VUKA Family Program: Supporting Perinatally HIV-infected Youth in South Africa

描述（由申请人提供）：拟议研究的主要目的是满足南非（SA）空前数量的围产期艾滋病毒感染（PHIV+）青年对理论驱动，经验信息，有效和可持续的艾滋病毒预防和护理方法的迫切需求。本研究旨在1)增加我们对这一新兴人群的行为和健康风险的理解，2)检验家庭/家庭层面的干预，即VUKA家庭计划（VUKA），对促进青少年整体健康和心理健康，降低行为风险的影响。社会行动理论（SAT）；与PRISM（实用、稳健实施和可持续发展模型）理论框架相结合，VUKA是一种基于卡通的干预措施，由SA调查员、图形艺术家、医务人员、成人护理人员和艾滋病毒阳性青少年的大量投入开发而成。该应用程序建立在美国和SA研究人员和临床医生以及SA卫生部（SADOH）之间长期合作的基础上。我们提出了一项全面的随机对照试验（RCT）来检验VUKA相关的有效性、实施和整合过程，研究对象是在夸祖鲁-纳塔尔省4家公立儿科艾滋病诊所登记的360名HIV阳性早期青少年（9至14岁）。夸祖鲁-纳塔尔省是南非艾滋病血清患病率最高的省份之一。青少年及其家庭成员将被随机分配到以下两种研究条件之一：1)VUKA或；2)护理标准。采用三波实验研究设计，在基线、3个月（测试后）和基线后12个月随访时进行评估，以解决以下具体目标。目标1（主要）：在我们的SAT模型（图1）的指导下，基于作为拟议RCT的一部分收集的基线数据，确定南非新出现的PHIV+青年人群的行为（例如，抗逆转录病毒治疗依从性，性和药物使用行为），健康（例如，病毒血症水平，一般健康）和社会心理（例如，心理健康，与保护性成人资源的联系，社会决策技能）风险。目的2（主要）：研究VUKA对在南非公共医疗诊所接受标准治疗的青少年的行为、健康和心理社会结果的影响。目标#3（次要）：研究SAT模型中的理论结构（自我调节、社会/家庭调节和背景因素）如何调节结果；目标#4（次要）：阐明在南非夸祖鲁-纳塔尔省公共资助的儿科艾滋病护理站点中，由PRISM指导的影响VUKA实施和整合的多层次因素（例如，工作人员的交付技能、对负担的看法、诊所组织挑战、时间和空间限制）。

DESCRIPTION (provided by applicant): The primary aim of the proposed study is to meet the urgent need for theory-driven, empirically- informed, effective, and sustainable HIV prevention and care approaches for the unprecedented numbers of perinatally HIV-infected (PHIV+) youth in South Africa (SA). This study aims to 1) increase our understanding of behavioral and health risk in this emerging population, and 2) to examine the impact of a family/household-level intervention, the VUKA Family Program (VUKA), to promote youth overall health and mental health, and reduce behavioral risk. Informed by Social Action Theory, (SAT); and the PRISM (Practical, Robust Implementation and Sustainability Model) theoretical framework, VUKA is a cartoon-based intervention developed with intensive input from SA investigators, graphic artists, medical staff, adult caregivers and HIV+ adolescents. This application is built upon a long-standing collaboration among US and SA researchers and clinicians and the SA Department of Health (SADOH). We propose a full-scale randomized controlled trial (RCT) to examine the effectiveness, implementation, and integration processes associated with VUKA with a sample of 360 PHIV+ early adolescents (9 to 14 years of age) registered at 4 publicly financed pediatric HIV clinics in KwaZulu Natal, a SA province with one of the highest HIV seroprevalence rates. Youth and their family members will be randomly assigned to one of two study conditions: 1) VUKA or; 2) standard of care. A 3-wave experimental research design with assessments at baseline, 3 month (posttest) and 12 month follow-up from baseline will be employed to address the following Specific Aims. Aim #1 (Primary): To identify the behavioral (e.g., ART adherence, engagement in sexual and drug use behaviors), health (e.g., level of viremia, general health), and psychosocial (e.g mental health, connection to protective adult resources, social decision-making skills) risks of the emerging population of PHIV+ youth in South Africa, guided by our SAT model (Figure 1) and based on baseline data collected as part of the proposed RCT. Aim #2 (Primary): To examine the impact of VUKA on youth behavioral, health and psychosocial outcomes relative to those who receive standard care within South African public medical clinics. Aim #3 (Secondary): To investigate how outcomes are mediated by theoretical constructs in our SAT model (self-regulation, social/family regulation, and contextual factors); Aim #4 (Secondary): To elucidate multi-level factors guided by PRISM that influence implementation, and integration of VUKA (e.g. staff delivery skill, perceptions of burden, clinic organizational challenges, time and space constraints) in publicly funded, pediatric HIV care sites in KwaZulu-Natal, SA).