A user-centred implementation strategy for tuberculosis contact investigation in Uganda: protocol for a stepped-wedge, cluster-randomised trial.

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-over 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 and waived informed consent for the main trial implementation-effectiveness outcomes. We will submit results for publication in peer-reviewed journals and disseminate findings to local 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 settings using contact investigation. It will also help assess the suitability of human-centred design and communities of practice for tailoring implementation strategies and sustaining evidence-based interventions in low-and-middle-income countries. TRIAL REGISTRATION: The trial was registered(ClinicalTrials.gov Identifier NCT05640648) on 16 November 2022, after the trial launch on 7 March 2022.

Efficacy and Impact of Peer-Led Education for Persons with Tuberculosis in Kampala, Uganda: A Pre-Post Implementation Study.

Introduction: Universal TB education and counseling (TEC) is routinely recommended for promoting knowledge and medication adherence, but the quality of delivery often varies because of inadequate clinic space, time, and health worker training. Peer-led counseling is a promising but understudied solution to these challenges. We sought to evaluate the efficacy of a peer-led TEC strategy among newly diagnosed adults initiating TB treatment in Kampala, Uganda. Methods: We conducted a longitudinal, pre-post implementation study comparing the routine, healthcare-worker-led and peer-led strategies for delivery of TEC to consecutive adult persons with TB at a large, public primary-care clinic. Trained staff administered a standardized TB knowledge survey to all persons with TB immediately following TEC. We compared TB knowledge by type of TEC received using t-tests. Results: We enrolled 161 persons with TB, 80 who received conventional TEC from health workers between June and July 2018, and 81 who received peer-led TEC between August and November 2019. The proportions of women (28% vs. 31%, p = 0.64) and persons living with HIV (36% vs 30%, p = 0.37) were similar in the pre- and post-implementation periods. Peer-led TEC was associated with a more significant increase in disease-specific (difference +21%, 95% CI +18% to + 24%, p < 0.0001) and treatment-specific TB knowledge scores (difference +14%, 95% CI + 10% to + 18%, p< 0.0001) than routine healthcare worker-delivered TEC. All TB knowledge constructs were significantly higher for those in the post-implementation period than those in the pre-implementation period. Nine participants met our threshold for adequate knowledge (score ≥ 90%) for disease-specific TB knowledge in the pre-implementation period compared to 63 (78%) in the post-implementation period (+67%, 95% CI + 55% - +78%, p < 0.001). Twenty-eight (35%) met the adequate knowledge threshold for TB treatment-specific knowledge in the pre-implementation period compared to 60 (74%) in the post-implementation period (+ 39%, 95% CI + 25 to + 53%, p < 0.0001). Finally, the proportion achieving TB treatment success (cure or completed) increased substantially from the pre-implementation period (n = 49, 68%) to the post-implementation period (n = 63, 88%), a difference of + 19% (95% CI + 6% to + 33%, p = 0.005). Conclusion: Our findings suggest that peer-led TEC is more efficacious than routine TEC at improving TB knowledge and treatment outcomes. Future studies should evaluate the implementation and effectiveness of the peer-led TEC strategy when scaled to a larger number of clinics.

A user-centred implementation strategy for tuberculosis contact investigation in Uganda: Protocol for a stepped-wedge, cluster-randomised trial.

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.

Cultural Adaptation and Validation of the General Self-Efficacy Scale in Ugandan Community Health Workers.

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.