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，艾滋病毒感染者和艾滋病患者的寿命延长，使这一人群的吸烟问题成为一个重大的临床问题。尽管烟草使用的负担压倒性的，很少有研究评估了艾滋病毒感染者/艾滋病患者戒烟干预措施的交付。来自稀疏文献的结果是混合的，但表明PLWHA有兴趣戒烟，可以实现禁欲，特别是当使用尼古丁替代（NRT）等药物治疗时。然而，与一般人群中的调查结果相似，艾滋病毒感染者/艾滋病患者对NRT的依从性很低。鉴于有强有力的证据表明，将行为疗法和药物疗法相结合比单独使用更有效，并且NRT依从率较高与戒烟可能性增加密切相关，NRT依从性差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，戒烟药物的依从性却很少受到关注。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治疗方案和对NRT的负面信念。为了减少吸烟相关的健康差距，在这一服务不足的人口至关重要的是，戒烟干预措施的发展，包括战略，以提高治疗的依从性。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措施，通过测试短信提醒服用NRT的影响以及包括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。我们建议将从两家HIV/AIDS诊所招募的190名参与者随机分配到一项三组研究中，比较：1）标准治疗（SC），2）SC +短信提醒，3）SC +短信提醒+手机提供的NRT依从性集中行为疗法（ABT）。所有三组的参与者将接受为期八周的NRT。主要结局是8周和3个月随访时NRT依从性和经生化验证的戒烟。主要目标是：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对治疗结束（8周）和3个月随访时NRT依从性和戒烟率的影响。次要目的是1）探索NRT依从性与治疗结束时和3个月时戒烟之间的关系，2）探索NRT依从性干预效应的潜在介质。我们预计，这项研究的结果将为一项更大规模的随机试验奠定基础，该试验将为如何克服这一人群的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.