Smoking Cessation Medication And Rewards Using a Teamlet to Treat Tobacco Use Disorder (SMARTTT 2.0) Among Persons With HIV: A Multi-site Hybrid Type 2 Effectiveness-implementation Trial
Cigarette smoking is an important cause of illness and death among persons with HIV (PWH). This project will study the impact of adding contingency management (use of financial rewards) to receiving medications and counseling on promoting smoking abstinence and other health outcomes among PWH. As treatments will be provided by clinical pharmacists and other team members in HIV clinics, factors relevant for implementing this model to inform real-world practice will also be evaluated.
調査の概要
状態
条件
詳細な説明
Cigarette smoking is a major threat to health among persons with HIV (PWH). Via direct effects and link with TUD-related conditions (behaviors and medical conditions that drive poor outcomes), smoking causes more lost life years than treated HIV. Cardiovascular disease, lung disease, and cancer are indeed leading causes of death among PWH. Guidelines recommend medications for TUD (MTUD) and behavioral interventions to promote smoking cessation. Data also support use of contingency management (CM) to target smoking cessation and treatment adherence. Yet, adoption of these approaches in HIV clinics has been suboptimal. Past projects have found that clinical pharmacist-prescribed TUD treatment involving MTUD with CM integrated in HIV clinics offers a feasible, acceptable, and practical solution to overcome multi-level challenges to adoption of such TUD treatments. Past projects have identified opportunities for enhanced patient-centeredness with: 1) creation of teamlets (little teams) to collaborate with clinical pharmacists to address challenges with MTUD access and implement CM; 2) use of multi-target CM to reward progress in addressing TUD-related care, HIV, and TUD-related conditions plus smoking abstinence; 3) promotion of patient choice in MTUD selection and flexibility for remote versus in-person services; and 4) focus on reducing health disparities. Grounded in the socioecological model and implementation science principles, this project will include a randomized trial to compare the effectiveness of teamlet-delivered CM as an adjunct to clinical pharmacist prescribed MTUD with teamlet telephone booster over 12 weeks among 794 PWH receiving care in one of six sites. This study will develop procedures directly informed by perspectives of PWH. The primary outcome is exhaled carbon monoxide-confirmed 7-day smoking abstinence at week 12 (Aim 1). This study will explore whether the effectiveness of the interventions differ based on access to basic needs (Aim 2). Consistent with a hybrid type 2 effectiveness-implementation approach, this study will include an implementation-focused evaluation incorporating perspectives of PWH, clinical pharmacists, and other teamlet members using qualitative and quantitative data; measures of intervention delivery; and economic viability via micro-costing and cost-effectiveness analyses (Aim 3). The research team brings together expertise in HIV, pharmacy, addiction medicine, smoking cessation, CM, clinical trials, health disparities, implementation science, and health economics. Innovative features of the proposal are: 1) clinical pharmacist delivered TUD treatment with teamlets integrated in HIV clinics; and 2) collaboratively created multi-target CM program to address smoking, HIV, and TUD-related conditions. The study has potential for high impact by generating data on and associated costs of a reproducible, scalable, sustainable strategy suitable for transforming TUD treatment in HIV clinics nationally.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：E. Jennifer Edelman, MD, MHS
- 電話番号：203-737-7115
- メール：ejennifer.edelman@yale.edu
研究連絡先のバックアップ
- 名前：June-Marie Weiss, MA, MEd
- 電話番号：203-737-3347
- メール：junemarie.weiss@yale.edu
研究場所
-
-
Connecticut
-
Bridgeport、Connecticut、アメリカ、06610
- Bridgeport Hospital Primary Care Center Infectious Disease Clinic
-
コンタクト：
- Manisha Gupta, MD
- 電話番号：(203) 384-3079
- メール：Manisha.Gupta@bpthosp.org
-
New Haven、Connecticut、アメリカ、06511
- Yale Center for Infectious Diseases
-
コンタクト：
- Erika Payne, PharmD
- 電話番号：(203) 200-6899
- メール：erika.payne@ynhh.org
-
-
New Jersey
-
Jersey City、New Jersey、アメリカ、07305
- Center for Comprehensive Care at Jersey City Medical Center
-
コンタクト：
- Nina Cooperman, PhD
- 電話番号：(201) 395-7600
- メール：cooperna@rwjms.rutgers.edu
-
Paterson、New Jersey、アメリカ、07503
- Center for Comprehensive Care at St. Joseph's Health
-
コンタクト：
- Nina Cooperman, PhD
- 電話番号：(973) 754-4701
- メール：cooperna@rwjms.rutgers.edu
-
-
New York
-
Brooklyn、New York、アメリカ、11203
- Special Treatment And Research (STAR) at SUNY Downstate
-
コンタクト：
- Jessica Yager, MD
- 電話番号：(718) 270-3745
- メール：jessica.yager@downstate.edu
-
-
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:
- Have been diagnosed with HIV;
- Receive care at one of the participating sites;
- Are >18 years old;
- Have smoked >100 cigarettes lifetime;
- Smoke everyday or some days;
- Smoke, on average, >5 cigarettes per day; and
- Provide written informed consent.
Exclusion Criteria:
- Exclusive use of non-cigarette tobacco or nicotine products, including e-cigarettes;
- Self-report or urine testing confirming pregnancy, nursing, or trying to conceive;
- Life-threatening or unstable medical, surgical, or psychiatric condition;
- Anticipate being unable to return for follow-up for any reason, such as travel, planned procedure;
- Inability to provide >1 form of contact information;
- Inability to read or understand English or Spanish.
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：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：Clinical pharmacist-prescribed MTUD with teamlet booster
|
Clinical pharmacist prescribed MTUD, based on participant choice: nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion. Participants on nicotine replacement may choose both a long acting (patch) and short acting (gum, lozenge) option to use at the same time. Participants will receive a booster call by a teamlet member after MTUD is prescribed to address any MTUD access issues and answer MTUD related questions. |
|
実験的：Clinical pharmacist-prescribed MTUD + teamlet delivered CM and booster
|
Clinical pharmacist prescribed MTUD, based on participant choice: nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion. Participants on nicotine replacement may choose both a long acting (patch) and short acting (gum, lozenge) option to use at the same time. Participants will receive a booster call by a teamlet member after MTUD is prescribed to address any MTUD access issues and answer MTUD related questions. Participants will earn prizes for progress towards tobacco abstinence, achieving tobacco abstinence, and progress in improving HIV and other related health conditions. |
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 |
|---|---|---|
|
7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)
時間枠：12 weeks
|
Self-reported tobacco abstinence over the past 7 days, confirmed by eCO of <6ppm |
12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)
時間枠：24 weeks
|
Self-reported tobacco abstinence over the past 7 days, confirmed by eCO <6ppm |
24 weeks
|
|
Self-reported 7 day point prevalence smoking abstinence
時間枠：Week 18
|
Week 18
|
|
|
Cigarettes per day
時間枠：Week 12
|
Self-reported reduction in mean number of cigarettes per day |
Week 12
|
|
Cigarettes per day
時間枠：Week 18
|
Self-reported reduction in mean number of cigarettes per day |
Week 18
|
|
Cigarettes per day
時間枠：Week 24
|
Self-reported reduction in mean number of cigarettes per day |
Week 24
|
|
HIV viral load, detectable
時間枠：Week 24
|
HIV viral load greater than 50 copies per milliliter of blood and detectable on standard lab test |
Week 24
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：E. Jennifer Edelman, MD, MHS、Yale University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
- 2000043556
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
This project will generate data from patients with HIV and tobacco use disorder being seen for HIV primary care. Data generated will include responses to standardized ratings scales/questionnaires on tobacco use, alcohol, other substance use, depression, hypertension, physical activity, HIV symptoms, and lab data. Data will be collected at baseline, week 12, week 18, week 24. This study will also generate qualitative data and codebooks from in-depth interviews to inform revision and refinement of the intervention and post study participant experiences. Finally, this study will generate longitudinal mixed methods data on teamlet member implementation experiences from surveys and focus groups as well as cost data.
Data describing the patient sample, outcome measures, and cost analyses will be de-identified and shared. Interview/focus group guides and codebooks will also be shared. Recordings and transcripts will not be shared publicly since voice is PHI.
IPD 共有時間枠
All de-identified data will be made available after completion of the project and publication of related work and will remain available indefinitely.
IPD 共有アクセス基準
A Data Dictionary will be created, and the study Data Manager and the Program Manager will work with National Addiction & HIV Data Archive Program (NAHDAP), an NIH-funded repository, to define an appropriate data structure, if one does not already exist. Data will be formatted to align with NAHDAP standards to promote interoperability and data reuse.
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
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。