Mail-in HPV Screening Program in NJ
3 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Inscrevendo-se por convite
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
200
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
New Jersey
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Newark, New Jersey, Estados Unidos, 07103
- Rutgers New Jersey Medical School
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Triagem
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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
|
|
Experimental: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Completion of CC screening within 6 months of initial outreach.
Prazo: 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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Screening Pathway Choices and Performance
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Reach and Adoption
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Ana Tergas, MD, MPH, Rutgers, The State University of New Jersey
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
20 de julho de 2026
Conclusão Primária (Estimado)
1 de fevereiro de 2027
Conclusão do estudo (Estimado)
16 de abril de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
8 de fevereiro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de maio de 2026
Primeira postagem (Real)
8 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de agosto de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- Pro2025001687
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Sim
produto fabricado e exportado dos EUA
Sim
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