Emergency Room HPV Self-Sampling Study (ACT NOW)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2024-10-11

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.

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Detailed Description

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Conditions

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Cervical Cancer Screening

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Intervention arm (single arm)

Intervention arm to complete HPV self-sampling

Group Type EXPERIMENTAL

HPV Self-Sampling

Intervention Type BEHAVIORAL

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.

Interventions

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HPV Self-Sampling

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.

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes