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Virus Therapy

HPV Self-Testing Intervention for Cervical Cancer Screening

N/A

Recruiting

Led By Paul Reiter

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether a self-testing intervention for HPV can increase cervical cancer screening rates among women in Appalachia.

Who is the study for?

This trial is for women in Appalachia who haven't had a cervical cancer screening (Pap test) in the last 3 years, or a Pap plus HPV test in 5 years. Participants should not be pregnant, have no history of invasive cervical cancer, must have an intact cervix and telephone, live in an Appalachian county, and have visited a participating clinic recently.

What is being tested?

The study tests if self-testing for HPV can help more women get screened for cervical cancer. It includes reviewing medical charts, providing information about HPV and screening, guiding patients through the healthcare system (patient navigation), conducting surveys on their experience, and promoting best practices.

What are the potential side effects?

Since this intervention involves non-invasive procedures like surveys and self-collection tests rather than medications or surgeries, side effects are minimal but may include discomfort or anxiety related to testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effectiveness of human papillomavirus (HPV) intervention

Secondary study objectives

Safety of HPV intervention

Satisfaction with HPV self-testing and PN

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (intervention)Experimental Treatment3 Interventions

Participants receive the HPV self-testing intervention consisting of mailed HPV self-test devices. Participants also receive an information about cervical cancer. Participants who do not return their self-test within a few weeks receive telephone-based patient navigation.

Group II: Group II (usual care continued)Active Control4 Interventions

Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HPV Self-Collection

2022

N/A

~20

Patient Navigation Program

2018

N/A

~150