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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02431520

Enrollment

100

Registered

2015-05-01

Start date

2007-05-31

Completion date

2007-12-31

Last updated

2015-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Compliance

Keywords

Patient Compliance, HPV-DNA probes, Papanicolaou test, Cervical cancer

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.

Interventions

PROCEDURESelf-collection

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

PROCEDUREGynecologist collection

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 59 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026