Clinical trial NCT04093388: Self-Collection of the Pap Smear as Agency: A Novel Way to Improve Refractory Low Cervical Cancer Screening Rates in Rural Alabama
Official title: Self-Collection of the Pap Smear as Agency: A Novel Way to Improve Refractory Low Cervical Cancer Screening Rates in Rural Alabama
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Keywords: Pap smear
Papanicolaou
self-collection
cervical cancer screening
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Cahaba Medical Care Foundation
name: Laboratory Corporation of America
First posted: 2019-09-18
Enrollment: 250
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the self-PAP against the traditional Pap smear procedure
timeFrame: Baseline through 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Medical Care - West End
state: Alabama
city: Birmingham
country: United States
facility: Cahaba Medical Care - Ensley
state: Alabama
city: Centreville
country: United States
facility: Cahaba Medical Care
state: Alabama
Study officials:
affiliation: PI
name: John B Waits, MD
role: PRINCIPAL_INVESTIGATOR
References:
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