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

Oswaldo Cruz Foundation

Status: Completed

Conditions: Compliance; Cervical Cancer

Treatments: Procedure: Self-collection; Procedure: Gynecologist collection

Study type: Interventional

Funder types: Other

Identifiers

NCT02431520

58/07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 25 to 59 years old

Volunteers: No 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

Trial design

100 participants in 2 patient groups

Self-collection

Experimental group

Description:

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

Treatment:

Procedure: Self-collection

Gynecologist collection

Active Comparator group

Description:

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

Treatment:

Procedure: Gynecologist collection