Health Improvement Project - Providence (HIP)
2019年12月23日 更新者：Michael P. Carey、The Miriam Hospital
Mindfulness Training to Improve ART Adherence and Reduce Risk Behavior Among Persons Living With HIV
This study will investigate whether phone-delivered mindfulness training is feasible and acceptable for persons living with HIV and whether it may help them improve adherence to medications and reduce risky sexual behaviors.
調査の概要
詳細な説明
Two-thirds of people living with HIV show sub-optimal adherence to antiretroviral therapy (ART) and one-third engages in risky sex. Both non-adherence and risky sex have been associated with emotional distress and impulsivity. In this trial, the investigators will examine the utility of phone-delivered mindfulness training (MT) for people living with HIV. The primary outcomes comprise feasibility and acceptability of phone-delivery; secondary outcomes are estimates of efficacy of MT on adherence to ART and safer sexual practices as well as on their hypothesized antecedents.
Fifty participants will be enrolled in this parallel-group randomized clinical trial (RCT). Outpatients recruited from an HIV treatment clinic will be randomized (1:1 ratio) to either MT or to health coaching intervention; both interventions will be administered during 8 weekly phone calls. ART adherence (self-reported measure and unannounced phone pill counts), sexual behavior (self-reports and biomarkers), mindfulness, depression, stress, and impulsivity will be measured at baseline, post-intervention, and 3 months post-intervention.
研究の種類
介入
入学 (実際)
50
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
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Rhode Island
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Providence、Rhode Island、アメリカ、02906
- The Miriam Hospital
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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～80年 (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:
- HIV infection
- Sub-optimal adherence to ART (Less than "always" taking ART medication and/or viral load > 20 copies/mL);
- Psychological distress (PHQ-4 score ≥ 2);
- Recent risky sexual behavior (any unprotected sex OR > 1 sexual partner over the past 6 months)
- Access to a telephone or cell phone
Exclusion Criteria:
- Unwilling or unable to provide informed consent
- Cognitive impairment
- Non-English speaking
- Low literacy (i.e., reporting they "often" or "always" need someone to read instructions, pamphlets, or other written material from a doctor or pharmacy to them
- Enrolled in another behavioral trials
- Prior formal mindfulness training or have practiced of mindfulness or related mind-body techniques in the previous year
- Severe hearing impairment not allowing phone delivery
- Suicidal ideation
- Planning to move out of the area within the study period
- Clinic provider advising against recruitment in the study.
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：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：独身
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：Mindfulness training (MT)
Eight, 30-minute phone delivered MT sessions once a week for 8 weeks
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Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks.
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In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
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アクティブコンパレータ：Health Coaching (HC)
Eight, 30-minute phone delivered HC sessions once a week for 8 weeks
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The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition.
To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics
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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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Feasibility of Intervention
時間枠：post-intervention, 9 to 10 weeks after baseline
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Feasibility - as indicated by the number of patients attending at least 50% of sessions
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post-intervention, 9 to 10 weeks after baseline
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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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Acceptability of the Intervention
時間枠：post-intervention, 9 to 10 weeks after baseline
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Number of patients reporting "very satisfied" or "mostly satisfied" with their intervention
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post-intervention, 9 to 10 weeks after baseline
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Antiretroviral Medication Adherence
時間枠：Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
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Self-reported number of missed days of medication
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Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
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Self-reported Sexual Risk Behavior
時間枠：Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
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Self-reported risky sexual behavior as indicated by the percentage of episodes of condom protected sexual intercourse Higher values are better outcome
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Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
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Five Facet Mindfulness Questionnaire
時間枠：Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
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Five Facet of Mindfulness Questionnaire (15 items; short form) Construct = Mindfulness Minimum total scale score = 15 Maximum total scale score = 75 Scoring: sum across all 15 items Higher scores represent a better outcome
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Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
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Perceived Stress Scale
時間枠：Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
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Perceived Stress Scale (4-item version) Construct = perceived stress Minimum total scale score = 0 Maximum total scale score = 16 Scoring: reverse score items 2 and 3, then sum across all 4 items Higher scores represent a worse outcome
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Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
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Barratt Impulsiveness Scale
時間枠：Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
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Barratt Impulsiveness Scale (short form, 8 items) Construct = Impulsivity Minimum total scale score = 8 Maximum total scale score = 32 Scoring: reverse score items 1, 4, 5, 6, and then sum across all 8 items Higher scores represent a worse outcome
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Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
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Patient Health Questionnaire
時間枠：Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
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Patient Health Questionnaire (9 item version) Construct measured = depression Minimum total scale score = 0 Maximum total scale score = 27 Scoring: sum across all 9 items Higher scores represent a worse outcome
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Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
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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
捜査官
- 主任研究者：MIchael P Carey, PhD、Centers for Behavioral and Preventive Medicine, The Miriam Hospital
- 主任研究者：Elena Salmoirago-Blotcher, MD, PhD、Centers for Behavioral and Preventive Medicine, The Miriam Hospital
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)
2018年8月1日
研究の完了 (実際)
2018年8月1日
試験登録日
最初に提出
2016年8月18日
QC基準を満たした最初の提出物
2016年8月26日
最初の投稿 (見積もり)
2016年9月1日
学習記録の更新
投稿された最後の更新 (実際)
2020年1月13日
QC基準を満たした最後の更新が送信されました
2019年12月23日
最終確認日
2019年12月1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
- R34AT008930 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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