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Spots Global Cancer Trial Database for Human Papilloma Virus (HPV) Self-collection and Women Adherence

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Trial Identification

Brief Title: Human Papilloma Virus (HPV) Self-collection and Women Adherence

Official Title: Effect of HPV Self-collection in Adherence to Cervical Cancer Screening Algorithms

Study ID: NCT05059015

Study Description

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

Minimum Age: 30 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Instituto Nacional de Cancerología, Bogotá, Cundinamarca, Colombia

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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