Comparing the effectiveness and cost-effectiveness of alternative Type 2 Diabetes monitoring intervals in resource limited settings.

Type 2 Diabetes (T2D) represents a growing disease burden in South Africa. While glycated haemoglobin (HbA1c) testing is the gold standard for long-term blood glucose management, recommendations for HbA1c monitoring frequency are based on expert opinion. This study investigates the effectiveness and cost effectiveness of alternative HbA1c monitoring intervals in the management of T2D. A Markov model with three health states (HbA1c <7%, HbA1c ≥ 7%, Dead) was used to estimate lifetime costs and quality-adjusted-life-years (QALYs) of alternative HbA1c monitoring intervals among patients with T2D, using a provider's perspective and a 3% discount rate. HbA1c monitoring strategies (three-monthly, four-monthly, six-monthly, and annual tests) were evaluated with respect to the incremental cost-effectiveness ratio (ICER) assessing each comparator against a less costly, undominated alternative. The scope of costs included the direct medical costs of managing diabetes. Transition probabilities were obtained from routinely collected public sector HbA1c data, while health service utilization and health-related-quality-of-life (HRQoL) data were obtained from a local cluster randomized controlled trial. Other parameters were obtained from published studies. Robustness of findings was evaluated using one-way and probabilistic sensitivity analyses. A South African indicative cost-effectiveness threshold of USD2,665 was adopted. Annual and lifetime costs of managing diabetes increased with HbA1c monitoring, while increased monitoring provides higher QALYs and Life Years. For the overall cohort, the ICER for six-monthly vs annual monitoring was cost-effective (USD 2,322.37 per QALY gained), whereas the ICER of moving from six-monthly to three-monthly monitoring was not cost-effective(USD 6,437.79 per QALY gained). The ICER for four-monthly vs six-monthly monitoring was extended dominated. The sensitivity analysis showed that the ICERs were most sensitive to health service utilization rates. While the factors influencing glycaemic control are multifactorial, six-monthly monitoring is potentially cost-effective while more frequent monitoring could further improve patient HrQoL.

'We are in control of this thing, and we know what to do now': Pilot and process evaluation of 'Diabetes Together', a couples-focused intervention to support self-management of Type 2 Diabetes in South Africa.

We piloted the delivery of a prototype couples-focused intervention, 'Diabetes Together' with 14 people living with diabetes (PLWD) and their partners, in Cape Town, South Africa in 2022. We aimed to: assess feasibility of recruiting couples in this setting; explore acceptability of intervention materials and changes needed; and investigate whether our prespecified logic model captured how the intervention may work. We used questionnaires, interviews and focus groups after each workshop and after couples completed counselling. We conducted a process evaluation to identify intervention modifications and used inductive thematic analysis to explore whether the data supported our logic model. Twelve of the 14 couples completed the second workshop and 2 couples completed two counselling sessions post-workshop. Feedback showed participants appreciated the intervention and limited improvements were made. Thematic analysis identified four main themes: (1) involving partners matters; (2) group work supports solidarity with other couples; (3) improving communication between partners is crucial; and (4) taking part helped couples to take control of diabetes. Data suggested the logic model should explicitly acknowledge the importance of group education and of equalising partners' knowledge. This pilot suggests that 'Diabetes Together' increased knowledge and skills within couples and could facilitate improved, collaborative self-management of diabetes.

Interdisciplinary perspectives on multimorbidity in Africa: Developing an expanded conceptual model.

Multimorbidity is an emerging challenge for health systems globally. It is commonly defined as the co-occurrence of two or more chronic conditions in one person, but its meaning remains a lively area of academic debate, and the utility of the concept beyond high-income settings is uncertain. This article presents the findings from an interdisciplinary research initiative that drew together 60 academic and applied partners working in 10 African countries to answer the questions: how useful is the concept of multimorbidity within Africa? Can the concept be adapted to context to optimise its transformative potentials? During a three-day concept-building workshop, we investigated how the definition of multimorbidity was understood across diverse disciplinary and regional perspectives, evaluated the utility and limitations of existing concepts and definitions, and considered how to build a more context-sensitive, cross-cutting description of multimorbidity. This iterative process was guided by the principles of grounded theory and involved focus- and whole-group discussions during the workshop, thematic coding of workshop discussions, and further post-workshop development and refinement. Three thematic domains emerged from workshop discussions: the current focus of multimorbidity on constituent diseases; the potential for revised concepts to centre the priorities, needs, and social context of people living with multimorbidity (PLWMM); and the need for revised concepts to respond to varied conceptual priorities amongst stakeholders. These themes fed into the development of an expanded conceptual model that centres the catastrophic impacts multimorbidity can have for PLWMM, families and support structures, service providers, and health systems.

Kisspeptin signalling and its correlation with placental ultrastructure and clinical outcomes in pregnant South African women with obesity and gestational diabetes.

INTRODUCTION: Gestational diabetes mellitus (GDM) is a major pregnancy metabolic disorder and is strongly linked with obesity. Kisspeptin is a hormone that increases several thousand-fold in the maternal circulation during human pregnancy, with placenta as its main source. Studies have suggested that kisspeptin regulates trophoblast invasion and promotes pancreatic insulin secretion and peripheral insulin sensitivity. METHODS: In a well-characterized cohort of pregnant South African women and molecular and histological techniques, this study explored the impact and interaction of maternal obesity and GDM on kisspeptin (KISS1) signalling in relation to placental morphology and maternal and neonatal parameters. RESULTS: We found that GDM had no effect on placental KISS1 and KISS1R (KISS1 receptor) mRNA and/or protein expression. However, obesity reduced placental KISS1R mRNA expression even though overall KISS1 protein abundance or localization was not different from the non-obese group. Maternal and cord circulating KISS1 concentrations did not vary with obesity or GDM, but maternal circulating KISS1 was positively correlated with placenta weight in non-GDM obese women, and negatively correlated with placental intervillous space volume in non-GDM non-obese women. Cord serum KISS1 was positively correlated with infant weight in GDM obese women, but negatively correlated with maternal BMI in the non-obese GDM group. Placental syncytiotrophoblast extracellular vesicles exhibited detectable KISS1 and its abundance was ∼50 % lower in those from obese GDM compared to non-GDM women. DISCUSSION: This study shows maternal obesity and GDM can modulate placental kisspeptin signalling and placental morphological development with potential pathophysiological implications for clinically-relevant pregnancy and perinatal outcomes.

Call to action for a life course approach.

Gestational diabetes remains the most common medical disorder in pregnancy, with short-term and long-term consequences for mothers and offspring. New insights into pathophysiology and management suggest that the current gestational diabetes treatment approach should expand from a focus on late gestational diabetes to a personalised, integrated life course approach from preconception to postpartum and beyond. Early pregnancy lifestyle intervention could prevent late gestational diabetes. Early gestational diabetes diagnosis and treatment has been shown to be beneficial, especially when identified before 14 weeks of gestation. Early gestational diabetes screening now requires strategies for integration into routine antenatal care, alongside efforts to reduce variation in gestational diabetes care, across settings that differ between, and within, countries. Following gestational diabetes, an oral glucose tolerance test should be performed 6-12 weeks postpartum to assess the glycaemic state. Subsequent regular screening for both dysglycaemia and cardiometabolic disease is recommended, which can be incorporated alongside other family health activities. Diabetes prevention programmes for women with previous gestational diabetes might be enhanced using shared decision making and precision medicine. At all stages in this life course approach, across both high-resource and low-resource settings, a more systematic process for identifying and overcoming barriers to preventative care and treatment is needed to reduce the current global burden of gestational diabetes.

Shifting roles of community health workers in the prevention and management of noncommunicable disease during the COVID-19 pandemic: a scoping review.

Community Health Workers (CHWs) play a crucial role in the prevention and management of noncommunicable diseases (NCDs). The COVID-19 pandemic triggered the implementation of crisis-driven responses that involved shifts in the roles of CHWs in terms of delivering services for people with NCDs. Strategically aligning these shifts with health systems is crucial to improve NCD service delivery. The aim of this review was to identify and describe COVID-19-triggered shifting roles of CHWs that are promising in terms of NCD service delivery. We searched Ovid Medline, Embase, CINAHL, Web of Science and CABI for Global Health for relevant articles published between 1 January 2020 and 22 February 2022. Studies that were conducted within a COVID-19 context and focused on the shifted roles of CHWs in NCD service delivery were included. We used Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines to report the findings. A total of 25 articles from 14 countries were included in this review. We identified 12 shifted roles of CHWs in NCD service delivery during COVID-19, which can be categorized in three dimensions: 'enhanced' role of CHWs that includes additional tasks such as medication delivery; 'extended' roles such as the delivery of NCD services at household level and in remote communities; and 'enabled' roles through the use of digital health technologies. Health and digital literacy of people with NCDs, access to internet connectivity for people with NCDs, and the social and organizational context where CHWs work influenced the implementation of the shifted roles of CHWs. In conclusion, the roles of CHWs have shifted during the COVID-19 pandemic to include the delivery of additional NCD services at home and community levels, often supported by digital technologies. Given the importance of the shifting roles in the prevention and management of NCDs, adaptation and integration of these shifted roles into the routine activities of CHWs in the post-COVID period is recommended.

Human resources challenges in the management of diabetes and hypertension in Mozambique.

BACKGROUND: The major burden of non-communicable diseases (NCDs) globally occurs in low-and middle-income countries, where this trend is expected to increase dramatically over the coming years. The resultant change in demand for health care will imply significant adaptation in how NCD services are provided. This study aimed to explore self-reported training and competencies of healthcare providers, and the barriers they face in NCD services provision. METHODS: A qualitative design was used to conduct this study. Data was collected through semi-structured interviews with government officials within the Mozambican Ministry of Health, district health authorities, health facility managers, and health providers at urban and rural health facilities of Maputo, in Mozambique. The data was then analyzed under three domains: provider´s capacity building, health system structuring, and policy. RESULTS: A total of 24 interviews of the 26 planed with managers and healthcare providers at national, district, and health facility levels were completed. The domains analyzed enabled the identification and description of three themes. First, the majority of health training courses in Mozambique are oriented towards infectious diseases. Therefore, healthcare workers perceive that they need to consolidate and broaden their NCD-related knowledge or else have access to NCD-related in-service training to improve their capacity to manage patients with NCDs. Second, poor availability of diagnostic equipment, tools, supplies, and related medicines were identified as barriers to appropriate NCD care and management. Finally, insufficient NCD financing reflects the low level of prioritization felt by managers and healthcare providers. CONCLUSION: There is a gap in human, financial, and material resources to respond to the country's health needs, which is more significant for NCDs as they currently compete against major infectious disease programming, which is better funded by external partners. Healthcare workers at the primary health care level of Mozambique's health system are inadequately skilled to provide NCD care and they lack the diagnostic equipment and tools to adequately provide such care. Any increase in global and national responses to the NCD challenge must include investments in human resources and appropriate equipment.

A model-based approach to estimating the prevalence of disease combinations in South Africa.

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.

Integrated health system intervention aimed at reducing type 2 diabetes risk in women after gestational diabetes in South Africa (IINDIAGO): a randomised controlled trial protocol.

INTRODUCTION: South Africa has a high prevalence of gestational diabetes mellitus (GDM; 15%) and many of these women (48%) progress to type 2 diabetes mellitus (T2DM) within 5 years post partum. A significant proportion (47%) of the women are not aware of their diabetes status after the index pregnancy, which may be in part to low postnatal diabetes screening rates. Therefore, we aim to evaluate a intervention that reduces the subsequent risk of developing T2DM among women with recent GDM. Our objectives are fourfold: (1) compare the completion of the nationally recommended 6-week postpartum oral glucose tolerance test (OGTT) between intervention and control groups; (2) compare the diabetes risk reduction between control and intervention groups at 12 months' post partum; (3) assess the process of implementation; and (4) assess the cost-effectiveness of the proposed intervention package. METHODS AND ANALYSES: Convergent parallel mixed-methods study with the main component being a pragmatic, 2-arm individually randomised controlled trial, which will be carried out at five major referral centres and up to 26 well-baby clinics in the Western Cape and Gauteng provinces of South Africa. Participants (n=370) with GDM (with no prior history of either type 1 or type 2 diabetes) will be recruited into the study at 24-36 weeks' gestational age, at which stage first data collection will take place. Subsequent data collection will take place at 6-8 weeks after delivery and again at 12 months. The primary outcome for the trial is twofold: first, the completion of the recommended 2-hour OGTT at the well-baby clinics 6-8 weeks post partum, and second, a composite diabetes risk reduction indicator at 12 months. Process evaluation will assess fidelity, acceptability, and dose of the intervention. ETHICS AND DISSEMINATION: Ethics approval has been granted from University of Cape Town (829/2016), University of the Witwatersrand, Johannesburg (M170228), University of Stellenbosch (N17/04/032) and the University of Montreal (2019-794). The results of the trial will be disseminated through publication in peer-reviewed journals and presentations to key South African Government stakeholders and health service providers. PROTOCOL VERSION: 1 December 2022 (version #2). Any protocol amendments will be communicated to investigators, Human Ethics Research Committees, trial participants, and trial registries. TRIAL REGISTRATION NUMBER: PAN African Clinical Trials Registry (https://pactr.samrc.ac.za) on 11 June 2018 (identifier PACTR201805003336174).

Phenotype and predictors of insulin independence in adults presenting with diabetic ketoacidosis: a prospective cohort study.

AIMS/HYPOTHESIS: The aim of this work was to describe the phenotype of adults presenting with a first episode of diabetic ketoacidosis (DKA) in Cape Town, South Africa, and identify predictors of insulin independence at 12 and 60 months after presentation. METHODS: A prospective, descriptive cohort study of all individuals, 18 years or older, presenting for the first time with DKA to four public-sector hospitals of the Groote Schuur Academic Health Complex was performed. Clinical, biochemical and laboratory data including GAD antibody and C-peptide status were collected at baseline. Insulin was systematically weaned and stopped in individuals who achieved normoglycaemia within the months after DKA. Individuals were followed for 12 months and then annually until 5 years after initial presentation with ketoacidosis. RESULTS: Eighty-eight individuals newly diagnosed with diabetes when presenting with DKA were included and followed for 5 years. The mean ± SD age was 35±10 years and the median (IQR) BMI at diagnosis was 28.5 (23.3-33.4) kg/m2. Overall, 46% were insulin independent 12 months after diagnosis and 26% remained insulin independent 5 years after presentation. Forty-one participants (47%) tested negative for anti-GAD and anti-IA-2 antibodies and had C-peptide levels >0.3 nmol/l; in this group, 68% were insulin independent at 12 months and 37% at 5 years after diagnosis. The presence of acanthosis nigricans was strongly associated with insulin independence (OR 27.1 [95% CI 7.2, 102.2]; p<0.001); a positive antibody status was associated with a lower likelihood of insulin independence at 12 months (OR 0.10 [95% CI 0.03, 0.36]; p<0.001). On multivariable analysis only acanthosis (OR 11.5 [95% CI 2.5, 53.2]; p=0.004) was predictive of insulin independence 5 years after diagnosis. CONCLUSIONS/INTERPRETATION: The predominant phenotype of adults presenting with a first episode of DKA in Cape Town, South Africa, was that of ketosis-prone type 2 diabetes. These individuals presented with obesity, acanthosis nigricans, negative antibodies and normal C-peptide and could potentially be weaned off insulin at follow-up. Classic type 1 diabetes (lower weight, antibody positivity, low or unrecordable C-peptide levels and long-term insulin dependence) was less common. The simple clinical sign of acanthosis nigricans is a strong predictor of insulin independence at 12 months and 5 years after initial presentation.

Perceptions of Health, Body Size, and Nutritional Risk Factors for Obesity in People with HIV in South Africa.

Metabolic disease is increasing in people with HIV (PWH) in South Africa, but little is known about self-perceptions of body size, health, and nutritional behavior in this population. We performed a cross-sectional analysis of individual-level data from the 2016 South Africa Demographic and Health Survey. This survey measured HIV serostatus and body mass index (BMI). We categorized participants into six BMI groups: 18.5-22 kg/m2, 22-25 kg/m2, 25-27.5 kg/m2, 27.5-30 kg/m2, 30-35 kg/m2, and ≥ 35 kg/m2 and stratified them by HIV serostatus. Our outcomes were self-reported (1) body size and (2) health status among all participants, and intake of (3) chips and (4) sugar-sweetened beverages (SSB) in PWH. We described these metrics and used multivariable regression to evaluate the relationship between the nutritional behaviors and BMI ≥ 25 kg/m2 in PWH only, adjusting for age, sex, educational attainment, and household wealth quintile. Of 6138 participants, 1163 (19.7%) were PWH. Among PWH, < 10% with a BMI 25-30 kg/m2, < 20% with a BMI 30-35 kg/m2 and < 50% with a BMI ≥ 35 kg/m2 self-reported as overweight or obese. PWH reported being in poor health at higher rates than those without HIV at each BMI category except ≥ 35 kg/m2. In adjusted models, SSB consumption was associated with BMI ≥ 25 kg/m2 (1.13 [1.01-1.25], t-statistic = 2.14, p = 0.033) in PWH. Perceptions of body size may challenge efforts to prevent weight gain in PWH in South Africa. SSB intake reduction should be further explored as a modifiable risk factor for obesity.

Multi-country collaborative citizen science projects to co-design cardiovascular disease prevention strategies and advocacy: findings from Ethiopia, Malawi, Rwanda, and South Africa.

BACKGROUND: Cardiovascular diseases (CVD) were responsible for 20.5 million annual deaths globally in 2021, with a disproportionally high burden in sub-Saharan Africa (SSA). There is growing evidence of the use of citizen science and co-design approaches in developing interventions in different fields, but less so in the context of CVD prevention interventions in SSA. This paper reports on the collaborative multi-country project that employed citizen science and a co-design approach to (i) explore CVD risk perceptions, (ii) develop tailored prevention strategies, and (iii) support advocacy in different low-income settings in SSA. METHODS: This is a participatory citizen science study with a co-design component. Data was collected from 205 participants aged 18 to 75 years in rural and urban communities in Malawi, Ethiopia and Rwanda, and urban South Africa. Fifty-one trained citizen scientists used a mobile app-based (EpiCollect) semi-structured survey questionnaire to collect data on CVD risk perceptions from participants purposively selected from two communities per country. Data collected per community included 100-150 photographs and 150-240 voice recordings on CVD risk perceptions, communication and health-seeking intentions. Thematic and comparative analysis were undertaken with the citizen scientists and the results were used to support citizen scientists-led stakeholder advocacy workshops. Findings are presented using bubble graphs based on weighted proportions of key risk factors indicated. RESULTS: Nearly three in every five of the participants interviewed reported having a relative with CVD. The main perceived causes of CVD in all communities were substance use, food-related factors, and litter, followed by physical inactivity, emotional factors, poverty, crime, and violence. The perceived positive factors for cardiovascular health were nutrition, physical activity, green space, and clean/peaceful communities. Multi-level stakeholders (45-84 persons/country) including key decision makers participated in advocacy workshops and supported the identification and prioritization of community-specific CVD prevention strategies and implementation actions. Citizen science-informed CVD risk screening and referral to care interventions were piloted in six communities in three countries with about 4795 adults screened and those at risk referred for care. Health sector stakeholders indicated their support for utilising a citizen-engaged approach in national NCDs prevention programmes. The citizen scientists were excited by the opportunity to lead research and advocacy. CONCLUSION: The collaborative engagement, participatory learning, and co-designing activities enhanced active engagement between citizen scientists, researchers, and stakeholders. This, in turn, provided context-specific insights on CVD prevention in the different SSA settings.

Ubuntu as a mediator in coping with multimorbidity treatment burden in a disadvantaged rural and urban setting in South Africa.

BACKGROUND: People living with multimorbidity in economically precarious circumstances in low- and middle-income countries (LMICs) experience a high workload trying to meet self-management demands. However, in countries such as South Africa, the availability of social networks and support structures may improve patient capacity, especially when networks are governed by cultural patterns linked to the Pan-African philosophy of Ubuntu, which promotes solidarity through humanness and human dignity. We explore the mediating role Ubuntu plays in people's ability to self-manage HIV/NCD multimorbidity in underprivileged settings in urban and rural South Africa. METHODS: We conducted semi-structured interviews with 30 patients living with HIV/NCD multimorbidity between February-April 2022. Patients attended public health clinics in Gugulethu, Cape Town and Bulungula, Eastern Cape. We analysed interviews using framework analysis, using the Cumulative Complexity Model (CuCoM) and Burden of Treatment Theory (BoTT) as frameworks through which to conceptualise the data. RESULTS: Despite facing economic hardship, people with multimorbidity in South Africa were able to cope with their workload. They actively used and mobilized family relations and external networks that supported them financially, practically, and emotionally, allowing them to better self-manage their chronic conditions. Embedded in their everyday life, patients, often unconsciously, embraced Ubuntu and its core values, including togetherness, solidarity, and receiving Imbeko (respect) from health workers. This enabled participants to share their treatment workload and increase self-management capacity. CONCLUSION: Ubuntu is an important mediator for people living with multimorbidity in South Africa, as it allows them to navigate their treatment workload and increase their social capital and structural resilience, which is key to self-management capacity. Incorporating Ubuntu and linked African support theories into current treatment burden models will enable better understandings of patients' collective support and can inform the development of context-specific social health interventions that fit the needs of people living with chronic conditions in African settings.

'I accept his manhood is on life-support': A qualitative understanding of the impact of diabetes on sexual relationships among men and women living with type 2 diabetes and their partners in South Africa.

AIMS: To explore the impact of diabetes on sexual relationships among men and women living with type 2 diabetes People living with type 2 diabetes (PLWD) and their partners in Cape Town, South Africa. METHODS: As part of a larger study developing an intervention to improve type 2 diabetes mellitus (T2DM) self management, we conducted in-depth individual interviews with 10 PLWD and their partners without diabetes about experiences living with T2DM, between July 2020 and January 2021. We used inductive thematic analysis. RESULTS: Both PLWD and partners felt that their sexual relationships and desires changed post-diagnosis, in ways beyond biomedical issues. Although couples' reports on the quality of their sexual relationships were concordant, most participants had not communicated their sexual desires and concerns with each other, causing unhappiness and fears of disappointing or losing their partner. Participants felt uninformed about sexual dysfunction but had not discussed this with their healthcare provider, leading to increased anxiety. CONCLUSION: PLWD and their partners need more informational support to increase their understanding of diabetes-associated sexual dysfunction and to decrease fears and anxiety. Strengthening communication within couples on sexual issues may empower them to find solutions to problems experienced. This may improve couples' relationships and quality of life, and indirectly result in better self management of T2DM.

Associations of HIV and antiretroviral therapy with gestational diabetes in South Africa.

OBJECTIVE: To estimate associations of HIV status and antiretroviral (ART) regimen with gestational diabetes (GDM) and postpartum glucose metabolism. DESIGN: Prospective cohort study. METHODS: We enrolled pregnant persons with HIV (PWH) and without HIV in Cape Town, South Africa who were at least 18 years of age at 24-28 weeks' gestation and followed up to 26 months postpartum. Participants were tested for GDM in pregnancy and for diabetes postpartum using a 75 g 2 h oral glucose tolerance test (OGTT) and diagnosed via WHO criteria. We estimated associations of HIV status and ART regime [efavirenz (EFV) versus dolutegravir (DTG)] with GDM and postpartum impaired glucose metabolism using multivariable log binomial or linear regression models. RESULTS: Among 397 participants [median age 30 (interquartile range (IQR) 25-34; n  = 198 without HIV, n  = 199 PWH], the prevalence of GDM was 6% (9 PWH versus 3% without HIV). In multivariable analyses, PWH were at higher risk of GDM [risk ratio (RR) 3.9, 95% confidence interval (CI) 1.4-10.7] after adjustment for prepregnancy BMI and other confounders. GDM risk did not differ by ART regimen (unadjusted prevalence 8.1% DTG versus 5.6% EFV, adjusted RR 1.1, 95% CI 0.2-6.6). Few participants had diabetes, impaired glucose tolerance (IGT), or impaired fasting glucose postpartum ( n  = 13, 6%) with no differences by HIV or ART status. CONCLUSION: In a setting of universal GDM testing, PWH had an increased risk of impaired glucose metabolism during pregnancy but not postpartum. Among PWH, GDM risk was similar regardless of EFV or DTG use. Given concerns about DTG and weight gain, diabetes risk should continue to be monitored.

Using the COM-B model and Behaviour Change Wheel to develop a theory and evidence-based intervention for women with gestational diabetes (IINDIAGO).

BACKGROUND: In South Africa, the prevalence of gestational diabetes (GDM) is growing, concomitant with the dramatically increasing prevalence of overweight/obesity among women. There is an urgent need to develop tailored interventions to support women with GDM to mitigate pregnancy risks and to prevent progression to type 2 diabetes post-partum. The IINDIAGO study aims to develop and evaluate an intervention for disadvantaged GDM women attending three large, public-sector hospitals for antenatal care in Cape Town and Soweto, SA. This paper offers a detailed description of the development of a theory-based behaviour change intervention, prior to its preliminary testing for feasibility and efficacy in the health system. METHODS: The Behaviour Change Wheel (BCW) and the COM-B model of behaviour change were used to guide the development of the IINDIAGO intervention. This framework provides a systematic, step-by-step process, starting with a behavioural analysis of the problem and making a diagnosis of what needs to change, and then linking this to intervention functions and behaviour change techniques to bring about the desired result. Findings from primary formative research with women with GDM and healthcare providers were a key source of information for this process. RESULTS: Key objectives of our planned intervention were 1) to address women's evident need for information and psychosocial support by positioning peer counsellors and a diabetes nurse in the GDM antenatal clinic, and 2) to offer accessible and convenient post-partum screening and counselling for sustained behaviour change among women with GDM by integrating follow-up into the routine immunisation programme at the Well Baby clinic. The peer counsellors and the diabetes nurse were trained in patient-centred, motivational counselling methods. CONCLUSIONS: This paper offers a rich description and analysis of designing a complex intervention tailored to the challenging contexts of urban South Africa. The BCW was a valuable tool to use in designing our intervention and tailoring its content and format to our target population and local setting. It provided a robust and transparent theoretical foundation on which to develop our intervention, assisted us in making the hypothesised pathways for behaviour change explicit and enabled us to describe the intervention in standardised, precisely defined terms. Using such tools can contribute to improving rigour in the design of behavioural change interventions. TRIAL REGISTRATION: First registered on 20/04/2018, Pan African Clinical Trials Registry (PACTR): PACTR201805003336174.

Intervention development of 'Diabetes Together' using the person-based approach: a couples-focused intervention to support self-management of type 2 diabetes in South Africa.

OBJECTIVES: Type 2 diabetes (T2D) is a growing concern in South Africa, where many find self-management challenging. Behaviour-change health interventions are enhanced by involving partners of patients. We aimed to develop a couples-focused intervention to improve self-management of T2D among adults in South Africa. DESIGN: We used the person-based approach (PBA): synthesising evidence from existing interventions; background research; theory; and primary qualitative interviews with 10 couples to ascertain barriers and facilitators to self-management. This evidence was used to formulate guiding principles that directed the intervention design. We then prototyped the intervention workshop material, shared it with our public and patient involvement group and ran iterative co-discovery think-aloud sessions with nine couples. Feedback was rapidly analysed and changes formulated to improve the intervention, optimising its acceptability and maximising its potential efficacy. SETTING: We recruited couples using public-sector health services in the area of Cape Town, South Africa, during 2020-2021. PARTICIPANTS: The 38 participants were couples where one person had T2D. INTERVENTION: We developed the 'Diabetes Together' intervention to support self-management of T2D among couples in South Africa, focussing on: improved communication and shared appraisal of T2D; identifying opportunities for better self-management; and support from partners. Diabetes Together combined eight informational and two skills-building sections over two workshops. RESULTS: Our guiding principles included: providing equal information on T2D to partners; improving couples' communication; shared goal-setting; discussion of diabetes fears; discussing couples' roles in diabetes self-management; and supporting couples' autonomy to identify and prioritise diabetes self-management strategies.Participants viewing Diabetes Together valued the couples-focus of the intervention, especially communication. Feedback resulted in several improvements throughout the intervention, for example, addressing health concerns and tailoring to the setting. CONCLUSIONS: Using the PBA, our intervention was developed and tailored to our target audience. Our next step is to pilot the workshops' feasibility and acceptability.

Cost-effectiveness of Lifestyle Africa: an adaptation of the diabetes prevention programme for delivery by community health workers in urban South Africa.

BACKGROUND: Lifestyle Africa is an adapted version of the Diabetes Prevention Program designed for delivery by community health workers to socioeconomically disadvantaged populations in low- and middle-income countries (LMICs). Results from the Lifestyle Africa trial conducted in an under-resourced community in South Africa indicated that the programme had a significant effect on reducing haemoglobin A1c (HbA1c). OBJECTIVE: To estimate the cost of implementation and the cost-effectiveness (in cost per point reduction in HbA1c) of the Lifestyle Africa programme to inform decision-makers of the resources required and the value of this intervention. METHODS: Interviews were held with project administrators to identify the activities and resources required to implement the intervention. A direct-measure micro-costing approach was used to determine the number of units and unit cost for each resource. The incremental cost per one point improvement in HbA1c was calculated. RESULTS: The intervention equated to 71 United States dollars (USD) in implementation costs per participant and a 0.26 improvement in HbA1c per participant. CONCLUSIONS: Lifestyle Africa reduced HbA1c for relatively little cost and holds promise for addressing chronic disease in LMIC. Decision-makers should consider the comparative clinical effectiveness and cost-effectiveness of this intervention when making resource allocation decisions. TRIAL REGISTRATION: Trial registration is at ClinicalTrials.gov (NCT03342274).

The impact of persistent precarity on patients' capacity to manage their treatment burden: A comparative qualitative study between urban and rural patients with multimorbidity in South Africa.

Background: People living with multimorbidity in low-and middle-income countries (LMICs) experience a high workload trying to meet the demands of self-management. In an unequal society like South Africa, many people face continuous economic uncertainty, which can impact on their capacity to manage their illnesses and lead to poor health outcomes. Using precariousness - the real and perceived impact of uncertainty - as a lens, this paper aims to identify, characterise, and understand the workload and capacity associated with self-management amongst people with multimorbidity living in precarious circumstances in urban and rural South Africa. Methods: We conducted qualitative semi-structured interviews with 30 patients with HIV and co-morbidities between February and April 2021. Patients were attending public clinics in Cape Town (Western Cape) and Bulungula (Eastern Cape). Interviews were transcribed and data analysed using qualitative framework analysis. Burden of Treatment Theory (BoTT) and the Cumulative Complexity Model (CuCoM) were used as theoretical lenses through which to conceptualise the data. Results: People with multimorbidity in rural and urban South Africa experienced multi-faceted precariousness, including financial and housing insecurity, dangerous living circumstances and exposure to violence. Women felt unsafe in their communities and sometimes their homes, whilst men struggled with substance use and a lack of social support. Older patients relied on small income grants often shared with others, whilst younger patients struggled to find stable employment and combine self-management with family responsibilities. Precariousness impacted access to health services and information and peoples' ability to buy healthy foods and out-of-pocket medication, thus increasing their treatment burden and reducing their capacity. Conclusion: This study highlights that precariousness reduces the capacity and increases treatment burden for patients with multimorbidity in low-income settings in South Africa. Precariousness is both accumulative and cyclic, as financial insecurity impacts every aspect of peoples' daily lives. Findings emphasise that current models examining treatment burden need to be adapted to accommodate patients' experiences in low-income settings and address cumulative precariousness. Understanding treatment burden and capacity for patients in LMICs is a crucial first step to redesign health systems which aim to improve self-management and offer comprehensive person-centred care.

Digital Health Solutions for Community-Based Control of Diabetes During COVID-19 Pandemic: A Scoping Review of Implementation Outcomes.

BACKGROUND: The COVID-19 pandemic has added to the pre-existing challenges of diabetes management in many countries. It has accelerated the wider use of digital health solutions which have tremendous potential to improve health outcomes for people with diabetes. However, little is known about the attributes and the implementation of these solutions. OBJECTIVE: To identify and describe digital health solutions for community-based diabetes management and to highlight their key implementation outcomes. METHODS: We searched Ovid Medline, CINAHL, Embase, PsycINFO, and Web of Science for relevant articles. A purposive search was also used to identify grey literature. Articles that described digital health solutions that aimed to improve community-based diabetes management were included in this review. We applied a thematic synthesis of evidence to describe the characteristics of digital health solutions, and to summarize their key implementation outcomes. RESULTS: We included 15 articles that reported digital health solutions that primarily focused on community-based diabetes management. Nine of the 15 innovations involved were mobile applications and/or web-based platforms, and five were based on social media platforms. The majority of the digital health solutions were used for diabetes education and support. High engagement, utilization, and satisfaction rates with digital health solutions were observed. The use of digital health solutions was also associated with improvement in self-management, taking medication, and reduction in glycated hemoglobin (HbA1c) levels. CONCLUSION: COVID-19 triggered digital health solutions have tremendous potential to improve health outcomes for people with diabetes. Further studies are needed to evaluate the sustainability and scale-up of these solutions.