Isoniazid preventive therapy (IPT) reduces the risk of tuberculosis in over 60%. Young children are at higher risk of developing severe forms of TB, though this can be prevented with a full course of IPT. Preliminary data from the study districts indicate that 70% of eligible children start IPT, and 30% complete it. Counseling to caretakers to complete IPT depends on the knowledge, motivation and time of the research staff. Caretakers have a limited understanding of the importance of IPT and the higher risk of TB in the young child. Very few interventions have evaluated strategies to improve IPT completion among children. This career development award seeks 1) to design and validate three tools: an educational booklet for caretakers, SMS reminders to be sent weekly throughout the 24 week IPT course, a children storybook to be given in weekly installments throughout the 24 week IPT course and 2) test the efficacy of an intervention combining the three tools in increasing IPT completion and determine its acceptability and feasibility. The design and validation will be done using qualitative methods and an iterative approach with direct participation of the intended audience (caretakers and children) and the health care workers. A pilot randomized control trial will determine the efficacy of the combined intervention. I will recruit 60 caretakers and children and randomize them (1:1) to an intervention (receives the three tools) and control (standard of care) group. I will follow them up throughout the duration of the six months course. Intermediate outcomes will be the presence of isoniazid in urine, and the reach and fidelity in the delivery of the intervention. The results will inform the design of a cluster-randomized trial to study the effectiveness of the combined intervention to prevent pediatric TB, and submit it for R01 funding. If successful, it would deliver a scalable approach to reduce pediatric TB. I will be supported by a multi-disciplinary mentoring team whose expertise span the disciplines related to my career plan: Tuberculosis treatment and prevention trials and evaluation of interventions (Dr. Sterling), pediatrics studies (Dr. Ochoa), qualitative methods and health promotion (Dr. Bayer), implementation science, (Dr. Zunt), TB prevention and control in Peru (Dr. Seas), evaluation of interventions and quantitative data analysis (Dr. Van der Stuyft). With them, I have designed a training plan to fill the gaps in knowledge and skills I need to succeed in my goals. I will get additional training in health promotion, mobile health, health communication, evaluation of interventions and implementation science. I will also acquire skills in grant writing and I will pursue continuous training in responsible conduct of research. This mentored research training support will enable me to achieve my goal of becoming a leading global health researcher at Universidad Peruana Cayetano Heredia, actively collaborating with top international institutions and fostering health policies with rigorous evidence.
Young children exposed to a person with infectious tuberculosis, can get sick with severe forms of the disease despite the existence of a treatment to prevent it. However, tuberculosis preventive treatments are long and they frequently stopped before completion. If children who would benefit from the preventive treatment completed the treatment, there would be fewer cases of tuberculosis among them. I will develop and validate three tools to educate and motivate the caretakers and the children to complete the preventive treatment, and I will test if the combined tools make more children complete the preventive treatment.
