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：切塔纳研究报告指出，对抗逆转录病毒治疗的良好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。为了实现这一点，至关重要的是，我们开发和测试文化上适当的遵守干预措施，针对当地的遵守模式和障碍，并能够迅速扩大规模，并由当地团体维持。还需要可靠和有效的客观遵守监测战略来补充自我报告，因为自我报告往往高估了真实的遵从率。最近开发的“Wisepill”，将在这项研究中使用，具有实现这一目标的潜力。它使用移动和无线技术来实时监控遵从性，并似乎克服了其他客观措施的许多限制，如MEMS上限、药房充填记录或未公布的药片计数，这些在资源有限设置(RLS)中并不总是可行的。为RLS制定的遵守干预措施很少，在印度也没有显示出有效的干预措施。此应用程序解决了这一差距，直接基于我们正在进行的合作研究计划在印度孟加卢市审查ART依从性的结果(R01MH067513)。到目前为止，我们已经确定了局部不依从性模式，这些模式预测了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遵守的障碍，包括艾滋病污名的作用。在这项工作的基础上，我们开发了“Chetana”，并进行了试点测试，这是一种有前途的、与文化相关的、加强坚持的干预措施，以全面的方式解决艾滋病毒/艾滋病患者(PLHA)的需求。这一创新计划以社会认知理论(SCT)为基础，以我们之前的描述性研究和广泛的试点测试为基础，有具体的内容。作为对参与者反馈的回应，它不仅针对服药依从性，还包括其他与文化相关的主题，旨在加强PLHA的身心健康，包括瑜伽/冥想、营养、法律服务和帮助获得当地资源。它以团体和个人两种形式管理，旨在为那些没有得到家人和朋友足够支持的人提供同行支持，具有足够的灵活性，可以根据个人需要量身定做，如果被发现有效，可以很容易地在当地非政府组织的帮助下扩大和维持规模。初步研究表明，这种干预在依从性不佳的PLHA患者中是可行的和可接受的，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。我们现在建议在500名次优依从性患者中进行的随机对照试验中评估这一有希望的干预的效果，并将其与时间匹配的积极对照条件进行比较，积极对照条件仅包括干预的非依从性特定成分和标准的临床咨询。

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.