Telehealth & HPV Self-Collection

Study Overview
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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.

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.

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

Conditions
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Gynecologic Cancer

Intervention / Treatment
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* Other: Receive routine instructions
* Other: Telehealth-based instructional visit and receive routine instructions


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Receive routine instructions<br>Participants will receive routine instructions included in the myLAB Box Clinical Laboratory Improvement Amendments (CLIA) certified collection kit | Other: Receive routine instructions<br>* 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.<br>|
| Active Comparator: Telehealth Visit<br>Participants will have a telehealth-based instructional visit and receive routine instructions included in the myLAB Box commercially available, CLIA certified collection kit | Other: Telehealth-based instructional visit and receive routine instructions<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Post-intervention: 2 weeks after receipt of test results | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Post-intervention: 2 weeks after receipt of test results | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pap Smear, Human papillomavirus, Telehealth