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Clinical Trials/NCT06178549
NCT06178549
Completed
Not Applicable

Feasibility and Effectiveness of HPV Self-Sampling for Cervical Cancer Screening Among Women Seeking Health Care At a Safety Net Hospital Emergency Room

Baylor College of Medicine1 site in 1 country100 target enrollmentNovember 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervical Cancer Screening
Sponsor
Baylor College of Medicine
Enrollment
100
Locations
1
Primary Endpoint
HPV self-sampling completion
Status
Completed
Last Updated
last year

Overview

Brief Summary

The goal of this study is to develop and evaluate an evidence-based public health intervention using HPV self-sampling approach in an opportunistic setting to increase cervical cancer screening among screening non-attendees, particularly those uninsured or underinsured, who use emergency services to access medical care. The proposed pilot study will examine the feasibility and efficacy of HPV self-sampling among women at a safety net hospital emergency room. Participant recruitment and self-sample will take place in the waiting rooms in the ER. All women sitting in the waiting room will serve as the source population for the study and will be approached and invited to participate in the study.

Registry
clinicaltrials.gov
Start Date
November 15, 2023
End Date
October 11, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aaron Peter Thrift

Associate Professor

Baylor College of Medicine

Eligibility Criteria

Inclusion Criteria

  • Eligible participants are women ages 25 years to 65 years, with a cervix, presenting in the waiting areas at the Ben Taub General Hospital Emergency Department

Exclusion Criteria

  • Women under 25 years or older than 65 years of age,
  • self-reported current pregnancy,
  • self-reported history of cervical cancer,
  • past hysterectomy,
  • had Pap Smear within past 3 years or HPV/Pap co-test within past 5 years.

Outcomes

Primary Outcomes

HPV self-sampling completion

Time Frame: 1 day

Participation rate for self-sample HPV testing (percent of eligible women who complete self-sampling).

Secondary Outcomes

  • HPV self-sampling acceptability(1 day)
  • Attendance for cervical cancer screening among HR-HPV positive women(6 months)

Study Sites (1)

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