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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Implementing HPV SCREENED (Self-Collection REach and ENgagement in Emergency Departments) to Improve Cancer Equity
- ClinicalTrials.gov ID
- NCT07657104
- Acronym / sponsor ID
- Pro2025001198
- Conditions
- Cervical Cancer Screening, Human Papilloma Virus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 15 Oct 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV SCREENED | Other | Behavioral: HPV Self-collection in the EDA single-arm pilot trial of HPV self-sampling among under-screened women in the ED |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (4 listed)
- currently pregnant (as diagnostic procedures for cervical cancer are often deferred during pregnancy);
- previous hysterectomy;
- previous diagnosis of cervical cancer;
- current menses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV Self-collection in the EDParticipants will be asked to collect a vaginal sample for HPV screening. | Behavioural | HPV SCREENED |
Primary outcome
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.
3 secondary outcomes
HPV Self Sampling Acceptability
Time frame: After results notification, an average of 1 week
HPV Self Sampling Feasibility
Time frame: After results notification, an average of 1 week
Screening Completion
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Heinert, PhD, MPH principal investigator
Department of Emergency Medicine, Rutgers Robert Wood Johnson Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Heinert, PhD, MPH ((732) 235-7872, sara.heinert@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of ED-Based HPV Self-Sampling (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.