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

NCT05059015 | Unknown DMC

• 1 other identifier: C19010300532
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; HPV Infection

Keywords

Cervical Cancer; Screening programs; HPV tests

Outcome Measures

Primary Outcomes (2)

• Participation

  Number of women that undergo the screening test / total number of women invited.

  1 year

• 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 Outcomes (3)

• Quality of HPV samples

  1 year

• CIN2 + rate in the study population

  1 year

• CIN2 + rate in population with positive screening

  1 year

Study Arms (3)

CERVICAL HPV

ACTIVE COMPARATOR

Routine screening procedure based on HPV tests with cervical sampling by a health personnel

Diagnostic Test: CERVICAL HPV

SELF SAMPLING HPV ARM 2

EXPERIMENTAL

Screening based on HPV self-testing and colposcopic evaluation

Diagnostic Test: SELF SAMPLING HPV

SELF SAMPLING HPV ARM 3

EXPERIMENTAL

Arm 3: screening based only on HPV self-testing

Diagnostic Test: SELF SAMPLING HPV

Interventions

CERVICAL HPV DIAGNOSTIC_TEST

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.

CERVICAL HPV

SELF SAMPLING HPV DIAGNOSTIC_TEST

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.

SELF SAMPLING HPV ARM 2; SELF SAMPLING HPV ARM 3

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: Women with no history of cytology or any other screening test for cancer of the cervix in the past 5 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Cancerologia, Columbia: lead

Study Sites (1)

Instituto Nacional de Cancerología

Bogotá, Cundinamarca, 00000, Colombia

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: September 28, 2021
• Study Start: May 1, 2019
• Primary Completion: September 24, 2020
• Study Completion: December 3, 2022
• Last Updated: December 10, 2021

Record last verified: 2021-08

Locations

CO (1)