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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05059015
• Other study ID #: C19010300532
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: December 3, 2022

Study information

• Verified date: August 2021
• Source: Instituto Nacional de Cancerologia, Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 3, 2022
• Est. primary completion date: September 24, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• HPV Infection
• Papillomavirus Infections
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• CERVICAL HPV
A screening test with an HPV test is performed by a health professional plus cytology taking, if it reports positive, colposcopy and biopsy are taken, those with a CIN2 + report are directed to receive treatment.
• SELF SAMPLING HPV
A screening test is performed with an HPV test by self-testing, if it reports positive, women will receive ablative treatment according to eligibility criteria. If they do not meet the criteria for ablation, they will be referred for excisional treatment.

Locations

Country	Name	City	State
Colombia	Instituto Nacional de Cancerología	Bogotá	Cundinamarca

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cancerologia, Columbia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation	Number of women that undergo the screening test / total number of women invited.	1 year
Primary	Adherence	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.	1 year
Secondary	Quality of HPV samples	Number of samples suitable for analysis / Total number of samples	1 year
Secondary	CIN2 + rate in the study population	Number of CIN2 + diagnosed / total women screened	1 year
Secondary	CIN2 + rate in population with positive screening	Number of CIN2 + diagnosed / total of women positive at screening	1 year