やめることは、人間の免疫不全ウイルスハイブリッド試験に問題があります (QMH)
HIVと一緒に住んでいる人の間で喫煙禁止のためのデジタル治療のハイブリッド試験
The purpose of this study is to compare the advantages and disadvantages of two approaches for quitting smoking among people living with HIV (PWH). Participants will complete a 24- week (~6-month) study where the Participants will be assigned to one of two smartphone apps to help with quitting smoking. Regardless of the group participants are assigned to, they will also receive a combination of nicotine replacement therapy (patches and gums) that have been shown to help people quit smoking. The main questions this study aims to answer are:
Participants will complete 6 video call visits over about 6 months. Participants will install their assigned smoking cessation app onto their phone and will be asked to use the app for the duration of the study along with their provided Nicotine Replacement Therapy (NRT) products. During the study visits, participants will meet with study staff to complete questionnaires and interviews. Participants may be asked to provide breath and saliva samples to measure the level of carbon monoxide and nicotine.
調査の概要
状態
詳細な説明
Tobacco use has alarmingly high rates among people with Human Immunodeficiency Virus (HIV) (PWH), 43% compared with 15% in the general population. Due to the development of highly effective treatments for HIV and the resulting increased longevity among PWH, this population now loses more life years to smoking than to HIV infection itself. Novel and effective models to deliver wider reaching smoking cessation interventions for PWH are highly needed and indicated as a priority for National Institute of Health. Digital therapeutics (DTx) may be a novel, scalable, and highly available approach for engaging and treating smoking in this population. However, although DTx for smoking cessation have been shown effective in the general population, no large trial to date has examined the effectiveness of a tailored DTx for smoking cessation in PWH, and no implementation science work has examined barriers and facilitators of implementation of DTx for smoking cessation in this population.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Clinical Studies Coordinator
- 電話番号：(984) 377-4306
- メール：caitlyn.arnold@advocatehealth.org
研究連絡先のバックアップ
- 名前：Roger Vilardaga Vierra, Ph.D.
- 電話番号：336-716-1495
- メール：Roger.Vilardaga@wfusm.edu
研究場所
-
-
North Carolina
-
Winston-Salem、North Carolina、アメリカ、27101
- 募集
- Wake Forest University, Implementation Science
-
コンタクト：
- Principal Investigator
- 電話番号：919-439-3498
- メール：Roger.Vilardagaviera@advocatehealth.org
-
コンタクト：
- Clinical Studies Coordinator
- 電話番号：(984)377-4306
- メール：caitlyn.arnold@advocatehealth.org
-
主任研究者：
- Roger Vilardaga
-
-
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:
- Self-reported daily cigarette smoking over the past 30 days
- Self-reported HIV status
- Age 18 or older
- Desire to quit smoking
- Willing and medically eligible to use NRT
- Currently receiving HIV care
- Currently owning an Android or iOS smartphone
Exclusion Criteria:
- Current acute psychotic episode or unsafe to participate in the study
- Pregnant or intending to become pregnant in the next 6 months
- Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation
- Any medical condition or medication that could compromise subject safety, as determined by the PIs and/or study physician
- Not able to fluently speak and write in English
- Hearing, comprehension, visual, speech, or motor limitations that preclude study participation
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：Learn to Quit - HIV (LTQ-H) App
a smoking cessation Digital Therapeutic (DTx) for people with HIV (PWH) |
LTQ-H consists of 319 screens divided into: (a) HIV-tailored smoking cessation ACT skills, (b) education about tobacco dependence and treatment (USCPG), and (c) NRT psychoeducation and adherence. Content is gradually presented across 28 modules (14 education and 14 skills) that can be completed in 14 days.
他の名前：
|
|
アクティブコンパレータ：QuitStart App
an evidence-based DTx designed for the general population |
This DTx, QuitGuide was adapted from the National Cancer Institute Smokefree.gov Initiative's QuitGuide's 5 modules have the following intervention components: (a) psychoeducation about the impact of smoking on health, (b) setting up a quit date and a quit plan, (c) selecting reasons for quitting, (d) tracking triggers and smoking habits, and (e) tips for quitting.
他の名前：
|
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 |
|---|---|---|
|
Biochemically verified 7-day point prevalence abstinence at 6, 12, 18, and 24-weeks
時間枠：Weeks 6, 12, 18, and 24
|
Abstinence is determined by a self-report of not smoking any cigarettes for greater than or equal to 7 days prior to Weeks 6, 12, 18, and 24 and biochemically verified by an expired carbon monoxide breath test or a cotinine level saliva test at Weeks 6, 12, 18, and 24. Criteria for the bioverification tests to be considered abstinent includes a reading of <6 parts per million using an iCOquit Smokerlyzer carbon monoxide breath test OR a cotinine level of 30 or less ng/ml using an iScreen saliva test. If the participant does not meet both criteria of the self report of 7 or more days of abstinence plus a bioverification test below the thresholds listed above, they are not considered abstinent. As per convention, participants are assumed to be smoking if they report smoking at the time-point, cannot be reached to provide data at the time-point, fail to provide a breath sample at the time-point, or provide a breath sample at the time-point that is greater than or equal to 6 ppm. |
Weeks 6, 12, 18, and 24
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Self-reported 7-day point prevalence abstinence at 6 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
時間枠：6 weeks
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint. |
6 weeks
|
|
Self-reported 7-day point prevalence abstinence at 12 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
時間枠：12 weeks
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint. |
12 weeks
|
|
Self-reported 7-day point prevalence abstinence at 18 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
時間枠：18 weeks
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint. |
18 weeks
|
|
Self-reported 7-day point prevalence abstinence at 24 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
時間枠：24 weeks
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint. |
24 weeks
|
|
Self-reported 30-day point prevalence abstinence at 6 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
時間枠：6 weeks
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days but < 30 days prior to the timepoint. |
6 weeks
|
|
Self-reported 30-day point prevalence abstinence at 12 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
時間枠：12 weeks
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days prior to the timepoint. |
12 weeks
|
|
Self-reported 30-day point prevalence abstinence at 18 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
時間枠：18 weeks
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days prior to the timepoint. |
18 weeks
|
|
Self-reported 30-day point prevalence abstinence at 24 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
時間枠：24 weeks
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days prior to the timepoint. |
24 weeks
|
|
Change in average number of cigarettes smoked per day
時間枠：6 weeks
|
Change in self-reported number of cigarettes smoked per day, averaged within groups. |
6 weeks
|
|
Change in average number of cigarettes smoked per day
時間枠：12 weeks
|
Change in self-reported number of cigarettes smoked per day, averaged within groups. |
12 weeks
|
|
Change in average number of cigarettes smoked per day
時間枠：18 weeks
|
Change in self-reported number of cigarettes smoked per day, averaged within groups. |
18 weeks
|
|
Change in average number of cigarettes smoked per day
時間枠：24 weeks
|
Change in self-reported number of cigarettes smoked per day, averaged within groups. |
24 weeks
|
|
Average number of quit attempts
時間枠：6 weeks
|
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking cigarettes at all for 24 hours or more. |
6 weeks
|
|
Average number of quit attempts
時間枠：12 weeks
|
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking cigarettes at all for 24 hours or more. |
12 weeks
|
|
Average number of quit attempts
時間枠：18 weeks
|
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking cigarettes at all for 24 hours or more. |
18 weeks
|
|
Average number of quit attempts
時間枠：24 weeks
|
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking cigarettes at all for 24 hours or more. |
24 weeks
|
|
Average acceptance of physical smoking cravings
時間枠：6 weeks
|
Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings. |
6 weeks
|
|
Average acceptance of physical smoking cravings
時間枠：12 weeks
|
Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings. |
12 weeks
|
|
Average acceptance of physical smoking cravings
時間枠：18 weeks
|
Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings. |
18 weeks
|
|
Average acceptance of physical smoking cravings
時間枠：24 weeks
|
Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings. |
24 weeks
|
|
Average frequency of app use
時間枠：Weeks 0-24
|
Average frequency of app use over the 24-week study period. Measured by average number of app openings. |
Weeks 0-24
|
|
Average duration of app use
時間枠：Weeks 0-24
|
Average duration of app use over the 24-week study period. |
Weeks 0-24
|
|
Average number of app modules completed
時間枠：Weeks 0-24
|
Average number of app modules completed over the 24-week study period. |
Weeks 0-24
|
協力者と研究者
捜査官
- 主任研究者：Roger Vilardaga Viera, Ph.D.、Wake Forest University Health Sciences
研究記録日
主要日程の研究
研究開始 (実際)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- IRB00112958
- 7R01CA285331-02 (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
米国で製造され、米国から輸出された製品。
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