Project RETAIN: Providing Integrated Care for HIV-Infected Crack Cocaine Users
調査の概要
詳細な説明
This study will evaluate the efficacy of an integrated "Retention Clinic" in achieving virologic suppression among HIV-infected cocaine (including crack) users by using a two-group randomized, prospective trial.
Participants will be randomized to one of two groups: 1) "Retention Clinic" group and 2) Treatment as Usual. The intervention content of these groups is briefly described below:
Retention Clinic (RC) Group: This group will receive comprehensive and integrated services from a Retention Clinic. Services include HIV primary care, substance abuse treatment and mental health services, as needed. Participants in this group will also receive hands-on assistance with navigating through the clinic and accessing these services from a patient navigator.
Treatment as Usual (TAU) Group: This group will receive no protocol directed intervention. They will get the standard retention services from their local clinic.
All participants will provide informed consent and will complete a baseline audio computer-assisted self-interview or ACASI focusing on drug use, mental health, demographics and socio-economic factors, HIV care, and drug treatment history as well as blood draws for viral load and CD4 count. Follow-up assessments consisting of both ACASI and blood draws in all groups will be collected at 6 and 12 months post-randomization. Medical records will be reviewed to document use of HIV care, drug treatment and mental health services during the study period.
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
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Florida
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Miami、Florida、アメリカ、33136
- Jackson Health System-Special Immunology Clinic
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Georgia
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Atlanta、Georgia、アメリカ、30308
- Grady Health System-Ponce De Leon Center
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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:
Participating individuals must:
- be at least 18 years old
- be HIV-seropositive (confirmed via medical record/laboratory results or via rapid HIV test in conjunction with confirmatory test or viral load)
- meet one of the following: a) have an (*)AIDS-defining illness OR b) have a CD4 count <350 cells/uL AND a viral load >1000 copies/mL in the medical record in the past 3 months OR c) have a CD4 count <350 cells/uL AND a viral load >200 copies/mL as obtained via baseline blood draw OR d) have a clinical profile indicative of a persistently detectable HIV viral load (>200 copies/mL) attributed to non-adherence to HIV medications as per PI evaluation of the individual and/or individual's medical record
- report (OR have evidence in the medical record of) any cocaine (including crack) use in the past 3 months OR (**)have a positive toxicology result for cocaine via the study toxicology screen
- agree to have their blood drawn for CD4 and viral load testing
- report living in or near either Miami, Florida (FL), or Atlanta, Georgia (GA), and be able to return for follow-up visits
- provide locator information
- be able to communicate in English
- provide written informed consent
- sign a HIPAA Authorization form/medical record release to facilitate medical record abstraction
- be willing to go to the study clinic
(*)Site PI discretion will be used to assess whether or not the AIDS-defining illness is a good indicator of eligibility. For example, if a patient does not meet the CD4 and viral load criteria and does have an AIDS-defining illness, the Site PI will assess the AIDS-defining illness to determine whether or not the patient is a suitable candidate for the study.
(**)Per PI discretion, the urine toxicology screen may be administered as part of the screening process if the participant's self-report and/or medical record data renders him/her ineligible on the drug use criterion.
Exclusion Criteria:
Individuals will be excluded from study participation if they:
- do not meet any one or more of the above-described inclusion criteria
- are receiving patient navigator services for HIV care and/or substance abuse treatment
- have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent
- are terminated via site PI decision
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：処理
- 割り当て：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 |
|---|---|
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実験的：Intervention
The Retention Clinic will incorporate HIV primary care and mental health services with on-site substance abuse treatment and patient navigation.
The central components will include: Primary HIV Care; Mental Health Services; Skill-building; and On-Site substance abuse treatment (including Motivational Enhancement Therapy and Cognitive Behavioral Therapy).
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The central components of the Retention Clinic will include: Primary HIV Care; Patient Navigator services (including Informational support, Educational information, Motivational/Emotional support, Skill Building activities); Mental Health Services; and On-Site Substance Abuse Treatment (including Motivational Enhancement Therapy and Cognitive Behavioral Therapy).
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介入なし：Treatment as Usual (TAU)
The treatment as usual (TAU) group condition will represent standard of care at both of the participating clinics.
Standard of care at both clinics includes primary HIV care, the provision of mental health services, and the assignment of a clinic case manager.
These case managers meet with patients when they first come to clinic and then meet with them as needed and typically offer substance-using patients a referral to substance abuse treatment in the community as needed.
Case managers usually do not follow up to determine the uptake of these referrals.
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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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Virologic suppression
時間枠：12 months
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To evaluate the effectiveness of the integrated "Retention Clinic" in achieving virologic suppression (defined as having an HIV-1 viral load <200 copies/mL at 6 and 12 months) among HIV-infected cocaine (including crack) users
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12 months
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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 |
|---|---|---|
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Attendance to HIV Care Visits
時間枠：12 months
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To evaluate the effectiveness of the integrated care Retention Clinic in increasing attendance at HIV care visits.
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12 months
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Adherence to HIV Treatment Regimens
時間枠：12 months
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To evaluate the effectiveness of the integrated care Retention Clinic in increasing adherence to HIV treatment regimens.
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12 months
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Attendance to Substance Abuse Treatment
時間枠：12 months
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To evaluate the effectiveness of the integrated care Retention Clinic in increasing attendance at substance abuse treatment.
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12 months
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Decreasing Substance Use
時間枠：12 months
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To evaluate the effectiveness of the integrated care Retention Clinic in decreasing substance use.
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12 months
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Lisa R. Metsch, Ph.D.、Columbia University
- 主任研究者：Carlos del Rio, M.D.、Emory University
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 (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
その他の研究ID番号
- AAAK0606
- R01DA032098 (米国 NIH グラント/契約)
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。
HIVの臨床試験
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University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public Health募集HIV | HIV検査 | HIV とケアの関係 | HIV治療アメリカ
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French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS Foundation完了パートナーの HIV 検査 | カップルの HIV カウンセリング | カップルのコミュニケーション | HIV の発生率カメルーン, ドミニカ共和国, グルジア, インド
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University of Minnesota引きこもったHIV感染症 | HIV/エイズ | HIV | AIDS | エイズ・HIV問題 | エイズと感染症アメリカ
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Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University of Southampton と他の協力者募集
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ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement; Centre Pasteur... と他の協力者わからないHIV | HIVに感染していない子供たち | HIVにさらされた子供たちカメルーン
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Erasmus Medical Centerまだ募集していません
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University of Maryland, Baltimore引きこもった
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Hospital Clinic of Barcelona完了
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University of WashingtonNational Institute of Mental Health (NIMH)募集
Retention Clinicの臨床試験
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Massachusetts General HospitalBeth Israel Deaconess Medical Center; Boston Children's Hospital; Brigham and Women's Hospital募集
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Africa Health Research Institute募集
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University of Kansas Medical CenterNational Institute for Biomedical Imaging and Bioengineering (NIBIB)完了
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University of Floridaまだ募集していません子宮頸がんのスクリーニング方法