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Completed

NCT Number: NCT05089825

Telehealth & 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.

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Key information

Conditions

Gynecologic Cancer

Age range

25 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Receive routine instructions

Other

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 instructions

Other

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.

Primary outcomes

  1. Proportion of participants preferring self-collection to provider collection

    Time frame: 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 outcomes

  1. Median perceived difficulty understanding self-collection instructions

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • Oregon Health and Science University
  • Robert Wood Johnson Foundation

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 22, 2021
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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