ウクライナのプライマリケアクリニックに依存症治療とHIVサービスを統合 (IMPACT)
A randomized controlled trial to:
- To compare both primary (composite quality health indicator (QHI) scores) and secondary (individual HIV/methadone maintenance treatment (MMT)/TB/primary care QHI scores, quality of life, and stigma) outcomes in an anticipated 1,350 people who inject drugs (PWID) receiving MMT from 13 regions (clusters) and 39 clinical settings using a stratified, phase-in, controlled design over 24 months. After stratifying PWIDs based on their current receipt of MMT, they will be randomized to receive MMT in specialty addiction clinics (N=450) or in an ECHO-IC/QI-enhanced primary care clinic with (N=450) or without (N=450) pay for performance (P4P) incentives.
- Using a multi-level implementation science framework, to examine the contribution of client, clinician and organizational factors that contribute to the comprehensive composite (primary outcome) and individual (secondary) QHI scores.
調査の概要
詳細な説明
Original outcomes were edited and Implementation outcomes were added November 2023.
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
-
-
-
Kyiv、ウクライナ
- European Institute for Public Health Policy
-
-
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:
- PWID
- Interested in MMT
- Meets DSM-V criteria for Opioid Dependence
Exclusion Criteria:
- Not willing to consent
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：防止
- 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 |
|---|---|
|
介入なし：依存症専門クリニック
|
|
|
実験的：ECHO-IC/QI を強化したプライマリケアクリニック
|
Co-location of clinical services for HIV and PWID patients |
|
アクティブコンパレータ：ECHO-IC/QI を強化した成果報酬型のプライマリ ケア クリニック
|
Co-location of clinical services for HIV and PWID patients |
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 |
|---|---|---|
|
Average Percentage of Recommended Quality Health Indicator Services Accessed by Participants to Assess Efficacy
時間枠：every 6 months up to 24 months
|
The total average percentage of the 17 recommended Quality Health Indicator screenings and services that were accessed by participants to assess efficacy. Recommended QHI screenings are as follows: General medical examination; blood analysis; urine analysis; cardiogram; mammogram; cervical cancer screening; prostate cancer screening; hepatitis B screening; hepatitis C screening; HIV screening; CD4 or viral load; ART treatment; TB screening; TB treatment; received take-home MMT; adequate MMT dose; on MMT for 12 months. Data presented here is for adjusted average values of services accessed at 24 months. |
every 6 months up to 24 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Average Percentage of Recommended Primary Quality Health Indicator Services Accessed to Assess Efficacy
時間枠：every 6 months up to 24 months
|
The total average percentage of Primary Quality Health Indicator screenings and services that were accessed by participants to assess efficacy. Recommended QHI screenings are as follows: HIV screening; CD4 or viral load; ART treatment. Data presented here is for adjusted average values of services accessed at 24 months. |
every 6 months up to 24 months
|
|
Average Percentage of Recommended Specialty Quality Health Indicator Services Accessed to Assess Efficacy
時間枠：every 6 months up to 24 months
|
The total average percentage of Specialty(encompasses HIV, TB and MMT) Quality Health Indicator screenings and services that were accessed by participants to assess efficacy. Recommended QHI screenings are as follows: received take-home MMT; adequate MMT dose; on MMT for 12 months. Data presented here is for adjusted average values of services accessed at 24 months. |
every 6 months up to 24 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Frederick Altice, MD、Yale University
出版物と役立つリンク
一般刊行物
- Machavariani E, Esserman D, Dumchev K, Filippovych M, Pykalo I, Ivasiy R, Madden LM, Bromberg DJ, Haddad M, Morozova O, Oliveros D, Ahmad B, Dvoriak S, Altice FL. Integrating Methadone Services Into Primary Care in Ukraine: Two-Year Outcomes From a Randomized Trial. Ann Intern Med. 2026 Feb;179(2):177-186. doi: 10.7326/ANNALS-25-01764. Epub 2025 Dec 9.
- Machavariani E, Bromberg DJ, Dumchev K, Esserman D, Earnshaw VA, Pykalo I, Filippovich M, Ivasiy R, Ahmad B, Long J, Haddad MS, Madden LM, Oliveros D, Dvoriak S, Altice FL. Decrease in provider stigma is associated with improved quality health indicators among individuals receiving methadone in primary care centers in Ukraine. Int J Drug Policy. 2025 Feb;136:104682. doi: 10.1016/j.drugpo.2024.104682. Epub 2024 Dec 19.
- Machavariani E, Dumchev K, Pykalo I, Filippovych M, Ivasiy R, Esserman D, Madden LM, Bromberg DJ, Haddad M, Morozova O, Ahmad B, Gomez DO, Farnum SO, Dvoriak S, Altice FL. Design and implementation of a Type-2 hybrid, prospective randomized trial of opioid agonist therapies integration into primary care clinics in Ukraine. Contemp Clin Trials. 2024 Nov;146:107690. doi: 10.1016/j.cct.2024.107690. Epub 2024 Sep 14.
- Pashchenko O, Bromberg DJ, Dumchev K, LaMonaca K, Pykalo I, Filippovych M, Esserman D, Polonsky M, Galvez de Leon SJ, Morozova O, Dvoriak S, Altice FL. Preliminary analysis of self-reported quality health indicators of patients on opioid agonist therapy at specialty and primary care clinics in Ukraine: A randomized control trial. PLOS Glob Public Health. 2022 Nov 2;2(11):e0000344. doi: 10.1371/journal.pgph.0000344. eCollection 2022.
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
追加の関連 MeSH 用語
その他の研究ID番号
- 2000020067
- 1R01DA043125-01 (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?
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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