← Back to Search

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
No history of invasive cervical cancer
Intact cervix
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have never had invasive cervical cancer.
Select...
My cervix has not been removed.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effectiveness of human papillomavirus (HPV) intervention
Secondary outcome measures
Safety of HPV intervention
Satisfaction with HPV self-testing and PN

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
Patient Navigation Program
2018
N/A
~110
HPV Self-Collection
2022
N/A
~20

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
288,216 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,925,395 Total Patients Enrolled
Paul ReiterPrincipal Investigator - Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center

Media Library

HPV Self-Collection (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04411849 — N/A
Cervical Cancer Research Study Groups: Group II (usual care continued), Group I (intervention)
Cervical Cancer Clinical Trial 2023: HPV Self-Collection Highlights & Side Effects. Trial Name: NCT04411849 — N/A
HPV Self-Collection (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04411849 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment opportunities currently available for this research project?

"Correct. Per the information found on clinicaltrials.gov, this research project is presently recruiting participants; it was initially advertised on August 27th 2021 and last updated November 4th 2022."

Answered by AI

Does this trial open the door for participants aged 60 and above?

"The parameters of this clinical research call for participants aged 30 to 64. Additionally, there are 29 other studies targeting people younger than 18 and 328 specifically designed for individuals 65 or older."

Answered by AI

What is the ideal demographic for partaking in this medical study?

"To qualify for this medical trial, applicants must be aged 30 to 64 and have been diagnosed with human papillomavirus (HPV). This experiment is looking to recruit a total of 2000 participants."

Answered by AI

How many individuals are currently involved in this investigational research?

"This medical study mandates 2000 participants that meet the specified criteria. Patients can join this trial from several locations, such as Ohio State University Comprehensive Cancer Center in Columbus, OH and West virginia University in Morgantown, WV."

Answered by AI

How widespread is the implementation of this trial?

"Qualified patients may enroll in this trial at Ohio State University Comprehensive Cancer Center, West virginia University or the University of Virginia. Additionally, 4 other sites are available to sign up participants."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
~0 spots leftby Mar 2024