Recruiting

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

Sponsor:

University of Alabama at Birmingham

Code:

NCT04093388

Conditions

Cervical Cancer

Eligibility Criteria

Sex: Female

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Self-PAP

Traditional Pap smear

Study Details

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.

Conditions

Cervical Cancer

Study ID

NCT04093388

Start date

Apr 26, 2021

Status verified date

Mar, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 21 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

250 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

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.

Interventions

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.

Traditional Pap smear

Primary outcome measure

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

Central Contacts and Locations

Central contacts

John B Waits, MD

2052772379 john.waits@cahabamedicalcare.com

Lacy Smith, PhD

2053378726 lacy.smith@cahabamedicalcare.com

Locations

Cahaba Medical Care - West End

Recruiting

Birmingham, Alabama, United States, 35211

Contacts

Kelsey Price, RN

2059262992 kelsey.price@cahabamedicalcare.com

John B Waits, MD

2059262992 john.waits@cahabamedicalcare.com

Cahaba Medical Care - Ensley

Recruiting

Birmingham, Alabama, United States, 35218

Contacts

Claire Ahalt

2059262992 claire.ahalt@cahabamedicalcare.com

John Waits, MD

2059262992 John.waits@cahabamedicalcare.com

Cahaba Medical Care

Recruiting

Centreville, Alabama, United States, 35042

Contacts

John B Waits, MD

2059262992 john.waits@cahabamedicalcare.com

Nikki Savage, CRNP

2059262992 nikki.savage@cahabamedicalcare.com

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Keywords

Pap smear
Papanicolaou
self-collection
cervical cancer screening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-03-31.