HPV Self-Test Intervention in Ohio Appalachia

Study Overview
=================
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.

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.

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

Conditions
-----------------
Cervical Carcinoma, Human Papillomavirus Infection

Intervention / Treatment
-----------------
* Procedure: Disease Screening
* Other: Educational Intervention
* Other: Informational Intervention
* Other: Laboratory Biomarker Analysis
* Other: Survey Administration


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (intervention)<br>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<br>* Complete HPV self-test<br>* Other names: Screening Intervention;Other: Educational Intervention<br>* 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<br>* Other names: Intervention, Educational;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Survey Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (control)<br>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<br>* Complete HPV self-test<br>* Other names: Screening Intervention;Other: Informational Intervention<br>* Receive standard instructions and information sheet<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Survey Administration<br>* Ancillary studies<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HPV