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Background: The development of strategies to better detect and manage patients with multiple long-term conditions requires estimates of the most prevalent condition combinations. However, standard meta-analysis tools are not well suited to synthesising heterogeneous multimorbidity data., Methods: We developed a statistical model to synthesise data on associations between diseases and nationally representative prevalence estimates and applied the model to South Africa. Published and unpublished data were reviewed, and meta-regression analysis was conducted to assess pairwise associations between 10 conditions: arthritis, asthma, chronic obstructive pulmonary disease (COPD), depression, diabetes, HIV, hypertension, ischaemic heart disease (IHD), stroke and tuberculosis. The national prevalence of each condition in individuals aged 15 and older was then independently estimated, and these estimates were integrated with the ORs from the meta-regressions in a statistical model, to estimate the national prevalence of each condition combination., Results: The strongest disease associations in South Africa are between COPD and asthma (OR 14.6, 95% CI 10.3 to 19.9), COPD and IHD (OR 9.2, 95% CI 8.3 to 10.2) and IHD and stroke (OR 7.2, 95% CI 5.9 to 8.4). The most prevalent condition combinations in individuals aged 15+ are hypertension and arthritis (7.6%, 95% CI 5.8% to 9.5%), hypertension and diabetes (7.5%, 95% CI 6.4% to 8.6%) and hypertension and HIV (4.8%, 95% CI 3.3% to 6.6%). The average numbers of comorbidities are greatest in the case of COPD (2.3, 95% CI 2.1 to 2.6), stroke (2.1, 95% CI 1.8 to 2.4) and IHD (1.9, 95% CI 1.6 to 2.2)., Conclusion: South Africa has high levels of HIV, hypertension, diabetes and arthritis, by international standards, and these are reflected in the most prevalent condition combinations. However, less prevalent conditions such as COPD, stroke and IHD contribute disproportionately to the multimorbidity burden, with high rates of comorbidity. This modelling approach can be used in other settings to characterise the most important disease combinations and levels of comorbidity., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Background and Aims: South Africa is a middle-income country with high levels of income inequality and a rapidly aging population and increasing dementia prevalence. Little is known about which risk factors for dementia are important and how they differ by social determinants of health as well as key demographic characteristics such as sex and wealth. We sought to calculate the population attributable risks (PARs) for established potentially modifiable risk factors for dementia among these different groups. Methods: We obtained risk factor prevalence from population-based surveys for established dementia risk factors (diabetes, midlife hypertension, midlife obesity, physical inactivity, depression, smoking, low educational attainment, social isolation). We used relative risk estimates reported in previous meta-analyses and estimated PARs using Levin's formula and accounting for communality. We tested for one-way and two-way interactions by sex and wealth using Pearson's χ2. In stratified analyses, we performed tests for trend using logistic regression. Results: The prevalence of established risk factors for dementia ranged from 5% for depression to 64% for low education. After accounting for communality, the risk factors contributing the greatest PAR were low education (weighted PAR 12%, 95% CI 7% to 18%), physical inactivity (9, 5-14%), and midlife hypertension (6, 5-14%). Together, 45% of dementia cases may be attributable to modifiable risk factors (95% CI 25-59%). We found significant interactions ( p < 0.005) between sex, wealth, or both (sex * wealth) and each risk factor except social isolation and physical activity. Low education was inversely associated with wealth in both male and female. The PAR for midlife hypertension, obesity, and diabetes was associated with increasing wealth, and was higher in female. In contrast, the PAR for smoking was higher in male (8% vs. 2%) and was associated with increasing wealth among female only. We found that either a strategy of large reductions in selected risk factors with the highest PAR (midlife hypertension, smoking, physical inactivity) or small reductions across all risk factors could potentially reduce dementia cases by as many as 250,000 by 2050. Discussions: The potential impact on dementia risk by decreasing exposure to established dementia risk factors is large and differs by sex and social determinants of health like wealth. Risk factor PAR should inform national and local health policy dementia initiatives in South Africa including which risk factors to target in the whole population and which to target in high-risk groups for maximum public health benefit., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Bobrow, Hoang, Barnes, Gardner, Allen and Yaffe.)

Background: High dietary salt intake is an avoidable cause of hypertension and associated cardiovascular diseases (CVDs). Thus, salt reduction is recommended as one of the most cost-effective interventions for CVD prevention and for achieving the World Health Organization's (WHO) 25% reduction in premature non-communicable disease (NCD) mortality by 2025. However, current and comprehensive information about national salt reduction policies and related actions across different regions are difficult to access and impede progress and monitoring., Objectives: As an initial step to developing an online repository of salt reduction policies and related actions, and to track nation-wise progress towards the WHO's 25 by 25 goal, we aimed to identify and assess salt reduction policies and actions in select countries from two of the top five most populous regions of the world- the South-East Asia and Latin America., Methods: We conducted a literature review to identify national and regional salt reduction policies in the selected South-East Asian and Latin American countries, from January 1990-August 2020, available in English and Spanish. We also contacted selected WHO country offices (South-East Asian region) or relevant national authorities (Latin America) to gain access to unpublished documents., Results: In both regions, we found only a few dedicated stand-alone salt reduction policies: Bhutan, Sri-Lanka and Thailand from South East Asia and Costa Rica from Latin America. Available polices were either embedded in other national health/nutritional policy documents/overall NCD policies or were unpublished and had to be accessed via personal communication., Conclusions: Salt reduction policies are limited and often embedded with other policies which may impede their implementation and utility for tracking national and international progress towards the global salt reduction target associated with the 25 by 25 goal. Developing an online repository could help countries address this gap and assist researchers/policymakers to monitor national progress towards achieving the salt reduction target., Competing Interests: The authors have no competing interests to declare., (Copyright: © 2021 The Author(s).)

Introduction: Monitoring and treatment of type 2 diabetes in South Africa usually takes place in primary care using random blood glucose testing to guide treatment decisions. This study explored the feasibility of using point-of-care haemoglobin A1c (HbA 1c ) testing in addition to glucose testing in a busy primary care clinic in Cape Town, South Africa., Subjects: 185 adults aged 19-88 years with type 2 diabetes., Materials and Methods: Participants recruited to this mixed methods cohort study received a point-of-care HbA 1c test. Doctors were asked to use the point-of-care HbA 1c result for clinical decision-making. Qualitative interviews were held with clinical staff., Results: Point-of-care HbA 1c test results were obtained for 165 participants of whom 109 (65%) had poor glycaemic control (>8% HbA 1c , 64 mmol/mol). Medical officers reported using a combination of HbA 1c and blood glucose 77% of the time for clinical decision-making. Nurses found the analyser easy to use and doctors valued having the HbA 1c result to help with decision-making., Discussion: Our results suggest that 30% of patients may have received inappropriate medication or not received necessary additional medication if random blood glucose alone had been used in routine appointments. Clinicians valued having access to the HbA 1c test result to help them make treatment decisions., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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.

Objective: People living with HIV (PLWH) may be at an increased risk for dementia as they age. Surprisingly, it remains unclear whether PLWH have a higher risk of developing dementia in late life than those without. We explored whether HIV-infection is associated with incident dementia diagnosis in older U.S. veterans accounting for potential confounders and competing risk of death., Methods: We included 1114 veterans diagnosed with HIV, ages at least 55 years (mean = 62 years, SD = 6), followed in the Veterans Health Administration healthcare system from 2004 to 2015, and a propensity-matched comparison group (n = 1114) without HIV. HIV and dementia diagnoses were determined using electronic medical records. Using Fine-Gray proportional hazards models, we examined whether HIV status was associated with a greater risk of incident dementia., Results: During follow-up (mean = 7 years, SD = 4 from date of HIV diagnosis), 5% of veteran PLWH developed dementia compared with 3% without (P = 0.01). Accounting for the competing risk of death and adjusted for demographics, substance use, education and income, PLWH remained 50% more likely to receive a dementia diagnosis [adjusted hazard ratio (aHR) = 1.50, 95% confidence interval 0.96-2.35]. Although combination antiretroviral therapy (cART) exposure was associated with an increased risk of incident dementia, this was driven by differences in illness severity as captured by CD4 cell count. There was no evidence of a differential effect by cART class., Conclusion: In a cohort of older USA veterans, HIV infection increased risk of dementia by 50%, while exposure to cART did not offset this risk. It is critical to understand the mechanisms by which HIV increases risk for developing dementia in later life.

Objective: Community-based peer and community health worker-led diabetes self-management programs (COMP-DSMP) can benefit diabetes care, but the supporting evidence has been inadequately assessed. This systematic review explores the nature of COMP-DSMP in low- and middle-income countries' (LMIC) primary care settings and evaluates implementation strategies and diabetes-related health outcomes., Methods: We searched the Cochrane Library, PubMed-MEDLINE, SCOPUS, CINAHL PsycINFO Database, International Clinical Trials Registry Platform, Clinicaltrials.gov, Pan African Clinical Trials Registry (PACTR), and HINARI (Health InterNetwork Access to Research Initiative) for studies that evaluated a COMP-DSMP in adults with either type 1 or type 2 diabetes in World Bank-defined LMIC from January 2000 to December 2019. Randomised and non-randomised controlled trials with at least 3 months follow-up and reporting on a behavioural, a primary psychological, and/or a clinical outcome were included. Implementation strategies were analysed using the standardised implementation framework by Proctor et al. Heterogeneity in study designs, outcomes, the scale of measurements, and measurement times precluded meta-analysis; thus, a narrative description of studies is provided., Results: Of the 702 records identified, eleven studies with 6090 participants were included. COMP-DSMPs were inconsistently associated with improvements in clinical, behavioural, and psychological outcomes. Many of the included studies were evaluated as being of low quality, most had a substantial risk of bias, and there was a significant heterogeneity of the intervention characteristics (for example, peer definition, selection, recruitment, training and type, dose, and duration of delivered intervention), such that generalisation was not possible., Conclusions: The level of evidence of this systematic review was considered low according to the GRADE criteria. The existing evidence however does show some improvements in outcomes. We recommend ongoing, but well-designed studies using a framework such as the MRC framework for the development and evaluation of complex interventions to inform the evidence base on the contribution of COMP-DSMP in LMIC.

Background : Mobile health (mHealth) has been hailed as a potential gamechanger for non-communicable disease (NCD) management, especially in low- and middle-income countries (LMIC). Individual studies illustrate barriers to implementation and scale-up, but an overview of implementation issues for NCD mHealth interventions in LMIC is lacking. This paper explores implementation issues from two perspectives: information in published papers and field-based knowledge by people working in this field. Methods : Through a scoping review publications on mHealth interventions for NCDs in LMIC were identified and assessed with the WHO mHealth Evidence Reporting and Assessment (mERA) tool. A two-stage web-based survey on implementation barriers was performed within a NCD research network and through two online platforms on mHealth targeting researchers and implementors. Results : 16 studies were included in the scoping review. Short Message Service (SMS) messaging was the main implementation tool. Most studies focused on patient-centered outcomes. Most studies did not report on process measures and on contextual conditions influencing implementation decisions. Few publications reported on implementation barriers. The websurvey included twelve projects and the responses revealed additional information, especially on practical barriers related to the patients' characteristics, low demand, technical requirements, integration with health services and with the wider context. Many interventions used low-cost software and devices with limited capacity that not allowed linkage with routine data or patient records, which incurred fragmented delivery and increased workload. Conclusion : Text messaging is a dominant mHealth tool for patient-directed of quality improvement interventions in LMIC. Publications report little on implementation barriers, while a questionnaire among implementors reveals significant barriers and strategies to address them. This information is relevant for decisions on scale-up of mHealth in the domain of NCD. Further knowledge should be gathered on implementation issues, and the conditions that allow universal coverage., Competing Interests: No competing interests were disclosed., (Copyright: © 2020 van Olmen J et al.)

Background : Mobile health (mHealth) has been hailed as a potential gamechanger for non-communicable disease (NCD) management, especially in low- and middle-income countries (LMICs). Individual studies illustrate barriers to implementation and scale-up, but an overview of implementation issues for NCD mHealth interventions in LMICs is lacking. This paper explores implementation issues from two perspectives: information in published papers and field-based knowledge by people working in this field. Methods : Through a scoping review publications on mHealth interventions for NCDs in LMICs were identified and assessed with the WHO mHealth Evidence Reporting and Assessment (mERA) tool. A two-stage web-based survey on implementation barriers was performed within a NCD research network and through two online platforms on mHealth targeting researchers and implementors. Results : 18 studies were included in the scoping review. Short Message Service (SMS) messaging was the main implementation tool. Most studies focused on patient-centered outcomes. Most studies do not report on process measures and on contextual conditions influencing implementation decisions. Few publications reported on implementation barriers. The websurvey included twelve projects and the responses revealed additional information, especially on practical barriers related to the patients' characteristics, low demand, technical requirements, integration with health services and with the wider context. Many interventions used low-cost software and devices with limited capacity that not allowing linkage with routine data or patient records, which incurred fragmented delivery and increased workload. Conclusion : Text messaging is a dominant mHealth tool for patient-directed of quality improvement interventions in LMICs. Publications report little on implementation barriers, while a questionnaire among implementors reveals significant barriers and strategies to address them. This information is relevant for decisions on scale-up of mHealth in the domain of NCD. Further knowledge should be gathered on implementation issues, and the conditions that allow universal coverage., Competing Interests: No competing interests were disclosed., (Copyright: © 2020 van Olmen J et al.)

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 A 1c (HbA 1c ) 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., (©Andrew Farmer, Kirsty Bobrow, Natalie Leon, Nicola Williams, Enita Phiri, Hazel Namadingo, Sara Cooper, John Prince, Amelia Crampin, Donela Besada, Emmanuelle Daviaud, Ly-Mee Yu, Jonathan Ngoma, David Springer, Bruno Pauly, Shane Norris, Lionel Tarassenko, Moffat Nyirenda, Naomi Levitt. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 30.05.2019.)

Background: Interventions delivered by mobile phones have the potential to prevent cardiovascular disease (CVD) by supporting behavior change toward healthier lifestyles and treatment adherence. To allow replication and adaptation of these interventions across settings, it is important to fully understand how they have been developed. However, the development processes of these interventions have not previously been systematically examined., Objective: This study aimed to systematically describe and compare the development process of text messaging interventions identified in the Text2PreventCVD systematic review., Methods: We extracted data about the development process of the 9 interventions identified in the Text2PreventCVD systematic review. Data extraction, which was guided by frameworks for the development of complex interventions, considered the following development stages: intervention planning, design, development, and pretesting. Following data extraction, we invited the developers of the interventions to contribute to our study by reviewing the accuracy of the extracted data and providing additional data not reported in the available publications., Results: A comprehensive description of the development process was available for 5 interventions. Multiple methodologies were used for the development of each intervention. Intervention planning involved gathering information from stakeholder consultations, literature reviews, examination of relevant theory, and preliminary qualitative research. Intervention design involved the use of behavior change theories and behavior change techniques. Intervention development involved (1) generating message content based on clinical guidelines and expert opinions; (2) conducting literature reviews and primary qualitative research to inform decisions about message frequency, timing, and level of tailoring; and (3) gathering end-user feedback concerning message readability, intervention acceptability, and perceived utility. Intervention pretesting involved pilot studies with samples of 10 to 30 participants receiving messages for a period ranging from 1 to 4 weeks., Conclusions: The development process of the text messaging interventions examined was complex and comprehensive, involving multiple studies to guide decisions about the scope, content, and structure of the interventions. Additional research is needed to establish whether effective messaging systems can be adapted from work already done or whether this level of development is needed for application in other conditions and settings., (©Ignacio Ricci-Cabello, Kirsten Bobrow, Sheikh Mohammed Shariful Islam, Clara K Chow, Ralph Maddison, Robyn Whittaker, Andrew J Farmer. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 29.03.2019.)

Introduction: Sexual dysfunction is a common complication for men with diabetes, yet little is known about the lived experiences of sexual difficulties within the context of diabetes, particularly in low-and-middle-income countries. This study explores how men with type 2 diabetes in three sub-Saharan African settings (Cape Town and Johannesburg, South Africa; Lilongwe, Malawi) perceive and experience sexual functioning and sexual well-being, and the biopsychosocial contexts in which these occur and are shaped., Methods: We used a qualitative research design, including individual interviews (n = 15) and focus group discussions (n = 4). Forty-seven men were included in the study. We used an inductive thematic analysis approach to develop our findings. A biopsychosocial conceptual model on the relationship between chronic illness and sexuality informed the interpretation of findings., Results: Men across the study settings identified sexual difficulties as a central concern of living with diabetes. These difficulties went beyond biomedical issues of erectile dysfunction, comprising complex psychological and relational effects. Low self-esteem, related to a sense of loss of masculinity and reduced sexual and emotional intimacy in partner relationships were common experiences. Specific negative relational effects included suspicion of infidelity, mutual mistrust, general unhappiness, and fear of losing support from partners. These effects may impact on men's ability to cope with their diabetes. Further stressors were a lack of information about the reasons for their sexual difficulties, perceived lack of support from healthcare providers and an inability to communicate with partners about sexual difficulties., Conclusion: More in-depth research is needed to better understand sexual functioning and well-being within the context of diabetes, and its potential impact on diabetes self-management. Holistic and patient-centered care should include raising awareness of sexual problems as a potential complication of diabetes amongst patients, their partners and care providers, and incorporating sexual well-being as part of routine clinical care., Competing Interests: The authors have declared that no competing interests exist.

Objective: The extent to which diabetes (DM) practice guidelines, often based on evidence from high-income countries (HIC), can be implemented to improve outcomes in low- and middle-income countries (LMIC) is a critical challenge. We carried out a systematic review to compare type 2 DM guidelines in individual LMIC versus HIC over the past decade to identify aspects that could be improved to facilitate implementation., Research Design and Methods: Eligible guidelines were sought from online databases and websites of diabetes associations and ministries of health. Type 2 DM guidelines published between 2006 and 2016 with accessible full publications were included. Each of the 54 eligible guidelines was assessed for compliance with the Institute of Medicine (IOM) standards, coverage of the cardiovascular quadrangle (epidemiologic surveillance, prevention, acute care, and rehabilitation), translatability, and its target audiences., Results: Most LMIC guidelines were inadequate in terms of applicability, clarity, and dissemination plan as well as socioeconomic and ethical-legal contextualization. LMIC guidelines targeted mainly health care providers, with only a few including patients (7%), payers (11%), and policy makers (18%) as their target audiences. Compared with HIC guidelines, the spectrum of DM clinical care addressed by LMIC guidelines was narrow. Most guidelines from the LMIC complied with less than half of the IOM standards, with 12% of the LMIC guidelines satisfying at least four IOM criteria as opposed to 60% of the HIC guidelines ( P < 0.001)., Conclusions: A new approach to the contextualization, content development, and delivery of LMIC guidelines is needed to improve outcomes., (© 2018 by the American Diabetes Association.)

Background: Several frameworks now exist to guide intervention development but there remains only limited evidence of their application to health interventions based around use of mobile phones or devices, particularly in a low-resource setting. We aimed to describe our experience of using the Medical Research Council (MRC) Framework on complex interventions to develop and evaluate an adherence support intervention for high blood pressure delivered by SMS text message. We further aimed to describe the developed intervention in line with reporting guidelines for a structured and systematic description., Methods: We used a non-sequential and flexible approach guided by the 2008 MRC Framework for the development and evaluation of complex interventions., Results: We reviewed published literature and established a multi-disciplinary expert group to guide the development process. We selected health psychology theory and behaviour change techniques that have been shown to be important in adherence and persistence with chronic medications. Semi-structured interviews and focus groups with various stakeholders identified ways in which treatment adherence could be supported and also identified key features of well-regarded messages: polite tone, credible information, contextualised, and endorsed by identifiable member of primary care facility staff. Direct and indirect user testing enabled us to refine the intervention including refining use of language and testing of interactive components., Conclusions: Our experience shows that using a formal intervention development process is feasible in a low-resource multi-lingual setting. The process enabled us to pre-test assumptions about the intervention and the evaluation process, allowing the improvement of both. Describing how a multi-component intervention was developed including standardised descriptions of content aimed to support behaviour change will enable comparison with other similar interventions and support development of new interventions. Even in low-resource settings, funders and policy-makers should provide researchers with time and resources for intervention development work and encourage evaluation of the entire design and testing process., Trial Registration: The trial of the intervention is registered with South African National Clinical Trials Register number (SANCTR DOH-27-1212-386; 28/12/2012); Pan Africa Trial Register (PACTR201411000724141; 14/12/2013); ClinicalTrials.gov ( NCT02019823 ; 24/12/2013).

Introduction: Text message interventions have been shown to be effective in prevention and management of several non-communicable disease risk factors. However, the extent to which their effects might vary in different participants and settings is uncertain. We aim to conduct a systematic review and individual participant data (IPD) meta-analysis of randomised clinical trials examining text message interventions aimed to prevent cardiovascular diseases (CVD) through modification of cardiovascular risk factors (CVRFs)., Methods and Analysis: Systematic review and IPD meta-analysis will be conducted according to Preferred Reporting Items for Systematic review and Meta-Analysis of IPD (PRISMA-IPD) guidelines. Electronic database of published studies (MEDLINE, EMBASE, PsycINFO and Cochrane Library) and international trial registries will be searched to identify relevant randomised clinical trials. Authors of studies meeting the inclusion criteria will be invited to join the IPD meta-analysis group and contribute study data to the common database. The primary outcome will be the difference between intervention and control groups in blood pressure at 6-month follow-up. Key secondary outcomes include effects on lipid parameters, body mass index, smoking levels and self-reported quality of life. If sufficient data is available, we will also analyse blood pressure and other secondary outcomes at 12 months. IPD meta-analysis will be performed using a one-step approach and modelling data simultaneously while accounting for the clustering of the participants within studies. This study will use the existing data to assess the effectiveness of text message-based interventions on CVRFs, the consistency of any effects by participant subgroups and across different healthcare settings., Ethics and Dissemination: Ethical approval was obtained for the individual studies by the trial investigators from relevant local ethics committees. This study will include anonymised data for secondary analysis and investigators will be asked to check that this is consistent with their existing approvals. Results will be disseminated via scientific forums including peer-reviewed publications and presentations at international conferences., Trial Registration Number: CRD42016033236., Competing Interests: Conflicts of Interest: None declared., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Background: We assessed the effect of automated treatment adherence support delivered via mobile phone short message system (SMS) text messages on blood pressure., Methods and Results: In this pragmatic, single-blind, 3-arm, randomized trial (SMS-Text Adherence Support [StAR]) undertaken in South Africa, patients treated for high blood pressure were randomly allocated in a 1:1:1 ratio to information only, interactive SMS text messaging, or usual care. The primary outcome was change in systolic blood pressure at 12 months from baseline measured with a validated oscillometric device. All trial staff were masked to treatment allocation. Analyses were intention to treat. Between June 26, 2012, and November 23, 2012, 1372 participants were randomized to receive information-only SMS text messages (n=457), interactive SMS text messages (n=458), or usual care (n=457). Primary outcome data were available for 1256 participants (92%). At 12 months, the mean adjusted change in systolic blood pressure compared with usual care was -2.2 mm Hg (95% confidence interval, -4.4 to -0.04) with information-only SMS and -1.6 mm Hg (95% confidence interval, -3.7 to 0.6) with interactive SMS. Odds ratios for the proportion of participants with a blood pressure <140/90 mm Hg were 1.42 (95% confidence interval, 1.03-1.95) for information-only messaging and 1.41 (95% confidence interval, 1.02-1.95) for interactive messaging compared with usual care., Conclusions: In this randomized trial of an automated adherence support program delivered by SMS text message in a general outpatient population of adults with high blood pressure, we found a small reduction in systolic blood pressure control compared with usual care at 12 months. There was no evidence that an interactive intervention increased this effect., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02019823. South African National Clinical Trials Register, number SANCTR DOH-27-1212-386; Pan Africa Trial Register, number PACTR201411000724141., (© 2016 American Heart Association, Inc.)

Background: Effective use of proven treatments for high blood pressure, a preventable health risk, is challenging for many patients. Prompts via mobile phone SMS-text messaging may improve adherence to clinic visits and treatment, though more research is needed on impact and patient perceptions of such support interventions, especially in low-resource settings., Method: An individually-randomised controlled trial in a primary care clinic in Cape Town (2012-14), tested the effect of an adherence support intervention delivered via SMS-texts, on blood pressure control and adherence to medication, for hypertensive patients. (, Trial Registration: ClinicalTrials.gov NCT02019823). We report on a qualitative evaluation that explored the trial participants' experiences and responses to the SMS-text messages, and identified barriers and facilitators to delivering adherence support via patients' own mobile phones. Two focus groups and fifteen individual interviews were conducted. We used comparative and thematic analysis approaches to identify themes and triangulated our analysis amongst three researchers., Results: Most participants were comfortable with the technology of using SMS-text messages. Messages were experienced as acceptable, relevant and useful to a broad range of participants. The SMS-content, the respectful tone and the delivery (timing of reminders and frequency) and the relational aspect of trial participation (feeling cared for) were all highly valued. A subgroup who benefitted the most, were those who had been struggling with adherence due to high levels of personal stress. The intervention appeared to coincide with their readiness for change, and provided practical and emotional support for improving adherence behaviour. Change may have been facilitated through increased acknowledgement of their health status and attitudinal change towards greater self-responsibility. Complex interaction of psycho-social stressors and health service problems were reported as broader challenges to adherence behaviours., Conclusion: Adherence support for treatment of raised blood pressure, delivered via SMS-text message on the patient's own phone, was found to be acceptable, relevant and helpful, even for those who already had their own reminder systems in place. Our findings begin to identify for whom and what core elements of the SMS-text message intervention appear to work best in a low-resource operational setting, issues that future research should explore in greater depth.

Background: Interventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes, but delivery on a wide scale and at low cost is challenging. Some trials evaluating clinical interventions using short message service (SMS) text-messaging systems have shown important outcomes, although evidence is limited. We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-resource setting. We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care., Methods/design: The SMS Text-message Adherence suppoRt trial (StAR) is a pragmatic individually randomised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town, South Africa. The intervention is a structured programme of clinic appointment, medication pick-up reminders, medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages. Usual care is supplemented by infrequent non-hypertension related SMS text-messages. Participants are 1:1:1 individually randomised, to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender, age, baseline systolic blood pressure, years with hypertension, and previous clinic attendance. The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation. Secondary outcomes include the proportion of patients with 80% or more of days medication available, proportion of participants achieving a systolic blood pressure less than 140 mmHg and a diastolic blood pressure less than 90 mmHg, hospital admissions, health status, retention in clinical care, satisfaction with treatment and care, and patient related quality of life. Anonymised demographic data are collected on non-participants., Discussion: The StAR trial uses a novel, low cost system based on widely available mobile phone technology to deliver the SMS-based intervention, manage communication with patients, and measure clinically relevant outcomes. The results will inform implementation and wider use of mobile phone based interventions for health care delivery in a low-resource setting., Trial Registration: NCT02019823.