Music for Health Project (MFH)
2019年11月12日 更新者：Marcia McDonnell Holstad, DSN, FNP-BC、Emory University
An Audio Music Self-Management Program to Improve ART Adherence in Rural GA
The overall goal of this project is to use technology to improve adherence to antiretroviral therapy (ART)and increase access to ART adherence care for those HIV+ persons living in rural areas.
The LIVE Network audio music program mobile application (app) is innovative, practical, portable, and could be rapidly scaled up to address the adherence self-management needs of rural groups nationwide.
If successful, the impact on HIV care will be immense and could transform the delivery of HIV self-management and adherence education by overcoming barriers of geographic isolation, transportation, stigma and confidentiality in this vulnerable group.
調査の概要
詳細な説明
The project has two primary aims and one exploratory aim. 1.0 Revise and adapt the Live Network (LN) program and manual for rural persons living with HIV/AIDS (PLWHA) and develop into a mobile application.
2.0 Conduct a randomized controlled trial to test the efficacy of the program. When compared with an educational music control condition at 3, 6, and 9 months post-baseline, those randomized to the LN will have: H1: Significantly higher mean antiretroviral therapy (ART) adherence rates (measured by pill counts, self report).
H2: Significantly higher mean levels of ART drug levels in hair sample analyses.
H3: Significantly better clinical indicators: higher mean CD4 lymphocyte counts and percents, a larger proportion achieving virologic suppression (proportion with HIV RNA PCR <50 copies/ml), and smaller proportion with evidence of drug resistance, all as measured by medical record review.
3.0 Explore: a) the effects of LN on symptoms and symptom management; b) the roles of self-efficacy, outcome expectancies, and personal goal setting as mediators, and depression and health literacy as moderators of adherence.
研究の種類
介入
入学 (実際)
149
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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Georgia
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Atlanta、Georgia、アメリカ、30322
- Emory University
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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:
- HIV+ individuals initiating ART for the first time (except women who may have had ART during pregnancy); or HIV+ individuals changing ART regimen within the past 3 months due to side effects or virologic resistance; or HIV+ individuals with a detectable viral load ≥ 40copies/ml; or HIV+ individuals on ART medication
- English speaking
- Willing to complete 4 assessments
- Willing to complete monthly, unannounced pill counts
- Willing to allow collection of hair samples
- Willing to be randomly assigned to either condition
- Willing to participate in study activities that include using smart phone and mobile app
Exclusion Criteria:
- Have a history of bilateral hearing loss (health care provider diagnosed or self-identified)
- Homeless
- Have a cognitive impairment (inability to comprehend the informed consent)
- Display psychotic symptoms, as determined by the Brief Symptom Inventory (BSI)
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：支持療法
- 割り当て：ランダム化
- 介入モデル：単一グループの割り当て
- 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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アクティブコンパレータ：Educational music mobile app
A prerecorded program of songs on various topics in a mobile phone application (app).
It is designed to provide education about non-health related topics and will be equivalent in length to the intervention app.
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実験的：Live Network mobile phone App
The LN is a prerecorded mobile phone application (app).
It employs a radio talk show format in which a Disc Jockey entertains HIV medication-, adherence-, and self-management-related questions and comments from callers and poses them to expert care providers, whose responses to these questions are augmented by songs that shed additional light on these issues.
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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 |
|---|---|---|
|
Change in Antiretroviral Therapy (ART) Adherence Rates
時間枠：Baseline, 3 months post-baseline, 6 months post-baseline and 9 months post-baseline
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Adherence rate was measured with the Antiretroviral General Adherence Scale (AGAS) which measures the general ease and ability to take one's medication as prescribed in the past 30 days.
It includes 5 items scored 1 to 6, with the possible scores for this instrument ranging from 5 to 30, and higher scores reflect better adherence.
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Baseline, 3 months post-baseline, 6 months post-baseline and 9 months post-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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Change in Antiretroviral (ART) Drug Levels in Hair Sample Analyses.
時間枠：3, 6, and 9 months post-baseline
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No data available due to inability of the lab to accurately extract drug from hair.
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3, 6, and 9 months post-baseline
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Clinical Indicator: Change in Mean CD4 Percentage
時間枠：Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention
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CD4 count is a test that measures the number of CD4 cells in your blood.
CD4 cells, also known as T cell lymphocytes, are white blood cells that fight infection and play an important role in your immune system.
A CD4 count is used to check the health of the immune system in people infected with HIV (human immunodeficiency virus).
The count measures the number of CD4 cells in a small sample of blood.
The percent of CD4 cells measure the percentage of all lymphocytes that are CD4 cells.
The study assesses the percentage of CD4 lymphocytes over time.
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Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention
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Clinical Indicator: Number of Participants With Non-detectable Viral Load
時間枠：Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention
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Change in number of participants with viral load presented as number of copies if <50 copies versus ≥ 50 copies.
Subjects were coded as having non-detectable viral loads if the "load" was < 50 copies.
The analyses performed reflects the number of subjects with non-detectable load (<50) at Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention.
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Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention
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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：Marcia M Holstad, PhD、Emory University
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
2014年6月1日
一次修了 (実際)
2017年4月19日
研究の完了 (実際)
2017年6月30日
試験登録日
最初に提出
2013年2月5日
QC基準を満たした最初の提出物
2013年2月6日
最初の投稿 (見積もり)
2013年2月7日
学習記録の更新
投稿された最後の更新 (実際)
2019年11月29日
QC基準を満たした最後の更新が送信されました
2019年11月12日
最終確認日
2019年11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
- IRB00055077
- 1R01NR012923 (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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