Telehealth & HPV Self-Collection

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

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Other: Receive routine instructions; Other: Telehealth-based instructional visit and receive routine instructions

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 Type: Interventional
• Enrollment (Actual): 131
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Receive routine instructions; Participants will receive routine instructions included in the myLAB Box Clinical Laboratory Improvement Amendments (CLIA) certified collection kit	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.
Active Comparator: Telehealth Visit; Participants will have a telehealth-based instructional visit and receive routine instructions included in the myLAB Box commercially available, CLIA certified collection kit	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants preferring self-collection to provider collection	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.	Post-intervention: 2 weeks after receipt of test results

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University; Robert Wood Johnson Foundation
• Investigators: Principal Investigator: Amanda Bruegl, MD, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Actual): January 12, 2023
• Study Completion (Actual): January 19, 2023

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Telehealth; Human papillomavirus; Pap Smear
• Other Study ID Numbers: STUDY00023478; OHSU IRB 23478 (Other Identifier: OHSU Institutional Review Board)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No