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Weight gain on tenofovir alafenamide fumarate-based therapy compared to tenofovir disoproxil fumarate- and abacavir-based therapy in children and young people living with HIV in Europe.
Get PDFOBJECTIVE: To compare BMI-for-age z-score (zBMI) changes in treatment-experienced children and young people living with HIV aged 6 to <25 years on tenofovir alafenamide fumarate (TAF) to those on tenofovir disoproxil fumarate (TDF) and abacavir (ABC). METHODS: Cohort study of children and young people living with HIV from 12 European countries were grouped by drug exposure: 1 - on TAF with prior TDF use; 2 - on TAF no prior TDF; 3 - on TDF; and 4 - on ABC. Outcomes, adjusted for characteristics at drug start, were (i) incidence of overweight or obesity by 96 weeks, (ii) zBMI change 48 weeks before/after drug start, (iii) association between TAF/TDF/ABC and anchor drug on zBMI change and (iv) factors associated with zBMI change on TAF over 96 weeks. RESULTS: Overall, 162, 189, 270 and 144 were in groups 1, 2, 3 and 4, respectively. Median ages at drug start were 16, 13, 14 and 12 years. Obesity incidence by 96 weeks was 16%, 13%, 6% and 12% and higher on TAF than TDF (p = 0.018) but comparable to ABC (p = 0.568). Similar trends were seen for overweight/obesity, although differences were not significant. Over 48 weeks, zBMI increased at a higher rate on TAF than TDF (p = 0.001) but similar to ABC (p = 0.652). zBMI change was higher after than before drug start in group 1 (p = 0.059) but similar in other groups. Over 96 weeks zBMI change on TAF/TDF/ABC combined with dolutegravir vs. other anchor drugs was not statistically different (p = 0.196). zBMI change on TAF varied by age (p = 0.001), prior TDF (p = 0.019), viral load (p = 0.042) and zBMI (p = 0.004) at TAF start. CONCLUSION: zBMI increased on TAF, faster than TDF, but similar to ABC. Weight gain on TAF was associated with multiple factors including prior TDF use
'They Just Said It Was My Mood. I Was Trying to Get Attention': Exploring Barriers to Psychological Support for People Impacted by Contaminated Blood in England.
Get PDFOBJECTIVES: Between the 1970s and the early 1990s, over 30,000 individuals in the United Kingdom were infected with human immunodeficiency virus (HIV) and/or hepatitis C virus following treatment with NHS-supplied blood and blood products, with devastating consequences. This study aims to better understand the psychological support needs of these individuals and their families, and to identify barriers to accessing support in England. METHODS: Forty-one individuals infected with HIV and/or hepatitis C virus and 11 affected family members were interviewed, as well as 14 mental health practitioners and experts involved in psychological support services across the United Kingdom. Data were analysed using a thematic approach. RESULTS: Only a few infected and affected participants had received mental health support, and only just over half knew about the availability of funding for psychological support from the England Infected Blood Support Scheme. Participants identified a number of barriers preventing them from accessing support. These included personal and social factors such as family responsibilities, stigma and secrecy. Structural barriers to access were a lack of available mental health support, limited understanding among professionals of the contaminated blood scandal, discrimination in healthcare, and difficulties finding suitable therapists and navigating referral systems. When individuals managed to access support, it was often perceived as inadequate or ineffective. Practitioners also identified a substantial need for psychological support within the infected and affected communities, and described support provided as inadequate, with little guidance and limited availability of competent practitioners. Practitioners also emphasised the need for long-term and tailored treatment approaches to address the profound mental and physical health impacts of infected blood. CONCLUSIONS: Existing psychological support systems in England, both public and private, fail to meet the needs of infected and affected communities. Our findings show a substantial and increasing need for accessible, effective and individualised services. PATIENT OR PUBLIC CONTRIBUTION: This study was carried out from August 2022 to August 2023, during the period when the statutory Infected Blood Inquiry was conducting public hearings and soliciting witness statements from people infected or affected by the contaminated blood scandal. A key consideration of our work was therefore the potential additional burden on participants who were asked to reflect on their experiences as survivors and/or bereaved family members of infected individuals within the broader context of the Inquiry. We were aware of the emotional weight this might place on participants. To address this, we collaborated with several organisations supporting infected and affected individuals in autumn 2022: the British Red Cross, the Haemophilia Society, the Hepatitis C Trust, the Terrence Higgins Trust, and the Haemophilia & Bleeding Disorders Counselling Association. Representatives of these organisations included individuals who had been infected themselves, as well as mental health practitioners. We held extensive discussions with these organisations on the contaminated blood scandal, the experiences of those impacted, and the support available. They also provided feedback on our draft research materials (information sheet and interview topic guide), which we incorporated into our final versions, and reviewed our findings. In addition, these organisations also acted as facilitators to engage infected and affected people to participate in the study, where this was possible
Randomization procedures in parallel-arm cluster randomized trials in low- and middle-income countries: a review of 300 trials published between 2017-2022.
No full textOBJECTIVES: Cluster randomized trials (CRTs) are frequently used to evaluate interventions in low- and middle-income countries (LMICs). Robust execution and transparent reporting of randomization procedures are essential for successful implementation and accurate interpretation of CRTs. Our objectives were to review the quality of reporting and implementation of randomization procedures in a sample of parallel-arm CRTs conducted in LMICs. STUDY DESIGN AND SETTING: We selected a random sample of 300 primary reports of parallel-arm CRTs from a database of 800 CRTs conducted in LMICs between 2017 and 2022. Data were extracted by two reviewers per trial and summarized using descriptive statistics. RESULTS: Among 300 trials, 192 (64%) reported the method of sequence generation, 213 (71%) reported the type of randomization procedure used, 146 (49%) reported who generated the sequence, 136 (45%) reported whether randomization was implemented by an independent person, and 75 (25%) reported a method of allocation concealment. Among those reporting the methods used, suboptimal randomization procedures were common: 28% did not use a computer, 21% did not use restricted randomization, 58% did not use a statistician to generate the sequence, in 53% the person was not independent from the trial, and 80% did not use central randomization. Public randomization ceremonies were used in 10% of trials as an alternative method of allocation concealment and to reassure participants of fair allocation procedures. CONCLUSION: The conduct and reporting of randomization procedures of CRTs in LMICs is suboptimal. Dissemination of guidance to promote robust implementation of randomization in LMICs is required, and future research on the implementation of public randomization ceremonies is warranted. PLAIN LANGUAGE SUMMARY: Cluster randomized trials (CRTs) are trials where entire groups, rather than individuals, are randomly assigned to different treatments (eg, intervention or usual care). This randomization process can be challenging in CRTs; clear reporting and proper execution are important to ensure fairness and accurate results. In this study, we reviewed how well randomization procedures were reported and carried out in 300 CRTs, selected from a larger database of 800 CRTs, conducted in low- and middle-income countries (LMICs), and published between 2017 and 2022. We found that reporting on key aspects of randomization was often incomplete: 64% reported how they created the random allocation sequence, 71% reported the type of randomization method used, 49% reported who generated the sequence, 45% reported whether a person independent from the trial handled the randomization, and 25% reported how they kept group assignments hidden until the intervention was ready to begin. Even when trials did reported these methods, many did not follow best practices: 28% did not use a computer, 21% did not apply techniques to ensure balanced treatment arms, 58% did not involve a statistician to generate the sequence, 53% had someone involved in the trial handle randomization (as opposed to an independent person), and 80% did not use central randomization to assign groups, where a third party reveals treatment assignment to groups. Interestingly, 10% of trials used public randomization ceremonies (events where group assignments are revealed in a public setting) to keep group assignments hidden until revealment and to reassure participants that the process was fair. Overall, we found that randomization procedures in CRTs were often not well reported or carried out optimally. It is important for researchers to follow established guidelines to ensure randomization is done properly in CRTs in LMICs. More research is also needed to understand how public randomization ceremonies are used in practice
HIV PrEP programmes as a framework for diagnosing and treating HBV infection in adolescents and young adults in KwaZulu-Natal, South Africa.
Get PDFBACKGROUND: Guidelines for Hepatitis B treatment released by the World Health Organization in 2024 include the potential for use of dual therapy, combining tenofovir with either emtricitabine or lamivudine. These fixed-dose combinations are also used for Pre-Exposure Prophylaxis (PrEP) in people at risk of Human Immunodeficiency Virus (HIV). We hypothesize that pre-existing HIV PrEP programmes can support access to HBV testing and treatment. METHODS: At the Africa Health Research Institute (AHRI) in KwaZulu Natal, South Africa, we evaluated PrEP uptake and retention amongst adolescents and young adults aged 15-30 years. We reviewed HBV status, acceptance of PrEP and retention in follow-up between June 2022-Sept 2024. RESULTS: 15847 adolescents and young adults received an assessment in the community, of whom 3481/15847 (21.9 %) were eligible for sexual health prevention interventions. 3431/3481 (98.6 %) accepted HBV screening, of whom 21/3431 (0.6 %) tested positive for HBsAg. These 21 individuals had not previously been aware of their HBV status, but one was already on antiretroviral therapy for HIV infection. Amongst the others, 16/20 (80 %) were considered eligible for PrEP, and 15/16 started PrEP. When investigating retention in care, among 15 individuals due for a refill, 8/15 (53.3 %) returned at least once. CONCLUSION: Sexual reproductive health and PrEP programmes provide an opportunity for HBV testing and treatment. However, attrition from the care cascade at each step highlights the pressing need for interventions that address barriers to sustainable delivery of long-term care
Re-Evaluating Recurrent Events in Heart Failure Trials: Patterns, Prognostic Implications, and Analytical Improvements.
No full textAnalyses using repeat hospitalizations (HFHs) are common in heart failure trials and typically assume that such repeat events occur randomly over time. Also, many think that using repeat events enhances statistical power. This article challenges those assumptions, using data from 4 heart failure trials of sodium-glucose cotransporter 2 inhibitors. We found marked within-patient time clustering of repeat events: risks of subsequent HFH and cardiovascular death are markedly elevated following a hospitalization, especially early on. The Lin-Wei-Yang-Ying and negative binomial models do not account for this. Alternative approaches using area under the curve and win ratio methods for the composite of cardiovascular death and all HFHs strengthened the treatment effect. But still, time-to-first event analyses tended to give the strongest evidence. Overall, some commonly used repeat event analyses appear not to be the best. It is time to rethink how best to use repeat events data in heart failure trials
Spatial and temporal variation of malaria incidence in children under 10 years in a pyrethroid-resistant vector area in southern Benin.
Get PDFBACKGROUND: Spatial and temporal identification of malaria-endemic areas is a key component of vector-borne disease control. Strategies to target the most vulnerable populations, the periods of high transmission and the most affected geographical areas, should make vector-borne disease control and prevention programmes more cost-effective. The present study focuses on the spatial and temporal dynamics of malaria cases and the exogenous factors influencing the transmission in an area with pyrethroid-resistant mosquito vector populations. METHODS: A prospective cohort study of 1806 children under 10 years of age was conducted over 20 months to assess the risk of malaria incidence in the Cove-Zagnanado-Ouinhi (CoZO) health zone located in southern Benin. Childhood malaria data were used to identify malaria hotspots according to months of follow-up using spatial scanning methods based on the Kulldoff algorithm. Stability scores were calculated by season to assess incidence heterogeneity. Incidence values by month were aggregated with meteorological data; and demographic data were merged to detect cross-correlation between incidence and meteorological variables. Generalized equation estimators were chosen for their ability to handle intra-group correlation, ensuring robust and interpretable results despite the complexity of the data to identify factors explaining the spatio-temporal heterogeneity of malaria incidence in the CoZO health zone. RESULTS: Malaria incidence ranged from 1.41 (95% IC 0.96-2.08) to 13.91 (95% IC 12.22-15.84) cases per 100 child-months. Spatial heterogeneity in malaria transmission hotspots was observed over the study period, with relative risks ranging from 1.59 (p-value = 0.032) to 16.24 (p-value = 0.002). There was a significant negative association (correlation coefficient = - 0.56) between malaria incidence and temperature; and a slightly positive association (correlation coefficient = 0.58) between malaria incidence and rainfall. A significant association between malaria incidence with average house altitude (adjusted incidence rate ratio [aIRR] 1 (95% IC 0.99-1) P < 0.001), soil type aIRR 0.54 (0.39-0.75) p < 0.001 and temperature (incidence rate ratio [IRR] 0.69 (0.66-0.73) p < 0.001). CONCLUSION: This study uses innovative technologies such as remote sensing and geographic information systems (GIS) to analyse the environmental, meteorological and geographical factors influencing malaria transmission, thereby identifying high-risk areas and associated factors. It demonstrates that these tools improve the accuracy of control strategies, while highlighting the crucial role of the environment and human behaviour, paving the way for more targeted interventions against malaria and other vector-borne diseases
A systematic review of foraging as lifestyle, livelihood, and landscape management strategy.
Get PDFThis systematic review of 353 studies evaluates the knowledge on foraging by humans, situating it in the wider context of human ecology. We highlight the strengths and weaknesses, and the micro (individual) to macro (landscape) level implications of foraging, as concerns livelihoods and social-ecological systems. Descriptive statistics of ethnobotanical studies yielded 1410 genera foraged globally. Foraging can contribute to food and nutritional security, human health and wellbeing, adaptation to global environmental change, and good governance. Research priorities include establishing baselines for species suitability, nutritional quality and biophysical tolerance, social utility, innovation, and foraging impact. Policy recommendations include integrated spatial planning and supporting devolved local economies nested within larger governance and market frameworks to enhance human and natural capital and social cohesion. Actions to foster social-ecological resilience include improving access to forageable resources and spaces, sharing information on sustainable foraging, and landscape stewardship through sustainable foraging
Global excess deaths associated with heatwaves in 2023 and the contribution of human-induced climate change.
Get PDFAn unprecedented heatwave swept the globe in 2023, marking it one of the hottest years on record and raising concerns about its health impacts. However, a comprehensive assessment of the heatwave-related mortality and its attribution to human-induced climate change remains lacking. We aim to address this gap by analyzing high-resolution climate and mortality data from 2,013 locations across 67 countries/territories using a three-stage modeling approach. First, we estimated historical heatwave-mortality associations using a quasi-Poisson regression model with distributed lag structures, considering lag effects, seasonality, and within-week variations. Second, we pooled the estimates in meta-regression, accounting for spatial heterogeneity and potential changes in heatwave-mortality associations over time. Third, we predicted grid-specific (0.5 0.5) association in 2023 and calculated the heatwave-related excess deaths, death ratio, and death rate per million people. Attribution analysis was conducted by comparing heatwave-related mortality under factual and counterfactual climate scenarios. We estimated 178,486 excess deaths (95% empirical confidence interval [eCI], 159,892≥204,147) related to the 2023 heatwave, accounting for 0.73% of global deaths, corresponding to 23 deaths per million people. The highest mortality rates occurred in Southern (120, 95% eCI, 116≥126), Eastern (107, 95% eCI, 100≥114), and Western Europe (66, 95% eCI, 62≥70), where the excess death ratio was also higher. Notably, 54.29% (95% eCI, 45.71%≥61.36%) of the global heatwave-related deaths were attributable to human-induced climate change. These results underscore the urgent need for adaptive public health interventions and climate mitigation strategies to reduce future mortality burdens in the context of increasing global warming
How and why do young people engage in STI screening, treatment, and partner notification? A qualitative positive deviance study in Zimbabwe.
Get PDFYoung people have a high burden of sexually transmitted infections (STIs) but low uptake of and high attrition from services. We adopted a positive deviance approach to explore uptake of STI screening, treatment, and partner notification within a sexual and reproductive health service. We conducted in-depth interviews with young people (aged 16-24 years) who accepted screening, treatment, and partner notification slips (n = 15), and healthcare providers who delivered the service (n = 13). We used thematic analysis to understand decisions at each stage of the STI care cascade. Young people who accepted STI screening and returned to receive their results were influenced by the friendliness and informativeness of providers, which helped overcome their anxiety. Experiencing symptoms and health being a priority were also motivators to seek treatment and overcame the inconvenience of returning to the service and the fear of the test result. While all participants accepted partner notification slips, only those in secure relationships felt able to tell their partners. This study identified both supply (positive provider attitudes, information provision, and same-day treatment provision) and demand side factors (prioritise one's health, experiencing symptoms, and knowledge about asymptomatic infections) that STI interventions can build on to support young people's engagement with STI services
A systems perspective on promoting sustainable food systems
Get PDFGlobal food systems are at the center of some of the most pressing modern societal challenges: They are significant contributors to a range of systemic issues, including health problems and chronic diseases, greenhouse gas emissions and general environmental degradation, and increasing financial burdens on healthcare and economies. Within these complex systems, final sustainable consumption, which refers to the adoption of diets that are both healthy and environmentally friendly, plays a critical role. Significant changes in contemporary dietary patterns are essential to address the rising burden of chronic diseases and public health outcomes and the escalating climate crisis. Achieving these shifts requires coordinated action from policymakers, consumers, and the scientific community in an effort to support the development, implementation, and evaluation of advertising and policy instruments that promote healthier and more sustainable dietary choices. However, driving changes in dietary behavior is a complex challenge, shaped by the interplay of heterogeneous influences, including biological, social, cultural, environmental, political, and economic factors, and further complicated by the difficulty of validating proposed approaches in ways that are both efficient and ethically sound. This vision paper presents the problem of promoting healthy and environmentally friendly diets and their implications for environmental sustainability. In particular, it discusses a systems approach based on social network dynamics and social interventions, illustrating recent findings that demonstrate the potential of influence strategies to drive dietary change. Finally, key scientific challenges and emerging research opportunities are highlighted