Emergency Room HPV Self-Sampling Study (ACT NOW)

NCT06178549 | Completed

• 1 other identifier: H-52653
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer Screening

Outcome Measures

Primary Outcomes (1)

• HPV self-sampling completion

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

  1 day

Secondary Outcomes (2)

• HPV self-sampling acceptability

  1 day

• Attendance for cervical cancer screening among HR-HPV positive women

  6 months

Study Arms (1)

Intervention arm (single arm)

EXPERIMENTAL

Intervention arm to complete HPV self-sampling

Behavioral: HPV Self-Sampling

Interventions

HPV Self-Sampling 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.

Intervention arm (single arm)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 21, 2023
• Study Start: November 15, 2023
• Primary Completion: April 11, 2024
• Study Completion: October 11, 2024
• Last Updated: January 15, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)