Telehealth & HPV Self-Collection

• Sponsor: OHSU Knight Cancer Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05089825
• Collaborator: Robert Wood Johnson Foundation (Other), Oregon Health and Science University (Other)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.4
• Patients Per Site Per Month: 6.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gynecologic Cancer	Other: Receive routine instructions; Other: Telehealth-based instructional visit and receive routine instructions	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Cervical Cancer Screening: Evaluation of Telehealth to Enhance HPV Self-Collection
• Actual Study Start Date: Jan 19, 2022
• Anticipated Primary Completion Date: Jan 31, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 85 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OHSU Knight Cancer Institute	Portland	Oregon	United States	97239

Sponsors and Collaborators

• OHSU Knight Cancer Institute
• Robert Wood Johnson Foundation
• Oregon Health and Science University

Investigators

• Principal Investigator: Amanda Bruegl, MD, OHSU Knight Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amanda Bruegl, MD, Clinical Instructor, OHSU Knight Cancer Institute
• ClinicalTrials.gov Identifier: NCT05089825
• Other Study ID Numbers: STUDY00023478; OHSU IRB 23478
• First Posted: Oct 22, 2021
• Last Update Posted: Jun 1, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Amanda Bruegl, MD, Clinical Instructor, OHSU Knight Cancer Institute: Pap Smear; Human papillomavirus; Telehealth

Study Results

No Results Posted as of Jun 1, 2022