Telehealth & HPV Self-Collection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-19

Study Completion Date

2023-01-19

Brief Summary

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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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Detailed Description

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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.

Conditions

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Gynecologic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Receive routine instructions

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

Group Type ACTIVE_COMPARATOR

Receive routine instructions

Intervention Type 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 Visit

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

Group Type ACTIVE_COMPARATOR

Telehealth-based instructional visit and receive routine instructions

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes