Emergency Room HPV Self-Sampling Study (ACT NOW)

Study Overview
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Brief Summary
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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.

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

Conditions
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Cervical Cancer Screening

Intervention / Treatment
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* Behavioral: HPV Self-Sampling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm (single arm)<br>Intervention arm to complete HPV self-sampling | Behavioral: HPV Self-Sampling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV self-sampling completion | Participation rate for self-sample HPV testing (percent of eligible women who complete self-sampling). | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV self-sampling acceptability | acceptability of self-sample HPV testing using the global acceptability score | 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) | 6 months |