NCT05089825

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 19, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2023

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

12 months

First QC Date

October 11, 2021

Last Update Submit

August 14, 2023

Conditions

Gynecologic Cancer

Keywords

Pap SmearHuman papillomavirusTelehealth

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Median perceived difficulty understanding self-collection instructions

    Post-intervention: 2 weeks after receipt of test results

  • Median discomfort level with self-collection

    Post-intervention: 2 weeks after receipt of test results

Study Arms (2)

Receive routine instructions

ACTIVE COMPARATOR

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

Other: Receive routine instructions

Telehealth Visit

ACTIVE COMPARATOR

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

Interventions

Receive routine instructionsOTHER

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.

Receive routine instructions
Telehealth-based instructional visit and receive routine instructionsOTHER

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.

Telehealth Visit

Eligibility Criteria

Age25 Years - 85 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

Study Officials

  • Amanda Bruegl, MD

    OHSU Knight Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Instructor

Study Record Dates

First Submitted

October 11, 2021

First Posted

October 22, 2021

Study Start

January 19, 2022

Primary Completion

January 12, 2023

Study Completion

January 19, 2023

Last Updated

August 16, 2023

Record last verified: 2023-08

Locations

US(1)