A Novel Smartphone-based Intervention to Support Smoking Cessation and Adherence to Antiretroviral Therapy Among People Living With HIV: A Pilot Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Number of Participants With Smoking Cessation
研究概览
简要总结
The purpose of this study is to learn if a mindfulness-based smoking cessation smartphone app can help people quit smoking and stay on antiretroviral therapies.
详细描述
The current study aims to test the feasibility of a three-arm randomized clinical trial testing the combined mindfulness training + Emocha apps intervention versus the mindfulness training app only with brief advice to improve ART adherence and usual care (UC; brief advice to quit and improve ART adherence). Our primary hypothesis is that the combination of mindfulness training + Emocha apps would be superior to the mindfulness training app with brief advice to improve ART adherence, and these two interventions would be superior to the UC in terms of the feasibility, acceptability, and potential efficacy (3-month smoking cessation; improvement in adherence to ART).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old
- •Diagnosed with HIV
- •Have been prescribed ART medication in the prior 6 months
- •Have smoked ≥ 5 cigarettes/day in the past year
- •Be interested in making a quit attempt in the next 30 days
- •Own a smartphone (apple/android)and plan to keep it active for the following 3 months
- •Read/speak English
- •Be able to provide consent
- •Have no plans to move in the next 3 months
- •Not pregnant or planning to be pregnant in the following 3 months
排除标准
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
- •Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder)
- •Currently being treated for a psychiatric condition
- •Currently being treated for smoking cessation, alcoholism, or illicit drug use
研究组 & 干预措施
Usual Care
Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART.
干预措施: Nicoderm C-Q Transdermal Product (Drug)
Usual Care
Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART.
干预措施: Adherence to Antiretroviral Therapy Counseling (Behavioral)
Smoking cessation only intervention
Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls.
干预措施: Nicoderm C-Q Transdermal Product (Drug)
Smoking cessation only intervention
Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls.
干预措施: Adherence to Antiretroviral Therapy Counseling (Behavioral)
Smoking cessation only intervention
Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls.
干预措施: Behavioral Smoking Cessation Counseling (Behavioral)
Smoking cessation only intervention
Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls.
干预措施: "Crave-to-Quit" app (Behavioral)
Combined smoking cessation and HIV intervention
Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication.
干预措施: Nicoderm C-Q Transdermal Product (Drug)
Combined smoking cessation and HIV intervention
Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication.
干预措施: Adherence to Antiretroviral Therapy Counseling (Behavioral)
Combined smoking cessation and HIV intervention
Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication.
干预措施: Behavioral Smoking Cessation Counseling (Behavioral)
Combined smoking cessation and HIV intervention
Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication.
干预措施: "Crave-to-Quit" app (Behavioral)
Combined smoking cessation and HIV intervention
Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication.
干预措施: vDOT "emocha" app (Behavioral)
结局指标
主要结局
Number of Participants With Smoking Cessation
时间窗: Up to 3 months
Participants who self-report seven days of non-smoking.
Number of Participants With ≥ 95% Adherence to ART Medication Based on the Visual Analogue Scale
时间窗: 3 months
Number of participants with ≥ 95% Adherence to ART Medication Based on the Visual Analogue Scale ranging from 0 to 100%. The ART medication visual analogue scale is an instrument for patients to rate their dose taken percentages (≥ 95% of doses taken will be regarded as good adherence). Higher score (0 to 100%) indicates higher adherence to ART.
Usability of Intervention Questionnaire Score
时间窗: 3 months
The usability of the Craving-to Quit and Emocha apps will be assessed via a questionnaire with scores ranging from 0-10 with the higher score indicating increased comfortability with using the app.
Acceptability of Intervention Questionnaire Scores
时间窗: 3 months
The acceptability is be assessed by 3 items "How satisfied were you with the intervention?", "How likely are you to recommend this intervention to a friend?" and "How useful was the intervention?" Each question is scored from 0-10 with the higher score indicating increased acceptability.
Number of Participants Reporting Engagement With the Intervention
时间窗: Up to 3 months
Participant engagement is evaluated via self-reported use of the Craving-to-Quit and Emocha apps. Participants will complete a questionnaire indicating how often they used the apps. The response categories include: Everyday, often, some days, not often, not at all. We report the number of participants in each category or combination of categories.
Feasibility of Delivery
时间窗: At screening through study completion (up to 3 months)
The feasibility of delivery will be assessed via evaluating the: 1. eligible, defined as number of participants eligible out of total screened 2. recruitment rate, defined as number of participants enrolled out of total screened 3. total completing all study activities, defined as the number of participants completing all activities out of total enrolled
次要结局
- Number of Cigarettes Smoked Per Day(At baseline and at 3 months)
- Number of Participants With Reported Relapse(Up to 3 months)
研究者
Taghrid Asfar
Research Assistant Professor
University of Miami