HPV Self-Test Intervention in Ohio Appalachia

The Ohio State University

Status: Completed

Conditions: Human Papillomavirus Infection; Cervical Carcinoma

Treatments: Procedure: Disease Screening; Other: Survey Administration; Other: Informational Intervention; Other: Laboratory Biomarker Analysis; Other: Educational Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02460237

NCI-2015-00726 (Registry Identifier)

OSU-14282

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

Arm I (intervention)

Experimental group

Description:

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.

Treatment:

Other: Educational Intervention

Other: Survey Administration

Other: Laboratory Biomarker Analysis

Procedure: Disease Screening

Arm II (control)

Active Comparator group

Description:

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.

Treatment:

Other: Informational Intervention

Other: Survey Administration

Other: Laboratory Biomarker Analysis

Procedure: Disease Screening