cervical cancer screening in Italy: a four-arm randomised controlled trial
Study objectivesThe use of a self-sampler may remove some of the barriers for women's participation to cervical cancer screening programs.
Ethics approval(s)The Ethical Committee of ISPO, a Cancer Prevention and Study Centre, approved on the 6th June 2008 (ref: 6)
Health condition(s) or problem(s) studiedCervical cancer prevention
InterventionControl 1: standard recall letter to perform Pap test at the clinic
Control 2: standard recall letter to perform Pap test at the clinic
Intervention 1: direct mailing of the self sampling device at home
Intervention 2: invitation to contact the centre to receive the self sampling device at home

Total duration of follow-up for all arms: 3 months.
Intervention typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measurePerforming a test (HPV or Pap) within 3 months since the recall letter.
Secondary outcome measuresHow many of the women performing a test after the intervention were never-screened or under-screened (last Pap test more than 3 years before)?
Overall study start date01/02/2009
Completion date20/11/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants600 women per arm (total 2400)
Key inclusion criteriaAll women (aged 35 - 64 years) non-responding to the screening invitation in the previous year and eligible for recall
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/02/2009
Date of final enrolment20/11/2009

Locations

Countries of recruitment

  • Italy

Study participating centre

Laziosanità - Agenzia di Sanità Pubblica, Regione Lazio
Rome
00198
Italy

Sponsor information

Centre for Disease Control and Prevention, Italian Ministry of Health (Italy)
Government

Viale Giorgio Ribotta, 5
Rome
00144
Italy

an.federici@sanita.it
http://www.ministerosalute.it/
ROR logo https://ror.org/00789fa95

Funders

Funder type

Government

Centre for Disease Control and Prevention, Italian Ministry of Health (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 18/01/2011 Yes No
BMC - Part of Springer Nature Springer Nature