Enhancing HIV treatment adherence in Bangalore: The Chetana study

描述（由申请人提供）：加强南印度艾滋病毒治疗依从性：Chetana研究出色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环境中。为实现这一目标，至关重要的是，我们开发和测试适合文化的依从性干预措施，针对当地的依从性模式和障碍，并可以迅速扩大规模，并由当地团体维持。还需要可靠和有效的客观依从性监测策略来补充自我报告，这往往高估了真实的依从率。最近开发的“Wisepill”将在本研究中使用，具有实现这一目标的潜力。它使用移动和无线技术实时监测依从性，似乎克服了其他客观措施的许多局限性，例如MEMS上限，药房补充记录或未公布的药丸数量，这些措施在资源有限的环境（RLS）中并不总是可行。很少有针对RLS的依从性干预措施，在印度没有一个显示出有效。该应用程序直接建立在我们正在进行的合作研究项目（R01MH067513）的基础上，解决了这一差距。该项目调查了印度班加罗尔的抗逆转录病毒治疗依从性。到目前为止，我们已经确定了局部不依从模式，可以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最佳依从性的障碍，包括艾滋病耻辱感的作用。在这项工作的基础上，我们开发并试点了“Chetana”，这是一个有希望的、与文化相关的增强依从性的干预措施，以全面的方式解决艾滋病毒/艾滋病感染者（PLHA）的需求。这一创新方案以社会认知理论（SCT）为基础，具体内容基于我们之前的描述性研究和广泛的试点测试。根据参与者的反馈，它不仅针对服药依从性，而且还包括其他与文化相关的主题，旨在增强PLHA的身心健康，包括瑜伽/冥想、营养、法律服务和帮助获取当地资源。它以团体和个人两种形式进行，旨在为那些没有足够家人和朋友支持的人提供同伴支持，灵活到可以根据个人需要量身定制，如果发现有效，可以很容易地在当地非政府组织的帮助下扩大和维持。初步研究表明，这种干预在次优依从性的PLHA中是可行和可接受的，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。我们现在提议在一项随机对照试验中评估这种有希望的干预措施的效果，该试验在500名次优依从患者中进行，将其与时间匹配的主动对照条件进行比较，后者仅由干预措施的非依从性特定成分和标准临床咨询组成。

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.