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.

Association between exposure to family planning messages on different mass media channels and the utilization of modern contraceptives among young women in Sierra Leone: insights from the 2019 Sierra Leone Demographic Health Survey.

BACKGROUND: Access to sexual and reproductive health information enables young women to make appropriate decisions. We examined the association between exposure to family panning messages on different mass media and the use of modern contraceptives among young women in Sierra Leone. METHODS: This was a secondary analysis of the 2019 Sierra Leone Demographic and Health Survey data of young women aged 15-24 years. Multistage stratified sampling was used to select study participants in the survey. We used multivariable logistic regression to determine the association between exposure to family panning messages on different types mass media channels and utilization of modern contraceptives. All our analyses were done using SPSS version 25. RESULTS: Out of 6055 young women, 1506 (24.9%, 95% CI 24.0-26.2) were utilizing a modern contraceptive method with the prevalence higher among urban women (26.5%) compared to rural women (23.1%). Less than half (45.6%) had been exposed to family planning messages on mass media (radio 28.6%, television 10.6%, mobile phones 4.2% and newspapers or magazines 2.2%). Young women who had exposure to family planning messages on radio (AOR: 1.26, 95% CI 1.06-1.50) and mobile phones (AOR: 1.84, 95% CI 1.25-2.69) had higher odds of using modern contraceptives compared to their counterparts without the same exposure. Furthermore, having access to internet (AOR: 1.45, 95% CI 1.19-1.78), working (AOR: 1.49, 95% CI 1.27-1.74), being older (20-24 years) (AOR: 1.75, 95% CI 1.46-2.10), being married (AOR: 0.33, 95% CI 0.26-0.42), having visited a health facility within the last 12 months (AOR: 1.34, 95% CI 1.10-1.63), having secondary (AOR: 2.83, 95% CI 2.20-3.64) and tertiary levels of education (AOR: 3.35, 95% CI 1.83-6.13), higher parity (having above one child) AOR: 1.57, 95% CI 1.19-2.08) and residing in the southern (AOR: 2.11, 95% CI 1.61-2.79), northwestern (AOR: 1.87, 95% CI 1.39-2.52), northern (AOR: 2.11, 95% CI 1.59-2.82) and eastern (AOR: 1.68, 95% CI 1.27-2.22) regions of residence were associated with higher odds of modern contraceptives utilization. CONCLUSION: In Sierra Leon, only one in four young women were using modern contraception and more than half of them had not had any exposure to family planning messages on the different types of mass media channels. Behavior change communicators can prioritize family planning messages using radio, mobile phones and the internet. In order to publicize and encourage young women to adopt healthy behaviours and increase uptake of modern contraceptive.

Digital adherence technology for tuberculosis treatment supervision: A stepped-wedge cluster-randomized trial in Uganda.

BACKGROUND: Adherence to and completion of tuberculosis (TB) treatment remain problematic in many high-burden countries. 99DOTS is a low-cost digital adherence technology that could increase TB treatment completion. METHODS AND FINDINGS: We conducted a pragmatic stepped-wedge cluster-randomized trial including all adults treated for drug-susceptible pulmonary TB at 18 health facilities across Uganda over 8 months (1 December 2018-31 July 2019). Facilities were randomized to switch from routine (control period) to 99DOTS-based (intervention period) TB treatment supervision in consecutive months. Patients were allocated to the control or intervention period based on which facility they attended and their treatment start date. Health facility staff and patients were not blinded to the intervention. The primary outcome was TB treatment completion. Due to the pragmatic nature of the trial, the primary analysis was done according to intention-to-treat (ITT) and per protocol (PP) principles. This trial is registered with the Pan African Clinical Trials Registry (PACTR201808609844917). Of 1,913 eligible patients at the 18 health facilities (1,022 and 891 during the control and intervention periods, respectively), 38.0% were women, mean (SD) age was 39.4 (14.4) years, 46.8% were HIV-infected, and most (91.4%) had newly diagnosed TB. In total, 463 (52.0%) patients were enrolled on 99DOTS during the intervention period. In the ITT analysis, the odds of treatment success were similar in the intervention and control periods (adjusted odds ratio [aOR] 1.04, 95% CI 0.68-1.58, p = 0.87). The odds of treatment success did not increase in the intervention period for either men (aOR 1.24, 95% CI 0.73-2.10) or women (aOR 0.67, 95% CI 0.35-1.29), or for either patients with HIV infection (aOR 1.51, 95% CI 0.81-2.85) or without HIV infection (aOR 0.78, 95% CI 0.46-1.32). In the PP analysis, the 99DOTS-based intervention increased the odds of treatment success (aOR 2.89, 95% CI 1.57-5.33, p = 0.001). The odds of completing the intensive phase of treatment and the odds of not being lost to follow-up were similarly improved in PP but not ITT analyses. Study limitations include the likelihood of selection bias in the PP analysis, inability to verify medication dosing in either arm, and incomplete implementation of some components of the intervention. CONCLUSIONS: 99DOTS-based treatment supervision did not improve treatment outcomes in the overall study population. However, similar treatment outcomes were achieved during the control and intervention periods, and those patients enrolled on 99DOTS achieved high treatment completion. 99DOTS-based treatment supervision could be a viable alternative to directly observed therapy for a substantial proportion of patients with TB. TRIAL REGISTRATION: Pan-African Clinical Trials Registry (PACTR201808609844917).

C-Reactive Protein Testing for Active Tuberculosis among Inpatients without HIV in Uganda: a Diagnostic Accuracy Study.

The objective of this prospective cross-sectional study, conducted at a national referral hospital in Kampala, Uganda, was to determine diagnostic performance of serum C-reactive protein (CRP) as a triage test for tuberculosis (TB) among HIV-seronegative inpatients. We calculated the sensitivity, specificity, positive and negative likelihood ratios, and positive and negative predictive values to determine the diagnostic performance of a CRP enzyme-linked immunosorbent assay (ELISA) (Eurolyser) in comparison to that of a reference standard of Mycobacterium tuberculosis culture on two sputum samples. We constructed receiver operating curves and reported performance in reference to the manufacturer's cutoff and also to a threshold chosen to achieve sensitivity of >90%, in accordance with the WHO's target-product profile for a triage test. Among 119 HIV-seronegative inpatients, 46 (39%) had culture-positive pulmonary TB. In reference to M. tuberculosis culture, CRP had a sensitivity of 78% (95% confidence interval [CI], 64 to 89%) and a specificity of 52% (95% CI, 40 to 64%) at the manufacturer's threshold of 10 mg/liter. At a threshold of 1.5 mg/liter, the sensitivity was 91% (95% CI, 79 to 98%) but the specificity was only 21% (95% CI, 12 to 32%). Performance did not differ when stratified by illness severity at either threshold. In conclusion, among HIV-seronegative inpatients, CRP testing performed substantially below targets for a TB triage test. Additional studies among HIV-seronegative individuals in clinics and community settings are needed to assess the utility of CRP for TB screening.

Experiences and intentions of Ugandan household tuberculosis contacts receiving test results via text message: an exploratory study.

BACKGROUND: The World Health Organization (WHO) recommends household contact investigation for tuberculosis (TB) in high-burden countries. However, household contacts who complete evaluation for TB during contact investigation may have difficulty accessing their test results. Use of automated short-messaging services (SMS) to deliver test results could improve TB status awareness and linkage to care. We sought to explore how household contacts experience test results delivered via SMS, and how these experiences influence follow-up intentions. METHODS: We conducted semi-structured interviews with household contacts who participated in a randomized controlled trial evaluating home sputum collection and delivery of TB results via SMS (Pan-African Clinical Trials Registry #201509000877140). We asked about feelings, beliefs, decisions, and behaviors in response to the SMS results. We analyzed the content and emerging themes in relation to the Theory of Planned Behavior. RESULTS: We interviewed and achieved thematic saturation with ten household contacts. Nine received TB-negative results and one a TB-positive result. Household contacts reported relief upon receiving SMS confirming their TB status, but also said they lacked confidence in the results delivered by SMS. Some worried that negative results were incorrect until they spoke to a lay health worker (LHW). Household contacts said their long-term intentions to request help or seek care were influenced by perceived consequences of not observing the LHW's instructions related to the SMS and follow-up procedures; beliefs about the curability of TB; anticipated support from LHWs; and perceived barriers to responding to an SMS request for further evaluation. CONCLUSION: Household contacts experienced relief when they received results. However, they were less confident about results delivered via SMS than results delivered by LHWs. Delivery of results by SMS should complement continued interaction with LHWs, not replace them.

mHealth to improve implementation of TB contact investigation: a case study from Uganda.

BACKGROUND: Implementation science offers a systematic approach to adapting innovations and delivery strategies to new contexts but has yet to be widely applied in low- and middle-income countries. The Fogarty Center for Global Health Studies is sponsoring a special series, "Global Implementation Science Case Studies," to address this gap. METHODS: We developed a case study for this series describing our approach and lessons learned while conducting a prospective, multi-modal study to design, implement, and evaluate an implementation strategy for TB contact investigation in Kampala, Uganda. The study included formative, evaluative, and summative phases that allowed us to develop and test an adapted contact investigation intervention involving home-based sample collection for TB and HIV testing. We concurrently developed a multi-component mHealth implementation strategy involving fingerprint scanning, electronic decision support, and automated reporting of test results via text message. We then conducted a household-randomized, hybrid implementation-effectiveness trial comparing the adapted intervention and implementation strategy to usual care. Our assessment included nested quantitative and qualitative studies to understand the strategy's acceptability, appropriateness, feasibility, fidelity, and costs. Reflecting on this process with a multi-disciplinary team of implementing researchers and local public health partners, we provide commentary on the previously published studies and how the results influenced the adaptation of international TB contact investigation guidelines to fit the local context. RESULTS: While the trial did not show improvements in contact investigation delivery or public health outcomes, our multi-modal evaluation strategy helped us identify which elements of home-based, mHealth-facilitated contact investigation were feasible, acceptable, and appropriate and which elements reduced its fidelity and sustainability, including high costs. We identified a need for better tools for measuring implementation that are simple, quantitative, and repeatable and for greater attention to ethical issues in implementation science. CONCLUSIONS: Overall, a theory-informed, community-engaged approach to implementation offered many learnings and actionable insights for delivering TB contact investigation and using implementation science in low-income countries. Future implementation trials, especially those incorporating mHealth strategies, should apply the learnings from this case study to enhance the rigor, equity, and impact of implementation research in global health settings.

Implementation, feasibility, and acceptability of 99DOTS-based supervision of treatment for drug-susceptible TB in Uganda.

99DOTS is a low-cost digital adherence technology that allows people with tuberculosis (TB) to self-report treatment adherence. There are limited data on its implementation, feasibility, and acceptability from sub-Saharan Africa. We conducted a longitudinal analysis and cross-sectional surveys nested within a stepped-wedge randomized trial at 18 health facilities in Uganda between December 2018 and January 2020. The longitudinal analysis assessed implementation of key components of a 99DOTS-based intervention, including self-reporting of TB medication adherence via toll-free phone calls, automated text message reminders and support actions by health workers monitoring adherence data. Cross-sectional surveys administered to a subset of people with TB and health workers assessed 99DOTS feasibility and acceptability. Composite scores for capability, opportunity, and motivation to use 99DOTS were estimated as mean Likert scale responses. Among 462 people with pulmonary TB enrolled on 99DOTS, median adherence was 58.4% (inter-quartile range [IQR] 38.7-75.6) as confirmed by self-reporting dosing via phone calls and 99.4% (IQR 96.4-100) when also including doses confirmed by health workers. Phone call-confirmed adherence declined over the treatment period and was lower among people with HIV (median 50.6% vs. 63.7%, p<0.001). People with TB received SMS dosing reminders on 90.5% of treatment days. Health worker support actions were documented for 261/409 (63.8%) people with TB who missed >3 consecutive doses. Surveys were completed by 83 people with TB and 22 health workers. Composite scores for capability, opportunity, and motivation were high; among people with TB, composite scores did not differ by gender or HIV status. Barriers to using 99DOTS included technical issues (phone access, charging, and network connection) and concerns regarding disclosure. 99DOTS was feasible to implement and highly acceptable to people with TB and their health workers. National TB Programs should offer 99DOTS as an option for TB treatment supervision.

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.

Core components of a Community of Practice to improve community health worker performance: a qualitative study.

BACKGROUND: Communities of Practice (CoPs) offer an accessible strategy for healthcare workers to improve the quality of care through knowledge sharing. However, not enough is known about which components of CoPs are core to facilitating behavior change. Therefore, we carried out a qualitative study to address these important gaps in the literature on CoPs and inform planning for an interventional study of CoPs. METHODS: We organized community health workers (CHWs) from two tuberculosis (TB) clinics in Kampala, Uganda, into a CoP from February to June 2018. We conducted interviews with CoP members to understand their perceptions of how the CoP influenced delivery of TB contact investigation. Using an abductive approach, we first applied inductive codes characterizing CHWs' perceptions of how the CoP activities affected their delivery of contact investigation. We then systematically mapped these codes into their functional categories using the Behavior Change Technique (BCT) Taxonomy and the Behavior Change Wheel framework. We triangulated all interview findings with detailed field notes. RESULTS: All eight members of the CoP agreed to participate in the interviews. CHWs identified five CoP activities as core to improving the quality of their work: (1) individual review of feedback reports, (2) collaborative improvement meetings, (3) real-time communications among members, (4) didactic education sessions, and (5) clinic-wide staff meetings. These activities incorporated nine different BCTs and five distinct intervention functions. CHWs reported that these activities provided a venue for them to share challenges, exchange knowledge, engage in group problem solving, and benefit from social support. CHWs also explained that they felt a shared sense of ownership of the CoP, which motivated them to propose and carry out innovations. CHWs described that the CoP strengthened their social and professional identities within and outside the group, and improved their self-efficacy. CONCLUSIONS: We identified the core components and several mechanisms through which CoPs may improve CHW performance. Future studies should evaluate the importance of these mechanisms in mediating the effects of CoPs on program effectiveness.

Cost-effectiveness analysis of human-centred design for global health interventions: a quantitative framework.

INTRODUCTION: Human-centred design (HCD) is a problem-solving approach that is increasingly used to develop new global health interventions. However, there is often a large initial cost associated with HCD, and global health decision-makers would benefit from an improved understanding of the cost-effectiveness of HCD, particularly the trade-offs between the up-front costs of design and the long-term costs of delivering health interventions. METHODS: We developed a quantitative framework from a health systems perspective to illustrate the conditions under which HCD-informed interventions are likely to be cost-effective, taking into consideration five elements: cost of HCD, per-client intervention cost, anticipated number of clients reached, anticipated incremental per-client health benefit (ie, disability-adjusted life years (DALYs) averted) and willingness-to-pay. We evaluated several combinations of fixed and implementation cost scenarios based on the estimated costs of an HCD-informed approach to tuberculosis (TB) contact investigation in Uganda over a 2-year period to illustrate the use of this framework. RESULTS: The cost-effectiveness of HCD-informed TB contact investigation in Uganda was estimated to vary from US$8400 (2400 clients reached, lower HCD cost estimate) to US$306 000 per DALY averted (120 clients reached, baseline HCD cost estimate). In our model, cost-effectiveness was improved further when the interventions were expected to have wider reach or higher per-client health benefits. CONCLUSION: HCD can be cost-effective when used to inform interventions that are anticipated to reach a large number of clients, or in which the cost of HCD is smaller relative to the cost of delivering the intervention itself.

Perceptions, preferences, and experiences of tuberculosis education and counselling among patients and providers in Kampala, Uganda: A qualitative study.

Tuberculosis (TB) education seeks to increase patient knowledge about TB, while TB counselling seeks to offer tailored advice and support for medication adherence. While universally recommended, little is known about how to provide effective, efficient, patient-centred TB education and counselling (TEC) in low-income, high HIV-TB burden settings. We sought to characterise stakeholder perceptions of TEC in a public, primary care facility in Kampala, Uganda, by conducting focus group discussions with health workers and TB patients in the TB and HIV clinics. Participants valued TEC but reported that high-quality TEC is rarely provided, because of a lack of time, space, staff, planning, and prioritisation given to TEC. To improve TEC, they recommended adopting practices that have proven effective in the HIV clinic, including better specifying educational content, and employing peer educators focused on TEC. Patients and health workers suggested that TEC should not only improve TB patient knowledge and adherence, but should also empower and assist all those undergoing evaluation for TB, whether confirmed or not, to educate their households and communities about TB. Community-engaged research with patients and front-line providers identified opportunities to streamline and standardise the delivery of TEC using a patient-centred, peer-educator model.

A cost analysis of implementing mobile health facilitated tuberculosis contact investigation in a low-income setting.

INTRODUCTION: Mobile health (mHealth) applications may improve timely access to health services and improve patient-provider communication, but the upfront costs of implementation may be prohibitive, especially in resource-limited settings. METHODS: We measured the costs of developing and implementing an mHealth-facilitated, home-based strategy for tuberculosis (TB) contact investigation in Kampala, Uganda, between February 2014 and July 2017. We compared routine implementation involving community health workers (CHWs) screening and referring household contacts to clinics for TB evaluation to home-based HIV testing and sputum collection and transport with test results delivered by automated short messaging services (SMS). We carried out key informant interviews with CHWs and asked them to complete time-and-motion surveys. We estimated program costs from the perspective of the Ugandan health system, using top-down and bottom-up (components-based) approaches. We estimated total costs per contact investigated and per TB-positive contact identified in 2018 US dollars, one and five years after program implementation. RESULTS: The total top-down cost was $472,327, including $358,504 (76%) for program development and $108,584 (24%) for program implementation. This corresponded to $320-$348 per household contact investigated and $8,873-$9,652 per contact diagnosed with active TB over a 5-year period. CHW time was spent primarily evaluating household contacts who returned to the clinic for evaluation (median 30 minutes per contact investigated, interquartile range [IQR]: 30-70), collecting sputum samples (median 29 minutes, IQR: 25-30) and offering HIV testing services (median 28 minutes, IQR: 17-43). Cost estimates were sensitive to infrastructural capacity needs, program reach, and the epidemiological yield of contact investigation. CONCLUSION: Over 75% of all costs of the mHealth-facilitated TB contact investigation strategy were dedicated to establishing mHealth infrastructure and capacity. Implementing the mHealth strategy at scale and maintaining it over a longer time horizon could help decrease development costs as a proportion of total costs.

Theory-Informed Design of a Tailored Strategy for Implementing Household TB Contact Investigation in Uganda.

Since 2012, the World Health Organization has recommended household contact investigation as an evidence-based intervention to find and treat individuals with active tuberculosis (TB), the most common infectious cause of death worldwide after COVID-19. Unfortunately, uptake of this recommendation has been suboptimal in low- and middle-income countries, where the majority of affected individuals reside, and little is known about how to effectively deliver this service. Therefore, we undertook a systematic process to design a novel, theory-informed implementation strategy to promote uptake of contact investigation in Uganda, using the COM-B (Capability-Opportunity-Motivation-Behavior) model and the Behavior Change Wheel (BCW) framework. We systematically engaged national, clinic-, and community-based stakeholders and collectively re-examined the results of our own formative, parallel mixed-methods studies. We identified three core behaviors within contact investigation that we wished to change, and multiple antecedents (i.e., barriers and facilitators) of those behaviors. The BCW framework helped identify multiple intervention functions targeted to these antecedents, as well as several policies that could potentially enhance the effectiveness of those interventions. Finally, we identified multiple behavior change techniques and policies that we incorporated into a multi-component implementation strategy, which we compared to usual care in a household cluster-randomized trial. We introduced some components in both arms, including those designed to facilitate initial uptake of contact investigation, with improvement relative to historical controls. Other components that we introduced to facilitate completion of TB evaluation-home-based TB-HIV evaluation and follow-up text messaging-returned negative results due to implementation failures. In summary, the Behavior Change Wheel framework provided a feasible and transparent approach to designing a theory-informed implementation strategy. Future studies should explore the use of experimental methods such as micro-randomized trials to identify the most active components of implementation strategies, as well as more creative and entrepreneurial methods such as human-centered design to better adapt the forms and fit of implementation strategies to end users.

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.

Iterative Adaptation of a Tuberculosis Digital Medication Adherence Technology to Meet User Needs: Qualitative Study of Patients and Health Care Providers Using Human-Centered Design Methods.

BACKGROUND: Digital adherence technologies have been widely promoted as a means to improve tuberculosis medication adherence. However, uptake of these technologies has been suboptimal by both patients and health workers. Not surprisingly, studies have not demonstrated significant improvement in treatment outcomes. OBJECTIVE: This study aimed to optimize a well-known digital adherence technology, 99DOTS, for end user needs in Uganda. We describe the findings of the ideation phase of the human-centered design methodology to adapt 99DOTS according to a set of design principles identified in the previous inspiration phase. METHODS: 99DOTS is a low-cost digital adherence technology wherein tuberculosis medication blister packs are encased within an envelope that reveals toll-free numbers that patients can call to report dosing. We identified 2 key areas for design and testing: (1) the envelope, including the form factor, content, and depiction of the order of pill taking; and (2) the patient call-in experience. We conducted 5 brainstorming sessions with all relevant stakeholders to generate a suite of potential prototype concepts. Senior investigators identified concepts to further develop based on feasibility and consistency with the predetermined design principles. Prototypes were revised with feedback from the entire team. The envelope and call-in experience prototypes were tested and iteratively revised through focus groups with health workers (n=52) and interviews with patients (n=7). We collected and analyzed qualitative feedback to inform each subsequent iteration. RESULTS: The 5 brainstorming sessions produced 127 unique ideas that we clustered into 6 themes: rewards, customization, education, logistics, wording and imagery, and treatment countdown. We developed 16 envelope prototypes, 12 icons, and 28 audio messages for prototype testing. In the final design, we altered the pill packaging envelope by adding a front flap to conceal the pills and reduce potential stigma associated with tuberculosis. The flap was adorned with either a blank calendar or map of Uganda. The inside cover contained a personalized message from a local health worker including contact information, pictorial pill-taking instructions, and a choice of stickers to tailor education to the patient and phase of treatment. Pill-taking order was indicated with colors, chevron arrows, and small mobile phone icons. Last, the call-in experience when patients report dosing was changed to a rotating series of audio messages centered on the themes of prevention, encouragement, and reassurance that tuberculosis is curable. CONCLUSIONS: We demonstrated the use of human-centered design as a promising tool to drive the adaptation of digital adherence technologies to better address the needs and motivations of end users. The next phase of research, known as the implementation phase in the human-centered design methodology, will investigate whether the adapted 99DOTS platform results in higher levels of engagement from patients and health workers, and ultimately improves tuberculosis treatment outcomes.

Implementing mHealth Interventions in a Resource-Constrained Setting: Case Study From Uganda.

BACKGROUND: Mobile health (mHealth) interventions are becoming more common in low-income countries. Existing research often overlooks implementation challenges associated with the design and technology requirements of mHealth interventions. OBJECTIVE: We aimed to characterize the challenges that we encountered in the implementation of a complex mHealth intervention in Uganda. METHODS: We customized a commercial mobile survey app to facilitate a two-arm household-randomized, controlled trial of home-based tuberculosis (TB) contact investigation. We incorporated digital fingerprinting for patient identification in both study arms and automated SMS messages in the intervention arm only. A local research team systematically documented challenges to implementation in biweekly site visit reports, project management reports, and minutes from biweekly conference calls. We then classified these challenges using the Consolidated Framework for Implementation Research (CFIR). RESULTS: We identified challenges in three principal CFIR domains: (1) intervention characteristics, (2) inner setting, and (3) characteristics of implementers. The adaptability of the app to the local setting was limited by software and hardware requirements. The complexity and logistics of implementing the intervention further hindered its adaptability. Study staff reported that community health workers (CHWs) were enthusiastic regarding the use of technology to enhance TB contact investigation during training and the initial phase of implementation. After experiencing technological failures, their trust in the technology declined along with their use of it. Finally, complex data structures impeded the development and execution of a data management plan that would allow for articulation of goals and provide timely feedback to study staff, CHWs, and participants. CONCLUSIONS: mHealth technologies have the potential to make delivery of public health interventions more direct and efficient, but we found that a lack of adaptability, excessive complexity, loss of trust among end users, and a lack of effective feedback systems can undermine implementation, especially in low-resource settings where digital services have not yet proliferated. Implementers should anticipate and strive to avoid these barriers by investing in and adapting to local human and material resources, prioritizing feedback from end users, and optimizing data management and quality assurance procedures. TRIAL REGISTRATION: Pan-African Clinical Trials Registration PACTR201509000877140; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=877.

Study protocol and implementation details for a pragmatic, stepped-wedge cluster randomised trial of a digital adherence technology to facilitate tuberculosis treatment completion.

INTRODUCTION: Low-cost digital adherence technologies (DATs) such as 99DOTS have emerged as an alternative to directly observed therapy (DOT), the current standard for tuberculosis (TB) treatment supervision. However, there are limited data to support DAT scale-up. The 'DOT to DAT' trial aims to evaluate the effectiveness and implementation of a 99DOTS-based TB treatment supervision strategy. METHODS AND ANALYSIS: This is a pragmatic, stepped-wedge cluster randomised trial, with hybrid type 2 effectiveness-implementation design. The trial will include all adults (estimated N=1890) treated for drug-susceptible pulmonary TB over an 8-month period at 18 TB treatment units in Uganda. Three sites per month will switch from routine care (DOT) to the intervention (99DOTS-based treatment supervision) beginning in month 2, with the order determined randomly. 99DOTS enables patients to be monitored while self-administering TB medicines. Patients receive daily automated short message service (SMS) dosing reminders and confirm dosing by calling toll-free numbers. The primary effectiveness outcome is the proportion of patients completing TB treatment. With 18 clusters randomised into six steps and an average cluster size of 15 patients per month, the study will have 89% power to detect a 10% or greater increase in treatment completion between the routine care and intervention periods. Secondary outcomes include more proximal effectiveness measures as well as quantitative and qualitative assessments of the reach, adoption and implementation of the intervention. ETHICS AND DISSEMINATION: Ethics approval was granted by institutional review boards at Makerere University School of Public Health and the University of California San Francisco. Findings will be disseminated through peer-reviewed publications, presentations at scientific conferences and presentations to key stakeholders. TRIAL REGISTRATION NUMBER: PACTR201808609844917.

Home-based tuberculosis contact investigation in Uganda: a household randomised trial.

INTRODUCTION: The World Health Organization (WHO) recommends household tuberculosis (TB) contact investigation in low-income countries, but most contacts do not complete a full clinical and laboratory evaluation. METHODS: We performed a randomised trial of home-based, SMS-facilitated, household TB contact investigation in Kampala, Uganda. Community health workers (CHWs) visited homes of index patients with pulmonary TB to screen household contacts for TB. Entire households were randomly allocated to clinic (standard-of-care) or home (intervention) evaluation. In the intervention arm, CHWs offered HIV testing to adults; collected sputum from symptomatic contacts and persons living with HIV (PLWHs) if ≥5 years; and transported sputum for microbiologic testing. CHWs referred PLWHs, children <5 years, and anyone unable to complete sputum testing to clinic. Sputum testing results and/or follow-up instructions were returned by automated SMS texts. The primary outcome was completion of a full TB evaluation within 14 days; secondary outcomes were TB and HIV diagnoses and treatments among screened contacts. RESULTS: There were 471 contacts of 190 index patients allocated to the intervention and 448 contacts of 182 index patients allocated to the standard-of-care. CHWs identified 190/471 (40%) intervention and 213/448 (48%) standard-of-care contacts requiring TB evaluation. In the intervention arm, CHWs obtained sputum from 35/91 (39%) of sputum-eligible contacts and SMSs were sent to 95/190 (50%). Completion of TB evaluation in the intervention and standard-of-care arms at 14 days (14% versus 15%; difference -1%, 95% CI -9% to 7%, p=0.81) and yields of confirmed TB (1.5% versus 1.1%, p=0.62) and new HIV (2.0% versus 1.8%, p=0.90) diagnoses were similar. CONCLUSIONS: Home-based, SMS-facilitated evaluation did not improve completion or yield of household TB contact investigation, likely due to challenges delivering the intervention components.

Drop-out from the tuberculosis contact investigation cascade in a routine public health setting in urban Uganda: A prospective, multi-center study.

SETTING: Seven public tuberculosis (TB) units in Kampala, Uganda, where Uganda's national TB program recently introduced household contact investigation, as recommended by 2012 guidelines from WHO. OBJECTIVE: To apply a cascade analysis to implementation of household contact investigation in a programmatic setting. DESIGN: Prospective, multi-center observational study. METHODS: We constructed a cascade for household contact investigation to describe the proportions of: 1) index patient households recruited; 2) index patient households visited; 3) contacts screened for TB; and 4) contacts completing evaluation for, and diagnosed with, active TB. RESULTS: 338 (33%) of 1022 consecutive index TB patients were eligible for contact investigation. Lay health workers scheduled home visits for 207 (61%) index patients and completed 104 (50%). Among 287 eligible contacts, they screened 256 (89%) for symptoms or risk factors for TB. 131 (51%) had an indication for further TB evaluation. These included 59 (45%) with symptoms alone, 58 (44%) children <5, and 14 (11%) with HIV. Among 131 contacts found to be symptomatic or at risk, 26 (20%) contacts completed evaluation, including five (19%) diagnosed with and treated for active TB, for an overall yield of 1.7%. The cumulative conditional probability of completing the entire cascade was 5%. CONCLUSION: Major opportunities exist for improving the effectiveness and yield of TB contact investigation by increasing the proportion of index households completing screening visits by lay health workers and the proportion of at-risk contacts completing TB evaluation.