ART Adherence and Secondary Prevention of HIV

描述（由申请人提供）：坚持抗逆转录病毒药物治疗和二级预防艾滋病病毒抗逆转录病毒药物（ART）预防艾滋病病毒的发展。然而，相当大比例的艾滋病毒阳性个体未能充分坚持抗逆转录病毒治疗，导致潜在耐药菌株向社区传播。提高抗逆转录病毒治疗依从性从而减少艾滋病毒传播的一种低成本方法涉及手机提醒，我们的初步研究（Hardy et al., 2011）发现手机提醒对提高依从性有显著影响。应急管理（CM）也显示出改善抗逆转录病毒治疗依从性的希望。CM包括每次表现出行为（药物摄入）时提供切实的强化。评估CM增加ART依从性的研究依赖于MEMS帽，但通过MEMS帽增强依从性的频率相对较低且延迟，阻碍了其有效性。手机可以实时强化依从性。因为CM干预的效应大小越大，强化与改变目标行为的配对越迅速，基于手机的强化的整合应该提高依从性，而不仅仅是提醒。试点数据显示了可行性，可接受性，以及使用视频记录技术验证药物依从性的手机管理CM的初步疗效。此外，有效的CM干预已被证明可以减少高危人群的危险行为。在这项研究中，我们建议将165名hiv阳性患者随机分配到三种为期16周的治疗条件之一：(1)标准治疗；(2)标准护理+基于手机的依从提醒；(3)标准护理+基于手机的依从提醒和CM。在后一种情况下，患者将通过发送带有时间和日期戳的ART摄入自我视频获得强化。主要结果将包括依从性的自我报告测量和病毒载量的客观指标，并将在治疗期间和整个一年的随访期间评估效果。这些干预措施对危险行为的影响也将被评估。我们假设，相对于标准治疗，手机提醒条件会提高依从性，并且手机提醒加CM条件会有最好的结果。我们还将估计这些干预措施的成本效益。这项研究的结果可能对使用手机作为一种新技术来改善抗逆转录病毒治疗的最初依从性具有广泛的意义，从而减少耐药艾滋病毒毒株在社区的传播。

DESCRIPTION (provided by applicant): ART adherence and secondary prevention of HIV Anti-retroviral medications (ART) prevent the progression of HIV. However, substantial proportions of HIV positive individuals fail to adhere adequately to ART, resulting in spread of potentially drug-resistant strains to the community. A low cost method to boost ART adherence and thereby reduce the spread of HIV involves cell phone reminders, and our preliminary study (Hardy et al., 2011) finds significant effects of cell phone reminders for improving adherence. Contingency management (CM) also shows promise for improving ART adherence. CM involves providing tangible reinforcement each time the behavior (medication ingestion) is exhibited. Studies evaluating CM for increasing ART adherence have relied upon MEMS caps, but reinforcement of adherence via MEMS caps is done relatively infrequently and with delay, hindering its efficacy. Cell phones allow for reinforcement of adherence in real time. Because effect sizes of CM interventions are larger the more immediately the reinforcement is paired with the behavior targeted for change, integration of cell phone based reinforcement should improve adherence beyond reminders alone. Pilot data show feasibility, acceptability, and initial efficacy of cell phone administered CM using videoing recording techniques to verify medication adherence. Moreover, effective CM interventions have been shown to reduce risk behaviors in high-risk populations. In this study, we propose to randomize 165 HIV-positive patients to one of three 16-week treatment conditions: (1) standard care; (2) standard care + cell phone-based adherence reminders; or (3) standard care + cell phone-based adherence reminders and CM. In this latter condition, patients will earn reinforcement for sending in time- and date-stamped self videos of ART ingestion. Primary outcomes will include self-report measures of adherence and objective indices of viral loads, and effects will be evaluated both during the treatment period and throughout a one-year follow-up. Effects of these interventions on risk behaviors will be evaluated as well. We hypothesize that the cell phone reminder condition will improve adherence relative to standard care, and the cell phone reminder plus CM condition will have the best outcomes. We will also estimate the cost-effectiveness of these interventions. Results from this study may have widespread implications for the use of cell phones as a novel technology to improve initial adherence to ART, thereby reducing the spread of drug resistant HIV strains to the community.