NCT05089825

Telehealth & HPV Self-Collection

Cervical Cancer Screening: Evaluation of Telehealth to Enhance HPV Self-Collection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: Female
• Age: 25 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This study aims to compare the efficacy and participant experience of telehealth-based, self-collected cervical cancer screening to mail-based, self-collected cervical cancer screening across the adult female screening lifespan. This will be done by evaluating sufficient Human papillomavirus (HPV) sample collection and determining preference for self-collection verses provider collection, comparing role of telehealth in pre- and post- menopausal women's comfort with self-collection, comparing self-collection completion rates for women with and without telehealth visits.

Detailed description

This will be a prospective, randomized study of women ages 25 and older, stratified by menopausal status (defined as 12 months or greater without menses or time at which both ovaries have been surgically removed), who are eligible for cervical cancer screening.

Conditions

• Gynecologic Cancer

Interventions

Type	Name	Description
OTHER	Receive routine instructions	Study subjects randomized to this arm will receive a mailed myLab Box kit with instructions on HPV self-collection and postage to be shipped directly to the commercial lab. It should take less than 5 minutes to collect the sample.
OTHER	Telehealth-based instructional visit and receive routine instructions	Study subjects randomized to this arm will similarly receive a mailed myLab Box kit and also undergo a brief 5-10" telehealth instructional visit via video conference.

Timeline

• Start date: 2022-01-19
• Primary completion: 2023-01-12
• Completion: 2023-01-19
• First posted: 2021-10-22
• Last updated: 2023-08-16

Locations

1 site across 1 country: United States