Mail-in HPV Screening Program in NJ
2026年8月3日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
200
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
New Jersey
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Newark、New Jersey、アメリカ、07103
- Rutgers New Jersey Medical School
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ふるい分け
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Standard Pap Smear
Participants will have the option to choose a standard pap smear for cervical cancer screening
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Healthcare provider collected (in a hospital or clinical setting) cervicovaginal sample
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実験的：HPV Self-Sampling Test
Participants are able to opt-in for an at-home self-sampling HPV test for cervical cancer screening
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Self-collected cervicovaginal sample
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Completion of CC screening within 6 months of initial outreach.
時間枠：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.
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Outcome will be measured at 6 months post-initial outreach call.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Screening Pathway Choices and Performance
時間枠：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
|
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Screening Pathway Choices and Performance
時間枠：From enrollment to the end of participation at 9 months
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Timeliness of screening completion (measured as days from outreach to Pap attendance or kit return).
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From enrollment to the end of participation at 9 months
|
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Screening Pathway Choices and Performance
時間枠：From enrollment to the end of participation at 9 months
|
Screening test result distribution (categorized as negative, positive, or inadequate, stratified by modality).
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From enrollment to the end of participation at 9 months
|
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Screening Pathway Choices and Performance
時間枠：From enrollment to the end of participation at 9 months
|
HPV genotype distribution among positive samples (individual and group reporting per lab protocol)
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From enrollment to the end of participation at 9 months
|
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Clinical Follow-Up and Downstream Outcomes
時間枠：From enrollment to the end of participation at 9 months
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Clinical follow-up completion after abnormal results (attendance at colposcopy or initiation of treatment).
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From enrollment to the end of participation at 9 months
|
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Clinical Follow-Up and Downstream Outcomes
時間枠：From enrollment to the end of participation at 9 months
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Detection of histologically confirmed cervical intraepithelial neoplasia grade 2 or higher (CIN2+) or invasive cervical cancer.
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From enrollment to the end of participation at 9 months
|
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Clinical Follow-Up and Downstream Outcomes
時間枠：From enrollment to the end of participation at 9 months
|
Treatment initiation and completion rates among those diagnosed with CIN2+ or cancer.
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From enrollment to the end of participation at 9 months
|
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Exploratory and Patient-Reported Outcomes
時間枠：From enrollment to the end of participation at 9 months
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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
|
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Exploratory and Patient-Reported Outcomes
時間枠：From enrollment to the end of participation at 9 months
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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.
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From enrollment to the end of participation at 9 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Reach and Adoption
時間枠：From enrollment to the end of participation at 9 months
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Proportion of eligible participants successfully contacted and offered the intervention.
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From enrollment to the end of participation at 9 months
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Reach and Adoption
時間枠：From enrollment to the end of participation at 9 months
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Participant acceptance vs refusal rates, stratified by screening modality.
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From enrollment to the end of participation at 9 months
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Reach and Adoption
時間枠：From enrollment to the end of participation at 9 months
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Equity assessment: Differences in screening uptake across demographic and socioeconomic subgroups.
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From enrollment to the end of participation at 9 months
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Feasibility and Fidelity
時間枠：From enrollment to the end of participation at 9 months
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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
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Feasibility and Fidelity
時間枠：From enrollment to the end of participation at 9 months
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Proportion requiring replacement kits.
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From enrollment to the end of participation at 9 months
|
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Feasibility and Fidelity
時間枠：From enrollment to the end of participation at 9 months
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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
時間枠：From enrollment to the end of participation at 9 months
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Barriers and facilitators to participation identified via telephone structured surveys.
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From enrollment to the end of participation at 9 months
|
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Acceptability and Sustainability
時間枠：From enrollment to the end of participation at 9 months
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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
|
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Acceptability and Sustainability
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Ana Tergas, MD, MPH、Rutgers, The State University of New Jersey
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年7月20日
一次修了 (推定)
2027年2月1日
研究の完了 (推定)
2027年4月16日
試験登録日
最初に提出
2026年2月8日
QC基準を満たした最初の提出物
2026年5月4日
最初の投稿 (実際)
2026年5月8日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月4日
QC基準を満たした最後の更新が送信されました
2026年8月3日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- Pro2025001687
個々の参加者データ (IPD) の計画
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いいえ
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いいえ
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はい
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はい
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