Effect of HPV Self-collection in Adherence to Cervical Cancer Screening Algorithms
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Participation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
CERVICAL HPV
Routine screening procedure based on HPV tests with cervical sampling by a health personnel
Intervention: CERVICAL HPV (Diagnostic Test)
SELF SAMPLING HPV ARM 2
Screening based on HPV self-testing and colposcopic evaluation
Intervention: SELF SAMPLING HPV (Diagnostic Test)
SELF SAMPLING HPV ARM 3
Arm 3: screening based only on HPV self-testing
Intervention: SELF SAMPLING HPV (Diagnostic Test)
Outcomes
Primary Outcomes
Participation
Time Frame: 1 year
Number of women that undergo the screening test / total number of women invited.
Adherence
Time Frame: 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 Outcomes
- Quality of HPV samples(1 year)
- CIN2 + rate in the study population(1 year)
- CIN2 + rate in population with positive screening(1 year)