Telehealth & HPV Self-Collection

Not Applicable

Completed

• Conditions: Gynecologic Cancer

• Registration Number: NCT05089825
• Lead Sponsor: OHSU Knight Cancer Institute

Brief 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.

Study Timeline

• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-22
• Study Start: 2022-01-19
• Primary Completion: 2023-01-12
• Study Completion: 2023-01-19
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-14
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 131

Inclusion Criteria

• Individuals with a cervix who are eligible for primary HPV testing (age 25 and older) according to national cervical cancer screening guidelines.
• Pregnant women are eligible for participation in this study as the collection process poses no threat to the woman or her fetus.

Exclusion Criteria

• Individuals without a cervix
• Have had prior pelvic radiation therapy or brachytherapy
• Active or former diagnosis of ovarian, uterine, or cervical cancer unless determined eligible by PI upon further review of history and treatment
• Individuals less than age 25 or no longer eligible/recommended to undergo cervical cancer screening
• Adults who are unable to consent or are decisionally impaired
• Individuals who are not English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of participants preferring self-collection to provider collection	Post-intervention: 2 weeks after receipt of test results	In follow-up survey, participants will indicate how the would prefer to have their next cervical cancer screening performed: by their healthcare provider or by self-testing.

Secondary Outcome Measures

Name	Time	Method
Median discomfort level with self-collection	Post-intervention: 2 weeks after receipt of test results	In follow-up survey, participants will indicate how much discomfort their experienced during self-collection, on a 10-point Likert scale.
Median perceived difficulty understanding self-collection instructions	Post-intervention: 2 weeks after receipt of test results	In follow-up survey, participants will indicate how difficult the self-collection instructions were to understand, on a 10-point Likert scale.

Trial Locations

Locations (1)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States