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Recruiting NCT07453459

Feasibility of HPV Self-Collection Kits for Cervical Cancer Screening

No phase Interventional Cervical Cancer HPV Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Qualitative Interview, Virtual Visit Standard Instructions, Virtual Visit Standard Instructions + In-Person Registration Navigation.
Who it may be relevant to
Registry conditions: Cervical Cancer, HPV Infection. Basic parameters: from 25 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Feasibility of Community-based Distribution of HPV Self-Collection Kits for At Home Cervical Cancer Screening

Overview

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.

Interventions

  • Behavioral Qualitative Interview
    Participants will participate in a semi-structured qualitative interview conducted with a research coordinator and guided by the Capability, Opportunity, Motivation, Behavior model (COM-B).
  • Behavioral Virtual Visit Standard Instructions
    Participants 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.
  • Behavioral Virtual Visit Standard Instructions + In-Person Registration Navigation
    Participants 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.

Primary outcome measures

  • Proportion of participants who returned HPV samples [Time frame: Up to eight weeks after enrollment]
  • Proportion of participants with completed referral visits [Time frame: Up to eight weeks after enrollment]
  • Time to sample return [Time frame: Up to eight weeks after enrollment]
  • Time to referral [Time frame: Up to eight weeks after enrollment]
  • Thematic findings addressing opportunity [Time frame: Eight weeks after enrollment]
  • Thematic findings addressing capability [Time frame: Eight weeks after enrollment]
  • Thematic findings addressing motivation [Time frame: Eight weeks after enrollment]
  • Thematic findings addressing behavior [Time frame: Eight weeks after enrollment]
Secondary outcome measures (1)
  • Proportion of participants with positive results who completed follow-up [Time frame: Up to eight weeks after results available]

Eligibility criteria

Inclusion criteria

  • 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
  • Has access to the internet to engage with the Teal Health mobile app and complete a Zoom interview
  • Can read, speak, write and understand English well enough to take a survey and complete an interview

Exclusion criteria

  • Abnormal vaginal bleeding or discharge
  • A history of cancer of the reproductive system
  • A compromised immune system
  • Prior Diethylstilbestrol (DES) exposure
  • Currently pregnant or are within 6 weeks of giving birth
  • Treatment for a cervical precancer (e.g., loop electrosurgical excision procedure or conization) in the last 25 years.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Washington University School of Medicine — St Louis

Identifiers

NCT: NCT07453459 · 202602185

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗