ノートル：カルサル環境でのオピオイド使用障害介入のための長時間作用型の露出前予防と薬物の最適化 (NOTRE)
カルサル環境におけるオピオイド使用障害介入のための長時間作用型の曝露前予防と薬物の最適化
The investigators plan to conduct an R61/33 hybrid type 2 implementation-effectiveness trial that includes 1) a one-year exploratory R61 phase that will enable the development of the intervention protocol needed for the R33 trial phase including concrete R61 phase milestones; 2) a four-year R33 phase that will include a concurrent implementation evaluation and a randomized control trial.
調査の概要
状態
詳細な説明
Study aims are: Aim 1 (R61): Develop the intervention protocol for delivery of LAI PrEP + XR-B. We will conduct interviews with stakeholders (staff at partner and other carceral and community sites, n=18:) and currently or recently incarcerated individuals (n=18). Interviews will focus on how to optimize intervention components for the R33 phase. Aim 2 (R33): Evaluate implementation facilitation as a strategy to support co-located LAI PrEP + XR-B in carceral and re-entry settings. Guided by the Consolidated Framework for Implementation Research (CFIR), implementation outcomes from Proctor et al.,including acceptability, appropriateness, adoption, feasibility, and sustainability will be assessed using surveys, interviews, and administrative records. Aim 3 (R33): Compare the effectiveness of co-located LAI PrEP + XR-B to oral PrEP + SL-B. Patient preference trial for 450 adults who are clinically indicated for both PrEP and MOUD and soon-to-be-released from a carceral setting to either LAI Prep + X-RB (n=150) or oral PrEP + SL-B (n=150) treatment initiated in jail or prison. A baseline assessment will be conducted prior to release followed by monthly follow-up for 7 months and a final long-term follow-up visit at 12-months.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Hannah Camp, MPH, MSW
- 電話番号：9193600692
- メール：hannah.camp@duke.edu
研究場所
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North Carolina
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Durham、North Carolina、アメリカ、27710
- Duke University Medical System
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主任研究者：
- Michael Gordon, DPA
-
コンタクト：
- Hannah Camp, MPH, MSW
- 電話番号：9193600692
- メール：hannah.camp@duke.edu
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コンタクト：
- Lauren Brinkley-Rubinstein, PhD
- 電話番号：919 668 1753
- メール：lauren.br@duke.edu
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主任研究者：
- Lauren Brinkley-Rubinstein, PhD
-
主任研究者：
- Curt Beckwith, MD, FIDSA, FACP
-
-
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:
- Adults (age 18) at a participating carceral site;
- Eligible for release within 120 days (sentenced and/or pretrial). Individuals who might be sentenced to federal prison will be excluded;
- History of OUD (meeting DSM-5 criteria of moderate or severe opioid use disorder at the time of incarceration; individuals not meeting the opioid-disorder criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration or met OUD criteria in the year prior to incarceration);
- HIV negative (as confirmed by a HIV rapid test);
- Clinically indicated for PrEP based on CDC guidelines during incarceration and/or the year prior to incarceration;
- Willing to enroll in buprenorphine treatment and PrEP and be randomized to either study arm; and
- Report that, during community re-entry they will reside in the geographic locations of the study.
Exclusion Criteria:
- Liver function test levels greater than four times normal (if we are unable to obtain labs, a determination by our site partner physicians will be made to allow inclusion);
- Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease; renal impairment, Hepatitis B);
- Conditions or medications that may predispose to QTc prolongation (personal or family history of long QT syndrome, hypokalemia, medications that prolong QTc interval, e.g., macrolide antibiotics, azole antifungal compounds, anti-arrhythmics, antipsychotics and antidepressants);
- Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, treated psychiatric disorders will be allowed);
- Known allergic reaction to PrEP or buprenorphine; and
- Suicidal ideation.
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：防止
- 割り当て：非ランダム化
- 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：Daily Oral Pill Arm
Participants assigned to this arm will be administered daily oral pre-exposure prophylaxis for HIV prevention, as well as daily oral buprenorphine for opioid use disorder |
Oral PrEP + SL-B treatment initiated in jail or prison. Oral PrEP + SL-B treatment initiated in jail or prison. |
|
実験的：Long Acting Injectable Arm
Participants assigned to this arm will be administered the-long acting injectable formulation of pre-exposure prophylaxis every 1-2 months, as well as the long-acting injectable formulation of buprenorphine, at the same clinic visit. |
Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison. Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison. |
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 |
|---|---|---|
|
PrEP adherence, time to dropout
時間枠：up to 12 months
|
Dropout is defined as missing treatment for 7 consecutive days. |
up to 12 months
|
|
Buprenorphine adherence, time to dropout
時間枠：up to 12 months
|
Dropout is defined as missing treatment for 7 consecutive days. |
up to 12 months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
尿薬物検査陽性の参加者数によって測定される物質使用（UDT）
時間枠：最大12か月
|
最大12か月
|
|
致命的または致命的ではない過剰摂取を持つ参加者の数
時間枠：最大12か月
|
最大12か月
|
|
HIVリスク行動に従事する参加者の数
時間枠：最大12か月
|
最大12か月
|
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過去の刑事システムの関与を持つ参加者の数
時間枠：ベースライン
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ベースライン
|
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HIV獲得の参加者の数
時間枠：最大12か月
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最大12か月
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Lauren Brinkley-Rubinstein, PhD、Duke University
研究記録日
主要日程の研究
研究開始 (推定)
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
- Pro00117590
- R61DA060583 (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
Our data and research findings will be shared with other researchers through the customary means of peer-reviewed publications and at national and international conferences and symposia, such as the annual meeting of the Academic Consortium on Criminal Justice Health, the American Public Health Association.
We will ensure that publications reporting on study data and results will be made available to interested scientists by submitting an electronic version of all papers, upon acceptance for publication, to the National Library of Medicine's PubMed Central.
In addition, we will cite this grant in any products emanating from this research study. Whenever possible, we will make resulting publications open access. In addition, our team, whenever possible, will make the data underlying the conclusions of peer-reviewed scientific research publications freely available in public repositories at the time of initial publication.
IPD 共有時間枠
Scientific data will be made available after all longitudinal data is collected (baseline, follow-up data) and has undergone rigorous quality control. In addition, data will be made available after the primary outcome papers are accepted for publication. An exception to this will be sharing more routinely with the HIV/Justice Research Network Data Coordination Center.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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。