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Completed

NCT Number: NCT02431520

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

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.

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Key information

Conditions

Compliance Behavior Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Health Behavior Neoplasms Neoplasms by Site Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

25 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Saúde da Mulher, da Criança e do Adolescente Fernandes Figueira (IFF/Fiocruz)

Rio de Janeiro, 222250-020, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-collection

Procedure

Women allocated to this arm will be asked to obtain a specimen of vaginal/cervical by self-collection for HCII.

Gynecologist collection

Procedure

Women allocated to this arm will be asked to attend to medical office to have their Pap smear obtained by a gynecologist

Primary outcomes

  1. 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.

    Time frame: One week after inclusion

    Risk of compliance to self-collection for detection of HPV-DNA in relation to collection by medical personnel

Sponsors and collaborators

Lead sponsor

Oswaldo Cruz Foundation

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
May 1, 2015
Registry last updated
May 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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