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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT04093388
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Self-PAP — DIAGNOSTIC_TEST
    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.
  • Traditional Pap smear — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Apr 26, 2021
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • 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.
  • 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.

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Cahaba Medical Care - EnsleyBirminghamAlabama35218
Claire Ahalt
[email protected]
2059262992
John Waits, MD
[email protected]
2059262992
Cahaba Medical Care - West EndBirminghamAlabama35211
Kelsey Price, RN
[email protected]
2059262992
John B Waits, MD
[email protected]
2059262992
Cahaba Medical CareCentrevilleAlabama35042
John B Waits, MD
[email protected]
2059262992
Nikki Savage, CRNP
[email protected]
2059262992

Find similar trials in Birmingham, AL

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Cahaba Medical Care - Ensley· Birmingham, ALCahaba Medical Care - West End· Birmingham, ALCahaba Medical Care· Centreville, AL

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