Effectiveness of a comprehensive package based on electronic medication monitors at improving treatment outcomes among tuberculosis patients in Tibet: a multicentre randomised controlled trial.

BACKGROUND: WHO recommends that electronic medication monitors, a form of digital adherence technology, be used as a complement to directly observed treatment (DOT) for tuberculosis, as DOT is inconvenient and costly. However, existing evidence about the effectiveness of these monitors is inconclusive. Therefore, we evaluated the effectiveness of a comprehensive package based on electronic medication monitors among patients with tuberculosis in Tibet Autonomous Region (hereafter Tibet), China. METHODS: This multicentre, randomised controlled trial recruited patients from six counties in Shigatse, Tibet. Eligible participants had drug-susceptible tuberculosis and were aged 15 years or older when starting standard tuberculosis treatment. Tuberculosis doctors recruited patients from the public tuberculosis dispensary in each county and the study statistician randomly assigned them to the intervention or control group based on the predetermined randomised allocation sequence. Intervention patients received an electronic medication monitor box. The box included audio medication-adherence reminders and recorded box-opening data, which were transmitted to a cloud-based server and were accessible to health-care providers to allow remote adherence monitoring. A linked smartphone app enabled text, audio, and video communication between patients and health-care providers. Patients were also provided with a free data plan. Patients selected a treatment supporter (often a family member) who was trained to support patients with using the electronic medication monitor and app. Patients in the control group received usual care plus a deactivated electronic medication monitor, which only recorded and transmitted box-opening data that was not made available to health-care providers. The control group also had no access to the app or trained treatment supporters. The primary outcome was a binary indicator of poor monthly adherence, defined as missing 20% or more of planned doses in the treatment month, measured using electronic medication monitor opening data, and verified by counting used medication blister packages during consultations. We recorded other secondary treatment outcomes based on national tuberculosis reporting data. We analysed the primary outcome based on the intention-to-treat population. This trial is registered at ISRCTN, 52132803. FINDINGS: Between Nov 17, 2018, and April 5, 2021, 278 patients were enrolled into the study. 143 patients were randomly assigned to the intervention group and 135 patients to the control group. Follow-up ended when the final patient completed treatment on Oct 4, 2021. In the intervention group, 87 (10%) of the 854 treatment months showed poor adherence compared with 290 (37%) of the 795 months in the control group. The corresponding adjusted risk difference for the intervention versus control was -29·2 percentage points (95% CI -35·3 to -22·2; p<0·0001). Five of the six secondary treatment outcomes also showed clear improvements, including treatment success, which was found for 133 (94%) of the 142 individuals in the intervention arm and 98 (73%) of the 134 individuals in the control arm, with an adjusted risk difference of 21 percentage points (95% CI 12·4-29·4); p<0·0001. INTERPRETATION: The interventions were effective at improving tuberculosis treatment adherence and outcomes, and the trial suggests that a comprehensive package involving electronic medication monitors might positively affect tuberculosis programmes in high-burden and low-resource settings. FUNDING: TB REACH.

Acceptability and Potential Effectiveness of eHealth Tools for Training Primary Health Workers From Nigeria at Scale: Mixed Methods, Uncontrolled Before-and-After Study.

BACKGROUND: The in-service training of frontline health workers (FHWs) in primary health care facilities plays an important role in improving the standard of health care delivery. However, it is often expensive and requires FHWs to leave their posts in rural areas to attend courses in urban centers. This study reports the implementation of a digital health tool for providing video training (VTR) on maternal, newborn, and child health (MNCH) care to provide in-service training at scale without interrupting health services. The VTR intervention was supported by satellite communications technology and existing 3G mobile networks. OBJECTIVE: This study aims to determine the feasibility and acceptability of these digital health tools and their potential effectiveness in improving clinical knowledge, attitudes, and practices related to MNCH care. METHODS: A mixed methods design, including an uncontrolled pre- and postquantitative evaluation, was adopted. From October 2017 to May 2018, a VTR mobile intervention was delivered to FHWs in 3 states of Nigeria. We examined changes in workers' knowledge and confidence in delivering MNCH services through a pre- and posttest survey. Stakeholders' experiences with the intervention were explored through semistructured interviews that drew on the technology acceptance model to frame contextual factors that shaped the intervention's acceptability and usability in the work environment. RESULTS: In total, 328 FHWs completed both pre- and posttests. FHWs achieved a mean pretest score of 51% (95% CI 48%-54%) and mean posttest score of 69% (95% CI 66%-72%), reflecting, after adjusting for key covariates, a mean increase between the pre- and posttest of 17 percentage points (95% CI 15-19; P<.001). Variation was identified in pre- and posttest scores by the sex and location of participants alongside topic-specific areas where scores were lowest. Stakeholder interviews suggested a wide acceptance of VTR Mobile (delivered via digital technology) as an important tool for enhancing the quality of training, reinforcing knowledge, and improving health outcomes. CONCLUSIONS: This study found that VTR supported through a digital technology approach is a feasible and acceptable approach for supporting improvements in clinical knowledge, attitudes, and reported practices in MNCH. The determinants of technology acceptance included ease of use, perceived usefulness, access to technology and training contents, and the cost-effectiveness of VTR, whereas barriers to the adoption of VTR were poor electricity supply, poor internet connection, and FHWs' workload. The evaluation also identified the mechanisms of the impact of delivering VTR Mobile at scale on the micro (individual), meso (organizational), and macro (policy) levels of the health system. Future research is required to explore the translation of this digital health approach for the VTR of FHWs and its impact across low-resource settings to ameliorate the financial and time costs of training and support high-quality MNCH care delivery. TRIAL REGISTRATION: ISRCTN Registry 32105372; https://www.isrctn.com/ISRCTN32105372.

Protocol for a realist synthesis of health systems responsiveness in low-income and middle-income countries.

INTRODUCTION: Health systems responsiveness is a key objective of any health system, yet it is the least studied of all objectives particularly in low-income and middle-income countries. Research on health systems responsiveness highlights its multiple elements, for example, dignity and confidentiality. Little is known, however, about underlying theories of health systems responsiveness, and the mechanisms through which responsiveness works. This realist synthesis contributes to bridging these two knowledge gaps. METHODS AND ANALYSIS: In this realist synthesis, we will use a four-step process, comprising: mapping of theoretical bases, formulation of programme theories, theory refinement and testing of programme theories using literature and empirical data from Ghana and Vietnam. We will include theoretical and conceptual pieces, reviews, empirical studies and grey literature, alongside the primary data. We will explore responsiveness as entailing external and internal interactions within health systems. The search strategy will be purposive and iterative, with continuous screening and refinement of theories. Data extraction will be combined with quality appraisal, using appropriate tools. Each fragment of evidence will be appraised as it is being extracted, for its relevance to the emerging programme theories and methodological rigour. The extracted data pertaining to contexts, mechanisms and outcomes will be synthesised to identify patterns and contradictions. Results will be reported using narrative explanations, following established guidance on realist syntheses. ETHICS AND DISSEMINATION: Ethics approvals for the wider RESPONSE (Improving health systems responsiveness to neglected health needs of vulnerable groups in Ghana and Vietnam) study, of which this review is one part, were obtained from the ethics committees of the following institutions: London School of Hygiene and Tropical Medicine (ref: 22981), University of Leeds, School of Medicine (ref: MREC19-051), Ghana Health Service (ref: GHS-ERC 012/03/20) and Hanoi University of Public Health (ref: 020-149/DD-YTCC).We will disseminate results through academic papers, conference presentations and stakeholder workshops in Ghana and Vietnam. PROSPERO REGISTRATION NUMBER: CRD42020200353. Full record: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020200353.

Antibiotic practices among household members and their domestic animals within rural communities in Cumilla district, Bangladesh: a cross-sectional survey.

BACKGROUND: Antibiotic resistance is a global threat to human health, and inappropriate use of antibiotics in humans and animals is widely considered to be a key driver of antibiotic resistant infections. Antibiotic use in humans and animals is growing rapidly in low- and, particularly, middle-income countries. However, there is little detailed understanding about practices related to the use of antibiotics in humans and animals within community settings in such countries. Here we aimed to understand the antibiotic practices of rural households across Cumilla district, Bangladesh, in relation to household members and their domestic animals. METHODS: In 2018 we conducted a cross-sectional survey using representative cluster sampling methods. We collected self-reported information from 682 female and 620 male household heads, with women also asked about their children's antibiotic practices. RESULTS: Only 48% (95% CI: 40, 56%) of women and men had heard of antibiotics, and among those women and men who were aware of antibiotics and the children of those women 70% (95% CI: 64, 76%) reported having previously taken antibiotics, while among these individuals who reported previously taking antibiotics 21% (95% CI: 18, 25%) said they had done so most recently within the last month. Risky/inappropriate antibiotic practices in humans and animals were often reported. For example, among women and men who were aware of antibiotics and the children of those women 52% (95% CI: 40, 63%) reported previously taking antibiotics for a "cough/cold", despite antibiotics being typically inappropriate for use against viral upper respiratory tract infections. Among poultry-owning respondents who were aware of antibiotics 11% (95% CI: 8, 15%) reported previously giving healthy poultry antibiotics, mainly for growth/prophylaxis, while among cattle-owning respondents who were aware of antibiotics and reported previously giving their cattle feed 20% (95% CI: 9, 37%) said the feed had contained antibiotics at least sometimes. CONCLUSIONS: Our results highlight the need for context-adapted interventions at both the community level and the health systems level to reduce inappropriate antibiotic use among humans and domestic animals in rural Bangladesh. Successfully reducing inappropriate use of antibiotics among humans and animals is a required and critical step in tackling antimicrobial resistance.

Realist evaluation to improve health systems responsiveness to neglected health needs of vulnerable groups in Ghana and Vietnam: Study protocol.

BACKGROUND: Socio-economic growth in many low and middle-income countries has resulted in more available, though not equitably accessible, healthcare. Such growth has also increased demands from citizens for their health systems to be more responsive to their needs. This paper shares a protocol for the RESPONSE study which aims to understand, co-produce, implement and evaluate context-sensitive interventions to improve health systems responsiveness to health needs of vulnerable groups in Ghana and Vietnam. METHODS: We will use a realist mixed-methods theory-driven case study design, combining quantitative (household survey, secondary analysis of facility data) and qualitative (in-depth interviews, focus groups, observations and document and literature review) methods. Data will be analysed retroductively. The study will comprise three Phases. In Phase 1, we will understand actors' expectations of responsive health systems, identify key priorities for interventions, and using evidence from a realist synthesis we will develop an initial theory and generate a baseline data. In Phase 2, we will co-produce jointly with key actors, the context-sensitive interventions to improve health systems responsiveness. The interventions will seek to improve internal (i.e. intra-system) and external (i.e. people-systems) interactions through participatory workshops. In Phase 3, we will implement and evaluate the interventions by testing and refining our initial theory through comparing the intended design to the interventions' actual performance. DISCUSSION: The study's key outcomes will be: (1) improved health systems responsiveness, contributing to improved health services and ultimately health outcomes in Ghana and Vietnam and (2) an empirically-grounded and theoretically-informed model of complex contexts-mechanisms-outcomes relations, together with transferable best practices for scalability and generalisability. Decision-makers across different levels will be engaged throughout. Capacity strengthening will be underpinned by in-depth understanding of capacity needs and assets of each partner team, and will aim to strengthen individual, organisational and system level capacities.

Addressing Unintentional Exclusion of Vulnerable and Mobile Households in Traditional Surveys in Kathmandu, Dhaka, and Hanoi: a Mixed-Methods Feasibility Study.

The methods used in low- and middle-income countries' (LMICs) household surveys have not changed in four decades; however, LMIC societies have changed substantially and now face unprecedented rates of urbanization and urbanization of poverty. This mismatch may result in unintentional exclusion of vulnerable and mobile urban populations. We compare three survey method innovations with standard survey methods in Kathmandu, Dhaka, and Hanoi and summarize feasibility of our innovative methods in terms of time, cost, skill requirements, and experiences. We used descriptive statistics and regression techniques to compare respondent characteristics in samples drawn with innovative versus standard survey designs and household definitions, adjusting for sample probability weights and clustering. Feasibility of innovative methods was evaluated using a thematic framework analysis of focus group discussions with survey field staff, and via survey planner budgets. We found that a common household definition excluded single adults (46.9%) and migrant-headed households (6.7%), as well as non-married (8.5%), unemployed (10.5%), disabled (9.3%), and studying adults (14.3%). Further, standard two-stage sampling resulted in fewer single adult and non-family households than an innovative area-microcensus design; however, two-stage sampling resulted in more tent and shack dwellers. Our survey innovations provided good value for money, and field staff experiences were neutral or positive. Staff recommended streamlining field tools and pairing technical and survey content experts during fieldwork. This evidence of exclusion of vulnerable and mobile urban populations in LMIC household surveys is deeply concerning and underscores the need to modernize survey methods and practices.

Which mechanisms explain motivation the of primary health workers? Insights from the realist evaluation of a maternal and child health programme in Nigeria.

INTRODUCTION: Well-trained, adequately skilled and motivated primary healthcare (PHC) workers are essential for attaining universal health coverage (UHC). While there is abundant literature on the drivers of workforce motivation, published knowledge on the mechanisms of motivation within different contexts is limited, particularly in resource-limited countries. This paper contributes to health workforce literature by reporting on how motivation works among PHC workers in a maternal and child health (MCH) programme in Nigeria. METHODS: We adopted a realist evaluation design combining document review with 56 in-depth interviews of PHC workers, facility managers and policy-makers to assess the impact of the MCH programme in Anambra State, Nigeria. A realist process of theory development, testing and consolidation was used to understand how and under what circumstances the MCH programme impacted on workers' motivation and which mechanisms explain how motivation works. We drew on Herzberg's two-factor and Adam's equity theories to unpack how context shapes worker motivation. RESULTS: A complex and dynamic interaction between the MCH programme and organisational and wider contexts triggered five mechanisms which explain PHC worker motivation: (1) feeling supported, (2) feeling comfortable with work environment, (3) feeling valued, (4) morale and confidence to perform tasks and (5) companionship. Some mechanisms were mutually reinforcing while others operated in parallel. Other conditions that enabled worker motivation were organisational values of fairness, recognition of workers' contributions and culture of task-sharing and teamwork. CONCLUSIONS: Policy designs and management strategies for improving workforce performance, particularly in resource-constrained settings should create working environments that foster feelings of being valued and supported while enabling workers to apply their knowledge and skills to improve healthcare delivery and promote UHC. Future research can test the explanatory framework generated by this study and explore differences in motivational mechanisms among different cadres of PHC workers to inform cadre-related motivational interventions.

An antibiotic stewardship programme to reduce inappropriate antibiotic prescribing for acute respiratory infections in rural Chinese primary care facilities: study protocol for a clustered randomised controlled trial.

BACKGROUND: Inappropriate prescribing of antibiotics for acute respiratory infections at the primary care level represents the major source of antibiotic misuse in healthcare, and is a major driver for antimicrobial resistance worldwide. In this study we will develop, pilot and evaluate the effectiveness of a comprehensive antibiotic stewardship programme in China's primary care hospitals to reduce inappropriate prescribing of antibiotics for acute respiratory infections among all ages. METHODS: We will use a parallel-group, cluster-randomised, controlled, superiority trial with blinded outcome evaluation but unblinded treatment (providers and patients). We will randomise 34 primary care hospitals from two counties within Guangdong province into the intervention and control arm (1:1 overall ratio) stratified by county (8:9 within-county ratio). In the control arm, antibiotic prescribing and management will continue through usual care. In the intervention arm, we will implement an antibiotic stewardship programme targeting family physicians and patients/caregivers. The family physician components include: (1) training using new operational guidelines, (2) improved management and peer-review of antibiotic prescribing, (3) improved electronic medical records and smart phone app facilitation. The patient/caregiver component involves patient education via family physicians, leaflets and videos. The primary outcome is the proportion of prescriptions for acute respiratory infections (excluding pneumonia) that contain any antibiotic(s). Secondary outcomes will address how frequently specific classes of antibiotics are prescribed, how frequently key non-antibiotic alternatives are prescribed and the costs of consultations. We will conduct a qualitative process evaluation to explore operational questions regarding acceptability, cultural appropriateness and burden of technology use, as well as a cost-effectiveness analysis and a long-term benefit evaluation. The duration of the intervention will be 12 months, with another 24 months' post-trial long-term follow-up. DISCUSSION: Our study is one of the first trials to evaluate the effect of an antibiotic stewardship programme in primary care settings in a low- or middle-income country (LMIC). All interventional activities will be designed to be embedded into routine primary care with strong local ownership. Through the trial we intend to impact on clinical practice and national policy in antibiotic prescription for primary care facilities in rural China and other LMICs. TRIAL REGISTRATION: ISRCTN, ID: ISRCTN96892547. Registered on 18 August 2019.

Protocol for a randomised controlled trial to evaluate the effectiveness of improving tuberculosis patients' treatment adherence via electronic monitors and an app versus usual care in Tibet.

BACKGROUND: Treatment non-adherence is a serious challenge to effective tuberculosis (TB) control in Tibet. In this study we will pilot and evaluate the effectiveness of using new electronic monitors (e-monitors) and a smartphone app to improve treatment adherence among new pulmonary TB patients in Tibet. METHODS: We will use a multicentre, parallel-group, individually randomised controlled, superiority trial with blinded outcome evaluation and unblinded treatment. We will randomise new pulmonary TB outpatients (aged ≥ 15 years old and free from communication impairment) from Shigatse, Tibet to either the intervention or control arm in a 1:1 ratio at the time of their diagnosis. All patients will be treated according to the World Health Organisation standard 6-month TB treatment regimen and the China National TB programme guidelines. Intervention arm patients will be given their medication via e-monitors that have automatic voice reminders, and record medication adherence data and share it with health staff via Cloud connection. Intervention patients will also be encouraged to receive smartphone-based video-observed treatment if their adherence is problematic. Control arm patients will receive their medication in e-monitors that will collect medication adherence history, but will have their reminder function deactivated and are not linked to the app. The primary outcome is the rate of poor adherence, measured monthly during treatment as a binary indicator where poor adherence means missing ≥ 20% of doses in a month. We will conduct a qualitative process evaluation to explore operational questions regarding acceptability, cultural appropriateness and burden of technology use, as well as a cost-effectiveness analysis and an analysis of the long-term effects of the intervention on TB control. DISCUSSION: Our study is one of the first trials to evaluate the use of e-monitors and smartphone apps for customised treatment support in low- and middle-income countries (LMICs). All intervention activities are designed to be embedded into routine TB care with strong local ownership. Through the trial we intend to understand the feasibility of our intervention, its effectiveness, its cost-effectiveness and its long-term impacts to inform future scale-up in remote areas of China and other LMICs. TRIAL REGISTRATION: Current Controlled Trials, ID: ISRCTN52132803 . Registered on 9 November 2018.

A cross-sectional survey on the seroprevalence of dengue fever in febrile patients attending health facilities in Cross River State, Nigeria.

BACKGROUND: In Nigeria, recent reports suggest that dengue viruses could be a major cause of acute fevers. We sought to make a cross-sectional estimate of the prevalence of current and previous dengue infections in patients presenting with fever to healthcare centres in Cross River State Nigeria. METHODOLOGY/PRINCIPAL FINDINGS: This cross-sectional health facility survey recruited persons with temperature ≥38°C. Dengue virus immunoglobulin M (IgM)/immunoglobulin G (IgG) antibody testing using Onsite Duo dengue Ag-IgG/IgM lateral flow immunoassay cassettes was done. Samples which tested positive were further confirmed using the RecombiLISA dengue IgM and IgG enzyme linked immunosorbent assay kits and classified into primary and secondary dengue infection. Malaria testing was carried out using microscopy. Between 4 January 2017 and 24 August 2017 a total of 420 participants were sampled across 11 health centres. The mean age was 34 (range = 1-99), 63% were female, 49% reported sleeping under a treated mosquito net in the past week and 44% reported taking an antimalarial prior to seeking care. The mean number of days fever was present prior to seeking care was 8, and many of the participants presented with symptoms indicative of respiratory or urinary tract infections. Testing indicated that 6% (95% CI: 2, 13; n = 24) had either a primary or secondary dengue infection with or without co-existing malaria, while 4% (95% CI: 2, 9; n = 16) had either a primary or secondary dengue infection without co-existing malaria. 52% (95% CI: 46, 58; n = 218) had a malaria infection with or without any dengue infection, and 50% (95% CI: 44, 57; n = 210) had a malaria infection without any dengue infection. CONCLUSION: Our study confirms the presence of dengue at not insignificant levels in patients attending health centres with fever in this south eastern province of Nigeria. These data highlight the danger of the common presumption in this setting that fever is due to malaria. Surveillance for dengue is vital in this setting.

Improving household surveys and use of data to address health inequities in three Asian cities: protocol for the Surveys for Urban Equity (SUE) mixed methods and feasibility study.

INTRODUCTION: As rapid urbanisation transforms the sociodemographic structures within cities, standard survey methods, which have remained unchanged for many years, under-represent the urban poorest. This leads to an overly positive picture of urban health, distorting appropriate allocation of resources between rural and urban and within urban areas. Here, we present a protocol for our study which (i) tests novel methods to improve representation of urban populations in household surveys and measure mental health and injuries, (ii) explores urban poverty and compares measures of poverty and 'slumness' and (iii) works with city authorities to understand, and potentially improve, utilisation of data on urban health for planning more equitable services. METHODS AND ANALYSIS: We will conduct household surveys in Kathmandu, Hanoi and Dhaka to test novel methods: (i) gridded population sampling; (ii) enumeration using open-access online maps and (iii) one-stage versus two-stage cluster sampling. We will test reliability of an observational tool to categorise neighbourhoods as slum areas. Within the survey, we will assess the appropriateness of a short set of questions to measure depression and injuries. Questionnaire data will also be used to compare asset-based, consumption-based and income-based measures of poverty. Participatory methods will identify perceptions of wealth in two communities in each city. The analysis will combine quantitative and qualitative findings to recommend appropriate measures of poverty in urban areas. We will conduct qualitative interviews and establish communities of practice with government staff in each city on use of data for planning. Framework approach will be used to analyse qualitative data allowing comparison across city settings. ETHICS AND DISSEMINATION: Ethical approvals have been granted by ethics committees from the UK, Nepal, Bangladesh and Vietnam. Findings will be disseminated through conference papers, peer-reviewed open access articles and workshops with policy-makers and survey experts in Kathmandu, Hanoi and Dhaka.

Impact of using eHealth tools to extend health services to rural areas of Nigeria: protocol for a mixed-method, non-randomised cluster trial.

INTRODUCTION: eHealth solutions that use internet and related technologies to deliver and enhance health services and information are emerging as novel approaches to support healthcare delivery in sub-Saharan Africa. Using digital technology in this way can support cost-effectiveness of care delivery and extend the reach of services to remote locations. Despite the burgeoning literature on eHealth approaches, little is known about the effectiveness of eHealth tools for improving the quality and efficiency of health systems functions or client outcomes in resource-limited countries. eHealth tools including satellite communications are currently being implemented at scale, to extend health services to rural areas of Nigeria, in Ondo and Kano States and the Federal Capital Territory. This paper shares the protocol for a 2-year project ('EXTEND') that aims to evaluate the impact of eHealth tools on health system functions and health outcomes. METHODOLOGY AND ANALYSIS: This multisite, mixed-method evaluation includes a non-randomised, cluster trial design. The study comprises three phases-baseline, midline and endline evaluations-that involve: (1) process evaluation of video training and digitisation of health data interventions; (2) evaluation of contextual influences on the implementation of interventions; and (3) impact evaluation of results of the project. A convergent mixed-method model will be adopted to allow integration of quantitative and qualitative findings to achieve study objectives. Multiple quantitative and qualitative datasets will be repeatedly analysed and triangulated to facilitate better understanding of impact of eHealth tools on health worker knowledge, quality and efficiency of health systems and client outcomes. ETHICS AND DISSEMINATION: Ethics approvals were obtained from the University of Leeds and three States' Ministries of Health in Nigeria. All data collected for this study will be anonymised and reports will not contain information that could identify respondents. Study findings will be presented to Ministries of Health at scientific conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN32105372; Pre-results.

Intensive Patient Education Improves Glycaemic Control in Diabetes Compared to Conventional Education: A Randomised Controlled Trial in a Nigerian Tertiary Care Hospital.

BACKGROUND: Diabetes is now a global epidemic, but most cases are now in low- and middle-income countries. Diabetes self-management education (DSME) is key to enabling patients to manage their chronic condition and can reduce the occurrence of costly and devastating complications. However, there is limited evidence on the effectiveness of different DSME programmes in resource limited settings. METHODS: We conducted an unblinded, parallel-group, individually-randomised controlled trial at the University of Calabar Teaching Hospital (Nigeria) to evaluate whether an intensive and systematic DSME programme, using structured guidelines, improved glycaemic control compared to the existing ad hoc patient education (clinical practice was unchanged). Eligible patients (≥18 years, HbA1c > 8.5% and physically able to participate) were randomly allocated by permuted block randomisation to participate for six months in either an intensive or conventional education group. The primary outcome was HbA1c (%) at six-months. RESULTS: We randomised 59 participants to each group and obtained six-month HbA1c outcomes from 53 and 51 participants in the intensive and conventional education groups, respectively. Intensive group participants had a mean six-month HbA1c (%) of 8.4 (95% CI: 8 to 8.9), while participants in the conventional education group had a mean six-month HbA1c (%) of 10.2 (95% CI: 9.8 to 10.7). The difference was statistically (P < 0.0001) and clinically significant, with intensive group participants having HbA1c outcomes on average -1.8 (95% CI: -2.4 to -1.2) percentage points lower than conventional group participants. Results were robust to adjustment for a range of covariates and multiple imputation of missing outcome data. CONCLUSIONS: This study demonstrates the effectiveness of a structured, guideline-based DSME intervention in a LMIC setting versus a pragmatic comparator. The intervention is potentially replicable at other levels of the Nigerian healthcare system and in other LMICs, where nurses/diabetes educators can run the programme. TRIAL REGISTRATION: Pan African Clinical Trial Registry PACTR20130200047835.