Supporting Treatment Adherence Readiness Through Training (START) (START)
2020年10月5日 更新者：RAND
Controlled Evaluation of the Adherence Readiness Program for ART Adherence
Multi-site, randomized controlled trial of the Adherence Readiness Program (ARP) adherence intervention for HIV clients starting or restarting antiretroviral therapy (ART) for the purpose of achieving and sustaining optimal levels of ART adherence and virologic suppression.
Eligible participants will be randomized to receive either the ARP intervention or usual care (no intervention) and followed for 24 months.
調査の概要
詳細な説明
This study will evaluate the effects of the Adherence Readiness Program (ARP) intervention on the primary outcomes of dose-taking HIV antiretroviral (ART) adherence and undetectable HIV viral load in a multi-site randomized controlled trial.
The ARP is based on the Information Motivation Behavioral skills (IMB) model of behavior change and includes (1) brief pill taking practice trials for enhancing pre-treatment adherence counseling and providing a behavioral criterion for determining adherence readiness and the start of treatment, and (2) a performance driven dose regulation mechanism to tailor the amount of counseling (from pre-treatment through the full course of treatment) to the individual needs of the patient and conserve limited resources.
Participants will be randomized to receive either the ARP (adherence counseling sessions) or usual care.
Primary assessments will be administered at screening and every 6 months after ART initiation over a 24-month follow-up, making it one of the few studies to examine intervention effects longer than one year.
Secondary outcomes include dose-timing adherence and CD4 count.
If effective, the ARP will provide clinicians with an intervention that (1) informs providers and patients when the patient is ready to adhere well and start treatment, (2) enhances adherence readiness from the outset of treatment through the full course of therapy, and (3) tailors the amount of adherence support based on individual patient need and performance, thus more efficiently using clinic resources, fostering better acceptance from providers and patients, and increasing the likelihood of successful program adoption and dissemination.
This emphasis on efficient use of resources will be complemented by a cost-effectiveness analysis to further inform policy decisions regarding the transportability of the intervention and its potential for more wide scale use and sustainability if effective.
研究の種類
介入
入学 (予想される)
240
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
-
-
California
-
Long Beach、California、アメリカ
- CaRe Clinic
-
Los Angeles、California、アメリカ
- T.H.E. Clinic
-
Los Angeles、California、アメリカ
- UCLA CARE Center
-
-
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:
The patient's provider views the patient as medically appropriate to begin (ART naïve) or restart ART (has been off ART for at least 2 months), and either
- plans to start the patient on ART
- would like to start the patient on ART but the provider or patient is uncertain about the patient's readiness to adhere well.
Patients who are currently on ART are also eligible if they meet the following criteria, which are specific only to this type of patient:
i) the patient has 2 or more HIV viral load tests in the past year > 1000 copies/ml ii) the patient has had no HIV viral load tests that were undetectable in the past year iii) the patient has a genotype in the past year that does not show resistance as a reason for virologic failure (detectable viral load) iv) primary care provider views the patient as a good candidate for the study, with the understanding that the patient will interrupt ART if assigned to the intervention.
Criteria i to iii are intended to define a subgroup of nonadherent patients who are taking very little of their ART medications, as evidenced by the combination of consistently high viral load and no drug resistance. If the patient was taking at least a moderate level of drug and still had consistently high viral load, than they would have evidence of drug resistance. Providers are generally comfortable with this type of patient stopping their medication in order to facilitate the pre-treatment, adherence readiness assessment and training phase of the intervention prior to restarting the patient on treatment.
- The patient's health status is stable. There is no current acute OI or medical condition that calls for immediate ART, as determined by the patient's provider.
- Most recent HIV viral load is detectable.
- If CD4 < 200, the patient is on or will be prescribed prophylactic medication
- Patient is 18 or older.
- Patient is able and willing to give informed consent.
- English speaking.
Exclusion Criteria:
1. Patient just tested HIV+ and their provider suspects the patient may be acutely or recently infected (within past 6 months).
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：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 |
|---|---|
|
実験的：ARP intervention
Adherence counseling intervention
|
The ARP consists of pre-treatment (including practice trials to determine readiness for and timing of ART initiation), early-treatment, and ongoing maintenance training (using a performance-based, dose regulation mechanism to tailor the amount and intensity) phases
|
|
介入なし：usual care
no intervention, standard care practices regarding adherence support
|
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 |
|---|---|---|
|
HIV virologic suppression
時間枠：Month 24
|
undetectable HIV viral load at time of assessment
|
Month 24
|
|
log change in HIV viral load (log change in HIV RNA levels)
時間枠：Month 24
|
log change in HIV RNA levels from baseline to Month 24.
|
Month 24
|
|
optimal dose-taking adherence (whether at least 85% of prescribed doses were taken)
時間枠：Month 24
|
binary variable representing whether at least 85% of prescribed doses were taken between baseline and Month 24
|
Month 24
|
|
percent dose-taking adherence
時間枠：Month 24
|
percent of prescribed doses taken between baseline and Month 24
|
Month 24
|
|
HIV virologic suppression
時間枠：Month 6
|
undetectable HIV viral load at time of assessment
|
Month 6
|
|
log change in HIV viral load (log change in HIV RNA levels)
時間枠：Month 6
|
log change in HIV RNA levels from baseline to Month 6
|
Month 6
|
|
optimal dose-taking adherence (whether at least 85% of prescribed doses were taken)
時間枠：month 6
|
binary variable representing whether at least 85% of prescribed doses were taken between baseline and Month 6
|
month 6
|
|
percent dose-taking adherence
時間枠：month 6
|
percent of prescribed doses taken between baseline and Month 6
|
month 6
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
dose-timing adherence
時間枠：Month 24
|
percent of prescribed doses taken within correct time-window between baseline and Month 24
|
Month 24
|
|
dose-timing adherence
時間枠：Month 6
|
percent of prescribed doses taken within correct time-window between baseline and Month 6
|
Month 6
|
|
optimal dose-timing adherence
時間枠：Month 24
|
binary variable representing whether at least 85% of prescribed doses were taken within correct time-window between baseline and Month 24
|
Month 24
|
|
optimal dose-timing adherence
時間枠：Month 6
|
binary variable representing whether at least 85% of prescribed doses were taken within correct time-window between baseline and Month 6
|
Month 6
|
|
change in CD4 count
時間枠：Month 24
|
change in CD4 count from baseline to Month 24
|
Month 24
|
|
change in CD4 count
時間枠：Month 6
|
change in CD4 count from baseline to Month 6
|
Month 6
|
|
clinic attendance (number of missed clinic appointments)
時間枠：Month 24
|
number of missed clinic appointments between baseline and Month 24
|
Month 24
|
|
clinic attendance (number of missed clinic appointments)
時間枠：Month 6
|
number of missed clinic appointments between baseline and Month 6
|
Month 6
|
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：Glenn Wagner, PhD、RAND
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Wagner GJ, Seelam R, Hoffman R, Ghosh-Dastidar B. Mediators and moderators of ART adherence effects of supporting treatment adherence readiness through training (START): evidence that START helps vulnerable clients achieve better adherence. AIDS Care. 2022 Oct;34(10):1249-1256. doi: 10.1080/09540121.2021.2006133. Epub 2021 Nov 21.
- Wagner GJ, Hoffman R, Linnemayr S, Schneider S, Ramirez D, Gordon K, Seelam R, Ghosh-Dastidar B. START (Supporting Treatment Adherence Readiness through Training) Improves Both HIV Antiretroviral Adherence and Viral Reduction, and is Cost Effective: Results of a Multi-site Randomized Controlled Trial. AIDS Behav. 2021 Oct;25(10):3159-3171. doi: 10.1007/s10461-021-03188-x. Epub 2021 Apr 2.
- Wagner GJ, Linnemayr S, Ghosh-Dastidar B, Currier JS, Hoffman R, Schneider S. Supporting Treatment Adherence Readiness through Training (START) for patients with HIV on antiretroviral therapy: study protocol for a randomized controlled trial. Trials. 2016 Mar 24;17:162. doi: 10.1186/s13063-016-1287-3.
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)
2015年2月1日
一次修了 (実際)
2020年3月30日
研究の完了 (実際)
2020年3月30日
試験登録日
最初に提出
2014年12月22日
QC基準を満たした最初の提出物
2014年12月31日
最初の投稿 (見積もり)
2015年1月1日
学習記録の更新
投稿された最後の更新 (実際)
2020年10月6日
QC基準を満たした最後の更新が送信されました
2020年10月5日
最終確認日
2020年10月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- MH104086
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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