HPV Self-Test Intervention in Ohio Appalachia

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: Cervical Carcinoma; Human Papillomavirus Infection
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Survey Administration; Procedure: Disease Screening; Other: Educational Intervention; Other: Informational Intervention

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

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Survey Administration; Ancillary studies; Procedure: Disease Screening; Complete HPV self-test; Other Names: Screening; Disease Screening Procedure; Screening Intervention; 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; Other Names: Education for Intervention; Intervention, Educational
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.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Survey Administration; Ancillary studies; Procedure: Disease Screening; Complete HPV self-test; Other Names: Screening; Disease Screening Procedure; Screening Intervention; Other: Informational Intervention; 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	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)	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	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)	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)	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

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Paul Reiter, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

General Publications

• Reiter PL, Shoben AB, McDonough D, Ruffin MT, Steinau M, Unger ER, Paskett ED, Katz ML. Results of a Pilot Study of a Mail-Based Human Papillomavirus Self-Testing Program for Underscreened Women From Appalachian Ohio. Sex Transm Dis. 2019 Mar;46(3):185-190. doi: 10.1097/OLQ.0000000000000944.

Helpful Links

• The Jamesline

Study record dates

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: HPV
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Tumor Virus Infections; Papillomavirus Infections
• Other Study ID Numbers: OSU-14282; NCI-2015-00726 (Registry Identifier: CTRP (Clinical Trial Reporting Program))