Improving Antiretroviral Medication Adherence Among HIV-infected Youth
Improving Antiretroviral Medication Adherence Among HIV-infected Youth: Phase II
HIV is increasing among adolescents and young adults in the US. Antiretroviral medications, when taken correctly (≥ 90% of prescribed doses taken), can vastly improve life expectancy. However, adherence among HIV-infected young people is suboptimal, and few interventions are available to help adolescents adhere to treatment.
The study is a randomized controlled trial (RCT) pilot trial of Positive STEPS (the adapted form of the Life-Steps behavioral intervention) to improve medication adherence among HIV-infected youth. The study will allow us to demonstrate participant acceptance, ability to recruit, feasibility of intervention delivery with study counselors and all study procedures, and initial clinically significant improvement in medication adherence via MEMS caps. This research will lay the groundwork for a federal grant application for a multi-site randomized controlled intervention trial.
調査の概要
詳細な説明
Aims:
- To conduct a randomized controlled pilot test of a behavioral adherence intervention to improve medication adherence among HIV-infected youth aged 13-24. Feasibility of all study procedures and participant acceptability will be assessed.
- To explore whether the intervention leads to improved medication adherence among youth who receive the intervention, compared to a control group of youth who do not.
40 HIV-infected adolescents will be recruited for a RCT pilot of the Positive STEPS intervention at Fenway Health and Children's Hospital Boston. Participants will be randomized into one of two arms (half and half). Randomization for all participants will occur after the beginning of the week 2 study visit. The duration of the study is 3 months
Randomization:
The investigators will conduct block randomization based on two categories of electronic adherence: 85% or above versus < 85%. All participants will have exhibited some non-adherence in order to be eligible for the study, although they may vary in the extent of non-adherence. Because insufficient information is known about the range of non-adherence in the population to determine the most valid non-adherence cut-off points, the investigators may need to reconsider adherence categories over the course of the pilot study. The investigators will regularly examine the data to determine whether finer adherence categories are needed, and the investigators will adjust the categories if such a determination is made.
Intervention arm:
- Participants will receive one on one Positive STEPS counseling sessions (~1 hour sessions per week for 5 weeks).
- Participants will receive motivational reminders to take medications sent via text message to their cell phones
- Participants will receive the Medication Event Monitoring Systems (MEMS) pill cap monitoring device to measure antiretroviral medication adherence.
Comparison condition arm:
• Participants will receive the Medication Event Monitoring Systems (MEMS) pill cap monitoring device to measure antiretroviral medication adherence.
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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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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Boston、Massachusetts、アメリカ、02115
- Children's Hospital Boston
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Boston、Massachusetts、アメリカ、02215
- The Fenway Institute, Fenway Health
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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:
- Age 13 to 24 years
- HIV-infected
- Currently taking antiretroviral therapy or prescribed medication for HIV
- Self-reported difficulties adhering to HIV medications in the past 3 months (i.e., <95% compliant)
- If 18-24: Willing and able to provide informed consent
- If 13-17: Parent/guardian willing and able to provide parental permission and participant willing and able to provide assent
- Willing to attend all study visits
Exclusion Criteria:
- If 18-24:Unwilling or unable to provide informed consent
- If 13-17: Parent/guardian unwilling or unable to provide parental permission and participant willing and able to provide assent
- Has severe mental illness requiring immediate treatment (e.g. active psychotic episode) or a mental illness that would limit your ability to participate (e.g. dementia)
- Has severe cognitive limitation that would limit your ability to comprehend the informed consent or assent (see Decisional Capacity Determination SOP)
- Unwilling to attend all study visits
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：支持療法
- 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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介入なし：Condition
In the comparison condition, participants will receive MEMS only.
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実験的：Positive STEPS
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This intervention is given to patients in the experimental condition only.
The Positive STEPS intervention-developed by our team-is based on general principles of cognitive-behavioral therapy as well as more specific principles of motivational interviewing32,33 and problem solving therapy.
Informational, problem solving, and cognitive-behavioral STEPS are targeted over 5, in-person, intervention sessions with a PhD-level counselor.
The intervention will also include a series of short videos related to the topics that the Positive STEPS intervention covers with participants.
Participants in the experimental condition can also choose to receive text messages sent to their cell phone to remind them to take their medication.
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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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Electronically monitored (MEMS) antiretroviral medication adherence
時間枠：3 months
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The primary outcome will be antiretroviral medication adherence.
Adherence will be measured through the medication event monitoring device(MEMS).
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3 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Matthew J Mimiaga, ScD, MPH、Massachusetts General Hospital and Fenway Health
研究記録日
主要日程の研究
研究開始 (実際)
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
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感染症の臨床試験
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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
Positive STEPSの臨床試験
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Wake Forest University Health SciencesPatient-Centered Outcomes Research Institute; National Institute of Diabetes and Digestive and... と他の協力者積極的、募集していない
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Hospital Universitario GetafeKarolinska Institutet; Medical University of Lodz; Universidad Politecnica de Madrid; KTH Royal... と他の協力者わからない
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University of MichiganNational Institute on Aging (NIA); American Pain Society完了
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University of MichiganNational Institute on Aging (NIA)まだ募集していません慢性の痛み | 認識機能障害