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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cervical Cancer; HPV Infection
• Intervention / Treatment: Diagnostic test: CERVICAL HPV; Diagnostic test: SELF SAMPLING HPV

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Cundinamarca
    • Bogotá, Cundinamarca, Colombia, 00000
      • Instituto Nacional de Cancerologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CERVICAL HPV; Routine screening procedure based on HPV tests with cervical sampling by a health personnel	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.
Experimental: SELF SAMPLING HPV ARM 2; Screening based on HPV self-testing and colposcopic evaluation	Diagnostic test: 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.
Experimental: SELF SAMPLING HPV ARM 3; Arm 3: screening based only on HPV self-testing	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of HPV samples	Number of samples suitable for analysis / Total number of samples	1 year
CIN2 + rate in the study population	Number of CIN2 + diagnosed / total women screened	1 year
CIN2 + rate in population with positive screening	Number of CIN2 + diagnosed / total of women positive at screening	1 year

Collaborators and Investigators

• Sponsor: Instituto Nacional de Cancerologia, Columbia

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): September 24, 2020
• Study Completion (Anticipated): December 3, 2022

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): December 10, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Cervical Cancer; Screening programs; HPV tests
• Additional Relevant MeSH Terms: Virus Diseases; Infections; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; DNA Virus Infections; Tumor Virus Infections; Uterine Cervical Neoplasms; Papillomavirus Infections
• Other Study ID Numbers: C19010300532

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No