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。尽管最初的报告表明，撒哈拉以南非洲的抗逆转录病毒治疗依从率很高，但最近的数据表明，依从性可能是实现抗逆转录病毒治疗全部益处的主要障碍。依从性不足和相关的耐药性是导致抗逆转录病毒治疗开始后12个月内治疗失败率高的因素。患者对艾滋病毒疾病的了解和高度坚持抗逆转录病毒治疗的必要性，以及维持坚持治疗的社会支持，是抗逆转录病毒治疗长期成功的关键。鉴于医生/护士与患者的比例，辅助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咨询师进行，监督很少。咨询质量缺乏标准化和可变性，这促使人们迫切需要一种有效的依从性干预，这种干预可以由训练有素的非专业人员（忠实地）提供，以在开始抗逆转录病毒治疗的患者中建立最佳的依从性。在NIMH R34基金的支持下，我们开发了Masivukeni，这是一种创新的多媒体计算机干预措施，由我们的美国-SA研究团队与SA患者和护理提供者使用基于社区的参与式研究方法开发。Masivukeni以社会行为理论为基础，阐述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学结果的自我调节和社会支持因素。咨询师与患者及其治疗支持伙伴一起工作时，利用基于计算机的技术，使非专业咨询师在接受最少培训和监督的情况下，能够利用与文化相关的交互式图像，教授复杂的医疗信息和解决问题的技能。干预措施还提高了咨询师在开始抗逆转录病毒治疗的患者中筛查和转诊精神健康和药物使用问题的能力。我们的初步研究显示了较高的可接受性和可行性，并在关键的主要和次要结果上取得了良好的效果。通过开普敦市和省卫生部、南非（开普敦大学）和美国（纽约精神病学研究所/RFMH艾滋病毒临床和行为研究中心和哥伦比亚大学CCNMTL）的研究和临床合作伙伴之间的合作，我们建议将Masivukeni与“标准治疗”进行比较，随机分配360名开始抗逆转录病毒治疗的患者，在两家公共资助的医疗诊所接受两种研究条件中的一种，这些诊所主要服务于艾滋病毒高发的贫困社区。患者将被随访一年。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决策者的伙伴关系，如果证明有效，将迅速进行大规模推广。此外，这种模式的有效干预可以很容易地根据文化进行调整，并在世界其他地区实施，包括美国，在美国，长期坚持治疗仍然是一个挑战，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.