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.

PROJECT NARRATIVE A culturally-relevant, theoretically and empirically sound, patient-centered, standardized disclosure intervention that can be integrated into routine clinical pediatric HIV care that has the potential to prevent transmission and improve the welfare of children and their caregivers in low- and middle-income countries. We aim to build upon the successful Sankofa study by conducting a pragmatic, stepped wedge cluster randomized trial in high prevalence regions in Ghana to inform the benefits of pediatric HIV disclosure.