Telehealth & HPV Self-Collection

OHSU Knight Cancer Institute

Status: Completed

Conditions: Gynecologic Cancer

Treatments: Other: Receive routine instructions; Other: Telehealth-based instructional visit and receive routine instructions

Study type: Interventional

Funder types: Other

Identifiers

NCT05089825

OHSU IRB 23478 (Other Identifier)

STUDY00023478

Details and patient eligibility

About

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.

Full 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.

Enrollment: 131 patients

Sex: Female

Ages: 25 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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131 participants in 2 patient groups

Receive routine instructions

Active Comparator group

Description:

Participants will receive routine instructions included in the myLAB Box Clinical Laboratory Improvement Amendments (CLIA) certified collection kit

Treatment:

Other: Receive routine instructions

Telehealth Visit

Active Comparator group

Description:

Participants will have a telehealth-based instructional visit and receive routine instructions included in the myLAB Box commercially available, CLIA certified collection kit

Treatment:

Other: Telehealth-based instructional visit and receive routine instructions