Flexible InteRvention Strategy for TB prevention (FIRST) study

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PROJECT SUMMARY The significant TB burden in children, who are at great risk of progressing rapidly to severe TB disease and death, demands implementation of effective TB preventive treatment (TPT), which is paramount in mitigating TB-related morbidity and mortality in children. The World Health Organization recommends the Child Contact Management (CCM) approach to preventing TB in children in high TB and HIV burden settings. However, challenges to CCM implementation in low-resource, high TB incidence countries jeopardize its success. CCM has traditionally been delivered at health facilities, but given the limited success of facility-based CCM strategies, other implementation models are needed. To overcome challenges such as access to care and stigma, there has been a growing interest in the use of community-based CCM strategies, which entails both screening and TPT provision in the community. Patients’ involvement in healthcare choices, such as where to receive services, has been limited, especially in low-resource settings. However, this is changing with the realization that increased patient participation in decision-making may improve the quality and outcome of healthcare. Building off my current K01 (PREVENT study), where I evaluated a community-based intervention that was only partially effective, and utilizing preliminary results from my current R21 (PROTECT study), where I found that barriers to successful CCM for young children vary from family to family even within the same community, I propose the Flexible InteRvention Strategy for TB prevention (FIRST) study. This study will pilot test a family- centered flexible CCM model in which families choose whether they would like their children to receive facility- or community-based TB prevention services. FIRST will be delivered in the Manzini region of Eswatini by existing TB service personnel (Active Case Finders [ACFs] and nurses) to all families of child contacts, with training, mentoring, and quality assurance provided by the study’s Nurse Mentor. The intervention will include family- centered discussions and shared decision-making with the index TB patient and the child contact’s family. CCM cascade steps may be delivered at health facilities and/or in the community but TPT initiation will take place in health facilities. The Nurse Mentor will conduct monthly reviews of program indicators and provide structured feedback to healthcare providers, including nurses and ACFs. A participatory collaborative approach will be used with stakeholders to refine the FIRST intervention strategy and pilot test its feasibility and acceptability. Effective CCM through use of innovative tools could have substantial impact on morbidity from childhood TB both in Eswatini and in other settings with high TB and HIV rates, where children are particularly vulnerable. The proposed study is a natural progression of my K01- and R21-supported research and will lead to an independent line of investigation as the results from the pilot test will enable me to submit an R01 of a larger cluster randomized trial evaluating the effectiveness, cost-effectiveness, and acceptability of FIRST in Eswatini.