UPLIFT Study Protocol: Hybrid Type II Effectiveness-Implementation Trial of Psycho-Socioeconomic Support During Tuberculosis Treatment

Abstract Tuberculosis remains a leading public health and socioeconomic challenge in low- and middle-income countries such as Vietnam. Affected households often experience financial hardship, stigma, and psychological distress. Social protection interventions that integrate financial and psychosocial support may address these intersecting challenges. This study will evaluate the effectiveness and implementation of a psycho-socioeconomic support intervention combining conditional cash transfers with peer-led support groups (clubs) to improve tuberculosis treatment outcomes and reduce catastrophic costs. A hybrid type II effectiveness-implementation randomized controlled trial will be conducted in 12 districts across northern, central, and southern Vietnam. Adults with drug-sensitive pulmonary tuberculosis will be individually randomized 1:1 to receive standard of care or the intervention. Data will be collected at the individual, household, and club levels. The co-primary outcomes will include individual-level treatment success and household-level catastrophic cost incurrence. The primary implementation outcome will be club-level fidelity, measured through a composite adherence score. Secondary outcomes will be health-related quality of life, tuberculosis-related stigma, depression, sustainable livelihoods, uptake of tuberculosis-related healthcare services and social health insurance. A mixed-method process evaluation will assess acceptability, participation, quality, and contextual influences. Cost-effectiveness will be assessed. Developed through a people-centered design process, the intervention will target socioeconomic and psychosocial determinants of tuberculosis care. By combining cash transfers and peer support, it will seek to enhance treatment engagement, financial resilience, and equity. Findings will aim to generate actionable evidence for national scale-up in Vietnam and inform policies in other high-burden settings.