Urban Health Study II
Finding, Testing and Treating High-Risk Probationers and Parolees With HIV
調査の概要
詳細な説明
The study has two research objectives: (1) to expand access and options for HIV testing with individuals in the criminal justice system, by focusing on high-risk intravenous drug users (IDUs) and crack cocaine smokers in community settings; and (2) to improve access and maintenance of highly active antiretroviral treatment (HAART) among HIV-positive persons in this population, by implementing a promising intervention focused on continuity of HIV care, and evaluating it using a rigorous experimental design.
HIV-positive persons will be identified through the testing activities described in Objective 1. They will then be offered enrollment in a randomized controlled trial (RCT) of an intervention designed to engage and maintain HIV-positive people with criminal justice involvement in medical care. The intervention, Project Bridge, has shown great promise but has not yet been rigorously evaluated. The RCT will assess the efficacy of Project Bridge compared with a Usual Care arm. Our hypotheses are that, at quarterly data collection visits: (1) Intervention participants will have lower HIV viral load than usual care participants 2b: (2) Intervention participants will be more likely to be in HIV care than usual care participants (3) Intervention participants will be more likely to be on HAART than usual care participants.
The study design was changed from a randomized controlled trial to a quasi-experimental comparison group design. This change was approved by the NIMH Program Officer and the RTI IRB in June, 2012.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
California
-
San Francisco、California、アメリカ、94104
- RTI International Urban Health Program
-
-
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:
- Age 18 or older
- HIV antibody positive
- not currently receiving HIV care
Exclusion Criteria:
- already in care
- unable to provide informed consent
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:ヘルスサービス研究
- 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:Standard Referral
Participants randomized to this arm will be referred to local HIV care resources
|
Participants randomized to this arm will be referred to local HIV care resources
|
|
実験的:Project Bridge
Participants randomized to this arm will be given the Project Bridge intervention
|
Arm 2
|
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 |
|---|---|---|
|
Log10 viral load
時間枠:Every 3 months for 2 years
|
Changes in viral load over time will be compared between the standard referral and Project Bridge Groups
|
Every 3 months for 2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Engagement in HIV Care
時間枠:Every 3 months for 2 years
|
The proportion of participants entering HIV care will be compared between the standard referral and Project Bridge groups
|
Every 3 months for 2 years
|
|
Initiation of Highly Active Antiretroviral Therapy (HAART)
時間枠:Every 3 months for 2 years
|
The proportion of participants initiating HAART will be compared between the standard referral and Project Bridge groups
|
Every 3 months for 2 years
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Alex H Kral, PhD、RTI International
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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。