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Human Papilloma Virus DNA Self-Test (HPV)

University of Louisville (UOFL) logo

University of Louisville (UOFL)

Status

Completed

Conditions

Papilloma Virus, Human

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

HPV DNA testing by a clinician has been shown to be highly sensitive in detecting cervical disease. Can we prove that HPV self-testing will be sufficiently sensitive to detect disease in high risk population who for various reasons would not have routine pap smear screening?

Full description

Women between the ages of 18 years to post-menopausal with documented abnormal pap smear atypical squamous cells of undetermined significance and higher will be enrolled into the study. Patients will be taught how to collect vaginal samples with dacron swab and vaginal tampons by means of instructional video and manufacturer's instruction guide respectively. Physicians will perform pap smear and colposcopy. All samples will be sent to the University of Louisville lab for processing for HPV DNA detection by Hybrid capture 2 method.

Enrollment

171 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Abnormal pap smear ASCUS or higher

Age 18-postmenopausal

Exclusion criteria

Less than 18 years old

Prior hysterectomy

Pregnancy

Use of corticosteroids

HIV positive

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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