Feasibility of HPV Self-Collection Kits for Cervical Cancer Screening
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25+
SponsorWashington University School of Medicine
About this trial
This study is testing and implementing an equity-focused, community-based intervention that improves women's access to cervical cancer screening and adherence to follow up after an abnormal result. The study's objective is to assess and compare the feasibility of different methods of distributing at-home HPV testing kits for cervical cancer screening among individuals who are under-screened.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Are age 25 or older
Has an intact cervix
Self-reports that they have not been screened for cervical cancer within the last 3 years for 25-64, 5 years for 65 or older
Has a cellphone that can receive texts (including verification codes) and an email account
Disqualifiers
Abnormal vaginal bleeding or discharge
A history of cancer of the reproductive system
A compromised immune system
Prior Diethylstilbestrol (DES) exposure
Trial design
Design model
Parallel
Treatments tested in this trial
Qualitative Interview
BehavioralParticipants will participate in a semi-structured qualitative interview conducted with a research coordinator and guided by the Capability, Opportunity, Motivation, Behavior model (COM-B).
Virtual Visit Standard Instructions
BehavioralParticipants will be given information about the self-collection kit along with a QR code they can use to register with Teal and request the telehealth appointment needed to receive their Teal At-Home cervical cancer screening kit.
Virtual Visit Standard Instructions + In-Person Registration Navigation
BehavioralParticipants will be given information about the self-collection kit along with a QR code they can use to register with Teal and request the telehealth appointment needed to receive their Teal At-Home cervical cancer screening kit. Participants will scan the QR code and complete the registration process onsite with a study coordinator, leaving the event with a scheduled date and time for their telehealth appointment.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Aim 1: Standard instructionsActive comparator 2 interventions
Group B: Aim 1: Standard instructions + in-person guidanceExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Proportion of participants who returned HPV samples
Feasibility of the distribution methods between groups will be measured by the return rate of at home, self-collected HPV samples. Outcome will be reported via Pearson's chi-square test.
Time frame
Up to eight weeks after enrollment2
Proportion of participants with completed referral visits
Outcome will be reported via Pearson's chi-square test.
Time frame
Up to eight weeks after enrollment3
Time to sample return
Outcome will be analyzed by nominal regression model.
Time frame
Up to eight weeks after enrollment4
Time to referral
Outcome will be analyzed by nominal regression model.
Time frame
Up to eight weeks after enrollmentSecondary outcomes
1
Proportion of participants with positive results who completed follow-up
Outcome will be reported via Pearson's chi-square test.
Time frame
Up to eight weeks after results availableSponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
Teal Health, Inc.
Collaborator
Source ClinicalTrials.gov