Cervical Cancer ScreeningNCT07575217
Mail-in HPV Screening Program in NJ
A study testing BD Onclarity HPV test and Standard Pap Smear in people with Cervical Cancer Screening, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The purpose of this study is to help people who have missed their regular cervical cancer screening. The investigators are evaluating whether mailing an HPV self-sampling kit to participant home makes it easier and more convenient for people to get screened for cervical cancer. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Screening
- What is being tested?
- BD Onclarity HPV test and Standard Pap Smear
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2026to 16 Apr 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women, transgender men, and nonbinary individuals aged 30 to 75 who have a cervix.
- No history of hysterectomy or cervical cancer.
- No documented cervical cancer screening within guideline-recommended intervals: specifically, no Pap test in the past 3.5 years, no Pap/HPV co-test in the past 5.5 years, and no standalone HPV test results in the past 5.5 years. (A 6-month grace period is included to allow time for response to usual care outreach.)
- At least two visits to University Hospital ambulatory care over the past five years, ensuring opportunity for follow-up and continuity of care.
Who cannot join
- History of cervical dysplasia within the past 3.5 years, reflecting those likely under active surveillance or treatment protocols.
- Currently pregnant, due to differing screening recommendations and clinical considerations.
- Prior or current diagnosis of cervical cancer or ongoing treatment for cervical neoplasia.
- Physical, cognitive, or functional limitations that would preclude use of the mailed self-sampling kit without assistance. Examples include severe arthritis or significant impairment affecting self-collection capability.
- Lack of a telephone number or reliable mailing address on file.
- Inability to communicate in English or Spanish, given study materials and staffing capabilities. Use of additional language services is not available.
- Current enrollment in other cervical cancer screening or intervention studies that may interfere with participation or outcomes.
- Inability to provide informed consent or comprehend study procedures based on cognitive capacity, as assessed by the Research Coordinator during initial contact.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rutgers New Jersey Medical School
Newark, New Jersey, 07103
About this study
Official title: A Mail-based HPV Sampling Program to Increase Cervical Cancer Screening in New Jersey
The purpose of this study is to help people who have missed their regular cervical cancer screening. The investigators are evaluating whether mailing an HPV self-sampling kit to participant home makes it easier and more convenient for people to get screened for cervical cancer. This study will also help to understand if people find this process acceptable and whether it is an effective way to improve screening rates.
- Conditions
- Cervical Cancer Screening
- Being tested
- BD Onclarity HPV test, Standard Pap Smear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD Onclarity HPV testDiagnostic test
Self-collected cervicovaginal sample
Standard Pap SmearDiagnostic test
Healthcare provider collected (in a hospital or clinical setting) cervicovaginal sample
| Study group | Role | What they receive |
|---|---|---|
| Standard Pap Smear | Active comparator | Participants will have the option to choose a standard pap smear for cervical cancer screening Receives: Diagnostic Test: Standard Pap Smear |
| HPV Self-Sampling Test | Experimental | Participants are able to opt-in for an at-home self-sampling HPV test for cervical cancer screening Receives: Diagnostic Test: BD Onclarity HPV test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of CC screening within 6 months of initial outreach.
Defined as either (a) return of a valid HPV self-sample kit to the processing laboratory, or (b) attendance for a clinic-based Pap test documented in the medical record.
Measured: Outcome will be measured at 6 months post-initial outreach call.
Secondary outcomes (9)
Screening Pathway Choices and Performance
Proportion of participants selecting self-sampling vs clinic-based Pap test (percentage of women choosing each modality after initial outreach)
Measured: From enrollment to the end of participation at 9 months
Screening Pathway Choices and Performance
Timeliness of screening completion (measured as days from outreach to Pap attendance or kit return).
Measured: From enrollment to the end of participation at 9 months
Screening Pathway Choices and Performance
Screening test result distribution (categorized as negative, positive, or inadequate, stratified by modality).
Measured: From enrollment to the end of participation at 9 months
Screening Pathway Choices and Performance
HPV genotype distribution among positive samples (individual and group reporting per lab protocol)
Measured: From enrollment to the end of participation at 9 months
Clinical Follow-Up and Downstream Outcomes
Clinical follow-up completion after abnormal results (attendance at colposcopy or initiation of treatment).
Measured: From enrollment to the end of participation at 9 months
Clinical Follow-Up and Downstream Outcomes
Detection of histologically confirmed cervical intraepithelial neoplasia grade 2 or higher (CIN2+) or invasive cervical cancer.
Measured: From enrollment to the end of participation at 9 months
Clinical Follow-Up and Downstream Outcomes
Treatment initiation and completion rates among those diagnosed with CIN2+ or cancer.
Measured: From enrollment to the end of participation at 9 months
Exploratory and Patient-Reported Outcomes
Associations between demographic/clinical factors and screening completion (e.g., race/ethnicity, insurance status, education, prior screening history).
Measured: From enrollment to the end of participation at 9 months
Exploratory and Patient-Reported Outcomes
Patient-reported experiences including satisfaction, ease of kit use, clarity of instructions, stress/anxiety during self-sampling, trust in results, and willingness to undergo self-sampling in future screening.
Measured: From enrollment to the end of participation at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start20 Jul 2026
- Primary completionFeb 2027 (estimated)
- Study completion16 Apr 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will have the option to op-in for an at-home HPV sampling test or receive a standard pap smear.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Isabel Tergas, MD, MPH, Rutgers, The State University of New Jersey
- Investigators
- Ana Tergas, MD, MPH, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575217
- Sponsor's protocol ID
- Pro2025001687
- Status last verified
- Jul 2026
- First submitted
- 8 Feb 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mail-based HPV Sampling Program to Increase Cervical Cancer Screening in New Jersey
- ClinicalTrials.gov ID
- NCT07575217
- Acronym / sponsor ID
- Pro2025001687
- Conditions
- Cervical Cancer Screening
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- 16 Apr 2027 (estimated)
- First posted
- 8 May 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.
The purpose of this study is to help people who have missed their regular cervical cancer screening. The investigators are evaluating whether mailing an HPV self-sampling kit to participant home makes it easier and more convenient for people to get screened for cervical cancer. This study will also help to understand if people find this process acceptable and whether it is an effective way to improve screening rates.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will have the option to op-in for an at-home HPV sampling test or receive a standard pap smear.
| Arm | Type | Receives |
|---|---|---|
| Standard Pap Smear | Active comparator | Diagnostic Test: Standard Pap SmearParticipants will have the option to choose a standard pap smear for cervical cancer screening |
| HPV Self-Sampling Test | Experimental | Diagnostic Test: BD Onclarity HPV testParticipants are able to opt-in for an at-home self-sampling HPV test for cervical cancer screening |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women, transgender men, and nonbinary individuals aged 30 to 75 who have a cervix.
- No history of hysterectomy or cervical cancer.
- No documented cervical cancer screening within guideline-recommended intervals: specifically, no Pap test in the past 3.5 years, no Pap/HPV co-test in the past 5.5 years, and no standalone HPV test results in the past 5.5 years. (A 6-month grace period is included to allow time for response to usual care outreach.)
- At least two visits to University Hospital ambulatory care over the past five years, ensuring opportunity for follow-up and continuity of care.
Key exclusion criteria (8 listed)
- History of cervical dysplasia within the past 3.5 years, reflecting those likely under active surveillance or treatment protocols.
- Currently pregnant, due to differing screening recommendations and clinical considerations.
- Prior or current diagnosis of cervical cancer or ongoing treatment for cervical neoplasia.
- Physical, cognitive, or functional limitations that would preclude use of the mailed self-sampling kit without assistance. Examples include severe arthritis or significant impairment affecting self-collection capability.
- Lack of a telephone number or reliable mailing address on file.
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 |
|---|---|---|
| BD Onclarity HPV testSelf-collected cervicovaginal sample | Diagnostic test | HPV Self-Sampling Test |
| Standard Pap SmearHealthcare provider collected (in a hospital or clinical setting) cervicovaginal sample | Diagnostic test | Standard Pap Smear |
Primary outcome
Completion of CC screening within 6 months of initial outreach.
Time frame: Outcome will be measured at 6 months post-initial outreach call.
Defined as either (a) return of a valid HPV self-sample kit to the processing laboratory, or (b) attendance for a clinic-based Pap test documented in the medical record.
9 secondary outcomes
Screening Pathway Choices and Performance
Time frame: From enrollment to the end of participation at 9 months
Screening Pathway Choices and Performance
Time frame: From enrollment to the end of participation at 9 months
Screening Pathway Choices and Performance
Time frame: From enrollment to the end of participation at 9 months
Screening Pathway Choices and Performance
Time frame: From enrollment to the end of participation at 9 months
Clinical Follow-Up and Downstream Outcomes
Time frame: From enrollment to the end of participation at 9 months
Clinical Follow-Up and Downstream Outcomes
Time frame: From enrollment to the end of participation at 9 months
Clinical Follow-Up and Downstream Outcomes
Time frame: From enrollment to the end of participation at 9 months
Exploratory and Patient-Reported Outcomes
Time frame: From enrollment to the end of participation at 9 months
Exploratory and Patient-Reported Outcomes
Time frame: From enrollment to the end of participation at 9 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 4 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Cervical Cancer Screening
Active, not recruiting
Addressing Stigma in Screening and Diagnostic Delay for Cervical Cancer
Cervical Cancer Screening
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Recruiting
Developing and Implementing HPV SCREENED
Cervical Cancer Screening, Human Papilloma Virus
Recruiting
A Community Based Intervention to Improve Cervical Cancer Screening Among Women in the Hispanic and East African Immigrant Community
Cervical Carcinoma
Recruiting
Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Screen Positive Women Living With HIV in C1001P-CS2 Kenya
HIV (Human Immunodeficiency Virus), HPV
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.
Ana Tergas, MD, MPH principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BD Onclarity HPV test and Standard Pap Smear in people with Cervical Cancer Screening, run by Rutgers, The State University of New Jersey at 1 site 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 4 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of CC screening within 6 months of initial outreach. (time frame: Outcome will be measured at 6 months post-initial outreach call.). 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 4 Aug 2026.