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

Not Applicable

Recruiting

• Conditions: Cervical Cancer
• Interventions: Diagnostic Test: Self-PAP; Diagnostic Test: Traditional Pap smear

• Registration Number: NCT04093388
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Study Timeline

• Study First Submitted: 2019-09-16
• Study First Submitted QC: 2019-09-16
• Study First Posted: 2019-09-18
• Study Start: 2021-04-26
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-14
• Last Update Posted: 2024-04-16
• Primary Completion: 2024-12-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-PAP	Self-PAP	Each patient will participate in both arms of the study on the day of the clinical examination. This arm includes the self-administered Papanicolaou (Pap) smear. They will be compared to each other for congruence and accuracy.
Traditional Pap	Traditional Pap smear	Each patient will participate in both arms of the study on the day of the clinical examination. This arm includes the traditional, healthcare provider obtained Papanicolaou (Pap) smear specimen. They will be compared to each other for congruence and accuracy.

Primary Outcome Measures

Name	Time	Method
Evaluate the self-PAP against the traditional Pap smear procedure	Baseline through 14 days

Trial Locations

Locations (3)

Cahaba Medical Care; 🇺🇸 Centreville, Alabama, United States

Cahaba Medical Care - West End; 🇺🇸 Birmingham, Alabama, United States

Cahaba Medical Care - Ensley; 🇺🇸 Birmingham, Alabama, United States