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

April 14, 2024 updated by: John B. Waits, MD, University of Alabama at Birmingham
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: Self-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.
Experimental: Traditional Pap
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.
Diagnostic test: Traditional 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the self-PAP against the traditional Pap smear procedure
Time Frame: Baseline through 14 days
Baseline through 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Laboratory Corporation of America
Cahaba Medical Care Foundation

Investigators

  • Principal Investigator: John B Waits, MD, PI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2021

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

August 30, 2025

Study Registration Dates

First Submitted

September 16, 2019

First Submitted That Met QC Criteria

September 16, 2019

First Posted (Actual)

September 18, 2019

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 14, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300002819

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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