Self-Collected Pap Smears for Cervical Cancer Screening

This study is looking at whether a Pap smear you collect yourself (Self-PAP) is as accurate as a traditional Pap smear collected by a healthcare provider. The goal is to see if self-collection could be a good way to improve cervical cancer screening rates, especially in rural areas. You can join if you are a woman between 21 and 65 years old who needs a routine cervical cancer screening. You cannot join if you have a history of cervical cancer, a positive Pap smear, or have had a total hysterectomy. The study will compare the results of both types of Pap smears to see if they are similar. The study is currently unclear on its recruitment status and plans to enroll 250 participants.

Study design
This is an interventional study involving a single group of 250 participants. Both the self-collected and traditional Pap smears will be assessed by pathologists who don't know which sample came from which collection method (blinded assessment).
What's involved
You would perform a self-administered Pap smear immediately before having a traditional Pap smear done by a healthcare provider. Your results will be shared with you in the usual way by your clinic.
Compensation
Not stated in the trial record.
Follow-up
The study will evaluate the self-PAP against the traditional Pap smear procedure from when you join (Baseline) through 14 days.

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NCT04093388

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

Recruiting
NAAges 21–65InterventionalScreening
University of Alabama at Birmingham
~250 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:Self-PAPTraditional Pap smear

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate the self-PAP against the traditional Pap smear procedure
Measured over Baseline through 14 days
Cervical Cancer
3 sites across 1 states
Alabama3
  • John B Waits, MD · PRINCIPAL_INVESTIGATOR · PI

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.
  • Evaluate the self-PAP against the traditional Pap smear procedureBaseline through 14 days