Improving adherence to smoking cessation medication among PLWHA

描述（由申请人提供）：艾滋病毒/艾滋病感染者（PLWHA）的吸烟率是普通人群的两到三倍。由于治疗的进步，艾滋病毒感染者的寿命延长，使这一人群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巨大的负担，但很少有研究对艾滋病毒携带者中戒烟干预措施的实施情况进行评估。稀疏文献的结果是混杂的，但表明PLWHA对戒烟感兴趣，并且可以实现戒断，特别是当使用尼古丁替代（NRT）等药物治疗时。然而，与一般人群的发现相似，艾滋病感染者对NRT的依从性很低。鉴于有强有力的证据表明，行为疗法和药物疗法相结合比单独使用更有效，而且更高的NRT依从率与戒烟可能性的增加密切相关，不良的NRT依从性对治疗效果构成严重威胁，并可能对戒烟结果产生负面影响。然而，坚持服用戒烟药物却很少受到关注。对于艾滋病患者来说，坚持NRT治疗的几个潜在障碍已经被描述，包括已经很复杂的药物治疗方案和对NRT的负面看法。为了减少这一服务不足人群中与吸烟有关的健康差距，制定戒烟干预措施至关重要，其中包括改善治疗依从性的战略。R34机制提供了一个独特的机会来完善和试点测试理论驱动的戒烟干预，通过测试短信提醒采取NRT的影响，以及包括NRT坚持的行为戒烟咨询的可行性和额外影响，增强现有的行为方法。我们建议从两家HIV/AIDS诊所随机招募190名参与者，进行三组研究，比较：1)标准护理（SC）， 2) SC +短信提醒，3)SC +短信提醒+手机传递的NRT依从性行为治疗（ABT）。所有三个组的参与者将接受为期8周的NRT。在8周和3个月的随访中，主要结果是坚持NRT和生化验证的戒烟。主要目的是：1)确定在HIV+临床人群中进行电话传递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依从性和戒烟的影响。次要目的是：1)探索NRT依从性与治疗结束和3个月戒烟之间的关系；2)探索干预对NRT依从性影响的潜在中介。我们期望这项研究的结果将为更大规模的随机试验奠定基础，为如何在这一人群中克服戒烟障碍提供一个模型。

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.