Improving adherence to smoking cessation medication among PLWHA

描述(由申请人提供)：艾滋病毒/艾滋病患者(PLWHA)的吸烟率是普通人群的两到三倍。由于治疗的进步，PLWHA的寿命延长了，这使得这一人群中的吸烟问题成为一个重大的临床问题。尽管烟草使用造成了压倒性的负担，但很少有研究评估PLWHA提供的戒烟干预措施。来自稀少文献的结果好坏参半，但表明PLWHA对戒烟感兴趣，并可以实现戒烟，特别是在使用尼古丁替代(NRT)等药物治疗时。然而，与普通人群的研究结果相似，PLWHA对NRT的依从性很低。鉴于强有力的证据表明，行为疗法和药物疗法的结合比单独使用任何一种疗法都更有效，而且较高的NRT依从率与戒烟可能性的增加密切相关，不良的NRT依从性对治疗有效性构成严重威胁，并可能对戒烟结果产生负面影响。然而，坚持使用戒烟药物的人却很少受到关注。对于PLWHA，已经描述了NRT依从性的几个潜在障碍，包括已经复杂的药物方案和对NRT的负面看法。为了减少这一缺乏服务的人群中与吸烟有关的健康差距，至关重要的是制定戒烟干预措施，其中包括提高治疗依从性的战略。R34机制提供了一个独特的机会来改进和试点测试一种理论驱动的戒烟干预措施，该干预措施通过测试短信提醒服用NRT的影响以及包括以NRT依从性为重点的行为戒烟咨询的可行性和额外影响来增强现有的行为方法。我们建议从两个HIV/AIDS诊所招募190名参与者进行一项三组研究，比较：1)标准护理(SC)，2)SC+短信提醒，3)SC+短信提醒+手机递送NRT依从性重点行为疗法(ABT)。所有三个武器的参与者都将接受为期八周的NRT。主要结果是在8周和3个月的随访中坚持NRT和生化证实的戒烟。主要目的是：1)确定在HIV+门诊人群中进行电话戒烟咨询和短信干预的可行性和可接受性；2)评估和比较三种戒烟治疗模式在治疗结束(8周)和3个月随访时对NRT依从性和戒烟效果的影响。第二个目的是：1)探讨NRT依从性与治疗结束及3个月后戒烟的关系；2)探讨NRT依从性干预效果的潜在中介因素。我们希望这项拟议研究的结果将为一项更大规模的随机试验奠定基础，该试验将为如何在这一人群中克服戒烟障碍提供一个模型。 公共卫生相关性：在美国，烟草使用是可预防死亡的头号原因。在艾滋病毒/艾滋病患者(PLWHA)中，烟草使用的负担很大，吸烟率超过普通人群的50%或两到三倍。由于治疗的进步，PLWHA的寿命延长了，这使得这一人群中的吸烟问题成为一个重大的临床问题。然而，在PLWHA中解决烟草使用治疗的研究很少。这项研究将提供有关创新戒烟方法的影响的新信息，该方法解决了可能使PLWHA更难戒烟的障碍。

DESCRIPTION (provided by applicant): Smoking rates among people living with HIV/AIDS (PLWHA) are two to three times that of the general population. Due to treatment advances, PLWHA are living longer making the issue of cigarette smoking in this population a significant clinical concern. Despite the overwhelming burden of tobacco use, few studies have evaluated the delivery of smoking cessation interventions among PLWHA. Results from the sparse literature are mixed but suggest that PLWHA are interested in quitting and can achieve abstinence, particularly when pharmacotherapy such as nicotine replacement (NRT) is utilized. However, similar to findings in the general population, adherence to NRT among PLWHA is low. Given the strong evidence that combining behavioral therapy and pharmacotherapy is more effective than either alone, and that higher rates of NRT adherence are strongly associated with an increased likelihood of smoking cessation, poor NRT adherence poses a serious threat to treatment effectiveness and may negatively impact cessation outcomes. Yet adherence to smoking cessation medication has received remarkably little attention. For PLWHA, several potential barriers to NRT adherence have been described including an already complex medication regimen and negative beliefs about NRT. In order to reduce smoking-related health disparities within this underserved population it is critical that cessation interventions be developed that include strategies to improve treatment adherence. The R34 mechanism provides a unique opportunity to refine and pilot test a theory-driven smoking cessation intervention that enhances existing behavioral approaches by testing the impact of text message reminders to take NRT and the feasibility and additional impact of including NRT adherence-focused behavioral cessation counseling. We propose to randomize 190 participants, recruited from two HIV/AIDS clinic, to a three arm study that compares: 1) Standard Care (SC), 2) SC + text message reminders, and 3) SC + text message reminders + cell phone-delivered NRT adherence-focused behavioral therapy (ABT). Participants in all three arms will receive NRT for eight weeks. The primary outcomes are adherence to NRT and biochemically validated smoking abstinence at 8 weeks and 3-month follow-up. The primary aims are: 1) to determine the feasibility and acceptability of conducting a telephone delivered cessation counseling and text message intervention among a HIV+ clinic-based population, 2) to estimate and compare the effect of three models of smoking cessation treatment on NRT adherence and smoking abstinence at end of treatment (8 weeks) and 3-month follow-up. The secondary aims are to 1) to explore the relationship between NRT adherence and smoking cessation at end of treatment and 3 months and 2) to explore potential mediators of the intervention effect on NRT adherence. We expect that findings from the proposed study will lay the groundwork for a larger randomized trial that will provide a model for how to overcome barriers to smoking cessation in this population. PUBLIC HEALTH RELEVANCE: Tobacco use is the number one cause of preventable death in the U.S. Among persons living with HIV/AIDS (PLWHA) the burden of tobacco use is substantial with the prevalence of smoking over 50% or two to three times that of the general population. Due to treatment advances PLWHA are living longer, making the issue of cigarette smoking in this population a significant clinical concern. Yet research addressing tobacco use treatment among PLWHA is sparse. This study will provide new information about the impact of an innovative approach to tobacco cessation that addresses barriers that may make it harder for PLWHA to quit.