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

Not Applicable

Completed

• Conditions: Compliance; Cervical Cancer
• Interventions: Procedure: Gynecologist collection; Procedure: Self-collection

• Registration Number: NCT02431520
• Lead Sponsor: Oswaldo Cruz Foundation

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2007-09
• Study Completion: 2007-12
• Study First Submitted: 2014-09-15
• Study First Submitted QC: 2015-04-27
• Status Verified: 2015-05
• Study First Posted: 2015-05-01
• Last Update Submitted: 2015-05-05
• Last Update Posted: 2015-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gynecologist collection	Gynecologist collection	Women allocated to this arm will be asked to attend to medical office to have their Pap smear obtained by a gynecologist
Self-collection	Self-collection	Women allocated to this arm will be asked to obtain a specimen of vaginal/cervical by self-collection for Hybrid Capture II (HCII).

Primary Outcome Measures

Name	Time	Method
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.	One week after inclusion	Risk of compliance to self-collection for detection of HPV-DNA in relation to collection by medical personnel

Trial Locations

Locations (1)

Instituto Nacional de Saúde da Mulher, da Criança e do Adolescente Fernandes Figueira (IFF/Fiocruz); 🇧🇷 Rio de Janeiro, Brazil