Mobile Health Interventions for Varenicline Adherence Among HIV-positive Smokers
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- The average number of times per day that participants initiate an interaction with mobile app
研究概览
简要总结
Cigarette smoking remains highly prevalent among persons living with HIV (PLWH). Quitting smoking can have important health benefits for this population. However, PLWH have historically had a difficult time quitting smoking. This is likely due, at least in part, to poor medication adherence.
Poor adherence to medication is a well-documented issue among PLWH. Research shows that not taking smoking cessation medications as prescribed can limit their treatment effectiveness. Improving adherence to smoking cessation medications will likely increase smoking cessation attempt success.
Mobile phone applications and behavioral interventions show promise for improving adherence to smoking cessation medications and cessation outcomes among PLWH. Therefore, this trial will assess 1) whether a mobile phone application is a feasible and acceptable intervention for improving medication adherence; 2) whether use of the mobile phone app improves adherence to varenicline; and 3) smoking cessation outcomes.
详细描述
Cigarette smoking is a significant public health problem among persons living with HIV (PLWH). The prevalence of smoking among PLWH is 40-75%, compared to approximately 15% in the general population. In PLWH, smoking confers increased risk of cardiovascular disease, respiratory conditions, lung cancer, poor adherence to antiretroviral (ARV) therapy, poor HIV treatment outcomes, and all-cause mortality. Approximately 24% of deaths among PWLH on ARV are attributable to tobacco use. Moreover, smokers with HIV lose more life years to smoking than to HIV itself (13 versus 5 years).
Smoking cessation is a challenge for smokers with HIV. Smokers with HIV are interested in quitting, yet most quit attempts end in relapse. Poor cessation outcomes are likely attributable, in part, to poor adherence to smoking cessation medications. Not taking varenicline as prescribed significantly limits treatment effectiveness. Adherence to varenicline in smokers with HIV is poor, with only 56-62% of individuals in clinical trials taking the medication as prescribed. Putatively, real world adherence is expected to be lower. Medication adherence is a well-documented issue in HIV: only 62% achieve optimal adherence to ARV. Interventions are needed to improve smoking cessation medication adherence among smokers with HIV. Such interventions will improve cessation and reduce the burden of smoking in this population.
Mobile phone-delivered interventions show promise for improving cessation outcomes in smokers living with HIV. However, an intervention that provided text message medication reminders and motivational cessation messages with or without phone-delivered counseling, as compared to a control group, yielded no group differences for varenicline adherence. Thus, it is possible that more intensive, and multi-component, interventions are required to improve the effectiveness of mobile-phone-based interventions.
This trial will: 1) assess the feasibility and acceptability of a mobile phone app that aims to increase medication adherence; 2) whether use of the app and/or contingency management increases adherence to varenicline over varenicline treatment as usual; and 3) monitor smoking cessation outcomes.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18-65
- •HIV-positive
- •Currently engaged with an HIV care provider
- •Interested in quitting smoking within the next 30 days
- •Has an Android (v5.x.x or Lollipop) or iOS (v6.0) smartphone (interested participants without a compatible smartphone will be provided one, with costs offset by the study team)
- •English-speaking
- •Capable of giving written informed consent
排除标准
- •Inability to attend study sessions
- •Any medical condition or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator, Study Physician, and/or participant's HIV care provider
- •Current use of nicotine replacement therapy or other smoking cessation treatment (e.g., bupropion)
- •Pregnant, planning to become pregnant, nursing, or becoming pregnant during the study
- •BAL >0.000 at screening.
研究组 & 干预措施
Varenicline
An α4β2 nicotinic acetylcholine receptor partial agonist
干预措施: Varenicline (Drug)
Varenicline + mobile app
An α4β2 nicotinic acetylcholine receptor partial agonist + a mobile phone application designed to improve adherence to medications
干预措施: Varenicline (Drug)
Varenicline + mobile app
An α4β2 nicotinic acetylcholine receptor partial agonist + a mobile phone application designed to improve adherence to medications
干预措施: Mobile phone application (Device)
Varenicline + mobile app + contingency management
An α4β2 nicotinic acetylcholine receptor partial agonist + a mobile phone application designed to improve adherence to medications + monetary reinforcers for being adherent to medication
干预措施: Varenicline (Drug)
Varenicline + mobile app + contingency management
An α4β2 nicotinic acetylcholine receptor partial agonist + a mobile phone application designed to improve adherence to medications + monetary reinforcers for being adherent to medication
干预措施: Mobile phone application (Device)
Varenicline + mobile app + contingency management
An α4β2 nicotinic acetylcholine receptor partial agonist + a mobile phone application designed to improve adherence to medications + monetary reinforcers for being adherent to medication
干预措施: Contingency management (Behavioral)
结局指标
主要结局
The average number of times per day that participants initiate an interaction with mobile app
时间窗: Daily throughout study duration (12 weeks)
The average number of times per day that participants initiate an interaction with the app, as measured by background analytics
The average number of times per day participants respond to a prompt from mobile app
时间窗: Daily throughout study duration (12 weeks)
The average number of times per day that participants respond to prompts from the app, as measured by background analytics
Technical issues with using the mobile app
时间窗: Weekly throughout study (once every week for 12 weeks)
Average number of technical issues reported by participants throughout the course of the study
Perceived usefulness of mSMART app
时间窗: Week 12
Participants will be asked to respond to the following: "Overall, I find the mSMART app useful for remembering to take my varenicline." Response options include: Strongly disagree; Somewhat disagree; neither agree nor disagree; somewhat agree; strongly agree.
Perceived ease of use of mSMART app
时间窗: Week 12
Participants will be asked to respond to the following: "Overall, I find the mSMART app easy to use." Response options include: Strongly disagree; Somewhat disagree; neither agree nor disagree; somewhat agree; strongly agree.
次要结局
- Adherence to varenicline(Weekly throughout study duration (once a week, over the course of 12 weeks))
- Concentration of expired breath carbon monoxide(Baseline and Weekly throughout study (once every week for 12 weeks))
- Concentration of cotinine in urine sample(Weekly throughout study (once every week for 12 weeks))