PRovide Options for Treatment of Exposed Children against Tuberculosis (PROTECT) Study

PROJECT SUMMARY With one of the world?s most severe HIV and TB epidemics (HIV prevalence = 27%, TB incidence = 398 per 100,000, and >75% of TB patients are HIV-positive [HIV+]), Swaziland is an optimal setting to study TB preventive treatment (PT) preferences. Given the significant TB burden in young children, who are at great risk of rapidly progressing to severe TB disease and death, implementation of effective PT in children is paramount. However, poor isoniazid PT initiation and completion rates have been reported in high TB burden countries. Alternative shorter PT regimens for preventing TB have demonstrated efficacy and safety in children and may potentially improve adherence, but are not yet widely used in high TB burden countries. As countries begin to consider the use of newer PT regimens in children, it is important to determine the attitudes of key stakeholders (caregivers, children, and healthcare providers) regarding PT for HIV+ and HIV-negative (HIV-) children, their regimen and service delivery model preferences, and reasons behind their preferences. The PRovide Options for Treatment of Exposed Children against TB (PROTECT) Study will use discrete choice experiment (DCE) research methodology to examine preferences among key stakeholders regarding PT regimens offered to eligible children in Swaziland. We will employ a two-phase mixed-methods design involving the use of both qualitative and quantitative approaches. The DCE methodology requires an extensive development phase to determine optimal survey design, which involves use of qualitative methods to elicit such preferences from the target populations (Phase I). Quantitative activities will consist of: 1) determining preferences for attributes of PT regimens and service delivery models, and 2) assessing socio-demographic characteristics, TB/HIV history, stigma, attitudes toward TB prevention and health system use and satisfaction (Phase II). The study will leverage long-standing collaborations between ICAP, the Swaziland National AIDS and TB Control Programs, and a well-trained, highly productive team with substantial experience in implementation science research in sub-Saharan Africa to identify important attributes of TB PT for HIV+ children and HIV- child contacts of adult TB cases. The research will contribute to the current discussion about the drivers of PT regimen and service delivery model choice among key stakeholders, as well as the barriers and facilitators to the introduction of new PT regimens. Information garnered from this study will facilitate dissemination and implementation of this efficacious intervention in high TB and HIV burden countries facing challenges with TB PT implementation for children. Through the qualitative phase, the study will identify knowledge gaps about PT provision to inform the design of an intervention to enhance PT adherence among children and ultimately improve TB control among children living in high TB and HIV burden settings.