Enhancing HIV treatment adherence in Bangalore: The Chetana study

描述（由申请人提供）：提高印度南部的艾滋病毒治疗依从性：Chetana研究良好的抗逆转录病毒治疗依从性对于实现艾滋病毒抑制和长期治疗成功至关重要，特别是在抗逆转录病毒治疗选择可能有限的情况下。为了实现这一目标，至关重要的是，我们要制定和测试文化上适当的依从性干预措施，这些干预措施针对当地的依从性模式和障碍，并可以迅速扩大规模，并由当地群体维持。还需要可靠有效的客观依从性监测策略来补充自我报告，自我报告往往会高估真实依从率。最近开发的“Wisepill”将用于本研究，有可能实现这一目标。它使用移动的和无线技术来实时监测依从性，并且似乎克服了其他客观措施的许多局限性，例如MEMS瓶盖，药房再填充记录或未经宣布的药丸计数，这些措施在资源有限的环境中并不总是可行的。有几个依从性干预措施开发的RLS，并没有被证明是有效的，在印度。该应用程序解决了这一差距，直接建立在我们正在进行的合作研究项目的结果，该项目检查了印度Bengalu的ART依从性（R 01 MH 067513）。到目前为止，我们已经确定了当地模式的不遵守，预测治疗失败和耐药性的发展。我们还记录了在这种情况下实现最佳依从性的障碍，包括艾滋病污名的作用。在这项工作的基础上，我们开发并试行了“Chetana”，这是一种有前途的、与文化相关的增强依从性的干预措施，以全面的方式满足艾滋病毒/艾滋病感染者的需求。这项创新计划以社会认知理论（SCT）为基础，具体内容基于我们以前的描述性研究和广泛的试点测试。针对参与者的反馈，它不仅针对药物依从性，还包括旨在增强PLHA中身心健康的其他文化相关主题，包括瑜伽/冥想，营养，法律的服务和获得当地资源的援助。它以小组和个人两种形式管理，旨在为那些得不到家人和朋友充分支持的人提供同伴支持，它具有足够的灵活性，可以根据个人需要量身定制，如果发现有效，可以在当地非政府组织的帮助下很容易地扩大规模和维持。初步研究表明，这种干预措施的可行性和可接受性次最佳粘附PLHA和试点数据表明，它可以帮助参与者减少依从性障碍，提高依从性，减少治疗中断。我们现在建议在一项随机对照试验中，在500名次优依从患者中评估这种有希望的干预措施的效果，将其与时间匹配的主动对照条件进行比较，仅包括干预措施的非依从性特定成分和标准临床咨询。 公共卫生相关性：在全球范围内扩大抗逆转录病毒治疗的规模，降低了死亡率，提高了资源丰富和资源有限环境中的生活质量。然而，这些计划的长期成功取决于良好的药物依从性，以最大限度地提高可用方案的持久性并减少耐药性的发展。拟议的研究旨在通过测试一种新的和可持续的依从性增强干预措施来满足这一需求，该干预措施以全面的方式解决了印度艾滋病毒感染者的需求，如果发现有效，将对其他资源有限的环境和美国的依从性研究产生影响。

DESCRIPTION (provided by applicant): Enhancing HIV treatment adherence in South India: The Chetana Study Excellent adherence to antiretroviral therapy is essential to achieve HIV suppression and long term treatment success, especially in settings where antiretroviral treatment options may be limited. To accomplish this, it is vitally important that we develop and test culturally appropriate adherence interventions that target local adherence patterns and barriers and that can be quickly scaled up and sustained by local groups. There is also a need for reliable and valid objective adherence monitoring strategies to supplement self-report, which tends to overestimate true adherence rates. The recently developed "Wisepill", which will be used in this study, has the potential to accomplish this. It uses mobile and wireless technology to monitor adherence in real-time and appears to overcome many of the limitations of other objective measures, such as MEMS caps, pharmacy refill records or unannounced pill counts, which are not always feasible in Resource-Limited Settings (RLS). There are few adherence interventions developed for RLS and none have been shown effective in India. This application addresses this gap, building directly on findings from our ongoing collaborative research program examining ART adherence in Bengaluru, India (R01MH067513). To date, we have identified local patterns of non-adherence that predict both treatment failure and the development of drug resistance. We have also documented barriers to optimal adherence in this setting, including the role of AIDS stigma. Based on this work, we developed and pilot-tested "Chetana", a promising, culturally relevant adherence-enhancing intervention that addresses, in a comprehensive manner, the needs of People Living with HIV/AIDS (PLHA). This proposed innovative program is grounded in Social Cognitive Theory (SCT), with specific content based on our previous descriptive research and extensive pilot testing. In response to participant feedback, it targets not only medication adherence, but also includes other culturally-relevant topics designed to enhance physical and mental health among PLHA, including yoga/meditation, nutrition, legal services, and assistance accessing local resources. It is administered in both group and individual format, is designed to provide peer support for those who do not have sufficient support from family and friends, is flexible enough to be tailored to individual needs, and, if found to be efficacious, could easily be scaled up and sustained with the help of local NGOs. Preliminary research demonstrates the feasibility and acceptability of this intervention among sub-optimally adherent PLHA and pilot data suggest that it can help participants reduce adherence barriers, improve adherence and reduce treatment interruptions. We now propose to evaluate the effects of this promising intervention in a Randomized Controlled Trial among 500 sub-optimally adherent patients, comparing it to a time-matched active control condition, consisting of only the non-adherence specific components of the intervention and standard clinic counseling. PUBLIC HEALTH RELEVANCE: The global scale up of antiretroviral treatment has resulted in decreased mortality rates and improved quality of life in both resource rich and resource-limited settings. However, the long-term success of these programs depends on excellent medication adherence in order to maximize the durability of available regimens and reduce the development of drug resistance. The proposed study was designed to meet this need by testing a novel and sustainable adherence-enhancing intervention that addresses, in a comprehensive manner, the needs of People Living with HIV in India and, if found effective, would have implications for adherence research both in other resource-limited settings and in the US.