PHASES: Provision of HIV Treatment at ATN Sites: An Evaluation for Stakeholders
調査の概要
状態
条件
詳細な説明
研究の種類
入学 (実際)
連絡先と場所
研究場所
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California
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Aurora、California、アメリカ、80045
- University of Colorado/The Children's Hospital
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Los Angeles、California、アメリカ、90027
- Children's Hopsital of Los Angeles
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District of Columbia
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Washington、District of Columbia、アメリカ、20010
- Children's Hospital National Medical Center
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Florida
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Miami、Florida、アメリカ、33101
- University of Miami School of Medicine
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Tampa、Florida、アメリカ、33606
- University of South Florida
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Illinois
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Chicago、Illinois、アメリカ、60612
- Stroger Hospital of Cook County
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Louisiana
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New Orleans、Louisiana、アメリカ、70112
- Tulane University Health Sciences Center
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Maryland
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Baltimore、Maryland、アメリカ、21287
- Johns Hopkins University
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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- Fenway Institute
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Michigan
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Detroit、Michigan、アメリカ、48201
- Children's Hospital of Michigan
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New York
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Bronx、New York、アメリカ、10467
- Montefiore Medical Center
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Children's Hospital of Philadelphia
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Tennessee
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Memphis、Tennessee、アメリカ、38105
- St. Jude Children's Research Hospital
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Texas
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Houston、Texas、アメリカ、77030
- Baylor College of Medicine/Texas Children's Hospital
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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
サンプリング方法
調査対象母集団
- Behaviorally-infected, HIV-positive adolescents and young adults who are currently receiving or plan to receive their medical care at any clinical site that is part of the AMTU;
- Ages 13 through 24, inclusive, at the Baseline visit;
- Males and females;
- Ability to understand spoken English; and
- Ability for the AMTU staff to access the subject's medical records for a maximum of 78 weeks after enrollment or through February 2017, whichever occurs first.
説明
Inclusion Criteria:
- Laboratory evidence of HIV-1 infection per Centers for Disease Control and Prevention (CDC) Surveillance Case Definition for HIV Infection, 2014 (Section 1.1) http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6303a1.htm;
- Behaviorally-acquired HIV after age 9 years;
- Age 13 through 24 years, inclusive, at the baseline visit (Enrollment);
Planning to receive HIV medical care at an AMTU or at any clinical site that is part of the AMTU for the duration of study follow-up
• If transition to an adult health care provider must occur during the course of study participation, continued AMTU staff accessibility to medical and appointment records;
- Ability for the AMTU staff to access medical and appointment records for a maximum of 78 weeks after enrollment or through February 2017, whichever occurs first;
- Ability to understand spoken English;
- Willing and able to provide signed informed consent or assent;
NOTE: If consent/assent is obtained > 4 weeks prior to the enrollment date, reaffirmation of consent must be obtained prior to starting the Baseline visit.
-Parent or Legal Guardian permission, if applicable; and
In addition to all the criteria listed above, to be considered eligible for enrollment after August 31, 2015, an individual must also meet the following criterion.
-Must be considered either: (a) newly engaged in HIV medical care defined as no previous initial comprehensive HIV medical care visit with consent occurring before, at the time of, or within four weeks following that initial comprehensive visit; or (b) newly re-engaged in HIV medical care defined as attending the last medical appointment more than 52 weeks ago.
*NOTE: The initial HIV medical care appointment is defined as a routine HIV medical appointment where the adolescent attends with a medical provider authorized to prescribe medication.
This HIV medical appointment must be a non-emergency, routine condition-focused exam AND one or more of the following:
- CD4, VL lab draw and/or review of these lab results;
- Discussion around HIV ART options;
- Primary and/or secondary HIV prevention education and counseling; or
- Diagnosis and treatment of complications of HIV, and of AIDS-defining conditions.
Exclusion Criteria:
- Presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder) that would impair the individual's ability to provide true informed consent or participate in the baseline ACASI*;
- Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior) at the time of consent or the baseline ACASI*; or
Intoxicated or under the influence of alcohol or other substances at the time of consent or the baseline ACASI*
- NOTE: If consent/assent is obtained prior to the enrollment date, assessment for these exclusion criteria must be performed again prior to administration of the baseline ACASI (Enrollment). If any are present, the subject cannot be enrolled; do not administer the ACASI. Reassessment of eligibility and enrollment may take place at a later date per the discretion of the treating clinician.
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
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 |
時間枠 |
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The proportion of subjects engaged in care at Baseline, per subject year, as defined by the HRSA HAB measure
時間枠:Baseline
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Baseline
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The proportion of subjects engaged in care at Week 26, per subject year, as defined by the HRSA HAB measure
時間枠:Week 26
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Week 26
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The proportion of subjects engaged in care at Week 52, per subject year, as defined by the HRSA HAB measure
時間枠:Week 52
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Week 52
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The proportion of subjects engaged in care at Week 78, per subject year, as defined by the HRSA HAB measure
時間枠:Week 78
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Week 78
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The proportion of subjects engaged in care at Baseline, per subject year, as defined by the DHHS measure
時間枠:Baseline
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Baseline
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The proportion of subjects engaged in care at Week 26, per subject year, as defined by the DHHS measure
時間枠:Week 26
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Week 26
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The proportion of subjects engaged in care at Week 52, per subject year, as defined by the DHHS measure
時間枠:Week 52
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Week 52
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The proportion of subjects engaged in care at Week 78, per subject year, as defined by the DHHS measure
時間枠:Week 78
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Week 78
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The proportion of subjects prescribed antiretroviral therapy at Baseline per subject year
時間枠:Baseline
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Baseline
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The proportion of subjects prescribed antiretroviral therapy at Week 26 per subject year
時間枠:Week 26
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Week 26
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The proportion of subjects prescribed antiretroviral therapy at Week 52 per subject year
時間枠:Week 52
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Week 52
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The proportion of subjects prescribed antiretroviral therapy at Week 78 per subject year
時間枠:Week 78
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Week 78
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The proportion of subjects that have achieved viral suppression at Baseline per subject year
時間枠:Baseline
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Baseline
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The proportion of subjects that have achieved viral suppression at Week 26 per subject year
時間枠:Week 26
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Week 26
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The proportion of subjects that have achieved viral suppression at Week 52 per subject year
時間枠:Week 52
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Week 52
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The proportion of subjects that have achieved viral suppression at Week 78 per subject year
時間枠:Week 78
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Week 78
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二次結果の測定
結果測定 |
時間枠 |
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The proportion of subjects with advanced HIV disease at time of first clinical visit defined as a CD4 count < 200 cells/mm3
時間枠:Baseline
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Baseline
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The incidence of STIs in the study population as an indicator of transmission risk at Baseline
時間枠:Baseline
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Baseline
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The incidence of STIs in the study population as an indicator of transmission risk at Week 26
時間枠:Week 26
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Week 26
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The incidence of STIs in the study population as an indicator of transmission risk at Week 52
時間枠:Week 52
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Week 52
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The incidence of STIs in the study population as an indicator of transmission risk at Week 78
時間枠:Week 78
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Week 78
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Number of subjects with mental health issues at Baseline
時間枠:Baseline
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Baseline
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Number of subjects engaging in substance use at Baseline
時間枠:Baseline
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Baseline
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Number of subjects engaging in sexual risk behaviors at Baseline
時間枠:Baseline
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Baseline
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ART adherence rate at Baseline
時間枠:Baseline
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Baseline
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Frequency of missed clinic visits at Baseline
時間枠:Baseline
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Baseline
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Frequency of missed clinic visits at Week 26
時間枠:Week 26
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Week 26
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Frequency of missed clinic visits at Week 52
時間枠:Week 52
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Week 52
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Frequency of missed clinic visits at Week 78
時間枠:Week 78
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Week 78
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Types of services available at each AMTU at Baseline
時間枠:Baseline
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Baseline
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Types of services available at each AMTU at 48 weeks after Baseline
時間枠:Week 48
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Week 48
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Types of services available at each AMTU at 96 weeks after Baseline
時間枠:Week 96
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Week 96
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Proportion of subjects notifying their sexual partners after learning their HIV status
時間枠:Baseline
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Baseline
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Timing of subjects notifying their partners after learning about their HIV status
時間枠:Baseline
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Baseline
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Proportion of subjects with whom partner notification was discussed
時間枠:Baseline
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Baseline
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協力者と研究者
捜査官
- 主任研究者:Bret Rudy, MD、NYU Langone Health
出版物と役立つリンク
便利なリンク
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
キーワード
その他の研究ID番号
- ATN 125
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