遠隔医療を使用して HIV ケアにおけるアルコールの誤用に対処する (ReACH3)
This project will test the effects of a telehealth counseling program on reducing alcohol use and improving HIV viral control among people with HIV who drink heavily. In total, 600 heavy drinkers with HIV will be assigned to either (a) a single session of brief counseling on alcohol use or (b) brief counseling plus referral to a telehealth counseling program that includes multiple sessions of counseling by videoconferencing and text messaging support. To understand the effects of the program, participants' alcohol use, HIV outcomes, and health will be assessed over a 2-year period.
調査の概要
詳細な説明
The purpose of the proposed study is to test the real-world effectiveness of the ReACH (Reducing Alcohol use and related Comorbidities in HIV care) telehealth counseling protocol in a pragmatic Hybrid Type 1 effectiveness-implementation randomized trial. The study will recruit 600 heavy-drinking PLWH from four federally-qualified health centers in geographically distinct regions across the U.S, which provide services to over 14,000 PLWH. Upon completing enrollment, participants will be randomized to receive either single-session brief intervention (BI) by phone with referral to local treatment when appropriate or BI plus referral to ReACH telehealth counseling (TC). Participants will complete follow-ups through 24 months after baseline to assess longer-term changes in drinking and health outcomes. The study will test the hypothesis that TC compared to BI will result in (a) reduced number of drinks consumed per week and frequency of heavy drinking and (b) increased odds of having an undetectable viral load at 12- and 24-month follow-ups. Secondary outcomes include self-reported ART adherence, engagement in condomless sex with non-exclusive partners, frequency of other substance use, phosphatidylethanol levels (a biomarker of recent alcohol use), and Veterans Aging Cohort Study index scores. The study also will examine potential moderators of TC effectiveness. As a secondary aim, implementation measures corresponding to aspects of the Dynamic Sustainability Framework will be assessed including implementation outcomes of acceptability, appropriateness, and feasibility guided by Proctor's Implementation Outcomes Framework. Thus, this pragmatic Hybrid Type 1 trial will help establish the real-world effectiveness of the ReACH TC intervention while also providing key implementation-related measures and outcomes that will inform future ReACH TC scale up and sustainability.
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
-
-
Rhode Island
-
Providence、Rhode Island、アメリカ、02912
- Brown University
-
-
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:
- In care for HIV at one of 4 participating federally qualified health centers, report at least one heavy drinking day (4+ drinks) or average more than 7 drinks per week in the past 30 days
Exclusion Criteria:
- need for supervised alcohol detoxification, as indicated by having a history of severe withdrawal symptoms such as seizures and delirium tremens.
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：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 |
|---|---|
|
アクティブコンパレータ：Brief intervention
A brief alcohol intervention lasting about 10 minutes, delivered after the baseline assessments. |
Brief alcohol intervention delivered by telephone or videoconferencing focusing on advising participants to reduce drinking |
|
実験的：Brief Intervention plus Telehealth Counseling
A brief alcohol intervention followed by referral to a telehealth counseling protocol including 5 sessions of counseling based on Motivational Interviewing and delivered by videoconferencing. Telehealth counseling extends for up to two years and also includes a text messaging intervention to encourage reductions in drinking. |
Brief alcohol intervention delivered by telephone or videoconferencing focusing on advising participants to reduce drinking 5 sessions of counseling on alcohol use based on Motivational Interviewing. A daily and then monthly text messaging program designed to help participants monitor drinking, set goals, and reinforce successful reduction or abstinence. |
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 |
|---|---|---|
|
Alcoholics drinks consumed per week
時間枠：12 months
|
Average number of alcoholic drinks consumed per week over the past 30 days |
12 months
|
|
Alcoholics drinks consumed per week
時間枠：24 months
|
Average number of alcoholic drinks consumed per week over the past 30 days |
24 months
|
|
Number of heavy drinking days
時間枠：12 months
|
Number of days consuming 4 or more drinks in a day over the past 30 days |
12 months
|
|
Number of heavy drinking days
時間枠：24 months
|
Number of days consuming 4 or more drinks in a day over the past 30 days |
24 months
|
|
Proportion of participants with a detectable HIV viral load
時間枠：12 months
|
Viral load test result that indicates HIV virus is detectable in the blood |
12 months
|
|
Proportion of participants with a detectable HIV viral load
時間枠：24 months
|
Viral load test result that indicates HIV virus is detectable in the blood |
24 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of the past 30 days adherent to antiretroviral therapy
時間枠：12 months
|
Antiretroviral therapy adherence as assessed by self-report |
12 months
|
|
Proportion of the past 30 days adherent to antiretroviral therapy
時間枠：24 months
|
Antiretroviral therapy adherence as assessed by self-report |
24 months
|
|
Condomless sex with non-steady partners
時間枠：12 months
|
Number of days in the past 30 having condomless sex with a non-steady partner |
12 months
|
|
Condomless sex with non-steady partners
時間枠：24 months
|
Number of days in the past 30 having condomless sex with a non-steady partner |
24 months
|
|
Veterans Aging Cohort Study (VACS) index total score
時間枠：12 months
|
Index of physiologic health calculated using HIV viral load, CD4 cell counts, liver function, creatinine, hemoglobin, platelets, white blood cell count, and height/weight (for body mass index). Higher scores indicate greater physiologic injury and risk for mortality. |
12 months
|
|
Veterans Aging Cohort Study (VACS) index total score
時間枠：24 months
|
Index of physiologic health calculated using HIV viral load, CD4 cell counts, liver function, creatinine, hemoglobin, platelets, white blood cell count, and height/weight (for body mass index). Higher scores indicate greater physiologic injury and risk for mortality. |
24 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Christopher Kahler, PhD、Brown University School of Public 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 (実際)
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
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?
IPD プランの説明
Data will be shared through the National Data Archive. We also will post de-identified data used in the primary analyses of trial outcomes after those have been published.
IPD 共有時間枠
Data in the NDA will be available 6 months after the first participants are recruited and will remain in there.
IPD 共有アクセス基準
Investigators can access date in the NDA using the available portal. We will allow access to the outcomes data to all through Brown's data archive once the outcome paper is published.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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