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Cooperative Re-Engagement Controlled Trial (CoRECT) (CoRECT)

2021年2月18日 更新者：Centers for Disease Control and Prevention
CoRECT will help identify the important components of a data-sharing partnership between health departments and HIV care providers, and determine the extent to which a health department intervention can increase the number of HIV-infected persons out-of-care who: (a) link to an HIV clinic; (b) remain in HIV medical care; (c) achieve HIV viral load suppression within 12 months; and (d) achieve durable HIV viral load suppression over 18 months. We will also measure the cost-effectiveness of this intervention in regards to improved health in the individuals (re)-engaged in HIV care and reductions in further HIV transmission in the community.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Methods summary: Health departments will generate an out-of-care list using HIV laboratory surveillance data; collaborating clinics will concurrently generate out-of-care lists using appointment data. The combined out-of-care list will be reconciled by the health department and clinics, and discussed at monthly case conferences. All individuals determined to be out-of care will be randomized to receive either: (1) usual linkage and engagement in care services (standard of care [SOC]); or (2) an active health department field services intervention in addition to SOC. The active intervention activities will vary among jurisdictions; however all sites will include field services to locate, contact, and provide assistance, including a same-day appointment, to access HIV medical care.

Study design: Each site will enroll 600 out-of-care HIV-infected individuals (300 per arm) during a two-year enrollment period. An out-of-care individual will be defined as: (1) a person who has received HIV medical care at a CoRECT clinic and then disengages from care; or (2) a person with newly diagnosed HIV infection who has an appointment at a CoRECT clinic, but has not linked to medical care within 90 days.

Intervention: Individuals randomized to the intervention arm will receive field services to locate, contact, and provide assistance to access HIV medical care. Services provided as part of the intervention will vary by jurisdiction, but may include assistance with expedited medical appointments, transportation, access to community resources such as traditional case management, strengths-based case management, or financial incentives (Appendix A).

Primary outcomes: The following outcomes will be compared between out-of-care HIV-infected individuals receiving the study intervention to those receiving usual services:

  1. Attend 1 clinic visit within 90 days;
  2. Remain engaged in care, defined as 2 clinic visits at least 3 months apart within 12 months;
  3. Achieve viral load suppression within 12 months;
  4. Achieve durable viral load suppression, defined as 2 consecutive suppressed viral load results at least 3 months apart within 18 months

研究の種類

介入

入学 (実際)

1893

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Connecticut
      • Hartford、Connecticut、アメリカ、06106
        • Connecticut Department of Public Health
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02108
        • Massachusetts Department of Public Health
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19104
        • Philadelphia Department of Health

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Residents within the health department jurisdiction who have received HIV medical care at a CoRECT clinic and then disengage by either of the following definitions:

    • Clinic definition: did not have a visit with a prescribing provider for 6 months.
    • Health department definition: no CD4 or viral load test result reported to health department surveillance for more than 6 months.

  2. Residents within the health department jurisdiction with newly diagnosed HIV infection who have not linked to medical care within 90 days and have either:

    • Received, but did not attend, an appointment at a CoRECT clinic; or
    • Attended an enrollment visit but did not receive medical care at a CoRECT clinic.

Exclusion Criteria:

  1. Deceased
  2. Out of jurisdiction
  3. Changed providers
  4. Incarcerated

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：ダブル

武器と介入

参加者グループ / アーム
介入・治療
介入なし：standard of care (SOC) arm
Individuals found to be out of HIV medical care will receive standard of care to re-engage. This will not include use of disease intervention specialist to locate and recruit back to HIV medical care or use of the Anti-Retroviral Treatment and Access to Services (ARTAS) intervention.
実験的：Intervention arm
Individuals randomized to the intervention arm will receive field services to locate, contact, and provide assistance to access HIV medical care. Intervention may include use of disease intervention specialist to locate and recruit back to HIV medical care or use of the Anti-Retroviral Treatment and Access to Services (ARTAS) intervention.
他の：Anti-Retroviral Treatment and Access to Services (ARTAS)
Anti-Retroviral Treatment and Access to Services (ARTAS) is an individual-level, multi-session, time-limited intervention with the goal of linking recently diagnosed persons with HIV to medical care soon after receiving their positive test result. ARTAS is based on the Strengths-based Case Management (SBCM) model, which is rooted in Social Cognitive Theory (particularly self-efficacy) and Humanistic Psychology. SBCM is a model that encourages the client to identify and use personal strengths; create goals for himself/herself; and establish an effective, working relationship with the Linkage Coordinator (LC).

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
Attend one clinic visit
時間枠：within 90 days of randomization
Patient will attend one clinical visit at CoRECT clinic to receive HIV medical care
within 90 days of randomization
Remain engaged in care
時間枠：defined as 2 clinic visits at least 3 months apart within 12 months
Two or more medical visits at least 3 months apart within 12 months to demonstrate patient remains engaged in HIV medical care
defined as 2 clinic visits at least 3 months apart within 12 months
Viral load suppression
時間枠：within 12 months
Does the patient achieve viral load suppression within 12 months of randomization
within 12 months
Achieve durable viral load suppression
時間枠：defined as 2 consecutive suppressed viral load results at least 3 months apart within 18 months
Achieve durable viral load suppression, defined as 2 consecutive suppressed viral load results at least 3 months apart within 18 months
defined as 2 consecutive suppressed viral load results at least 3 months apart within 18 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Centers for Disease Control and Prevention

協力者

Connecticut State, Department of Mental Health and Addiction Services
Massachusetts Department of Health
Philadelphia Department of Public Health

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2016年8月1日

一次修了 (実際)

2020年8月1日

研究の完了 (実際)

2020年8月1日

試験登録日

最初に提出

2016年2月23日

QC基準を満たした最初の提出物

2016年2月25日

最初の投稿 (見積もり)

2016年2月26日

学習記録の更新

投稿された最後の更新 (実際)

2021年2月21日

QC基準を満たした最後の更新が送信されました

2021年2月18日

最終確認日

2021年2月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • FOA PS14-001

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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