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NCT04093388NARecruiting

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

University of Alabama at Birmingham

Start Date

4/26/2021

Completion Date

6/30/2027

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.

Detailed Description

Papanicolaou (Pap) smears will be both self-obtained by the patient and obtained by a licensed physician, nurse practitioner, or physician assistant. Specimens will then be collected by the nurse or medical assistant who will label each specimen separately. Specimens will be blinded so that the pathologist will not know which specimen was self-collected and which provider-collected. Specimens will then be sent to our clinical laboratory provider (LabCorp) for analysis. Once results from the Pap smears are received, participants will be notified in the usual manner in our clinical practice. Finally, analysis will be conducted to ascertain whether or not a self-administered (by the patient) Pap smear is as accurate as a traditional Pap smear administered by a healthcare provider.

Eligibility Criteria

Age Range: 21 years to 65 years

Inclusion Criteria: * Female of at least 21 years of age and not over 65 presenting who need routine cervical cancer screening per national guidelines. Exclusion Criteria: * 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_TEST

Self-PAP

DIAGNOSTIC_TEST

Traditional Pap smear

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Conditions

Cervical Cancer

Locations

Cahaba Medical Care - West End

Birmingham, Alabama 35211

United States

Cahaba Medical Care - Ensley

Birmingham, Alabama 35218

United States

Cahaba Medical Care

Centreville, Alabama 35042

United States