Emergency Room HPV Self-Sampling Study (ACT NOW)

Cervical Cancer Screening Clinical Trial

— ACT NOW  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06178549
• Other study ID #: H-52653
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: December 2023
• Source: Baylor College of Medicine
• Contact: Itunu Sokale, MD, DrPH
• Phone: 7137982972
• Email: itunu.sokale[@]bcm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer Screening
• Emergencies
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV self-sampling completion	Participation rate for self-sample HPV testing (percent of eligible women who complete self-sampling).	1 day
Secondary	HPV self-sampling acceptability	acceptability of self-sample HPV testing using the global acceptability score	1 day
Secondary	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