Researching Interventions and Implementation Strategies to Evaluate the Health and Development of Children Affected by HIV in Southern and Eastern Africa (RISE)

University Of Washington, Seattle WA

Investigators

Abstract

ABSTRACT Our RISE U19 Program will involve 4 countries (Botswana, Kenya, South Africa and Zimbabwe) with a high burden of children with peripartum HIV/ART exposure (CHEU). The RISE Program will involve 4 Projects that aim to move from observational data to intervention and implementation to improve CHEU outcomes. Our Projects leverage prior cohorts supported by NICHD R61/R33 (CHERISH [South Africa], FLOURISH [Botswana], HOPE [Kenya] and SHINE [Zimbabwe]). Project 1 (Imaging/Mechanism) will utilize low-field hyperfine MRIs to assess brain structures in children and older adolescent CHEU and CHUU who previously participated in the FLOURISH and HOPE cohorts. Project 1 will elucidate whether there are structural differences between CHEU and evaluate associations between brain structural differences and neurodevelopmental function. Project 2 (Interventional Randomized Trial) is a 3-country individual randomized controlled trial (RCT) that will test a novel multi-component nurturing care intervention for effect on neurodevelopment at 2 years of age. Project 3 (Implementation Science, Modeling) will assess risk stratification and determine cost-effectiveness, acceptability and feasibility of the Project 2 interventions and model potential impact of a universal screening, at- risk CHEU and CHUU, CHEU alone, or at-risk CHEU approach. Project 4 (Population-level Analyses, Surveillance) will utilize the CHERISH Pregnancy-Exposure registry in South Africa –a large population database of >500,000 mother-infant pairs – and analyze impact of novel antiretroviral regimens on outcomes among CHEU Project 4 includes collaborations with Ministries of Health in Botswana and Kenya to develop a toolkit to link maternal-infant pairs for long-term surveillance. Supporting our 4-country, 4-Project Program will be 3 Cores, the Scientific Administrative Core (SAC) which will oversee all scientific priority-making, study implementation, administrative, communication, and fiscal aspects; the Data Management and Analysis Core (DMAC), which oversee data management, analyses and capacity building; and the Dissemination and Engagement Core (DEC) which will engage community and policy makers to optimize impact of the research. The SAC has the following Broad Long-Range Objectives: 1. To provide scientific oversight to 4 Research Projects and 3 Cores. 2. To promote collaboration between Research Projects and Cores. a) To build and maintain a website for protocols, SOPs, ethical approvals, database links, publications, and training/dissemination materials. b) To convene MPI and team meetings, in-person meetings in Africa (in Botswana, Kenya, South Africa or Zimbabwe), and coordinate attendance of MPIs at annual DC meeting. 3. To oversee allocation of resources and fiscal accountability. 4. To provide input on administration, training, and dissemination for Projects/Cores.