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 |
| Protocol serial number | N/A |
| Sponsor | Centre for Disease Control and Prevention, Italian Ministry of Health (Italy) |
| Funder | Centre for Disease Control and Prevention, Italian Ministry of Health (Italy) |
- 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
Scientific
Laziosanità - Agenzia di Sanità Pubblica, Regione Lazio
via di S. Costanza 53
Rome
00198
Italy
| giorgirossi@asplazio.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Four-arm randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The 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 objectives | The 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) studied | Cervical cancer prevention |
| Intervention | Control 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 type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Performing a test (HPV or Pap) within 3 months since the recall letter. |
| Key secondary outcome measure(s) |
How many of the women performing a test after the intervention were never-screened or under-screened (last Pap test more than 3 years before)? |
| Completion date | 20/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 2400 |
| Key inclusion criteria | All women (aged 35 - 64 years) non-responding to the screening invitation in the previous year and eligible for recall |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/02/2009 |
| Date of final enrolment | 20/11/2009 |
Locations
Countries of recruitment
- Italy
Study participating centre
Laziosanità - Agenzia di Sanità Pubblica, Regione Lazio
Rome
00198
Italy
00198
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
