Telehealth & HPV Self-Collection

  • STATUS
    Recruiting
  • End date
    Sep 1, 2023
  • participants needed
    120
  • sponsor
    OHSU Knight Cancer Institute
Updated on 18 June 2022
Accepts healthy volunteers

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 postmenopausal women's comfort with self-collection, comparing self-collection completion rates for women with and without telehealth visits.

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.

Details
Condition Gynecologic Cancer
Treatment Receive routine instructions, Telehealth-based instructional visit and receive routine instructions
Clinical Study IdentifierNCT05089825
SponsorOHSU Knight Cancer Institute
Last Modified on18 June 2022

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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