Mail-in HPV Screening Program in NJ
3 sierpnia 2026 zaktualizowane przez: Ana Isabel Tergas, MD, MPH, Rutgers, The State University of New Jersey
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.
Przegląd badań
Status
Rejestracja na zaproszenie
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
200
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
New Jersey
-
Newark, New Jersey, Stany Zjednoczone, 07103
- Rutgers New Jersey Medical School
-
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Ekranizacja
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Standard Pap Smear
Participants will have the option to choose a standard pap smear for cervical cancer screening
|
Healthcare provider collected (in a hospital or clinical setting) cervicovaginal sample
|
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Eksperymentalny: HPV Self-Sampling Test
Participants are able to opt-in for an at-home self-sampling HPV test for cervical cancer screening
|
Self-collected cervicovaginal sample
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Completion of CC screening within 6 months of initial outreach.
Ramy czasowe: Outcome will be measured at 6 months post-initial outreach call.
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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.
|
Outcome will be measured at 6 months post-initial outreach call.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Screening Pathway Choices and Performance
Ramy czasowe: 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)
|
From enrollment to the end of participation at 9 months
|
|
Screening Pathway Choices and Performance
Ramy czasowe: 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).
|
From enrollment to the end of participation at 9 months
|
|
Screening Pathway Choices and Performance
Ramy czasowe: From enrollment to the end of participation at 9 months
|
Screening test result distribution (categorized as negative, positive, or inadequate, stratified by modality).
|
From enrollment to the end of participation at 9 months
|
|
Screening Pathway Choices and Performance
Ramy czasowe: From enrollment to the end of participation at 9 months
|
HPV genotype distribution among positive samples (individual and group reporting per lab protocol)
|
From enrollment to the end of participation at 9 months
|
|
Clinical Follow-Up and Downstream Outcomes
Ramy czasowe: From enrollment to the end of participation at 9 months
|
Clinical follow-up completion after abnormal results (attendance at colposcopy or initiation of treatment).
|
From enrollment to the end of participation at 9 months
|
|
Clinical Follow-Up and Downstream Outcomes
Ramy czasowe: 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.
|
From enrollment to the end of participation at 9 months
|
|
Clinical Follow-Up and Downstream Outcomes
Ramy czasowe: From enrollment to the end of participation at 9 months
|
Treatment initiation and completion rates among those diagnosed with CIN2+ or cancer.
|
From enrollment to the end of participation at 9 months
|
|
Exploratory and Patient-Reported Outcomes
Ramy czasowe: 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).
|
From enrollment to the end of participation at 9 months
|
|
Exploratory and Patient-Reported Outcomes
Ramy czasowe: 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.
|
From enrollment to the end of participation at 9 months
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Reach and Adoption
Ramy czasowe: From enrollment to the end of participation at 9 months
|
Proportion of eligible participants successfully contacted and offered the intervention.
|
From enrollment to the end of participation at 9 months
|
|
Reach and Adoption
Ramy czasowe: From enrollment to the end of participation at 9 months
|
Participant acceptance vs refusal rates, stratified by screening modality.
|
From enrollment to the end of participation at 9 months
|
|
Reach and Adoption
Ramy czasowe: From enrollment to the end of participation at 9 months
|
Equity assessment: Differences in screening uptake across demographic and socioeconomic subgroups.
|
From enrollment to the end of participation at 9 months
|
|
Feasibility and Fidelity
Ramy czasowe: From enrollment to the end of participation at 9 months
|
Return rate of mailed self-sampling kits (valid, invalid, and late returns).
|
From enrollment to the end of participation at 9 months
|
|
Feasibility and Fidelity
Ramy czasowe: From enrollment to the end of participation at 9 months
|
Proportion requiring replacement kits.
|
From enrollment to the end of participation at 9 months
|
|
Feasibility and Fidelity
Ramy czasowe: 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).
|
From enrollment to the end of participation at 9 months
|
|
Acceptability and Sustainability
Ramy czasowe: From enrollment to the end of participation at 9 months
|
Barriers and facilitators to participation identified via telephone structured surveys.
|
From enrollment to the end of participation at 9 months
|
|
Acceptability and Sustainability
Ramy czasowe: 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).
|
From enrollment to the end of participation at 9 months
|
|
Acceptability and Sustainability
Ramy czasowe: 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).
|
From enrollment to the end of participation at 9 months
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Ana Tergas, MD, MPH, Rutgers, The State University of New Jersey
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
20 lipca 2026
Zakończenie podstawowe (Szacowany)
1 lutego 2027
Ukończenie studiów (Szacowany)
16 kwietnia 2027
Daty rejestracji na studia
Pierwszy przesłany
8 lutego 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
4 maja 2026
Pierwszy wysłany (Rzeczywisty)
8 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
4 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
3 sierpnia 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- Pro2025001687
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Tak
produkt wyprodukowany i wyeksportowany z USA
Tak
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .