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Completed

NCT Number: NCT06178549

Emergency Room HPV Self-Sampling Study (ACT NOW)

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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Key information

Conditions

Cervical Cancer Screening

Age range

25 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. HPV self-sampling completion

    Time frame: 1 day

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

Secondary outcomes

  1. HPV self-sampling acceptability

    Time frame: 1 day

    acceptability of self-sample HPV testing using the global acceptability score

  2. Attendance for cervical cancer screening among HR-HPV positive women

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

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

Acronym: ACT NOW

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 21, 2023
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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