Patient Compliance to Self-collection for Detection of HPV-DNA

Study Overview
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Brief Summary
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A study to investigate the compliance of unassisted women to self-collection of specimens for Hybrid Capture (HC) for detection of Human Papilloma Virus (HPV) DNA compared to Pap smear collection by medical personnel, as screening method to identify precursor lesions of cervical cancer.

Detailed Description
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Women living in the community of the Morro dos Macacos, Vila Isabel, Rio de Janeiro, were randomly allocated for self-collection of specimens for HC II for detection of HPV-DNA or to Pap smear collection by medical personnel, as screening method to identify precursor lesions of cervical cancer. The compliance was measured by the delivery of the specimen obtained by self-collection or to attend to a visit at the community health center to be submitted to Pap smear collection, within a week.

Official Title
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Patient Compliance to Self-collection for Detection of HPV-DNA in Cervical Cancer Prevention: A Clinical Trial

Conditions
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Compliance, Cervical Cancer

Intervention / Treatment
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* Procedure: Self-collection
* Procedure: Gynecologist collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between 25-59 years-old Not pregnant Had held their last Pap smear for over a year Could read. Exclusion Criteria: Women with previous hysterectomy History of cervical cancer or its precursors Bearers of some state of chronic immunosuppression (such as HIV ou autoimmune diseases) Those who underwent self-collection of their specimen during menstrual period

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 59 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-collection<br>Women allocated to this arm will be asked to obtain a specimen of vaginal/cervical by self-collection for Hybrid Capture II (HCII). | Procedure: Self-collection<br>* Women allocated to this arm will be asked to obtain a specimen of vaginal/cervical by self-collection for HCII.<br>|
| Active Comparator: Gynecologist collection<br>Women allocated to this arm will be asked to attend to medical office to have their Pap smear obtained by a gynecologist | Procedure: Gynecologist collection<br>* Women allocated to this arm will be asked to attend to medical office to have their Pap smear obtained by a gynecologist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to self-collection for detection of HPV-DNA measured by the percentage of subjects that returned the vaginal self-collected sample or attended to the medical appointment according to allocation. | Risk of compliance to self-collection for detection of HPV-DNA in relation to collection by medical personnel | One week after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical cancer, Patient Compliance, HPV-DNA probes, Papanicolaou test