Cervical Cancer ScreeningNCT07657104
Developing and Implementing HPV SCREENED
A study testing HPV Self-collection in the ED in people with Cervical Cancer Screening and Human Papilloma Virus, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Screening, Human Papilloma Virus
- What is being tested?
- HPV Self-collection in the ED
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2026to 30 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- currently pregnant (as diagnostic procedures for cervical cancer are often deferred during pregnancy);
- previous hysterectomy;
- previous diagnosis of cervical cancer;
- current menses
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Sara Heinert, PhD, MPH
- Not yet recruiting
University Hospital
Newark, New Jersey, 07103
Ronald Ikechi, MD
About this study
Official title: Developing and Implementing HPV SCREENED (Self-Collection REach and ENgagement in Emergency Departments) to Improve Cancer Equity
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.
Read the detailed description
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.
- Conditions
- Cervical Cancer Screening, Human Papilloma Virus
- Being tested
- HPV Self-collection in the ED
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV Self-collection in the EDBehavioural
Participants will be asked to collect a vaginal sample for HPV screening.
| Study group | Role | What they receive |
|---|---|---|
| HPV SCREENED | Other | A single-arm pilot trial of HPV self-sampling among under-screened women in the ED Receives: Behavioral: HPV Self-collection in the ED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of ED-Based HPV Self-Sampling
Evaluate the proportion of eligible participants who complete HPV self-sampling during the emergency department visit.
Measured: Day 1
Secondary outcomes (3)
HPV Self Sampling Acceptability
Acceptability of Intervention Measure (AIM) scale (Weiner et al., 2017). Scale values range from 1 to 5, where higher is more acceptable.
Measured: After results notification, an average of 1 week
HPV Self Sampling Feasibility
Feasibility of Intervention Measure (FIM) scale (Weiner et al., 2017). Scale values range from 1 to 5, where higher is more feasible.
Measured: After results notification, an average of 1 week
Screening Completion
Proportion of HPV+ women who complete follow-up screening
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start15 Oct 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Heinert, PhD, MPH, Rutgers, The State University of New Jersey
- Investigators
- Sara Heinert, PhD, MPH, Principal investigator, Department of Emergency Medicine, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657104
- Sponsor's protocol ID
- Pro2025001198
- Status last verified
- Oct 2026
- First submitted
- 9 Jun 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No