HPV Self-Test Intervention in Ohio Appalachia

Human Papillomavirus Infection Clinical Trial

Official title:

Pilot Testing an HPV Self-Test Intervention: A Novel Strategy for Reducing Cervical Cancer in Appalachia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02460237
• Other study ID #: OSU-14282
• Secondary ID: NCI-2015-00726
• Status: Completed
• Phase: N/A
• First received: May 28, 2015
• Last updated: February 7, 2018
• Start date: November 2015
• Est. completion date: March 15, 2017

Study information

• Verified date: February 2018
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: March 15, 2017
• Est. primary completion date: June 14, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Carcinoma
• Human Papillomavirus Infection
• Papillomavirus Infections

Intervention

Procedure:
• Disease Screening
Complete HPV self-test

Other:
• Educational Intervention
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
• Informational Intervention
Receive standard instructions and information sheet
• Laboratory Biomarker Analysis
Correlative studies
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Receipt of a Pap test (received or not received)	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
Primary	The proportion of women who return HPV-self tests	A chi-square test will be used to test for a difference between the two groups.	Up to 4 weeks from kit distribution
Secondary	Attendance at a follow-up health care visit after HPV testing notification letters are sent (attended or did not attend)	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
Secondary	Prevalence of HPV infection	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
Secondary	Specimen adequacy (whether participants self-collected an adequate specimen [yes or no] to allow for HPV testing)	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

External Links

•   The Jamesline