HPV Self-Test Intervention in Ohio Appalachia
February 7, 2018 updated by: Paul Reiter, Ohio State University Comprehensive Cancer Center
Pilot Testing an HPV Self-Test Intervention: A Novel Strategy for Reducing Cervical Cancer in Appalachia
This study will pilot test a culturally appropriate human papillomavirus (HPV) self-test intervention among women from Ohio Appalachia in order to determine the feasibility of HPV self-testing as a potential cervical cancer screening strategy.
The intervention group will receive culturally appropriate materials and the control group will receive standard materials with their HPV self-test device.
Study Overview
Status
Completed
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the feasibility of HPV self-testing as a potential cervical cancer screening strategy and obtain preliminary efficacy data of culturally appropriate materials on self-test use.
OUTLINE:
Participants are randomized to 1 of 2 arms.
ARM I: Participants receive a study kit that includes culturally appropriate instructions for using and returning the HPV self-test device and a photo story information sheet about HPV and HPV self-testing. Participants are asked to complete the HPV self-test and return the test for HPV testing.
ARM II: Participants receive a study kit that includes standard instructions for using and returning the HPV self-test device and a standard information sheet about HPV and cervical cancer. Participants are asked to complete the HPV self-test and return the test for HPV testing.
Participants are followed up at 4 weeks for return of their HPV self-test device and then for 2 months after notification letters are sent.
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Ages 30-65
- No Pap test in the last 3 years
- Resident of an Ohio Appalachia county
- Not currently pregnant or was not pregnant in the last 3 months
- No history of invasive cervical cancer
- No history of hysterectomy; women will not be eligible for the pilot randomized controlled trial (RCT) if they participated in the focus groups that helped develop this study (focus groups were institutional review board [IRB] approved as Protocol 2014C0086) or the preliminary device test; we will also require women to read and understand English and have the ability to provide informed consent, which will be inferred upon completion and return of the study eligibility, consent, and Health Insurance Portability and Accountability Act (HIPAA) forms
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I (intervention)
Participants receive a study kit that includes culturally appropriate instructions for using and returning the HPV self-test device and a photo story information sheet about HPV and HPV self-testing.
Participants are asked to complete the HPV self-test and return the test for HPV testing.
|
Correlative studies
Ancillary studies
Complete HPV self-test
Other Names:
Receive culturally appropriate instructions for using and returning the HPV self-test device and a photo story information sheet about HPV and HPV self-testing
Other Names:
|
|
Active Comparator: Arm II (control)
Participants receive a study kit that includes standard instructions for using and returning the HPV self-test device and a standard information sheet about HPV and cervical cancer.
Participants are asked to complete the HPV self-test and return the test for HPV testing.
|
Correlative studies
Ancillary studies
Complete HPV self-test
Other Names:
Receive standard instructions and information sheet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The proportion of women who return HPV-self tests
Time Frame: Up to 4 weeks from kit distribution
|
A chi-square test will be used to test for a difference between the two groups.
|
Up to 4 weeks from kit distribution
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attendance at a follow-up health care visit after HPV testing notification letters are sent (attended or did not attend)
Time Frame: Up to 2 months after notification letters are sent
|
Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm.
|
Up to 2 months after notification letters are sent
|
|
Prevalence of HPV infection
Time Frame: After shipping the specimen, an expected average of 6 weeks
|
Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm.
|
After shipping the specimen, an expected average of 6 weeks
|
|
Specimen adequacy (whether participants self-collected an adequate specimen [yes or no] to allow for HPV testing)
Time Frame: After shipping the specimen, an expected average of 6 weeks
|
Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm.
|
After shipping the specimen, an expected average of 6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Receipt of a Pap test (received or not received)
Time Frame: Up to 2 months after receiving notification letters are sent
|
Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm.
|
Up to 2 months after receiving notification letters are sent
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Paul Reiter, PhD, Ohio State University Comprehensive Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2015
Primary Completion (Actual)
June 14, 2016
Study Completion (Actual)
March 15, 2017
Study Registration Dates
First Submitted
May 28, 2015
First Submitted That Met QC Criteria
May 29, 2015
First Posted (Estimate)
June 2, 2015
Study Record Updates
Last Update Posted (Actual)
February 8, 2018
Last Update Submitted That Met QC Criteria
February 7, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-14282
- NCI-2015-00726 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.