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

儿科 HIV 披露福利研究 (PhD-BS) - Sankofa 2

基本信息

批准号：
10240333
负责人：
ELIJAH PAINTSIL
金额：
$ 66.5万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-08-15 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10240333
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 Welfare Childhood Clinic Clinical Cluster randomized trial Communities Control Groups Counseling Data Development Diagnosis Disclosure Doctor of Philosophy Effectiveness 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 base cost cost effectiveness cost outcomes effective intervention effectiveness evaluation improved 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 virology

项目摘要

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，健康益处和成本，并获取信息以告知规模 - 新颖的儿科艾滋病毒披露干预措施（“ sankofa”）的UP和可持续性和7-18岁的儿童（他们不知道其HIV诊断）在加纳。这个调查领域是对数百万儿童及其家人在撒哈拉以南有深刻的理解和非常重要非洲。虽然广泛认为对更好的健康成果至关重要，但尤其是在更好地获得的时代 HIV治疗，许多儿童没有被告知他们的HIV诊断。各种社会文化背景障碍和技能不足，推动了护理人员和医疗保健提供者的持续不情愿的信息诊断的孩子。我们开发了一种基于诊所的披露干预措施，该干预措施作为积分不可或缺常规护理的组成部分。干预措施“ sankofa”是由HIV儿科披露模型指导的结合了信息动机行为技能的生物生物学系统理论和核心要素（IMB）健康行为改变模型。干预是第一个评估A的效果的随机试验关于儿童艾滋病毒状况的结构性披露干预。一年（主要终点）， Sankofa组中有51.4％的儿童在对照组中被披露为16.2％（p <0.001）。尽管很有希望，Sankofa干预仅在最佳条件下在单个站点中进行了检查。在这项研究中，我们旨在通过大规模测试干预措施来建立成功的Sankofa试验随着时间的流逝，在加纳的“现实世界”诊所条件下进行的研究。我们将进行务实的阶梯加纳的12个HIV儿科诊所的楔形群集随机试验，以确定有效性，健康益处，成本并获取信息以告知规模和可持续性。我们将招募720名儿童的二元组（7岁 - 18）及其护理人员。我们提出以下具体目的：（1）检查在加纳“现实世界”诊所存在下，Sankofa小儿披露干预措施；（2）评估 Sankofa小儿披露干预措施的健康益处和成本效益。有关儿童的药物依从性和健康成果（病毒学，免疫学，心理社会，行为）和照料者（社会心理）；（3）探索与有效的因素在存在“现实加纳的世界诊所状况。我们的发现将进一步了解行动，成本和个人（儿童和照顾者） - 以及组织级的促进者和有效的障碍以及在各种临床环境中进行干预的可持续交付。