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.

项目摘要 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- 一种新的儿科艾滋病毒披露干预（“Sankofa”）在护理人员中的应用和可持续性 以及加纳7-18岁的儿童（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百万儿童及其家庭来说，这一问题的研究深度不足，但却非常重要 非洲虽然人们普遍认为，特别是在更容易获得保健服务的时代， 在艾滋病毒治疗方面，许多儿童没有被告知他们的艾滋病毒诊断。各种社会文化背景 障碍和技能不足促使护理人员和卫生保健提供者持续不愿提供信息， 诊断的孩子。我们开发了一种基于诊所的披露干预， 常规护理的一部分。“Sankofa "干预措施以艾滋病毒儿科披露模式为指导， 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)健康行为改变模式。这项干预是第一个评估一种药物的效果的随机试验。 向儿童披露艾滋病毒状况的结构化披露干预措施。第1年（主要终点）， Sankofa组有51.4%的儿童被披露，而对照组只有16.2%（p<0.001）。而 Sankofa的干预措施非常有前途，但只在最佳条件下在一个地点进行了审查。 在这项研究中，我们的目标是通过在更大范围内测试干预措施， 在加纳的“真实世界”临床条件下进行的研究。我们将进行一次务实的、有步骤的 在加纳的12个艾滋病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- 18)和他们的照顾者。我们提出以下具体目标：（1）研究 Sankofa在加纳“真实世界”诊所条件下的儿科披露干预;（2）评估 健康效益和成本效益的Sankofa儿科披露干预辅助披露，因为它 与儿童的药物依从性和健康结果（病毒学，免疫学，心理社会学， 行为）和照顾者（心理社会）;（3）探索与有效的 在“真实的”存在的情况下，实施和维持Sankofa儿科披露干预措施， 世界”诊所条件在加纳。我们的研究结果将进一步科学地理解 行动、成本以及个人（儿童和照料者）和组织一级的促进因素和障碍， 以及在各种临床环境中可持续地提供干预。