Mail-in HPV Screening Program in NJ
ConditionCervical Cancer Screening
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-75
SponsorRutgers, The State University of New Jersey
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
BD Onclarity HPV test
Diagnostic testSelf-collected cervicovaginal sample
Standard Pap Smear
Diagnostic testHealthcare provider collected (in a hospital or clinical setting) cervicovaginal sample
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Standard Pap SmearActive comparator 1 intervention
Group B: HPV Self-Sampling TestExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Outcome will be measured at 6 months post-initial outreach call.Secondary outcomes
1
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)
Time frame
From enrollment to the end of participation at 9 months2
Screening Pathway Choices and Performance
Timeliness of screening completion (measured as days from outreach to Pap attendance or kit return).
Time frame
From enrollment to the end of participation at 9 months3
Screening Pathway Choices and Performance
Screening test result distribution (categorized as negative, positive, or inadequate, stratified by modality).
Time frame
From enrollment to the end of participation at 9 months4
Screening Pathway Choices and Performance
HPV genotype distribution among positive samples (individual and group reporting per lab protocol)
Time frame
From enrollment to the end of participation at 9 monthsOther outcomes
1
Reach and Adoption
Proportion of eligible participants successfully contacted and offered the intervention.
Time frame
From enrollment to the end of participation at 9 months2
Reach and Adoption
Participant acceptance vs refusal rates, stratified by screening modality.
Time frame
From enrollment to the end of participation at 9 months3
Reach and Adoption
Equity assessment: Differences in screening uptake across demographic and socioeconomic subgroups.
Time frame
From enrollment to the end of participation at 9 months4
Feasibility and Fidelity
Return rate of mailed self-sampling kits (valid, invalid, and late returns).
Time frame
From enrollment to the end of participation at 9 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: