Emergency Room HPV Self-Sampling Study (ACT NOW)

Baylor College of Medicine100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

100

Conditions

Cervical Cancer Screening

Interventions

HPV self-sampling. Participants will be provided with education regarding cervical cancer prevention and Aptima kit and instructions for self-sampling. Patient navigators will assist participants with positive HPV test results to connect with healthcare providers for follow-up screening and care.

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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

Time frame: 1 day

Secondary Outcomes

HPV self-sampling acceptability

acceptability of self-sample HPV testing using the global acceptability score

Time frame: 1 day

Attendance for cervical cancer screening among HR-HPV positive women

Rate of attendance for cervical cancer screening among HR-HPV positive women (percent of HR-HPV positive participants who obtain a Pap test following self-sample HPV testing)

Time frame: 6 months