IMPLEMENT: Implementation outcomes and cost-effectiveness of developmental monitoring for children exposed to HIV

University Of Washington, Seattle WA

Investigators

Abstract

ABSTRACT Children who are HIV-exposed, but uninfected (CHEU) are at higher risk for poorer neurodevelopmental (ND) outcomes than children who are HIV-unexposed and uninfected (CHU), impacting their life trajectories and future potential. With a growing population of CHEU, there is a critical need for implementation guidance to maximize the impact of effective screening, diagnostic, and therapeutic interventions to address ND delay in high HIV prevalence settings. Screening for ND delays typically involves a brief tool administered using either direct child observation or based on caregiver-report. One such tool is the Global Scales of Early Development (GSED), developed in partnership with the World Health Organization. Another promising approach for identifying children at highest risk for ND delays is utilizing an automated risk score as a clinical decision support tool, which could be embedded within an electronic medical record (EMR) system, pulling from existing clinical data closely linked to ND outcomes and automatically calculating a score indicating risk of ND delay. However, it is unclear whether implementing such a score is more pragmatic in real-world contexts than administering a ND screening tool. For both options, a referral would be needed for further evaluation using a more detailed ND assessment, such as the Malawi Developmental Assessment Tool (MDAT), and then intervention, if needed. Furthermore, it is unclear whether targeted approaches focusing only on CHEU versus universal approaches for both CHEU and CHU, are a better use of limited resources. Context-specific factors may impact how screening and referral services can be feasibly integrated into maternal and child health (MCH) clinical programs. The cost-effectiveness and affordability of screening, diagnostic, and therapeutic interventions are essential to inform country- or region- specific policies, and modeling can be useful to simulate a broad range of potential implementation scenarios and identify the most cost-effective approaches to ND intervention. Our objective is to evaluate the implementation outcomes and cost-effectiveness of various developmental screening and intervention approaches in diverse high HIV prevalence regions, which we will achieve in the following aims: 1) Validate and pilot a predictive risk score tool and evaluate its implementation and usability compared to the GSED within routine MCH clinic visits in Kenya, Botswana, and South Africa; 2) Identify determinants of implementation, acceptability, feasibility, appropriateness, and cost of incorporating Project 2 (BONDS Study) ND evaluation and interventions (Friendship Bench, optimal nutritional guidance, and parent-child play counseling) in Botswana, Kenya, and Zimbabwe. and 3) Determine the cost-effectiveness of universal versus HIV-exposure status-based screening, and the cost-effectiveness and budget impact of the Project 2 intervention bundle for ND within MCH care in contexts with different HIV prevalence. This study will provide critical, concrete guidance to policymakers to inform early, contextually specific policies for implementing ND screening, diagnostics, and therapeutics within programmatic settings with high HIV prevalence.