Masivukeni: A Multimedia ART Adherence Intervention for Resource-Limited Settings

描述（由申请人提供）：南非（SA）是世界上艾滋病毒感染人数最多的国家。虽然最初的报告表明，在撒哈拉以南非洲的抗逆转录病毒治疗坚持率很高，最近的数据表明，坚持可能是一个主要的障碍，以实现充分的抗逆转录病毒治疗的好处。不充分的坚持和相关的耐药性的因素，往往在抗逆转录病毒治疗开始的头12个月内观察到的治疗失败率高。艾滋病毒疾病的患者的理解和高ART坚持的必要性，以及社会的支持，坚持维护是关键的长期成功的ART。鉴于医生/护士的比例，病人，ART坚持咨询SA主要是由外行顾问进行不同的专业知识和技能，和最低限度的监督。由于缺乏标准化和咨询质量的可变性，迫切需要一种有效的依从性干预措施，这种干预措施可以由训练有素的外行人员提供在NIMH R34资助的支持下，我们开发了Masivukeni，一种创新的，我们的US-SA研究团队与SA患者和护理提供者使用基于社区的参与性研究方法开发了基于计算机的多媒体干预。基于社会行动理论，Masivukeni解决了可能促进或阻碍依从性的环境因素，以及可以改善行为和生物结果的自我调节和社会支持因素。与患者及其治疗支持合作伙伴一起工作的咨询师利用计算机技术，使非专业咨询师能够在最低限度的培训和监督下教授复杂的医疗信息和解决问题的技能，并具有文化相关性，互动图像。干预还提高了辅导员的能力，筛选和转介的精神健康和物质使用问题的患者启动ART。我们的试点研究表明，高的可接受性和可行性，以及对关键的主要和次要结果的有前途的影响。通过开普敦市和省卫生部之间的合作，南非的研究和临床合作伙伴（开普敦大学）和美国（纽约州精神病研究所/RFMH和哥伦比亚大学CCNMTL的HIV临床和行为研究中心），我们建议将Masivukeni与“标准护理”进行比较，通过随机分配360名患者开始抗逆转录病毒治疗的两个研究条件之一，在两个公共资助的医疗诊所服务主要是贫困社区的艾滋病毒高流行率。患者将接受为期一年的随访。将在基线、基线后6个月和12个月对患者进行评估。通过与临床医生和卫生部政策制定者的合作，如果证明有效，干预措施将迅速用于大规模传播。此外，这种方式的有效干预可以很容易地在世界其他地区进行文化定制和实施，包括美国，长期坚持仍然是一个挑战，特别是对于识字率低、心理健康和药物使用问题的患者。

DESCRIPTION (provided by applicant): South Africa (SA) has the largest number of HIV infections in the world. Although initial reports suggested that rates of ART adherence in sub-Saharan Africa were high, recent data indicate that adherence may be a major obstacle to actualizing the full benefits of ART. Inadequate adherence and associated drug resistance are factors contributing to high rates of treatment failure often observed within the first 12 months of ART initiation. Patient understanding of HIV disease and the necessity for high ART adherence, as well as the social support for maintenance of adherence are key to the long-term success of ART. Given the ratio of physicians/nurses to patients, ART adherence counseling in SA is conducted mostly by lay counselors with varied expertise and skills, and minimal supervision. Lack of standardization and variability in quality of counseling has prompted urgent calls for an effective adherence intervention that can be delivered by trained lay staff (with fidelity) to establish optimal adherence among patients initiating ART. With the support of an NIMH R34 grant, we developed Masivukeni, an innovative, multi-media computer-based intervention developed by our US-SA research team with SA patients and care providers using community based participatory research methods. Based on Social Action Theory, Masivukeni addresses contextual factors that may promote or impede adherence, and self-regulation and social support factors that can improve behavioral and biological outcomes. The utilization of computer-based technology by counselors working with patients and their treatment support partners enables lay counselors with minimal training and supervision to teach complex medical information and problem-solving skills, with culturally relevant, interactive imagery. The intervention also enhances counselor capacity for screening and making referrals for mental health and substance use problems among patients initiating ART. Our pilot study demonstrated high acceptability and feasibility, as well as promising effects on key primary and secondary outcomes. Through a collaboration among City and Provincial DOHs in Cape Town, research and clinical partners in SA (University of Cape Town) and the US (HIV Center for Clinical and Behavioral Studies at NYS Psychiatric Institute/RFMH and CCNMTL at Columbia University), we propose to compare Masivukeni to "standard care" by randomly assigning 360 patients initiating ART to one of the two study conditions in two publicly financed medical clinics serving predominantly poor communities with high HIV prevalence. Patients will be followed over the course of one year. Assessments will be administered to patients at baseline, 6 months and 12 months post baseline. Through partnership with clinicians and DOH policy-makers, the intervention will be quickly available for wide-scale dissemination if shown to be efficacious. Further, an efficacious intervention of this modality could readily be culturally tailored and implemented in other regions of the world, including the US where long-term adherence remains a challenge, particularly for patients with low literacy and mental health and substance use problems.