Preventing & Treating HIV Comorbidities in India: Multi-tiered Strategy for Women

描述（由申请人提供）：本项目的总体目标是证明，低成本、通过手机提供的干预措施是一种有希望、可行和可接受的方式，可以改善受艾滋病毒及相关精神健康和社会心理风险因素影响的印度妇女的预防和治疗结果。在过去十年中，在艾滋病毒预防和获得挽救生命的抗逆转录病毒治疗方面取得了显著进展。然而，在坚持艾滋病毒护理方面的缺陷对成功构成了重大障碍。女性处于特别不利的地位。性别不平等、身体和环境因素使许多妇女感染艾滋病毒的风险增加，精神健康状况不佳，以及相关的社会心理辅助因素（抑郁、性别歧视、暴力、缺乏社会支持等），这些都是公认的与艾滋病毒护理依从性和坚持性差有关的因素。在印度，除了预防母婴传播项目的短期预防外，很少有针对妇女的坚持干预措施。最近的研究表明，这些妇女在预防母婴传播和终身艾滋病毒护理服务之间的随访失失率高得惊人，特别是在分娩后的过渡期。为了解决这一差距，美国国家心理健康与神经科学研究所（NIMHANS）和耶鲁大学将利用印度和美国临床研究人员、利益相关者和资源组成的一支独特的、高素质的多学科团队的互补专业知识。我们的初步工作表明，理论指导的依从性电话干预可以很容易地整合和维持作为常规ART中心服务的组成部分，非常适合目标人群，但它需要适应社会文化背景。在印度完善干预措施的初步形成工作之后，我们将培训诊所护士提供干预措施，然后在一项随机试验中评估干预措施新应用的可行性、保真度和初步效果。基线评估后，女性（n=120）将被随机分配到照常治疗（TAU）或TAU加电话干预（16周以上），结果（如抑郁症状、依从性）将在随机化后6、14、24、36周进行评估。如果在这个项目中开发和试点测试的有前途的手机干预在第一阶段的研究中显示出我们所期望的前景，那么干预的功效和成本将在一个大规模的、多地点的研究中进行评估。如果成功，一个极端

DESCRIPTION (provided by applicant): The overall objective of this project is to demonstrate that a low cost, cell phone-delivered intervention is a promising, feasible and acceptable way to improve the prevention and treatment outcomes of women in India who are affected by HIV and inter-related mental health and psychosocial risk factors. Over the past decade there have been dramatic improvements in HIV prevention and access to life-saving antiretroviral therapy (ART). Yet, deficits in adherence to the spectrum of HIV care pose significant barriers to success. Women are at a particular disadvantage. Gender inequality, physical and situational factors place many women at increased risk for HIV acquisition and poor mental health and interrelated psychosocial co-factors (depression, gender-discrimination, violence, lack of social support, etc.) that are well established correlates of poor adherence and retention in HIV care. Few adherence interventions have focused on women in India outside of short-term prevention in PMTCT programs. Recent studies have shown alarmingly high rates of loss to follow-up for these women, particularly in the transition after delivery, between PMTCT and lifelong HIV care services. To address this gap, a collaborative partnership between the National Institute of Mental Health and Neuro Sciences (NIMHANS) and Yale University will leverage the complementary expertise of a uniquely well qualified, multidisciplinary team of Indian and U.S. of clinical investigators, stakeholders and resources. Our preliminary work indicates that a theory-guided adherence phone intervention that can be easily integrated and sustained as a component of routine ART Centre services is well suited for the target population, but it needs to be adapted to the sociocultural context. Following initial formative work to refine the interventio for delivery in India, we will train clinic nurses to deliver the intervention, and then evaluate te feasibility, fidelity and preliminary efficacy of the novel application of the intervention in a randomized trial. After baseline assessment, women (n=120) will be randomly assigned to treatment as usual (TAU) or TAU plus the phone intervention (delivered over 16 weeks) and outcomes (e.g., depressive symptoms, adherence) will be evaluated at 6, 14, 24, 36 weeks post-randomization. If the promising mobile phone intervention developed and pilot tested in this project shows promise in this Phase 1 study as we expect, the efficacy and cost of the intervention will then be evaluated in a large scale, multi-site study. If successful, an extremely practical approach will be available to improve the prevention and treatment outcomes of women with HIV and co-morbid mental health problems in India.