Mail-in HPV Screening Program in NJ
3 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Inscription sur invitation
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
200
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
New Jersey
-
Newark, New Jersey, États-Unis, 07103
- Rutgers New Jersey Medical School
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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
|
|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Completion of CC screening within 6 months of initial outreach.
Délai: 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.
|
Outcome will be measured at 6 months post-initial outreach call.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Screening Pathway Choices and Performance
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Reach and Adoption
Délai: 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
Délai: 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
Délai: 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
Délai: From enrollment to the end of participation at 9 months
|
Return rate of mailed self-sampling kits (valid, invalid, and late returns).
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From enrollment to the end of participation at 9 months
|
|
Feasibility and Fidelity
Délai: From enrollment to the end of participation at 9 months
|
Proportion requiring replacement kits.
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From enrollment to the end of participation at 9 months
|
|
Feasibility and Fidelity
Délai: 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).
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From enrollment to the end of participation at 9 months
|
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Acceptability and Sustainability
Délai: 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
Délai: 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).
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From enrollment to the end of participation at 9 months
|
|
Acceptability and Sustainability
Délai: 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).
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From enrollment to the end of participation at 9 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Ana Tergas, MD, MPH, Rutgers, The State University of New Jersey
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
20 juillet 2026
Achèvement primaire (Estimé)
1 février 2027
Achèvement de l'étude (Estimé)
16 avril 2027
Dates d'inscription aux études
Première soumission
8 février 2026
Première soumission répondant aux critères de contrôle qualité
4 mai 2026
Première publication (Réel)
8 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 août 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Pro2025001687
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
produit fabriqué et exporté des États-Unis.
Oui
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .