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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2022-12-03

Brief Summary

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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

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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.

Conditions

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Cervical Cancer HPV Infection

Keywords

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Cervical Cancer Screening programs HPV tests

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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