Telehealth & HPV Self-Collection

OHSU Knight Cancer Institute131 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

131

Conditions

Gynecologic Cancer

Interventions

Receive routine instructionsOTHER

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.

Telehealth-based instructional visit and receive routine instructionsOTHER

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.

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

OHSU Knight Cancer Institute

Portland, Oregon, United States

Outcomes

Primary Outcomes

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.

Time frame: Post-intervention: 2 weeks after receipt of test results

Secondary Outcomes

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.

Time frame: 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.

Time frame: Post-intervention: 2 weeks after receipt of test results

Data from ClinicalTrials.gov

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