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)空前数量的围产期感染艾滋病毒(PHIV+)青年对理论驱动、有经验的、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)增进我们对这一新兴人群的行为和健康风险的了解，2)考察家庭/家庭层面的干预措施--伏卡家庭计划(Vuka Family Program，VUKA)的影响，以促进青少年的整体健康和心理健康，降低行为风险。在社会行动理论(SAT)和PRISM(实用、稳健实施和可持续发展模式)理论框架的指导下，Vuka是一种基于卡通的干预措施，得到了SA调查人员、图形艺术家、医务人员、成人照顾者和艾滋病毒+青少年的大量投入。这一应用程序建立在美国和南澳研究人员、临床医生以及南澳卫生部(SADOH)之间的长期合作基础上。我们提出了一项全面的随机对照试验(RCT)来检查与Vuka相关的有效性、实施和整合过程，样本为360名PHIV+早期青少年(9至14岁)，在夸祖鲁纳塔尔省的4家公共资助的儿童艾滋病毒诊所注册，夸祖鲁纳塔尔省是艾滋病毒血清感染率最高的SA省之一。青少年及其家人将被随机分配到两种学习条件中的一种：1)伏卡或；2)护理标准。将采用三波实验研究设计，在基线、3个月(后测)和12个月的基础上进行评估，以实现以下具体目标。目标1(主要)：在我们的SAT模型(图1)的指导下，根据作为拟议RCT的一部分收集的基线数据，确定南非PHIV+青年新兴人口的行为风险(例如，对ART的遵守、参与性行为和药物使用行为)、健康(例如，病毒血症水平、一般健康状况)和心理社会风险(例如，心理健康、与保护性成人资源的连接、社会决策技能)。目标2(主要)：与在南非公共医疗诊所接受标准护理的人相比，检查伏卡对青年行为、健康和心理社会结果的影响。目标#3(次级)：调查我们的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##(次级)：阐明在PRISM指导下影响Vuka在南萨夸祖鲁-纳塔尔公共资助的儿科艾滋病毒护理地点的实施和整合的多层次因素(例如，工作人员交付技能、负担感、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).