Natalie Leon

The human papillomavirus (HPV) vaccine is one of the most powerful tools in cancer prevention and is central to global efforts to eliminate cervical cancer as a public health problem. Yet worldwide uptake remains suboptimal. Our 2025 Cochrane qualitative evidence synthesis - comprising 71 studies from diverse geographic and socioeconomic settings - provides the most comprehensive global understanding to date of caregivers' and adolescents' views and practices regarding HPV vaccination, and the reasons why some are reluctant to receive the vaccine. Our review found HPV vaccine decision-making to be influenced by a complex web of socio-cultural, political and trust-related factors, beyond awareness or a simple evaluation of vaccine benefits and risks. We synthesized these factors into eight overarching themes. Together these provide a novel conceptual framework of the multi-level, interacting influencing factors, distinguishing it from more narrow, individual HPV vaccination acceptance frameworks. In this commentary we describe this conceptual framework and propose how it might be used to inform strategies for improving HPV vaccine uptake in ways that are more person-centered, equitable and ultimately effective. As countries worldwide aim to upscale and optimize HPV vaccination programs, incorporating insights from this review into HPV vaccination policy, program design and service delivery is essential and urgent.

Heat extremes related to climate change increase the exposure of children to non-optimal learning environments, which may threaten children’s educational achievement and a country’s sustainable development, especially in low- and middle-income countries (LMICs). This is a systematic review of quantitative evidence on the potential effects of extreme heat on the educational outcomes of children in LMICs and on the potential causal pathways of such effects. The review is guided by a pre-specified registered protocol (ID: PROCEED-24-00313). We systematically searched electronic databases up to 23 September 2024 (no date limits), supplemented by open searching, reference mining, hand searching and articles from content experts. We critically appraised studies for risk of bias. The heterogeneity of the studies precluded a pooled estimate of effect. We present a narrative synthesis of the effects of heat extremes on educational outcomes, and we include modifying factors and causal pathways of these effects. Negative effects of heat were reported for academic performance in both mathematics and verbal test scores, with mixed effects for high-stakes university entrance examinations. Heat had potential negative effects on school completion and attendance. Mediating factors included gender, education and socio-economic level, urban/rural location and building characteristics. Potential causal pathways included the direct effects on a learner’s learning ability through physiological and cognitive stress, and the indirect effects on access to education via the loss of livelihoods, especially in poorer agrarian communities. There is evidence of potential negative effects of heat on academic performance in particular, although the range in the effect size and mediating factors highlight the complexity of the relationship between extreme heat and educational outcomes. Policies may be needed for the provision of climate-resilient education infrastructure and learning systems, and for social safety nets to attenuate economic vulnerability. More evidence is needed, especially on what multiple dimensions are needed for climate-resilient adaptation.

Background: Failure to take medicines for diabetes as prescribed contributes to poor outcomes from the condition. Mobile phones are ubiquitous and short message service (SMS) texts have shown promise as a low-cost intervention. We tested the effectiveness of SMS-text messaging in improving outcomes in adults with type 2 diabetes. Methods: StAR2D was a 12-month two-arm randomised trial of SMS-text messaging and usual care in Cape Town, South Africa and Lilongwe, Malawi. Messages used behaviour change theory and were developed with patients and staff. The intervention group received four messages each week. The primary outcome was change in HbA1c. Secondary outcomes were the proportion of patients who collected > 80% medication and changes in systolic blood pressure, lipids, cardiovascular risk, and the proportion of the participants reaching treatment goals. Results: The trial took place between 1 October, 2016 and 1 October 2018, 1186 participants were randomised to intervention (593) and control (593) groups. 91% of participants completed follow-up. There was a reduction in HbA1c (DCCT) in both groups but not in mean change (95% CI) between groups (− 0.08% (− 0.31 to 0.16) (IFCC − 0.82 mmol/mol (− 3.44 to 1.79). There was a small but not significant increase in the proportions of participants likely to have collected 80% or more of medication (Relative risk 1.11 (0.84 to 1.47; P = 0.47). There was a significant difference between groups in change in systolic blood pressure from baseline of 3.46 mmHg (1.48 to 5.44, P = 0.001) in favour of the intervention group. The between group difference in change in 10-year risk of coronary heart disease was − 0.71% (− 1.46 to 0.04, P = 0.064). The proportion of participants meeting treatment goals in the intervention group was 36.0% and in the control group 26.8% (Relative risk 1.36 (1.13 to 1.63, P = 0.001). Participants reported many challenges to adherence despite finding messages acceptable and useful. Conclusions: Whilst SMS text messages do not lead to improved glycaemia in these low-resource settings there appeared to be an impact on blood pressure and achievement of treatment goals but the mechanisms for this are unclear. Text messages alone, may be unsuccessful unless accompanied by health system strengthening and other forms of self-management support for type 2 diabetes. Trial registration: Trial registration: ISRCTN, ISRCTN70768808. Registered 1 July 2015, http://www.isrctn.com/I ISRCTN70768808.

Background: The SMS text Adherence suppoRt for people with type 2 diabetes (StAR2D) intervention is a pragmatic randomised controlled trial, testing the effectiveness of brief text messaging for improving clinical outcomes and medication adherence. The intervention did not impact glycaemic control. We conducted a pre-and post-trial process evaluation alongside the StAR2D study in Malawi and South Africa, exploring the experiences and perceptions of patient participants, to better understand potential underlying reasons for the trial outcomes. Methods: We employed a qualitative research design, including conducting semi structured in-depth interviews and focus groups at both trial sites. Purposive sampling was used to ensure representation of a wide range of patients with type 2 diabetes with regards to age, gender, ethnicity, language, and duration of diabetes. We interviewed the same participants at baseline and at the end of the trial. We used within-case and across-case thematic analysis to identify key themes. Results: Brief messages delivered by text were acceptable and useful for addressing informational and support needs for participants. Some participants reported behaviour changes because of the text reminders and advice on a healthy lifestyle. Both participating in the trial and the messages were experienced as a source of support, caring, and motivation. Participants’ ability to act on the messages was limited. A common theme was frustration over the lack of ability to effectively control one’s blood glucose level. They reported a range of routinised, partial diabetes care adherence behaviours, shaped by complex and interacting individual, social, and health service factors. Participant responses and intervention impact were similar across sites, despite differences in health services. Conclusion: This process evaluation provided context and insight into the factors influencing participants’ engagement with the text messaging intervention. The complex context in which patients take their diabetes medication, may explain in part, why brief text messaging may have been insufficient to bring about changes in health outcomes. The scale of need for self-management and health service support, suggests that health system strengthening, and other forms of self-management support should accompany digital communication interventions. (Current Controlled Trials ISRCTN70768808, registered 03/08/2015.)

Background: Brief messaging interventions, including Short Message Service (SMS) text-messages, delivered via mobile device platforms, show promise to support and improve treatment adherence. To understand how these interventions work, and to facilitate transparency, we need clear descriptions of the intervention development process. Method: We describe and reflect on the process of designing and pretesting an evidence- and theory-informed brief messaging intervention, to improve diabetes treatment adherence in sub-Saharan Africa. We followed the stepwise approach recommended by the Medical Research Council, United Kingdom (MRC UK) Framework for Development and Evaluation of Complex Health Interventions and guidance for mobile health intervention development. Results: We used a four-phase, iterative approach that first generated primary and secondary evidence on the lived experience of diabetes, diabetes treatment services and mobile-phone use. Second, we designed a type 2 diabetes-specific, brief text-message library, building on our previous hypertension text-message library, as well as drawing on the primary and secondary data from phase one, and on expert opinion. We then mapped the brief text-messages onto behaviour change (COM-B) theoretical constructs. Third, we refined and finalised the newly developed brief text-message library through stakeholder consultation and translated it into three local languages. Finally, we piloted the intervention by pre-testing the automated delivery of the brief text-messages in the trial sites in Malawi and South Africa. The final SMS text Adherence suppoRt for people with type 2 diabetes (StAR2D) intervention was tested in a randomised controlled trial in Malawi and South Africa (trial registration: ISRCTN70768808). Conclusion: The complexity of public health interventions requires that we give more attention to intervention development work. Our documentation and reflection on the StAR2D intervention development process promotes transparency, replicability, assessment of intervention quality, and comparison with other studies.

Background A well‐functioning routine health information system (RHIS) can provide the information needed for health system management, for governance, accountability, planning, policy making, surveillance and quality improvement, but poor information support has been identified as a major obstacle for improving health system management. Objectives To assess the effects of interventions to improve routine health information systems in terms of RHIS performance, and also, in terms of improved health system management performance, and improved patient and population health outcomes. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE Ovid and Embase Ovid in May 2019. We searched Global Health, Ovid and PsycInfo in April 2016. In January 2020 we searched for grey literature in the Grey Literature Report and in OpenGrey, and for ongoing trials using the International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov. In October 2019 we also did a cited reference search using Web of Science, and a ‘similar articles’ search in PubMed. Selection criteria Randomised and non‐randomised trials, controlled before‐after studies and time‐series studies comparing routine health information system interventions, with controls, in primary, hospital or community health care settings. Participants included clinical staff and management, district management and community health workers using routine information systems. Data collection and analysis Two authors independently reviewed records to identify studies for inclusion, extracted data from the included studies and assessed the risk of bias. Interventions and outcomes were too varied across studies to allow for pooled risk analysis. We present a 'Summary of findings' table for each intervention comparisons broadly categorised into Technical and Organisational (or a combination), and report outcomes on data quality and service quality. We used the GRADE approach to assess the certainty of the evidence. Main results We included six studies: four cluster randomised trials and two controlled before‐after studies, from Africa and South America. Three studies evaluated technical interventions, one study evaluated an organisational intervention, and two studies evaluated a combination of technical and organisational interventions. Four studies reported on data quality and six studies reported on service quality. In terms of data quality, a web‐based electronic TB laboratory information system probably reduces the length of time to reporting of TB test results, and probably reduces the overall rate of recording errors of TB test results, compared to a paper‐based system (moderate certainty evidence). We are uncertain about the effect of the electronic laboratory information system on the recording rate of serious (misidentification) errors for TB test results compared to a paper‐based system (very low certainty evidence). Misidentification errors are inaccuracies in transferring test results between an electronic register and patients' clinical charts. We are also uncertain about the effect of the intervention on service quality (timeliness of starting or changing a patient's TB treatment) (very low certainty evidence). A hand‐held electronic device probably improves the length of time to report TB test results, and probably reduces the total frequency of recording errors in TB test results between the laboratory notebook and the electronic information record system, compared to a paper‐based system (moderate‐certainty evidence). We are, however, uncertain about the effect of the intervention on the frequency of serious (misidentification) errors in recording between the laboratory notebook and the electronic information record, compared to a paper‐based system (very low certainty evidence). We are uncertain about the effect of a hospital electronic health information system on service quality (length of time outpatients spend at hospital, length of hospital stay, and hospital revenue collection), compared to a paper‐based system (very low certainty evidence). High‐intensity brief text messaging (SMS) may make little or no difference to data quality (in terms of completeness of documentation of pregnancy outcomes), compared to low‐intensity brief text messaging (low‐certainty evidence). We are uncertain about the effect of electronic drug stock notification (with either data management support or product transfer support) on service quality (in terms of transporting stock and stock levels), compared to paper‐based stock notification (very low certainty evidence). We are uncertain about the effect of health information strengthening (where it is part of comprehensive service quality improvement intervention) on service quality (health worker motivation, receipt of training by health workers, health information index scores, quality of clinical observation of children and adults) (very low certainty evidence). Authors' conclusions The review indicates mixed effects of mainly technical interventions to improve data quality, with gaps in evidence on interventions aimed at enhancing data‐informed health system management. There is a gap in interventions studying information support beyond clinical management, such as for human resources, finances, drug supply and governance. We need to have a better understanding of the causal mechanisms by which information support may affect change in management decision‐making, to inform robust intervention design and evaluation methods.

Background: Health outcomes for people treated for type 2 diabetes could be substantially improved in sub-Saharan Africa. Failure to take medicine regularly to treat diabetes has been identified as a major problem. Resources to identify and support patients who are not making the best use of medicine in low- and middle-income settings are scarce. Mobile phones are widely available in these settings, including among people with diabetes; linked technologies, such as short message service (SMS) text messaging, have shown promise in delivering low-cost interventions efficiently. However, evidence showing that these interventions will work when carried out at a larger scale and measuring the extent to which they will improve health outcomes when added to usual care is limited. Objective: The objective of this trial is to test the effectiveness of sending brief, automated SMS text messages for improving health outcomes and medication adherence in patients with type 2 diabetes compared to an active control. Methods: We will carry out a randomized trial recruiting from clinics in two contrasting settings in sub-Saharan Africa: Cape Town, South Africa, and Lilongwe, Malawi. Intervention messages will advise people about the benefits of their diabetes treatment and offer motivation and encouragement around lifestyle and use of medication. We allocated patients, using randomization with a minimization algorithm, to receive either three to four intervention messages per week or non-health-related messages every 6 weeks. We will follow up with participants for 12 months, measuring important risk factors for poor health outcomes and complications in diabetes. This will enable us to estimate potential health benefits, including the primary outcome of hemoglobin A1c (HbA1c) levels as a marker for long-term blood glucose control and a secondary outcome of blood pressure control. We will record the costs of performing these activities and estimate cost-effectiveness. We will also use process evaluation to capture the collection of medication and assess the reception of the intervention by participants and health care workers. Results: Recruitment to the trial began in September 2016 and follow-up of participants was completed in October 2018. Data collection from electronic health records and other routinely collected sources is continuing. The database lock is anticipated in June 2019, followed by analysis and disclosing of group allocation. Conclusions: The knowledge gained from this study will have wide applications and advance the evidence base for effectiveness of mobile phone-based, brief text messaging on clinical outcomes and in large-scale, operational settings. It will provide evidence for cost-effectiveness and acceptability that will further inform policy development and decision making. We will work with a wide network that includes patients, clinicians, academics, industry, and policy makers to help us identify opportunities for informing people about the work and raise awareness of what is being developed and studied. Trial Registration: ISRCTN Registry ISRCTN70768808; http://www.isrctn.com/ISRCTN70768808 (Archived by WebCite at http://www.webcitation.org/786316Zqk) International Registered Report Identifier (IRRID): DERR1-10.2196/12377

Data harmonisation is an important intervention to strengthen health systems functioning. It has the potential to enhance the production, accessibility and utilisation of routine health information for clinical and service management decision-making. It is important to understand the range of definitions and concepts of data harmonisation, as well as how its various social and technical components and processes are thought to lead to better health management decision-making. However, there is lack of agreement in the literature, and in practice, on definitions and conceptualisations of data harmonisation, making it difficult for health system decision-makers and researchers to design, implement, evaluate and compare data harmonisation interventions. This scoping review aims to synthesise (1) definitions and conceptualisations of data harmonisation as well as (2) explanations in the literature of the causal relationships between data harmonisation and health management decision-making. This review follows recommended methodological stages for scoping studies. We will identify relevant studies (peer-reviewed and grey literature) from 2000 onwards, in English only, and with no methodological restriction, in various electronic databases, such as CINAHL, MEDLINE via PubMed and Global Health. Two reviewers will independently screen records for potential inclusion for the abstract and full-text screening stages. One reviewer will do the data extraction, analysis and synthesis, with built-in reliability checks from the rest of the team. We will use a combination of sampling techniques, including two types of ‘purposeful sampling’, a methodological approach that is particularly suitable for a scoping review with our objectives. We will provide (a) a numerical synthesis of characteristics of the included studies and (b) a narrative synthesis of definitions and explanations in the literature of the relationship between data harmonisation and health management decision-making. We list potential limitations of this scoping review. To our knowledge, this scoping review will be the first to synthesise definitions and conceptualisations of data harmonisation in the literature as well as the underlying explanations in the literature of the causal links between data harmonisation and health management decision-making.

UNSTRUCTURED Background: Health outcomes for people treated for type 2 diabetes could be substantially improved in sub-Saharan Africa. Failure to take medicines regularly to treat diabetes has been identified as a major problem. Resources to identify and support patients who are not making best use of medicine in low and middle-income settings are scarce. Mobile phones are widely available in these settings including among people with diabetes, and linked technologies such as SMS-text messaging have shown promise in delivering low-cost interventions efficiently. However, evidence that these interventions will work when carried out at a larger scale, and of the extent to which they will improve health outcomes when added to usual care is limited. Methods: We will carry out a randomised clinical trial in two contrasting settings in sub-Saharan Africa, Cape Town in South Africa and Lilongwe in Malawi, to provide information about the impact of sending brief automated messages via SMS text-messaging. The messages will advise people about the benefits of their diabetes treatment and offer motivation and encouragement around lifestyle and use of medication. We will allocate patients using a randomly-generated assignment plan to receive either intervention messages, or an active control. We will follow up people for twelve months measuring important risk factors for poor health outcomes and complications in diabetes so we can estimate potential health benefits, including HbA1c as a marker for long-term blood glucose control and blood pressure control, We will record the costs of doing this, and estimate cost-effectiveness. We will also capture collection of medication and assess the reception of the intervention by participants and health care workers. Discussion: The knowledge gained will have wide application and advance the evidence base for effectiveness of mobile-phone based brief text-messaging on clinical outcomes and in large-scale, operational settings. It will provide evidence for cost-effectiveness that will further inform policy development and decision-making. We will work with a wide network that includes patients, clinicians, academics, industry, and policy makers to help us identify opportunities for informing people about the work and raise awareness of what is being developed and studied. Trial Registration: ISRCTN70768808 (Registered on 3 August 2015)