Enhancing HIV Medication Adherence in India

描述(由申请人提供)：印度人口超过10亿，估计有570万艾滋病毒携带者，其中可能只有10%-12%的人知道自己的血清状态(2005年联合国艾滋病规划署全国估计感染率为0.9%)。2004年4月推出的免费抗逆转录病毒(ARV)药物在负担过重的诊所造成了大量患者涌入，突显了确定战略的必要性，以提供“教学机会”，针对艾滋病毒血清阳性患者的服药依从性。提出申请的地点是昌迪加尔的医学教育和研究研究生研究所(PGIMER)，它是印度最负盛名的研究和教育公共教学医院之一，也是提供抗逆转录病毒(ARV)治疗的地区性分销中心。在印度不同地区，现有的服务于低SES患者群体的计划发现，由于污名和歧视(Ekstrand等人，2006a)、患者缺乏披露、前往诊所或药店的交通成本(Ekstrand等人，2006a，万楚，2007)以及获得护理的机会有限(Nukella，2007)，依从性不佳。供应商还将药品短缺、与患者相处的时间有限(万楚，正在出版中)、药物共享和工作人员倦怠列为贡献者。这些物质、个人、社会和结构因素阻碍了艾滋病毒药物的坚持。这项拟议研究的总体目标是开发一种干预措施，以提高印度昌迪加尔新的抗逆转录病毒使用者对抗逆转录病毒药物的依从性。我们打算开发一种机械化的认知行为团体依从性干预，并将其与护理标准(例如，提供者用药指令)进行比较。这项研究的目标是1)确定影响服药依从性的患者、提供者、疾病和背景因素，2)确定影响服药依从性的特定文化因素，3)开发和实施文化定制干预措施以提高依从性，4)评估结构化依从性干预对抗逆转录病毒药物依从性的影响。80名使用HIV+新型抗逆转录病毒药物的个体将被随机分配到以下两种情况之一：1)药物依从性干预(MAI)小组情况：在训练有素的健康从业者的带领下，参与者将以体验式/互动式小组形式收到结合解决问题技能的药物信息；或2)从业者医疗指令(护理标准)个人情况：由医生领导，参与者将以个人形式收到药物信息。该研究计划的目标是了解印度患者如何适应持续的抗逆转录病毒药物使用，随着时间的推移，是什么影响了患者的依从性，并开发了支持使用抗逆转录病毒药物的有效干预措施。这项研究旨在应对由于不遵守规定而产生艾滋病毒耐药毒株所带来的重大公共卫生风险。这项研究的目标代表了在印度北部预防耐药艾滋病毒的发展和传播的重要战略。 公共卫生相关性这项研究项目的目标是了解印度患者如何适应持续的抗逆转录病毒药物使用，随着时间的推移，是什么影响了患者的依从性，并开发了支持使用抗逆转录病毒药物的有效干预措施。这项研究旨在应对由于不遵守规定而产生艾滋病毒耐药毒株所带来的重大公共卫生风险。这项研究的目标是开发、实施和评估一种根据文化定制的方法，增加对抗逆转录病毒药物的依从性，这是防止印度北部耐药艾滋病毒的发展和传播的重要战略。

DESCRIPTION (provided by applicant): With a population of over 1 billion, India has an estimated 5.7 million individuals living with HIV, of whom perhaps only 10-12% are aware of their serostatus (0.9% prevalence national estimate, UNAIDS, 2005). The release of no cost antiretroviral (ARV) medication in April 2004 created a large patient influx at overburdened clinics, highlighting the need to identify strategies to provide "teaching opportunities" to target medication adherence among HIV seropositive patients. The site for the proposed application, the Post-Graduate Institute of Medical Education and Research (PGIMER) in Chandigarh is one of the most prestigious research and educational public teaching hospitals in India, and a regional distribution Center to provide antiretroviral (ARV) therapy. Existing programs serving low SES patient populations in various regions of India have identified suboptimal levels of adherence due to stigma and discrimination (Ekstrand et al., 2006a), patient lack of disclosure, the cost of transportation to clinics or pharmacies (Ekstrand et al., 2006a, Wanchu, 2007) and limited access to care (Nukella, 2007). Providers also cite medication stock outs, limited time with patients (Wanchu, in press), medication sharing and staff burnout as contributors. These physical, individual, social and structural factors act as impediments to HIV medication adherence. The overall aims of the proposed study are to develop an intervention to enhance ARV medication adherence among new ARV users in Chandigarh, India. We intend to develop a manualized cognitive behavioral group adherence intervention and compare it with the standard of care (e.g., provider medication directive). Goals of the study are 1) identify patient, provider, illness and contextual factors that influence medication adherence, 2) identify culture specific factors that influence adherence, 3) develop and implement a culturally tailored intervention to enhance adherence, 4) evaluate the effects of a structured adherence intervention on adherence to ARV medications. Eighty HIV+ new ARV using individuals will be randomly assigned to one of two conditions, 1) Medication Adherence Intervention (MAI) group condition: Led by a trained health practitioner, participants will receive medication information combined with problem solving skills in an experiential/interactive group format, or 2) Practitioner Medical Directive (Standard of Care) individual condition: Led by a medical practitioner, participants will receive medication information in an individual format. The objectives of the research program are to learn how Indian patients adapt to consistent ARV use, what influences adherence over time, and to develop an effective intervention that supports the use of ARVs. This research is designed to respond to the major public health risk of the development of resistant strains of HIV as a consequence of non-adherence. The goals of this research represent an important strategy for preventing the development and transmission of medication resistant HIV in northern India. PUBLIC HEALTH RELEVANCE The objectives of this research project are to learn how Indian patients adapt to consistent ARV use, what influences adherence over time, and to develop an effective intervention that supports the use of ARVs. This research is designed to respond to the major public health risk of the development of resistant strains of HIV as a consequence of non-adherence. The goals of this research, the development, implementation and evaluation of a culturally tailored method of increasing adherence to ARVs, represent an important strategy for preventing the development and transmission of medication resistant HIV in northern India.