HPV Self-Test Intervention in Ohio Appalachia

NCT02460237 | Completed DMC

• 2 other identifiers: OSU-14282NCI-2015-00726
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Carcinoma; Human Papillomavirus Infection

Keywords

HPV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Attendance at a follow-up health care visit after HPV testing notification letters are sent (attended or did not attend)

  Up to 2 months after notification letters are sent

• Prevalence of HPV infection

  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)

  After shipping the specimen, an expected average of 6 weeks

Other Outcomes (1)

• Receipt of a Pap test (received or not received)

  Up to 2 months after receiving notification letters are sent

Study Arms (2)

Arm I (intervention)

EXPERIMENTAL

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.

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

Arm II (control)

ACTIVE COMPARATOR

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.

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

Interventions

Disease Screening PROCEDURE

Complete HPV self-test

Also known as: Disease Screening Procedure, Screening, Screening Intervention

Arm I (intervention); Arm II (control)

Educational Intervention OTHER

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

Also known as: Education for Intervention, Intervention, Educational

Arm I (intervention)

Informational Intervention OTHER

Receive standard instructions and information sheet

Arm II (control)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (intervention); Arm II (control)

Survey Administration OTHER

Ancillary studies

Arm I (intervention); Arm II (control)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 30461597 DERIVED

Related Links

• The Jamesline

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections

Interventions

Mass Screening; Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Child Health Services; Community Health Services; Socioeconomic Factors; Population Characteristics

Study Officials

• Paul Reiter, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 2, 2015
• Study Start: November 1, 2015
• Primary Completion: June 14, 2016
• Study Completion: March 15, 2017
• Last Updated: February 8, 2018

Record last verified: 2018-02

Locations

US (1)