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570万艾滋病毒感染者，其中可能只有10-12%的人知道自己的血清状况（全国流行率估计为0.9%，艾滋病规划署，2005年）。2004年4月免费发放抗逆转录病毒药物，造成大量病人涌入负担过重的诊所，突出表明需要确定战略，提供“教学机会”，使艾滋病毒血清反应呈阳性的病人坚持服药。拟议申请的地点是昌迪加尔的医学教育和研究研究生院（PGIMER），它是印度最负盛名的研究和教育公立教学医院之一，也是提供抗逆转录病毒（ARV）治疗的区域配送中心。印度各地区服务于低SES患者人群的现有项目已经确定了由于耻辱和歧视而导致的次优依从性水平（Ekstrand et al.，2006 a），患者缺乏披露，到诊所或药房的运输成本（Ekstrand et al.，2006年a，Wanchu，2007年）和获得护理的机会有限（Nukella，2007年）。供应商还列举了药物缺货、与病人相处的时间有限（Wanchu，在新闻中）、药物共享和工作人员倦怠等因素。这些身体、个人、社会和结构性因素阻碍了艾滋病毒药物治疗的坚持。拟议研究的总体目标是制定一项干预措施，以提高印度昌迪加尔新的抗逆转录病毒药物使用者的抗逆转录病毒药物依从性。我们打算开发一种手动认知行为组依从性干预，并将其与护理标准（例如，提供者用药指令）。研究的目的是1）确定影响药物依从性的患者，提供者，疾病和背景因素，2）确定影响依从性的文化特定因素，3）开发和实施文化定制的干预措施，以提高依从性，4）评估结构化依从性干预对ARV药物依从性的影响。80名HIV+新抗逆转录病毒药物使用者将被随机分配到以下两种条件之一：1）药物依从性干预（MAI）组条件：由受过培训的保健医生领导，参与者将以体验/互动组形式获得药物信息和解决问题的技能，或2）从业者医疗指导（标准治疗）个体情况：在医生的指导下，参与者将以个体形式收到药物信息。该研究计划的目标是了解印度患者如何适应持续使用ARV，随着时间的推移影响依从性的因素，并制定支持使用ARV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的艾滋病毒耐药株的主要公共卫生风险。这项研究的目标是在印度北方预防耐药艾滋病毒的发展和传播的重要战略。 本研究项目的目标是了解印度患者如何适应持续使用ARV，随着时间的推移影响依从性的因素，并制定支持使用ARV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的艾滋病毒耐药株的主要公共卫生风险。这项研究的目标是制定、实施和评价一种适合不同文化的方法，以提高抗逆转录病毒药物的依从性，这是在印度北方预防抗药性艾滋病毒的发展和传播的一项重要战略。

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.