Evaluating a Youth focused economic empowerment approach to HIVTreatment

描述（由申请人提供）：拟议的研究调查了一项创新干预措施的影响和成本，以提高艾滋病毒感染（HIV+）青少年（以下简称Suubi+坚持）对艾滋病毒治疗的依从性。Suubi+依从性的依据是一项有效的经济赋权干预措施，此前在Suubi-乌干达艾滋病孤儿中进行了测试，并借鉴了资产理论和先前的依从性研究。Suubi+坚持旨在：1)促进创收活动——也称为微型企业——为贫穷的艾滋病毒+青少年及其家庭，以便有足够的收入来满足与将艾滋病毒作为一种慢性病进行管理相关的具体财务需求；2)为坚持抗逆转录病毒治疗（ART）提供支持。来自乌干达和撒哈拉以南非洲（SSA）大部分地区的研究表明，受艾滋病影响最大的一个群体是经济上脆弱的儿童。对于这一人群，坚持治疗方案可能需要一定程度的经济稳定，这是许多年轻人没有经历过的。事实上，不坚持的常见原因本质上是经济上的，比如缺乏药物资源、去诊所就诊的交通工具、食物和营养补充剂。贫困儿童不太可能坚持抗逆转录病毒治疗和其他与健康有关的治疗方案。然而，迄今为止，没有任何依从性干预措施关注潜在的经济驱动因素，这可能有助于解释为什么对贫困中的艾滋病毒阳性青少年的依从性干预结果最多只有很小到中等的效果。拟议的研究将随机分配736名艾滋病毒阳性青少年（研究开始时年龄在12至15岁），在乌干达南部Rakai、Masaka和Lwengo地区的32个卫生诊所接受治疗，这些地区受艾滋病毒/艾滋病影响严重，研究条件为：Suubi+依从性与加强标准护理（SOC）。评估将在基线、干预开始后12、24、36和48个月进行。更具体地说，我们将：1)检查Suubi+依从性干预对艾滋病毒阳性青少年艾滋病毒治疗方案关键依从性结果的影响，包括：参与者获取和补充处方药物的能力以及遵守处方日常用药程序的能力；a)不跳过剂量，b)在正确的时间服用剂量，c)参与者的健康素养和健康行为（例如，遵守医疗预约，遵循营养建议），d) CD4和hiv相关生物标志物（CD4 t细胞计数和病毒载量）；2)探讨Suubi+依从性干预对保护性健康行为、知识和信念（如财务稳定性、性冒险行为、个人药物信念、无望感、未来计划和愿望、自我效能感）的潜在机制的影响；3)检查与Suubi+依从性相关的成本。这项研究将促进知识的发展，并为旨在提高资源匮乏地区（如SSA）艾滋病毒阳性青少年对艾滋病毒治疗依从性的项目的制定提供信息。这项研究将为经济赋权计划对短期和长期影响的影响提供关键证据。

DESCRIPTION (provided by applicant): The proposed study examines the impact and cost associated with an innovative intervention to increase adherence to HIV treatment for HIV-infected (HIV+) adolescents (hereafter Suubi+Adherence). Suubi+Adherence is informed by an efficacious economic empowerment intervention previously tested with AIDS-orphaned children, Suubi-Uganda, and draws from Asset-Theory and previous adherence studies. Suubi+Adherence aims to: 1) promote income-generating activities -- also known as microenterprises -- for poor HIV+ adolescents and their families so that there is sufficient income to meet the specific financial needs associated with managing HIV as a chronic illness and; 2) provide support for adherence to antiretroviral therapy (ART). Studies from Uganda, and much of sub-Saharan Africa (SSA) indicate that one group disproportionately affected by HIV is economically vulnerable children. For this population, adherence to treatment regimens may require a level of economic stability that many youth do not experience. Indeed, the commonly cited reasons for non-adherence are economic in nature, such as lack of resources for medication, transportation to attend clinic appointments, and food and nutritional supplements. Poor children are less likely to adhere to ART and other health-related regimens. Yet, to date, no adherence interventions have focused on the underlying economic drivers, which might help explain why results of adherence interventions with HIV+ adolescents in poverty have had small to moderate effects at best. The proposed study will randomly assign 736 HIV+ adolescents (ages 12 to 15 years at study entry) under the care of 32 health clinics in Rakai, Masaka, and Lwengo Districts of southern Uganda - districts heavily affected by HIV/AIDS - to one of two study conditions: Suubi+Adherence vs. bolstered standard of care (SOC). Assessments will be conducted at baseline, and 12, 24, 36, and 48-months post-intervention initiation. More specifically, we will: 1) examine the impact of the Suubi+Adherence intervention on key adherence to HIV treatment regimen outcomes for HIV+ adolescents, including: participants' ability to access and refill prescribed medication and keep to prescribed daily medication routines: a) not skipping doses, b) taking doses at the right times, c) participants' health literay and health behaviors (e.g. keeping medical appointments, following nutritional recommendations), d) CD4, and HIV-related biomarkers (CD4 T-cell count and viral load); 2) explore the impact of the Suubi+Adherence intervention on potential mechanisms of protective health behaviors, knowledge, and beliefs (e.g. financial stability, sexual risk-taking behavior, personal beliefs about medication, hopelessness, future plans and aspirations, self-efficacy); and 3) examine the costs associated with the Suubi+Adherence. The study will advance knowledge and inform the development of programs aimed at increasing adherence to HIV treatment for HIV+ adolescents in low-resource regions such as SSA. The study will provide crucial evidence about the effects of an economic empowerment program on short, and long-term impacts.