RecruitingNot ApplicableNCT04093388

Self-Collection of the Pap Smear as Agency: A Novel Way to Improve Refractory Low Cervical Cancer Screening Rates in Rural Alabama


Sponsor

University of Alabama at Birmingham

Enrollment

250 participants

Start Date

Apr 26, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the study is to find out if a self-administered (by the patient) Papanicolaou (Pap) smear is as accurate as a traditional Pap smear administered by a healthcare provider.


Eligibility

Sex: FEMALEMin Age: 21 YearsMax Age: 65 Years

Inclusion Criteria1

  • Female of at least 21 years of age and not over 65 presenting who need routine cervical cancer screening per national guidelines.

Exclusion Criteria1

  • prior history of cervical cancer or a positive Pap smear, have had a total hysterectomy (removal of uterus and cervix), or currently enrolled in any other cancer prevention study.

Interventions

DIAGNOSTIC_TESTSelf-PAP

A single cohort of 250 patients will be recruited from among those who need a Papanicolaou (Pap) smear for routine cervical cancer screening, to perform a self-administered Pap smear immediately prior to the traditional Pap smear. Blinded assessment of both tests will be then conducted.

DIAGNOSTIC_TESTTraditional Pap smear

A single cohort of 250 patients will be recruited from among those who need a Papanicolaou (Pap) smear for routine cervical cancer screening, to perform a self-administered Pap smear immediately prior to the traditional Pap smear. Blinded assessment of both tests will be then conducted.


Locations(3)

Cahaba Medical Care - West End

Birmingham, Alabama, United States

Cahaba Medical Care - Ensley

Birmingham, Alabama, United States

Cahaba Medical Care

Centreville, Alabama, United States

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NCT04093388


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