Impart: Provider-Assisted HIV Partner Notification
Provider-Assisted HIV Partner Notification & Testing With Prisoners in Indonesia: A Randomized Controlled Trial
調査の概要
詳細な説明
This study compares three options for partner notification:
- Option 1 (Self-tell): Participant is encouraged to disclose his HIV+ status to his partner(s) and given information about sites where his partner(s) can receive free HIV testing.
- Option 2 (Tell together): Participant discloses his HIV+ status to his partners with a counselor (project staff) present. Counselor refers the partner to HIV testing, including a study-affiliated HIV testing site.
- Option 3 (Provider referral): Project staff (nurse or peer educator) will notify the partner anonymously - without identifying the participant (index patient). Partners are offered immediate HIV testing in their home or at a study-affiliated HIV testing site.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Jawa Barat
-
Jakarta Pusat、Jawa Barat、インドネシア
- Rutan Cipinang
-
-
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 for HIV-positive Prisoners (N=65): Index patients must beat least 18 years of age, HIV-seropositive and aware of their HIV+ status; (HIV-infection documented by a rapid HIV test); sexually active and/or sharing needles in the 12 months before incarceration; incarcerated within the past 3 years and ≥6 months of their prison sentence remaining. We will limit enrollment to index patients who are willing to notify partners and have 1 or more partner(s) who have not yet been notified.
Inclusion Criteria for Partners: Eligible partners will be persons who participants (index patients) are able to identify by first and/or last name, residential address and/or mobile phone number, and physical descriptors (e.g., approximate height) and have given nurses permission to contact. No named partner will be excluded on the basis of religion, ethnicity, age, sex, or gender identity.
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:診断
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
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:Group A
Subjects are encouraged to disclose their HIV status to their partner(s) with or without a counselor present (Options 1 & 2).
|
Subjects receive counseling about partner notification and are assisted in identifying all their partners and choosing a notification method for each partner.
Subjects are responsible for contacting and notifying their partner(s) on their own.
Subjects have the option to: 1) disclose their HIV status to their partner(s) by themselves (self-tell) or 2) disclose their HIV status to their partner(s) with a healthcare provider present (tell together).
Subjects may decide which partners to notify and may choose the same or a different method for each partner.
|
実験的:Group B
Subjects may choose to notify their partners themselves, with or without a counselor present (Options 1 & 2), or choose to have one or more partners notified anonymously by project staff (Option 3).
|
Subjects receive counseling about partner notification and are assisted in identifying all their partners and choosing a notification method for each partner.
Subjects have the option to: 1) disclose their HIV status to their partner(s) by themselves (self-tell), 2) disclose their HIV status to their partner(s) with a healthcare provider present (tell together), or 3) have their partner(s) notified confidentially by a disease notifier (anonymous provider referral), who will locate partners, notify them of potential HIV exposure, and offer them HIV testing.
Partners with an initial reactive HIV screening test will be referred to care and treatment services.
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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 |
---|---|---|
Notified
時間枠:6 weeks from index patient enrollment
|
Number of partners who are notified of shared HIV exposure
|
6 weeks from index patient enrollment
|
Tested
時間枠:6 weeks from index patient enrollment
|
Number of partners who receive HIV testing subsequent to notification
|
6 weeks from index patient enrollment
|
Diagnosed
時間枠:6 weeks from index patient enrollment
|
Number of partners who are HIV diagnosed subsequent to testing
|
6 weeks from index patient enrollment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Linked to Care
時間枠:6 weeks from index patient enrollment
|
Number of partners who have been evaluated for treatment by a physician subsequent to diagnosis
|
6 weeks from index patient enrollment
|
Initiated ART
時間枠:6 weeks from index patient enrollment
|
Number of partners who have initiated antiretroviral therapy (ART) subsequent to linkage to care
|
6 weeks from index patient enrollment
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
- 2018-0754
- R34MH115779 (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 共有サポート情報タイプ
- 研究プロトコル
- 統計分析計画 (SAP)
- インフォームド コンセント フォーム (ICF)
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
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。
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