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

描述(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撒哈拉以南非洲的抗逆转录病毒药物使用率很高，但最近的数据表明，坚持抗逆转录病毒药物可能是实现抗逆转录病毒药物的全部好处的主要障碍。依从性不足和相关的耐药性是导致治疗失败率高的因素，通常在ART开始治疗的前12个月内观察到。患者对艾滋病毒疾病的了解和高度坚持抗逆转录病毒疗法的必要性，以及对维持坚持的社会支持是抗逆转录病毒疗法长期成功的关键。考虑到医生/护士与患者的比例，SA的抗逆转录病毒治疗依从性咨询主要由具有不同专业知识和技能的非专业顾问进行，监督很少。咨询质量缺乏标准化和可变性，促使人们迫切呼吁进行有效的依从性干预，这种干预可以由训练有素的非专业工作人员(以保真度)提供，以在启动ART的患者中建立最佳的依从性。在NIMHR34拨款的支持下，我们开发了Masivukeni，这是一种创新的多媒体计算机干预方法，由我们的美国-SA研究团队开发，使用基于社区的参与式研究方法与SA患者和护理提供者进行合作。根据社会行动理论，Masivukeni阐述了可能促进或阻碍遵守的背景因素，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。辅导员与患者及其治疗支持合作伙伴利用计算机技术，使非专业辅导员能够通过与文化相关的互动图像，在最少的培训和监督下教授复杂的医疗信息和解决问题的技能。这项干预还提高了辅导员在开始抗逆转录病毒治疗的患者中筛查和转介精神健康和药物使用问题的能力。我们的初步研究显示了很高的可接受性和可行性，以及对关键的初级和次级结果有希望的效果。通过开普敦的市和省卫生部、SA(开普敦大学)和美国(纽约精神病研究所/RFMH和哥伦比亚大学CCNMTL的艾滋病毒临床和行为研究中心)的研究和临床合作伙伴的合作，我们建议通过在两个公共资助的医疗诊所中随机分配360名开始抗逆转录病毒治疗的患者到两种研究条件中的一种，将Masivukeni与“标准护理”进行比较。患者将接受为期一年的跟踪调查。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，如果证明是有效的，干预措施将迅速获得广泛传播。此外，这种模式的有效干预可以很容易地在文化上量身定做，并在世界其他地区实施，包括美国，在那里长期坚持仍然是一个挑战，特别是对于识字率低、精神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.