HPV Self-Test Intervention in Ohio Appalachia

Ohio State University Comprehensive Cancer Center103 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

103

Conditions

Cervical Carcinoma Human Papillomavirus Infection

Interventions

Disease ScreeningPROCEDURE

Complete HPV self-test

Educational InterventionOTHER

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 InterventionOTHER

Receive standard instructions and information sheet

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 4 weeks from kit distribution

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: After shipping the specimen, an expected average of 6 weeks

Data from ClinicalTrials.gov

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