Emergency Room HPV Self-Sampling Study (ACT NOW)

Not Applicable

Completed

• Conditions: Cervical Cancer Screening
• Interventions: Behavioral: HPV Self-Sampling

• Registration Number: NCT06178549
• Lead Sponsor: Baylor College of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-15
• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2023-12-20
• Study First Posted: 2023-12-21
• Primary Completion: 2024-04-11
• Status Verified: 2024-06
• Study Completion: 2024-10-11
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm (single arm)	HPV Self-Sampling	Intervention arm to complete HPV self-sampling

Primary Outcome Measures

Name	Time	Method
HPV self-sampling completion	1 day	Participation rate for self-sample HPV testing (percent of eligible women who complete self-sampling).

Secondary Outcome Measures

Name	Time	Method
HPV self-sampling acceptability	1 day	acceptability of self-sample HPV testing using the global acceptability score
Attendance for cervical cancer screening among HR-HPV positive women	6 months	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)

Trial Locations

Locations (1)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States