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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.

项目总结