Clinical trial NCT05059015: Human Papilloma Virus (HPV) Self-collection and Women Adherence
Official title: Effect of HPV Self-collection in Adherence to Cervical Cancer Screening Algorithms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
HPV Infection
Keywords: Cervical Cancer
Screening programs
HPV tests
Lead sponsor: Instituto Nacional de Cancerologia, Columbia
Sponsor class: OTHER_GOV
First posted: 2021-09-28
Enrollment: 80
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Participation
timeFrame: 1 year
measure: Adherence
timeFrame: 1 year
Secondary outcomes:
measure: Quality of HPV samples
timeFrame: 1 year
measure: CIN2 + rate in the study population
timeFrame: 1 year
measure: CIN2 + rate in population with positive screening
timeFrame: 1 year
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Instituto Nacional de Cancerología
state: Cundinamarca
Study officials:
References: