Cervical Cancer, HPV Infection
Conditions
Keywords
Cervical Cancer, Screening programs, HPV tests
Brief summary
Despite declining mortality in high-income countries, cervical cancer continues to be a public health problem in low and middle -income countries. HPV tests have shown a better sensibility and a higher capacity of reducing mortality than cytology based-screening. Greater participation has been demonstrated with the use of HPV self-testing when it is offered to women with a poor screening history; however, it is not clear whether getting tested necessarily translates into a greater adherence to the entire clinical protocol, including diagnosis and treatment of precancerous lesions. The aim of this study is to evaluate the effect of the self-testing techniques on the participation and adherence of women to cervical cancer screening.
Detailed description
The investigators will perform a randomized clinical trial with three arms including: regular HPV with cytology triage, colpo/biopsy, and treatment if indicated; HPV self-collection without cytology triage but with colpo/biopsy and treatment if indicated, HPV self-collection with immediate treatment for women with positive test results. This study will be carried out in two different settings with differential access to diagnosis and treatment. Two methods will be used for inviting women and collecting samples: mail and door-to-door. Participation (screening uptake) and adherence to the clinical protocol (compliance with diagnosis and treatment) will be evaluated.
Interventions
DIAGNOSTIC_TESTCERVICAL HPV
A screening test with an HPV test is performed by a health professional plus cytology taking, if it reports positive, colposcopy and biopsy are taken, those with a CIN2 + report are directed to receive treatment.
DIAGNOSTIC_TESTSELF SAMPLING HPV
A screening test is performed with an HPV test by self-testing, if it reports positive, women will receive ablative treatment according to eligibility criteria. If they do not meet the criteria for ablation, they will be referred for excisional treatment.
Sponsors
Instituto Nacional de Cancerologia, Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
A randomized clinical trial with three arms will be performed: One group with the routine screening procedure based on HPV tests with cervical sampling by a health personnel ( 3 visits: sampling, colpo/biopsy, treatment of CIN2 +), a second group with a screening based on HPV self-testing and colposcopic evaluation (2 visits: colpo/biopsy, treatment of CIN2 + ); and a third group with a screening based only on HPV self-testing (1 visit: HPV + treatment according to eligibility).
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Women 30-65 years old * No history of cytology or any other screening test for cancer of the cervix in the past 5 years * Be linked to one of the health providing entities participating in the study * Women who sign the informed consent.
Exclusion criteria
* Women 30-65 years old * No history of cytology or any other screening test for cancer of the cervix in the past 5 years * Be linked to one of the health providing entities participating in the study * Women who sign the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participation | 1 year | Number of women that undergo the screening test / total number of women invited. |
| Adherence | 1 year | Number of women that undergo the screening test + women who completed the diagnosis and treatment process / total number of women invited + total number of women with a positive screening in follow-up protocols. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of HPV samples | 1 year | Number of samples suitable for analysis / Total number of samples |
| CIN2 + rate in the study population | 1 year | Number of CIN2 + diagnosed / total women screened |
| CIN2 + rate in population with positive screening | 1 year | Number of CIN2 + diagnosed / total of women positive at screening |
Countries
Colombia
Outcome results
None listed