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

Primary Purpose

Cervical Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-PAP
Traditional Pap smear
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Cancer focused on measuring Pap smear, Papanicolaou, self-collection, cervical cancer screening

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cahaba Medical Care - West EndRecruiting
  • Cahaba Medical Care - EnsleyRecruiting
  • Cahaba Medical CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Self-PAP

Traditional Pap

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Evaluate the self-PAP against the traditional Pap smear procedure

Secondary Outcome Measures

Full Information

First Posted
September 16, 2019
Last Updated
April 28, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
Cahaba Medical Care Foundation, Laboratory Corporation of America
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1. Study Identification

Unique Protocol Identification Number
NCT04093388
Brief Title
Self-Collection of the Pap Smear as Agency: A Novel Way to Improve Refractory Low Cervical Cancer Screening Rates in Rural Alabama
Acronym
Pap
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Cahaba Medical Care Foundation, Laboratory Corporation of America

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Pap smear, Papanicolaou, self-collection, cervical cancer screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Pathologist (outcomes assessor) will be blinded
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-PAP
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional Pap
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Self-PAP
Intervention 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Traditional Pap smear
Intervention 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 Outcome Measure Information:
Title
Evaluate the self-PAP against the traditional Pap smear procedure
Time Frame
Baseline through 14 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John B Waits, MD
Phone
2052772379
Email
john.waits@cahabamedicalcare.com
First Name & Middle Initial & Last Name or Official Title & Degree
Karen E Dixon, PhD
Phone
2052934662
Email
karen.dixon@cahabamedicalcare.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John B Waits, MD
Organizational Affiliation
PI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cahaba Medical Care - West End
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Dixon, PhD
Phone
205-293-4662
Email
karen.dixon@cahabamedicalcare.com
First Name & Middle Initial & Last Name & Degree
John B Waits, MD
Phone
2059262992
Email
john.waits@cahabamedicalcare.com
Facility Name
Cahaba Medical Care - Ensley
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taylor Terrell
Phone
205-926-2992
Email
taylor.terrell@cahabamedicalcare.com
First Name & Middle Initial & Last Name & Degree
John Waits, MD
Phone
2059262992
Email
John.waits@cahabamedicalcare.com
Facility Name
Cahaba Medical Care
City
Centreville
State/Province
Alabama
ZIP/Postal Code
35042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John B Waits, MD
Phone
205-926-2992
Email
john.waits@cahabamedicalcare.com
First Name & Middle Initial & Last Name & Degree
Nikki Savage, CRNP
Phone
2059262992
Email
nikki.savage@cahabamedicalcare.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27647799
Citation
Chen K, Ouyang Y, Hillemanns P, Jentschke M. Excellent analytical and clinical performance of a dry self-sampling device for human papillomavirus detection in an urban Chinese referral population. J Obstet Gynaecol Res. 2016 Dec;42(12):1839-1845. doi: 10.1111/jog.13132. Epub 2016 Sep 20.
Results Reference
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PubMed Identifier
18708409
Citation
De Alba I, Anton-Culver H, Hubbell FA, Ziogas A, Hess JR, Bracho A, Arias C, Manetta A. Self-sampling for human papillomavirus in a community setting: feasibility in Hispanic women. Cancer Epidemiol Biomarkers Prev. 2008 Aug;17(8):2163-8. doi: 10.1158/1055-9965.EPI-07-2935.
Results Reference
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PubMed Identifier
12518778
Citation
Chang CC, Tseng CJ, Liu WW, Jain S, Horng SG, Soong YK, Hsueh S, Pao CC. Clinical evaluation of a new model of self-obtained method for the assessment of genital human papilloma virus infection in an underserved population. Chang Gung Med J. 2002 Oct;25(10):664-71.
Results Reference
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PubMed Identifier
25247320
Citation
Haguenoer K, Sengchanh S, Gaudy-Graffin C, Boyard J, Fontenay R, Marret H, Goudeau A, Pigneaux de Laroche N, Rusch E, Giraudeau B. Vaginal self-sampling is a cost-effective way to increase participation in a cervical cancer screening programme: a randomised trial. Br J Cancer. 2014 Nov 25;111(11):2187-96. doi: 10.1038/bjc.2014.510. Epub 2014 Sep 23.
Results Reference
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PubMed Identifier
27703293
Citation
Jahic M, Jahic E. Diagnostic Approach to Patients with Atypical Squamous Cells of Undetermined Significance Cytologic Findings on Cervix. Med Arch. 2016 Jul 27;70(4):296-298. doi: 10.5455/medarh.2016.70.296-298.
Results Reference
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PubMed Identifier
28086983
Citation
Kobetz E, Seay J, Amofah A, Pierre L, Bispo JB, Trevil D, Gonzalez M, Poitevien M, Koru-Sengul T, Carrasquillo O. Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial. Trials. 2017 Jan 13;18(1):19. doi: 10.1186/s13063-016-1721-6.
Results Reference
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PubMed Identifier
10632284
Citation
Wright TC Jr, Denny L, Kuhn L, Pollack A, Lorincz A. HPV DNA testing of self-collected vaginal samples compared with cytologic screening to detect cervical cancer. JAMA. 2000 Jan 5;283(1):81-6. doi: 10.1001/jama.283.1.81.
Results Reference
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PubMed Identifier
25171269
Citation
Labani S, Asthana S. Human papillomavirus viral load on careHPV testing of self-collected vaginal samples vs. clinician-collected cervical samples. Eur J Obstet Gynecol Reprod Biol. 2014 Oct;181:233-9. doi: 10.1016/j.ejogrb.2014.08.005. Epub 2014 Aug 13.
Results Reference
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PubMed Identifier
29971397
Citation
Ogilvie GS, van Niekerk D, Krajden M, Smith LW, Cook D, Gondara L, Ceballos K, Quinlan D, Lee M, Martin RE, Gentile L, Peacock S, Stuart GCE, Franco EL, Coldman AJ. Effect of Screening With Primary Cervical HPV Testing vs Cytology Testing on High-grade Cervical Intraepithelial Neoplasia at 48 Months: The HPV FOCAL Randomized Clinical Trial. JAMA. 2018 Jul 3;320(1):43-52. doi: 10.1001/jama.2018.7464. Erratum In: JAMA. 2018 Dec 4;320(21):2273.
Results Reference
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Self-Collection of the Pap Smear as Agency: A Novel Way to Improve Refractory Low Cervical Cancer Screening Rates in Rural Alabama

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