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

Last updated: April 30, 2025
Sponsor: University of Alabama at Birmingham
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cervical Cancer

Vaginal Cancer

Pelvic Cancer

Treatment

Traditional Pap smear

Self-PAP

Clinical Study ID

NCT04093388
IRB-300002819
IRB-300002819
  • Ages 21-65
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: Traditional Pap smear
Phase:
Study Start date:
April 26, 2021
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Cahaba Medical Care - Ensley

    Birmingham, Alabama 35218
    United States

    Active - Recruiting

  • Cahaba Medical Care - West End

    Birmingham, Alabama 35211
    United States

    Active - Recruiting

  • Cahaba Medical Care

    Centreville, Alabama 35042
    United States

    Active - Recruiting

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