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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer, HPV Infection

Intervention / Treatment
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* Diagnostic Test: CERVICAL HPV
* Diagnostic Test: SELF SAMPLING HPV


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Cancer, Screening programs, HPV tests