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NCT Number: NCT07657104

Developing and Implementing HPV SCREENED

This study will assess the feasibility of implementing HPV self-sampling as a primary cervical cancer screening strategy for under-screened women in the emergency department (ED). Eligible participants will receive education and an HPV self-sampling kit to complete in the ED. Individuals with HPV-positive results will be guided to follow-up care at a local clinic.

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Key information

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States

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About this study

The proposed study will implement HPV self-sampling as primary cervical screening for under-screened ED patients. The long-term goal is to increase access to cervical screening for women who may not routinely use primary care and thus face increased risk of cervical cancer. This pilot feasibility trial will implement HPV self-sampling kit distribution and navigation to follow-up care in the ED. The investigators hypothesize that ED-based in-person distribution and same-day return of HPV self-sampling kits will alleviate issues of prior mailed HPV self-sampling trials by reducing participant burden. Women (30-65 years with non-critically ill presentations) who present to the ED and are overdue for cervical screening will receive 1) cervical cancer screening education and 2) a HPV self-sampling kit where they return the kit immediately after self-sampling in the ED. ScreenNJ will navigate participants with HPV-positive results to follow-up care and management according to current standard guidelines at local clinics.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • biological women,
  • no prior hysterectomy or cervical cancer,
  • not pregnant,
  • last Pap >3 years, last co-test >5 years, or last HPV alone test >5 years,
  • speak English or Spanish,
  • has a working cellphone,
  • NJ residency
  • ED patient

Exclusion criteria

  • currently pregnant (as diagnostic procedures for cervical cancer are often deferred during pregnancy);
  • previous hysterectomy;
  • previous diagnosis of cervical cancer;
  • current menses

Treatment and study plan

HPV Self-collection in the ED

Behavioral

Participants will be asked to collect a vaginal sample for HPV screening.

Primary outcomes

  1. Completion of ED-Based HPV Self-Sampling

    Time frame: Day 1

    Evaluate the proportion of eligible participants who complete HPV self-sampling during the emergency department visit.

Secondary outcomes

  1. HPV Self Sampling Acceptability

    Time frame: After results notification, an average of 1 week

    Acceptability of Intervention Measure (AIM) scale (Weiner et al., 2017). Scale values range from 1 to 5, where higher is more acceptable.

  2. HPV Self Sampling Feasibility

    Time frame: After results notification, an average of 1 week

    Feasibility of Intervention Measure (FIM) scale (Weiner et al., 2017). Scale values range from 1 to 5, where higher is more feasible.

  3. HPV Knowledge

    Time frame: Day 1 and after results notification- an average of 1 week

    Cervical Cancer Knowledge Scale (CCKS)- 7 items where a higher score is more knowledge

  4. Screening Completion

    Time frame: 3 months

    Proportion of HPV+ women who complete follow-up screening

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Heinert, PhD, MPH

CONTACT

[email protected]

(732) 235-7872

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

Developing and Implementing HPV SCREENED (Self-Collection REach and ENgagement in Emergency Departments) to Improve Cancer Equity

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

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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