PROJECT SUMMARY Children born to HIV-infected mothers are more likely to have neurodevelopmental (ND) delays than HIV- unexposed children. Early identification and referral to intervention services is critical to improve the lives of children with ND delays, but it is not routinely performed in HIV-prevalent areas, such as sub-Saharan Africa. This is a critical missed opportunity for the >1 million children born to HIV-infected mothers annually. Integrating sustainable ND evaluation programs, with screening, assessment, and intervention services, is critically needed within clinical systems caring for children born to HIV-infected mothers. The long-term goal is to implement an effective ND screening and intervention program to combat ND delays in children born to HIV-infected mothers in resource-limited settings. The overall objectives of this application are: (1) to identify appropriate ND instruments for use in HIV-exposed Kenyan children and (2) to pilot an integrated ND screening program within the existing care system. The central hypothesis is that the integration of a ND evaluation program using appropriate tools will be feasible and effective at identifying HIV-exposed children with ND delays in Kenya. These objectives will be achieved by pursuing the following specific aims: 1) Determine and compare the reliability and validity of ND screening tools and assessments for use among children aged 18-36 months in Kenya and 2) Evaluate ND screening implementation in an existing health care system in Kenya. Under the first aim, a rigorous cross-cultural adaptation will be performed, and psychometric properties of two ND screening tools and two assessments will be evaluated among 240 Kenyan children. This will identify an optimal screening tool and assessment for the setting. Under the second aim, an implementation plan will be developed using principles of community-based participatory research and implementation science. An ND screening program will then be piloted at one clinic in Kenya. Within this pilot, the following implementation outcomes will be measured: acceptability, feasibility, fidelity, implementation cost, and sustainability. The diagnostic accuracy of ND screening at identifying ND delays will also be determined. This study is significant because of its potential to sustainably improve the neurodevelopment of HIV-exposed children by: 1) identifying HIV-exposed children with ND delays and referring them to therapy and 2) creating a research platform to support the evaluation of innovative interventions and track longitudinal outcomes. The proposed research is innovative because a sustainable ND screening program will be created and integrated within the current model of care. This will provide preliminary data for a cost-effectiveness analysis of a larger scale-up of implementation. An integrated, sustainable ND screening program will identify and treat children with ND delays and create a research platform to evaluate future interventions for ND delays.

PROJECT NARRATIVE The proposed research is relevant to public health because the successful creation of an implementation strategy to integrate neurodevelopmental screening for vulnerable populations in resource-limited settings will enable broad dissemination to similar settings. Thus, the proposed research is relevant to part of the NIH’s mission because it is develops fundamental knowledge to enhance health and reduce the burdens of human disability.