Cluster randomized trial of intermittent preventive treatment of malaria in school-agechildren to improve the health of students and decrease community transmission(CRITICal)

PROJECT SUMMARY/ABSTRACT Scale up of proven control interventions resulted in marked reductions in the global malaria burden following the turn of the century. However, since 2015 progress has stalled and even reversed course in some high burden African countries. These trends highlight the urgent need for new interventions, especially those that have shown promise but have been underutilized. One such intervention is intermittent preventive treatment in school-aged children (IPTsc), defined as giving full therapeutic courses of antimalarial drugs at regular intervals to clear and prevent malaria infections in children who are old enough to attend school. IPTsc has been shown to be safe and to improve the health and educational attainment of school-aged children, can easily be scaled up if integrated into school-based programs such as deworming, and has recently been recommended by the World Health Organization (WHO). However, some uncertainties remain, including what impact IPTsc may have at the community level. We believe that IPTsc will not only reduce malaria burden in schoolchildren but could be an innovative and cost-effective tool for reducing malaria burden in surrounding communities, in particular because schoolchildren comprise a majority of the human infectious reservoir driving malaria transmission. The use of IPTsc to reduce malaria burden at the community level could play a major role in turning the tide on malaria in high burden countries. We hypothesize that IPTsc will reduce the burden of malaria both in schoolchildren who receive the intervention and in people of all ages in the surrounding communities. To test this hypothesis, we propose to deliver IPTsc with dihydroartemisinin- piperaquine (DP) approximately every two months for 24 months to children attending primary school in highly endemic areas across Uganda. DP has been shown to be highly effective and safe when used for chemoprevention in a wide range of populations, including school-aged children.3,9,10 The intervention will be evaluated using a rigorous cluster randomized trial design to assess effectiveness at both the community level and among schoolchildren. Outcomes will be assessed during the 24-month period when the intervention is delivered and for an additional 12 months after the intervention is completed to assess for “resurgent” or “delayed” malaria. Our specific aims will be (1) to estimate the effectiveness of IPTsc with DP in reducing community level malaria burden, (2) to estimate the effectiveness of IPTsc with DP in reducing malaria burden in schoolchildren, and (3) to estimate the cost-effectiveness of IPTsc with DP as a tool for reducing community level malaria burden. This study will leverage infrastructure, resources, and baseline data from an existing robust malaria surveillance network in Uganda. If IPTsc is found to be a cost-effective intervention for reducing the burden of malaria among people of all ages, this study will have clear and achievable policy implications.