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

Not Applicable

• Conditions: Cervical Cancer; HPV Infection
• Interventions: Diagnostic Test: SELF SAMPLING HPV; Diagnostic Test: CERVICAL HPV

• Registration Number: NCT05059015
• Lead Sponsor: Instituto Nacional de Cancerologia, Columbia

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 Timeline

• Study Start: 2019-05-01
• Primary Completion: 2020-09-24
• Status Verified: 2021-08
• Study First Submitted: 2021-08-12
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-09-28
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-12-10
• Study Completion: 2022-12-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SELF SAMPLING HPV ARM 2	SELF SAMPLING HPV	Screening based on HPV self-testing and colposcopic evaluation
CERVICAL HPV	CERVICAL HPV	Routine screening procedure based on HPV tests with cervical sampling by a health personnel
SELF SAMPLING HPV ARM 3	SELF SAMPLING HPV	Arm 3: screening based only on HPV self-testing

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Instituto Nacional de Cancerología; 🇨🇴 Bogotá, Cundinamarca, Colombia