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

Instituto Nacional de Cancerologia, Columbia

Status: Unknown

Conditions: HPV Infection; Cervical Cancer

Treatments: Diagnostic Test: SELF SAMPLING HPV; Diagnostic Test: CERVICAL HPV

Study type: Interventional

Funder types: Other

Identifiers

NCT05059015

C19010300532

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

CERVICAL HPV

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: CERVICAL HPV

SELF SAMPLING HPV ARM 2

Experimental group

Description:

Screening based on HPV self-testing and colposcopic evaluation

Treatment:

Diagnostic Test: SELF SAMPLING HPV

SELF SAMPLING HPV ARM 3

Experimental group

Description:

Arm 3: screening based only on HPV self-testing

Treatment:

Diagnostic Test: SELF SAMPLING HPV