南アフリカのHIV陽性女性の子宮頸がんスクリーニングのための尿HPV検査
南アフリカのHIV陽性女性における子宮頸がんスクリーニングのための尿HPV検査の臨床性能検証
The purpose of this study explores the usefulness of urine samples for cervical cancer screening in human immunodeficiency virus (HIV)-infected women.
Cervical cancer occurs when women are infected with the human papillomavirus (HPV), which can cause changes in the cells that lead to cervical precancer and, eventually, cervical cancer if untreated. However, urine HPV testing has not been well validated low- and middle-income country settings, with no data available to guide its use in HIV-infected women.
調査の概要
状態
詳細な説明
Invasive cervical cancer is a significant health burden in low and middle income countries.
HIV-infected women in Africa are particularly affected and have an estimated invasive cervical cancer risk ~20-fold higher than women without HIV. Previous studies have been performed among only HIV-uninfected women or those whose HIV status was unknown. Additionally, HIV infected women are often diagnosed with invasive cervical cancer at younger ages.
Cervical cancer is preventable by regular screenings which includes doing a pap smear or HPV tests. There is also treatment of precancerous cervical lesions and vaccination against high risk types of HPV. World Health Organization currently recommends high risk HPV testing for cervical cancer screening in both high and low resources settings. National Guidelines in many low and middle income countries, including South Africa, have been updated to include plans to transition from cytology or visual screening to primary HPV screening. Urine HPV testing could provide a simpler approach for cervical screening that is more easily scaled in low and middle income countries.
The study hypothesizes that high-risk human papillomavirus (hrHPV) testing on urine specimens will be similar in sensitivity and specificity for the detection of cervical intra-epithelial neoplasia grade 2 or worse (CIN2+) compared to self- or clinician-collected sampling.
This study will investigate whether women can collect their own samples for HPV testing using either urine or a small brush in the vagina. The results of HPV tests on urine, self-collected vaginal samples, and provider-collected cervical samples will be compared to see which sample type works best.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Cheryl Hendrickson
- 電話番号：919-843-2541
- メール：cheryl_hendrickson@med.unc.edu
研究場所
-
-
Johannesburg
-
Westdene、Johannesburg、南アフリカ、2092
- 募集
- Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital
-
コンタクト：
- Sibusisiwe Luvuno
- 電話番号：+27-11-276-8800
- メール：sluvuno@witshealth.co.za
-
主任研究者：
- Carla Chibwesha, MD, MSc
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- Confirmed HIV-1 infection
- Age 25 years and older.
- Be willing and able to provide written informed consent.
Exclusion Criteria:
- Pregnant or intend to become pregnant within 90 days of enrollment
- Have been screened for cervical cancer within the preceding year (365 days)
- Have an active sexually transmitted infection (STI; women may participate once treated)
- Have a surgically absent cervix
- Have a history of cervical cancer
- have been vaccinated against HPV.
研究計画
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：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
他の：Single Arm
This is a single arm study. All participants will receive same interventions. |
Human papillomavirus (HPV) testing in urine sample. Human papillomavirus (HPV) testing in self-collected cervicovaginal specimen sample. Human papillomavirus (HPV) testing in healthcare provider collected cervicovaginal specimen sample. |
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 |
|---|---|---|
|
Clinical performance of hrHPV testing in the three sample types for the detection of CIN2
時間枠：4 weeks (Entry visit)
|
The clinical performance (sensitivity, specificity, positive predictive value, and negative predictive value) for CIN2+ detection of sample collection methods namely urine, self-collected samples, and provider-collected samples will be determined. |
4 weeks (Entry visit)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical performance of hrHPV testing in in the three sample types for the detection of CIN3 or worse
時間枠：4 weeks
|
The clinical performance (sensitivity, specificity, positive predictive value, and negative predictive value) for CIN3+ detection or worse of sample collection methods namely urine, self-collected samples, and provider-collected samples will be determined. |
4 weeks
|
|
The proportion of participants positive for hrHPV
時間枠：4 weeks
|
The high-risk human papillomavirus (hrHPV) positivity detection of urine, self-collected cervicovaginal specimen, and provider-collected cervical samples will be compared. |
4 weeks
|
協力者と研究者
捜査官
- 主任研究者：Carla Chibwesha, MD, MSc、Division of Global Women's Health Department of Obstetrics and Gynecology, UNC Chapel Hill, NC
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IGHID12022
- U54CA254564-01 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The rights and privacy of individuals who participate in research will be protected at all times. Thus, data intended for broader use will be stripped of identifiers that would permit linkages to individual research participants or variables that could lead to deductive disclosure of the identity of individual subjects. Research data that documents, supports and validates research findings will be made available after the main findings from the final research dataset have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers. All data sharing will abide by rules and/or policies defined by the sponsor, relevant IRBs, U.S. local, state, and federal laws and regulations, as well as South African laws and regulations.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。