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Clinical Trials/NCT06178549
NCT06178549CompletedNot 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 Medicine2 sites in 1 country100 target enrollmentStarted: November 15, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
2
Primary Endpoint
HPV self-sampling completion

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
25 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aaron Peter Thrift

Associate Professor

Baylor College of Medicine

Study Sites (2)

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