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）前所未有数量的围产期HIV感染（PHIV+）青年对理论驱动、经验丰富、有效和可持续的HIV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）检查家庭/家庭层面干预措施的影响，即武卡家庭计划（武卡），以促进青少年的整体健康和心理健康，并降低行为风险。武卡以社会行动理论（SAT）和PRISM（实用、稳健实施和可持续性模型）理论框架为基础，是一种基于卡通的干预措施，由SA调查人员、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提供大量投入。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），以检查与武卡相关的有效性，实施和整合过程，样本为360名在南非夸祖鲁纳塔尔省4个公共资助的儿科HIV诊所登记的PHIV+早期青少年（9至14岁），该省份是HIV血清阳性率最高的省份之一。青少年及其家庭成员将被随机分配至两种研究条件之一：1）武卡或; 2）标准治疗。将采用3波实验研究设计，在基线、3个月（测试后）和自基线起12个月随访时进行评估，以解决以下具体目标。目标#1（主要）：识别行为（例如，ART依从性、参与性行为和药物使用行为）、健康（例如，在我们的SAT模型（图1）的指导下，并基于作为拟议RCT的一部分收集的基线数据，对南非新出现的PHIV+青年人群的病毒血症水平、总体健康状况）和心理社会（例如，心理健康、与保护性成人资源的联系、社会决策技能）风险进行了评估。目标2（主要）：研究武卡对青少年行为、健康和心理社会结果的影响，相对于那些在南非公共医疗诊所接受标准治疗的青少年。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）如何介导结果;目标4（次要）：阐明在PRISM指导下影响武卡实施和整合的多层次因素（例如，工作人员交付技能、负担感知、诊所组织挑战、时间和空间限制），夸祖鲁-纳塔尔，SA的儿科HIV护理点）。

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).