BD Onclarity HPV test
Diagnostic TestSelf-collected cervicovaginal sample
NCT Number: NCT07575217
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.
Trial opening soon.
Get Notified30 year–75 year
Female
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Self-collected cervicovaginal sample
Healthcare provider collected (in a hospital or clinical setting) cervicovaginal sample
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.
Time frame: From enrollment to the end of participation at 9 months
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 months
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 months
Screening test result distribution (categorized as negative, positive, or inadequate, stratified by modality).
Time frame: From enrollment to the end of participation at 9 months
HPV genotype distribution among positive samples (individual and group reporting per lab protocol)
Time frame: From enrollment to the end of participation at 9 months
Clinical follow-up completion after abnormal results (attendance at colposcopy or initiation of treatment).
Time frame: From enrollment to the end of participation at 9 months
Detection of histologically confirmed cervical intraepithelial neoplasia grade 2 or higher (CIN2+) or invasive cervical cancer.
Time frame: From enrollment to the end of participation at 9 months
Treatment initiation and completion rates among those diagnosed with CIN2+ or cancer.
Time frame: From enrollment to the end of participation at 9 months
Associations between demographic/clinical factors and screening completion (e.g., race/ethnicity, insurance status, education, prior screening history).
Time frame: From enrollment to the end of participation at 9 months
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.
Time frame: From enrollment to the end of participation at 9 months
Proportion of eligible participants successfully contacted and offered the intervention.
Time frame: From enrollment to the end of participation at 9 months
Participant acceptance vs refusal rates, stratified by screening modality.
Time frame: From enrollment to the end of participation at 9 months
Equity assessment: Differences in screening uptake across demographic and socioeconomic subgroups.
Time frame: From enrollment to the end of participation at 9 months
Return rate of mailed self-sampling kits (valid, invalid, and late returns).
Time frame: From enrollment to the end of participation at 9 months
Proportion requiring replacement kits.
Time frame: From enrollment to the end of participation at 9 months
Staff adherence to outreach protocol (number, spacing, and mode of call attempts and reminders per protocol).
Time frame: From enrollment to the end of participation at 9 months
Barriers and facilitators to participation identified via telephone structured surveys.
Time frame: From enrollment to the end of participation at 9 months
Acceptability of self-sampling as routine care (participant endorsement of future use of mail-based HPV kits).
Time frame: From enrollment to the end of participation at 9 months
Institutional ability to sustain or scale implementation strategies (assessed through staff feedback and system-level considerations).
Contact information is provided by the study sponsor or research team.
Ana Tergas, MD, MPH
CONTACT
Yenny Tavarez, MPH
CONTACT
Rutgers, The State University of New Jersey
Other
A Mail-based HPV Sampling Program to Increase Cervical Cancer Screening in New Jersey
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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