Pediatric HIV Disclosure Benefits Study (PhD-BS) - Sankofa 2

儿科 HIV 披露福利研究 (PhD-BS) - Sankofa 2

• 批准号: 10662282
• 负责人: ELIJAH PAINTSIL
• 金额: $ 4.05万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-15 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10662282
• 关键词: 18 year old; Academy; Adherence; Adolescent; Africa South of the Sahara; Age; American; Anti-Retroviral Agents; Appointment; Area; Behavioral; Caregivers; Caring; Child; Child Care; Child Welfare; Childhood; Clinic; Clinical; Cluster randomized trial; Communities; Control Groups; Counseling; Data; Development; Diagnosis; Disclosure; Elements; Ethics; Family; Family Relationship; Fright; Future; Ghana; HIV; HIV Seropositivity; HIV diagnosis; Health; Health Benefit; Health Care Costs; Health Personnel; Health Services; Health behavior change; High Prevalence; Home; Immunologics; Individual; Intervention; Investigation; Knowledge; Maintenance; Modeling; Motivation; Outcome; Parents; Pediatrics; Predictive Factor; Probability; Process; Psychological adjustment; Recommendation; Research; Research Personnel; Risk; School-Age Population; Site; Standardization; Structure; Systems Theory; Testing; Time; Training; Uncertainty; Universities; World Health Organization; coping; cost; cost effectiveness; cost outcomes; effective intervention; effectiveness evaluation; health assessment; improved; intervention delivery; low and middle-income countries; medication compliance; member; novel; patient oriented; pediatric human immunodeficiency virus; post intervention; prevent; primary endpoint; primary outcome; psychosocial; randomized trial; recruit; routine care; scale up; secondary outcome; sexually active; skills; social; social culture; social stigma; sound; transmission process; treatment group

PROJECT SUMMARY The project aims to assess the effectiveness, health benefits, and cost and obtain information to inform scale- up and sustainability ofa novel pediatric HIV disclosure intervention (“Sankofa”) among dyads of caregivers and children 7-18 years of age (who do not know their HIV diagnosis) in Ghana. This area of investigation is profoundly understudied and of high importance to millions of children and their families in sub-Saharan Africa. While widely recognized as vital to better health outcomes, especially in the era of better access to HIV treatment, many children are not informed of their HIV diagnosis. A variety of socio-cultural contextual barriers and deficient skills drive the persistent reluctance of caregivers and health care providers to inform children of the diagnosis. We developed a clinic-based disclosure intervention delivered as an integral component of routine care. The intervention, `Sankofa', is guided by an HIV pediatric disclosure model that incorporates bioecological systems theory and core elements of the Information-Motivation-Behavioral Skills (IMB) model of Health Behavior Change. The intervention is the first randomized trial to evaluate the effect of a structured disclosure intervention on disclosure of HIV status to children. At one year (primary endpoint), 51.4% of children in the Sankofa group had been disclosed to versus 16.2% in the control (p<0.001). While highly promising, the Sankofa intervention has only been examined in a single site under optimal conditions. In this study, we aim to build upon the successful Sankofa trial by testing the intervention in a larger scale study delivered in “real-world” clinic conditions over time in Ghana. We will conduct a pragmatic, stepped wedge cluster randomized trial in 12 HIV pediatric clinics in Ghana to determine effectiveness, health benefits, cost and obtain information to inform scale-up and sustainability. We will recruit dyads of 720 children (ages 7- 18) and their caregivers. We propose the following specific aims: (1) To examine the effectiveness of the Sankofa pediatric disclosure intervention in the presence of “real-world” clinic conditions in Ghana; (2) Assess health benefits and cost-effectiveness of the Sankofa pediatric disclosure intervention-assisted disclosure as it pertains to medication adherence and health outcomes of children (virologic, immunologic, psychosocial, behavioral) and the caregiver (psychosocial); and (3) To explore factors associated with effective implementation and maintenance of the Sankofa pediatric disclosure intervention in the presence of “real- world” clinic conditions in Ghana. Our findings will further a scientific understanding of the mechanisms of action, cost, and individual (child and caregiver)- and organizational-level facilitators and barriers to effective and sustainable delivery of the intervention in a variety of clinical settings.

项目总结 该项目旨在评估有效性、健康效益和成本，并获得信息以告知规模- 一种新的儿科HIV披露干预措施(“Sankofa”)在照顾者双方中的建立和可持续性 加纳的7-18岁儿童(他们不知道自己的艾滋病毒诊断)。这一调查领域是 对撒哈拉以南地区数以百万计的儿童及其家庭来说，人们对他们的研究严重不足，而且非常重要 非洲。虽然被广泛认为对更好的健康结果至关重要，特别是在更好地获得 在艾滋病毒治疗期间，许多儿童不被告知他们的艾滋病毒诊断。各种社会文化背景 障碍和技能不足驱使照顾者和医疗保健提供者始终不愿告知 儿童的诊断。我们开发了一个以临床为基础的披露干预措施，作为一个完整的 常规护理的组成部分。这项名为Sankofa的干预措施是由艾滋病毒儿科披露模式指导的 结合了生物生态系统理论和信息-动机-行为技能的核心要素 (IMB)健康行为改变模型。这项干预是第一个评估阿司匹林疗效的随机试验。 对向儿童披露艾滋病毒状况的结构化披露干预。在一年(主要终点)， 桑科法组有51.4%的儿童已被披露，而对照组只有16.2%(p&lt；0.001)。而当 Sankofa的干预措施前景看好，但只在一个最佳条件下的单一地点进行了检查。 在这项研究中，我们的目标是在成功的Sankofa试验的基础上，在更大范围内测试干预措施 这项研究是在加纳的“真实世界”诊所条件下进行的。我们将进行务实、循序渐进的 在加纳12家艾滋病毒儿科诊所进行的楔形群随机试验，以确定有效性、健康益处 成本和获取信息，为扩大规模和可持续性提供信息。我们将招募720名儿童(7岁- 18)和他们的照顾者。我们建议的具体目标如下：(1)研究 在加纳存在“真实世界”临床条件的情况下，桑科法儿科披露干预；(2)评估 Sankofa儿科披露干预辅助披露的健康效益和成本效益 与儿童的服药依从性和健康结果有关(病毒学、免疫学、心理社会学、 行为)和照顾者(心理社会)；以及(3)探索与有效性相关的因素 Sankofa儿科信息披露干预措施的实施和维护 世界“加纳的诊所条件。我们的发现将进一步科学地理解这些机制。 行动、成本和个人(儿童和照顾者)--以及组织层面的促进者和障碍 并在各种临床环境中可持续地提供干预。