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：
10440454
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/10440454
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 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

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.

项目概要该项目旨在评估有效性、健康效益和成本，并获取信息以告知规模新型儿科艾滋病毒披露干预措施（“Sankofa”）在护理人员中的启动和可持续性加纳的 7-18 岁儿童（不知道自己的艾滋病毒诊断结果）是这一领域的调查对象。对撒哈拉以南地区数以百万计的儿童及其家庭来说，这一问题尚未得到充分研究，但却非常重要非洲虽然被广泛认为对改善健康结果至关重要，特别是在更容易获得医疗服务的时代。在艾滋病毒治疗过程中，许多儿童并未被告知其艾滋病毒诊断结果各种社会文化背景。障碍和技能不足导致护理人员和医疗保健提供者始终不愿告知情况我们开发了一种基于临床的披露干预措施，作为一个整体提供。 “Sankofa”干预措施是常规护理的组成部分，以艾滋病毒儿科披露模型为指导，该模型融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) 健康行为改变模型是第一个评估干预效果的随机试验。向儿童披露艾滋病毒状况的结构化披露干预措施一年时（主要终点）， Sankofa 组中 51.4% 的儿童已被披露，而对照组中这一比例为 16.2% (p<0.001)。 Sankofa 干预措施非常有前途，仅在最佳条件下在单个地点进行了检查。在这项研究中，我们的目标是在桑科法成功试验的基础上，通过更大规模的干预测试随着时间的推移，我们将在加纳进行一项务实、分步的研究。在加纳 12 个 HIV 儿科诊所进行的楔形整群随机试验，以确定有效性、健康益处、我们将招募 720 名儿童（7 岁至 7 岁）。 18）和他们的照顾者我们提出以下具体目标：（1）检查的有效性。 Sankofa 在加纳存在“真实世界”临床状况的情况下进行儿科披露干预 (2) 评估； Sankofa 儿科披露干预辅助披露的健康益处和成本效益与儿童的药物依从性和健康结果有关（病毒学、免疫学、社会心理、 (3) 探索与有效性相关的因素在“真实情况”存在的情况下实施和维持 Sankofa 儿科披露干预措施我们的研究结果将进一步科学地了解加纳的临床状况。行动、成本和个人（儿童和护理人员）和组织层面的促进因素和影响有效性的障碍以及在各种临床环境中可持续地提供干预措施。