Background: Delays in diagnosis and treatment of tuberculosis (TB) remain common in high-burden countries. To improve case detection, substantial investments have been made to scale-up Xpert MTB/RIF (Xpert), a cartridgebased nucleic acid amplification test that can detect TB within 2 hours, as a replacement for sputum smear microscopy. However, the optimal strategy for implementation of Xpert testing remains unclear. Methods: The Xpert Performance Evaluation for Linkage to Tuberculosis Care (XPEL-TB) trial uses an ultra-pragmatic, hybrid type II effectiveness-implementation design to assess the effectiveness and implementation of a streamlined strategy for delivery of Xpert testing in real-world settings. Twenty health centers with TB microscopy units were selected to participate in the trial, with ten health centers randomized to the intervention strategy (onsite molecular testing using GeneXpert Edge, process redesign to facilitate same-day TB diagnosis and treatment, and performance feedback) or routine care (onsite sputum smear microscopy plus referral of sputum samples to Xpert testing sites). The primary outcome is the number of patients with microbiologically confirmed TB who were initiated on treatment within 14 days of presentation to the health center, which reflects successful completion of the TB diagnostic evaluation process. Secondary outcomes include health outcomes (6-month vital status), as well as measures of the reach, adoption, and implementation of the intervention strategy.

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Background Tuberculosis (TB) is among the leading causes of infectious death worldwide. Contact investigation is an evidence-based, World Health Organisation-endorsed intervention for timely TB diagnosis, treatment, and prevention but has not been widely and effectively implemented. Methods We are conducting a stepped-wedge, cluster-randomised, hybrid Type III implementation-effectiveness trial comparing a user-centred to a standard strategy for implementing TB contact investigation in 12 healthcare facilities in Uganda. The user-centred strategy consists of several client-focused components including 1) a TB-education booklet, 2) a contact-identification algorithm, 3) an instructional sputum-collection video, and 4) a community-health-rider service to transport clients, CHWs, and sputum samples, along with several healthcare-worker-focused components, including 1) collaborative improvement meetings, 2) regular audit-and-feedback reports, and 3) a digital group-chat application designed to develop a community of practice. Sites will cross from the standard to the user-centred strategy in six, eight-week transition steps following a randomly determined site-pairing scheme and timeline. The primary implementation outcome is the proportion of symptomatic close contacts completing TB evaluation within 60 days of TB treatment initiation by the index person with TB. The primary clinical effectiveness outcomes are the proportion of contacts diagnosed with and initiating active TB disease treatment and the proportion initiating TB preventative therapy within 60 days. We will assess outcomes from routine source documents using intention-to-treat analyses. We will also conduct nested mixed-methods studies of implementation fidelity and context and perform cost-effectiveness and impact modelling. The Makerere School of Public Health IRB (#554), the Uganda National Council for Science and Technology (#HS1720ES), and the Yale Institutional Review Board (#2000023199) approved the study with a waiver of informed consent for the main trial implementation-effectiveness outcomes. We will submit trial results for publication in a peer-reviewed journal and disseminate findings to local shareholders, including policymakers and representatives of affected communities. Discussion This pragmatic, quasi-experimental implementation trial will inform efforts to find and prevent undiagnosed persons with TB in high-burden setting using contact investigation. It will help assess the suitability of human-centred design and communities of practice for tailoring implementation strategies and sustain evidence-based interventions in low-and-middle-income countries. Trial registration number ClinicalTrials.gov Identifier: NCT05640648.

Self-efficacy is central to community health workers' capacity and motivation to deliver evidence-based care; thus, validated measures of self-efficacy are needed to assess the effectiveness of community health worker programs. In this study, we culturally adapted and evaluated the General Self-Efficacy Scale among community health workers in Uganda using multiple methods. We adapted the ten-item General Self-Efficacy Scale through cross-cultural discussions within our multidisciplinary research team, translation from English into Luganda and back-translation into English, and six cognitive interviews with community health workers. We administered the adapted scale in a staged, two-part cross-sectional study, including a total of 147 community health workers. Exploratory factor analysis yielded three factors, which we labeled problem-solving, persistence, and resourcefulness. This three-factor solution had good model fit (standardized root mean square residual = 0.07) and explained 53.4% of the variance. We found evidence of convergent validity, as scores for the total scale were positively correlated with years of experience (r = 0.48; p < .001) and perceived social support (r = 0.39, p < .001). Scores were also higher among those with higher educational attainment in one-way analysis of variance and Bonferroni-corrected post hoc tests [F (2,72) = 9.16, p < .001]. We also found evidence of discriminant validity, as scores for the total scale were not correlated with age (r = − 0.07, p = .55), in agreement with literature showing that general self-efficacy is an age-independent construct. The internal consistency of the adapted scale was within the acceptable range for a pilot study (Cronbach's α = 0.61). This evaluation of a Uganda-adapted General Self-Efficacy Scale demonstrated promising psychometric properties; however, larger studies with repeated measures are warranted to further assess the adapted scale's factor structure, validity, reliability, and stability over time.