Contextualising missed opportunities for children's vaccination: A theory-informed qualitative study in primary care settings in Cape Town, South Africa.

This study aimed to explore the contextual factors that may be associated with missed opportunities for vaccination (MOV) from the perspectives of healthcare providers and caregivers attending primary healthcare facilities in the Cape Town Metro Health District, South Africa. The ultimate goal of the assessment was to help inform the design and implementation of a contextually appropriate quality improvement programme targeted at reducing MOV in primary healthcare settings. We used a theory-informed exploratory qualitative research design involving focus group discussions with caregivers of children aged 0-23 months; and in-depth interviews of facility staff. A thematic template analysis approach, integrating the theoretical domains framework (TDF) and the capability, opportunity and motivation model of behavior (COM-B) was used to code and analyze the data. Three focus group sessions were conducted, each consisting of 5-8 caregivers and five in-depth interviews involving facility staff. Capability factors comprised caregivers' knowledge, attitude and behavior toward children's immunization. Opportunity factors included the organization of immunization services, long waiting time, vaccine stock out, staff shortage and health workers' attitude, knowledge and capability to assess children's immunization status and needs. Motivation factors included optimism and beliefs about immunization, fear of vaccine-preventable diseases and immunization safety concerns. This study identified important caregiver-, provider- and health system-related factors, which influence immunization outcomes; offering useful contextual insights for informing quality improvement strategies for reducing MOV at primary healthcare level.

Randomised trials of COVID-19 vaccines in Africa – charting the path forward

Vaccines have played a critical role in controlling disease outbreaks, hence the proliferation of the development and testing of multiple vaccine candidates during the COVID-19 pandemic. Randomised trials are gold standards for evaluating the safety and efficacy of pharmaceutical interventions such as COVID-19 vaccines. However, contextual differences may attenuate effects of COVID-19 vaccines. Thus, the need to conduct COVID-19 vaccine trials in all settings, including in Africa. We conducted a crosssectional analysis of planned, ongoing, and completed COVID-19 vaccine trials in Africa. We searched the South African National Clinical Trials Register, Pan African Clinical Trials Registry, and International Clinical Trials Registry Platform (ICTRP) on 12 January and 30 April 2022: and complemented this with a search of ClinicalTrials.gov on 17 May 2022. We screened the search output and included randomised trials with at least one recruitment site in Africa. We identified only 108 eligible trials: 90 (83%) evaluating candidate COVID-19 vaccines, 11 (10%) assessing if existing vaccines could prevent SARS-CoV-2 infection, and 7 (7%) evaluating interventions for improving COVID-19 vaccination coverage. South Africa had the highest number of trials at 58 (54%). Beyond South Africa, countries with more than 10 trial sites include Kenya, Ghana, Egypt, Uganda, and Zimbabwe. Among the trials, 14 (13%) do not have principal investigators based in Africa, 39 (30%) are funded by industry, and 91 (84%) are funded by institutions based outside the host country. COVID-19 vaccine trials with recruitment sites in Africa represented only 7% of the 1453 COVID-19 vaccine trials in the ICTRP The paucity of COVID-19 vaccine trials conducted on the African continent is a cause for concern. This has implications for the role that Africa may play in future pandemics.

Clinical trial registration during COVID-19 and beyond in the African context: what have we learned?

Since the outbreak of COVID-19, many lives have been impacted especially on the African continent which is already fighting the burden of multiple diseases of poverty. However, clinical research has offered hope for treatment and prevention options for this infectious disease. Despite many COVID-19 clinical trials conducted globally, three countries in Africa account for more than 80% of all trials from the continent registered trials in clinical trial registries. This indicates geographic disparity among COVID-19 research in Africa. From the perspective of clinical trial registration, transparency in clinical research and the availability of data became important for making informed decisions to manage the pandemic. Registries serve as a source of planned, ongoing, and completed trials while allowing efficient funding allocation for research that would not duplicate efforts. Additionally, research gaps can be identified, which provide opportunities for collaboration among researchers. Therefore, a critical lesson learnt during this pandemic is that clinical trial registration is important in facilitating the process of tracking changes made to protocols and minimizing publication bias, thereby promoting and advocating for clinical research transparency. Moreover, registration in a clinical trial registry is a condition for publication and allows for trial summary results to be publicly available. Adhering to the principle of results sharing is especially important for the rapidly growing clinical research activities racing to find evidence-based interventions to end the COVID-19 pandemic.

Missed Opportunities for Vaccination and Associated Factors among Children Attending Primary Health Care Facilities in Cape Town, South Africa: A Pre-Intervention Multilevel Analysis

Despite the substantial efforts at ensuring universal access to routine immunisation services among children in South Africa, major gaps in immunisation coverage remain. This study assessed the magnitude of missed opportunities for vaccination (MOV) and associated factors among children aged 0–23 months attending primary health care (PHC) facilities in Cape Town. We used multilevel binomial logistic regression models to explore individual and contextual factors associated with MOV, with children aged 0–23 months at Level 1, nested within PHC facilities (Level 2). A total of 674 children and their caregivers were enrolled. MOV prevalence was 14.1%, ranging from 9.1% to 18.9% across sub-districts. Dose-specific MOV prevalence was highest for the second dose of measles vaccine (9.5%) and lowest for the first dose of rotavirus vaccine (0.6%). The likelihood of a child experiencing MOV was significantly associated with caregivers’ low level of education (Odds ratio (OR) = 3.53, 95% credible interval (CrI): 1.13–11.03), recent receipt of immunisation messages (OR = 0.46, 95%CrI: 0.25–0.87), shared immunisation decision making by both parents (OR = 0.21, 95%CrI: 0.07–0.62) and health facility staff number (OR = 0.18, 95%CrI: 0.06–0.61). The burden of MOV among children in Cape Town is influenced by individual and contextual factors, which provide important opportunities for quality improvement and broader strategies to improve routine immunisation service delivery.

COVID-19 vaccine demand protest might have increased vaccine acceptance and uptake in South Africa.

Safe and efficacious COVID-19 vaccines exist, but their success against the disease depends on public willingness to receive them. Vaccine hesitancy is one major obstacle to the achievement of herd immunity. On 25 June 2021, about 2000 supporters of the Economic Freedom Fighters (EFF) (the third biggest political party in South Africa) marched to the offices of the national regulatory authority (NRA) supporting COVID-19 vaccination and demanding approval of two additional vaccines (Sputnik V and Sinovac) in South Africa. The march was led by EFF leader, Julius Malema. By then, only three COVID-19 vaccines had received emergency use authorization in the country-the Janssen, AstraZeneca and Pfizer-BioNtech vaccines. It is worth noting that NRAs should only approve a vaccine if they are satisfied that its benefits outweigh any potential risks and not through political pressure. Nevertheless, we believe that this march might have increased COVID-19 vaccine acceptance and uptake among EFF supporters. The endorsement of COVID-19 vaccines by Malema, an influential political figure in South Africa, probably convinced some vaccine hesitant South Africans that COVID-19 vaccination is important. Therefore, we suggest vaccine endorsement by influential individuals in South Africa as one of the strategies to increase COVID-19 vaccine uptake.

Promotion of data sharing needs more than an emergency: An analysis of trends across clinical trials registered on the International Clinical Trials Registry Platform.

BACKGROUND: A growing body of evidence shows that sharing health research data with other researchers for secondary analyses can contribute to better health. This is especially important in the context of a public health emergency when stopping a pandemic depends on accelerating science. METHODS: We analysed the information on data sharing collected by the 18 clinical trial registries included in the WHO International Clinical Trials Registry Platform (ICTRP) to understand the reporting of data sharing plans and which studies were and were not planning to share data. Data on sponsor and funder organisations, country of recruitment, registry, and condition of study were standardised to compare the sharing of information and data across these facets. This represents the first ever comprehensive study of the complete data set contained in ICTRP. RESULTS: Across 132,545 studies registered between January 2019 and December 2020, 11.2% of studies stated that individual patient data (IPD) would be shared. Plans to share IPD varied across the 18 contributing registries- information on data sharing was missing in >95% of study records across 7/18 registries. In the 26,851 (20.3%) studies that were funded or sponsored by a commercial entity, intention to share IPD was similar to those that were not (11.5% vs 11.2%). Intention to share IPD was most common in studies recruiting across both high-income and low- or middle-income countries (21.4%) and in those recruiting in Sub-Saharan Africa (50.3%). Studies of COVID-19 had similar levels of data sharing to studies of other non-pandemic diseases in 2020 (13.7% vs 11.7%). CONCLUSIONS: Rates of planned IPD sharing vary between clinical trial registries and economic regions, and are similar whether commercial or non-commercial agencies are involved. Despite many calls to action, plans to share IPD have not increased significantly and remain below 14% for diseases causing public health emergencies.

Promotion of data sharing needs more than an emergency: An analysis of trends across clinical trials registered on the International Clinical Trials Registry Platform [version 1;peer review: 2 approved]

BACKGROUND: A growing body of evidence shows that sharing health research data with other researchers for secondary analyses can contribute to better health. This is especially important in the context of a public health emergency when stopping a pandemic depends on accelerating science. METHODS: We analysed the information on data sharing collected by the 18 clinical trial registries included in the WHO International Clinical Trials Registry Platform (ICTRP) to understand the reporting of data sharing plans and which studies were and were not planning to share data. Data on sponsor and funder organisations, country of recruitment, registry, and condition of study were standardised to compare the sharing of information and data across these facets. This represents the first ever comprehensive study of the complete data set contained in ICTRP. RESULTS: Across 132,545 studies registered between January 2019 and December 2020, 11.2% of studies stated that individual patient data (IPD) would be shared. Plans to share IPD varied across the 18 contributing registries– information on data sharing was missing in >95% of study records across 7/18 registries. In the 26,851 (20.3%) studies that were funded or sponsored by a commercial entity, intention to share IPD was similar to those that were not (11.5% vs 11.2%). Intention to share IPD was most common in studies recruiting across both high-income and low- or middle-income countries (21.4%) and in those recruiting in Sub-Saharan Africa (50.3%). Studies of COVID-19 had similar levels of data sharing to studies of other non-pandemic diseases in 2020 (13.7% vs 11.7%). CONCLUSIONS: Rates of planned IPD sharing vary between clinical trial registries and economic regions, and are similar whether commercial or non-commercial agencies are involved. Despite many calls to action, plans to share IPD have not increased significantly and remain below 14% for diseases causing public health emergencies.

Hospital acquired COVID-19 infections amongst patients before the rollout of COVID-19 vaccinations, a scoping review.

BACKGROUND: Hospital settings are at increased risk of spreading Coronavirus Disease 2019 (COVID-19) infections, hence non-pharmaceutical prevention interventions (NPPIs) and prioritized vaccination of healthcare workers and resident patients are critical. The status of COVID-19 hospital acquired infections (HAIs) in low-income settings is unclear. We aimed to identify and summarize the existing evidence on COVID-19 HAIs amongst patients, prior to the rollout of vaccines in countries worldwide. METHODS: We conducted a scoping review of English peer-reviewed literature in PubMed, Web of Science and Scopus using a combination of selected search terms. Full texts articles presenting results on COVID-19 HAIs in hospitalised patients before the rollout of vaccines in countries worldwide were eligible. Data extracted from eligible articles included estimates of COVID-19 HAIs, country, and type of hospital setting, and was summarized narratively. Quality assessment of included articles was not possible. RESULTS: Literature searches generated a total of 5920 articles, and 45 were eligible for analysis. Eligible articles were from Europe, North America, Asia, and Brazil and none were from low-income countries. The proportion of COVID-19 HAIs ranged from 0% when strict NPPIs were applied, to 65% otherwise. The estimates of COVID-19 HAIs did not differ by country but were lower in studies conducted after implementation of NPPIs and in specialized hospital settings for operative surgery. Studies conducted before the implementation of NPPIs or in long-term care and psychiatric wards often reported high estimates of HAI. Although there was no clear trend in general wards, those situated in academic hospitals managed to reduce HAI rates under strict NPPI protocols. Operative surgery settings, unlike psychiatric settings, effectively prevented COVID-19 HAI using tailored NPPIs. CONCLUSION: The available evidence shows a high risk of COVID-19 HAIs, the feasibility of preventing HAIs in different healthcare settings and the importance of appropriately tailored NPPIs. There were no data from low-income settings, therefore, it is unclear whether the reported NPPI approaches could be equally effective elsewhere. We recommend routine monitoring of COVID-19 HAIs in countries with low vaccination coverage, to identify and close gaps in NPPIs and understand gains made from vaccinating healthcare workers and hospitalized patients.

Health trends, inequalities and opportunities in South Africa's provinces, 1990-2019: findings from the Global Burden of Disease 2019 Study.

BACKGROUND: Over the last 30 years, South Africa has experienced four 'colliding epidemics' of HIV and tuberculosis, chronic illness and mental health, injury and violence, and maternal, neonatal, and child mortality, which have had substantial effects on health and well-being. Using data from the 2019 Global Burden of Diseases, Injuries and Risk Factors Study (GBD 2019), we evaluated national and provincial health trends and progress towards important Sustainable Development Goal targets from 1990 to 2019. METHODS: We analysed GBD 2019 estimates of mortality, non-fatal health loss, summary health measures and risk factor burden, comparing trends over 1990-2007 and 2007-2019. Additionally, we decomposed changes in life expectancy by cause of death and assessed healthcare system performance. RESULTS: Across the nine provinces, inequalities in mortality and life expectancy increased over 1990-2007, largely due to differences in HIV/AIDS, then decreased over 2007-2019. Demographic change and increases in non-communicable diseases nearly doubled the number of years lived with disability between 1990 and 2019. From 1990 to 2019, risk factor burdens generally shifted from communicable and nutritional disease risks to non-communicable disease and injury risks; unsafe sex remained the top risk factor. Despite widespread improvements in healthcare system performance, the greatest gains were generally in economically advantaged provinces. CONCLUSIONS: Reductions in HIV/AIDS and related conditions have led to improved health since 2007, though most provinces still lag in key areas. To achieve health targets, provincial governments should enhance health investments and exchange of knowledge, resources and best practices alongside populations that have been left behind, especially following the COVID-19 pandemic.

COVID-19 vaccines.

COVID-19 is a pandemic of unprecedented proportions in recent human history. Less than 18 months since the onset of the pandemic, there are close to two hundred million confirmed cases and four million deaths worldwide. There have also been massive efforts geared towards finding safe and effective vaccines. By July 2021 there were 184 COVID-19 vaccine candidates in pre-clinical development, 105 in clinical development, and 18 vaccines approved for emergency use by at least one regulatory authority. These vaccines include whole virus live attenuated or inactivated, protein-based, viral vector, and nucleic acid vaccines. By mid-2021 three billion doses of COVID-19 vaccine have been administered around the world, mostly in high-income countries. COVID-19 vaccination provides hope for an end to the pandemic, if and only if there would be equal access and optimal uptake in all countries around the world.

COVID-19 and the Gaping Wounds of South Africa's Suboptimal Immunisation Coverage: An Implementation Research Imperative for Assessing and Addressing Missed Opportunities for Vaccination.

Despite South Africa's substantial investments in and efforts at ensuring universal access to immunisation services, progress has stalled and remains suboptimal across provinces and districts. An additional challenge is posed by the ongoing coronavirus disease 2019 (COVID-19) pandemic, which has disrupted immunisation services globally, including in South Africa. While there is growing evidence that missed opportunities for vaccination (MOV) are a major contributor to suboptimal immunisation progress globally, not much is known about the burden and determinants of MOV in the South African context. Herein, we make a case for assessing MOV as a strategy to address current immunisation coverage gaps while mitigating the adverse impacts of the COVID-19 pandemic on immunisation services. We illustrate a practical implementation research approach to assessing the burden of MOV among children in primary care settings; for understanding the factors associated with MOV; and for designing, implementing, and evaluating context-appropriate quality improvement interventions for addressing missed opportunities. Such efforts are vital for building health system resilience and maintaining immunisation programme capacity to optimally deliver essential health services such as routine childhood immunisation, even during pandemics.

Vaccine hesitancy in the era of COVID-19: could lessons from the past help in divining the future?

Vaccine hesitancy, which embodies the unwillingness to receive vaccines when vaccination services are available and accessible, is one of the greatest threats to global health. Although vaccine hesitancy has existed among a small percentage of people for centuries, its harmful effects are likely to be more pronounced during the COVID-19 pandemic than ever before. COVID-19 vaccine hesitancy will pose substantial risks for both people who delay or refuse to be vaccinated and the wider community. It will make communities unable to reach thresholds of coverage necessary for herd immunity against COVID-19, thus unnecessarily perpetuating the pandemic and resulting in untold suffering and deaths. Vaccine hesitancy is pervasive, misinformed, contagious, and is not limited to COVID-19 vaccination. Our work shows that vaccine hesitancy is a complex and dynamic social process that reflects multiple webs of influence, meaning, and logic. People's vaccination views and practices usually comprise an ongoing engagement that is contingent on unfolding personal and social circumstances, which can potentially change over time. Therefore, as COVID-19 vaccination rolls out globally, scientists and decision-makers need to investigate the scale and determinants of vaccine hesitancy in each setting; so that tailored and targeted strategies can be developed to address it.

A scoping review of the impact of long-distance truck drivers on the spread of COVID-19 infection.

INTRODUCTION: long-distance truck drivers have been identified as a high-risk group for coronavirus disease (COVID-19) infection. Thus, the aim of this scoping review is to map out the existing evidence on the impact of long-distance truck drivers on the spread of COVID-19 and measures that countries can implement to mitigate this route of spread in the African region. METHODS: we searched the PubMed database and the website of the World Health Organization (WHO) in March 2020 for eligible studies. RESULTS: the search strategy identified 669 citations, of which six met the inclusion criteria. The most frequently reported interventions were maintaining hand hygiene, social distance, testing truck drivers, regulation of trade and transport e.g. only trucks with the food, medical supplies, fuels, agricultural supplies will be allowed to operate in interstate operations and regulating and controlling trucks carrying essential goods and services e.g. truck drivers are required to declare their final destination and are urged to stop only at designated points. Two studies from the African region reported about border closures and entry and exit screening, two studies from the US reported about the threat for public safety and risks and mitigation plans and 2 guidelines reported about harmonisation and facilitation of cross border in the context of the COVID-19 outbreak. CONCLUSION: this review highlights the countries response to mitigate the impact of the pandemic by implementing measures to facilitate safe cross-border trade and adopting regional harmonization of trucking regulations.

Cochrane corner: universal screening for SARS-CoV-2 infection.

INTRODUCTION: coronavirus disease 2019 (COVID-19) is caused by the novel coronavirus, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Most people infected with SARS-CoV-2 have mild disease with non-specific symptoms, although a few becoming critically ill with septic shock and multiple organ failure. There is an unknown proportion of infected individuals who remain asymptomatic and infectious. Universal screening for COVID-19 infections to detect individuals who are infected before they present clinically could therefore be an important measure to contain the spread of the disease. We highlight a Cochrane rapid review which assessed the effectiveness and accuracy of universal screening for COVID-19 infection. METHODS: the authors of the Cochrane review searched multiple electronic databases to identify studies reporting on the effectiveness of universal screening and reporting on screening test accuracy. Eligible participants for the review included people who had not sought care for potential COVID-19 symptoms. RESULTS: the authors included 22 publications, with none of them conducted in Africa. Two modelling studies reported on the beneficial and negative effects of screening; and 20 studies (cohort and modelling) reported data on the accuracy of screening tests. The included studies had wide variability in the baseline prevalence of COVID-19 infection as well as study settings and methods. All cohort studies compared screening strategies to reverse transcriptase-polymerase chain reaction (RT-PCR) as the gold standard. The rapid review suggests that there is low certainty of evidence that screening at travel hubs may slow the importation of infected cases. Furthermore, the review highlights the uncertainty and variation in the accuracy of screening. CONCLUSION: given the low accuracy of the tests included in this review, a high proportion of COVID-19 infected individuals may be missed and go on to infect others. In addition, some healthy individuals may be falsely identified as positive, requiring confirmatory testing and potentially leading to the unnecessary isolation of these individuals.

Cochrane corner: rapid point-of-care antigen and molecular-based tests for the diagnosis of COVID-19 infection.

INTRODUCTION: the COVID-19 pandemic, which results from infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), presents important diagnostic challenges. Diagnostic strategies available to identify or rule out current infection, or to identify people in need of care escalation, or to test for past infection and immune response have become available, to reduce household and community transmission. We highlight a Cochrane review, published in September 2020, on the assessment of diagnostic accuracy of point-of-care antigen and molecular-based tests to determine current SARS-CoV-2 infection. METHODS: the authors of the Cochrane review searched multiple electronic databases for studies, which assessed SARS-CoV-2 infection with a diagnostic test. Eligible participants for the review included people with suspected current SARS-CoV-2 infection, known to have, or not to have COVID-19 infection, or where tests were used to screen for infection. RESULTS: the authors included 18 studies of point-of-care tests conducted in various parts of the world, with none from Africa. The review shows that there is considerable variability in sensitivity and specificity of the antigen tests. The review also shows that molecular tests had less variability in sensitivity and specificity. CONCLUSION: the review suggests that the current evidence is not strong enough to determine the usefulness of point-of-care tests in all settings. However, the benefits are likely to be more noticeable in countries, like Africa where community transmission is high. An impact evaluation would be warranted when rapid point-of-care tests are implemented in African countries.

The Magnitude and Determinants of Missed Opportunities for Childhood Vaccination in South Africa.

Missed opportunities for vaccination (MOV) may be among the factors responsible for suboptimal vaccination coverage in South Africa. However, the magnitude and determinants of MOV in the country are not known. Thus, this study seeks to assess the prevalence and determinants of MOV in the country. South Africa is sub-divided into nine administrative provinces. We used nationally representative data from the 2016 South African Demographic and Health Survey. We considered MOV to have occurred if a child aged 12-23 months old had not taken all scheduled basic vaccine doses despite having any of the following contacts with health services: delivery in a health facility; postnatal clinic visit; receipt of vitamin A; and any child-related treatment at a health facility. Multilevel logistic regression was used to determine factors associated with MOV. The national prevalence of MOV among children aged 12-23 months was 40.1%. Children whose mothers attended facility-based antenatal care were considerably less likely to experience MOV than those whose mothers did not attend antenatal care: odds ratio (OR) 0.41, 95% confidence interval (CI) 0.19 to 0.88. Conversely, the independent predictor of an increased MOV among children was residence in either the Gauteng province (OR 2.97, 95% CI 1.29 to 6.81) or Mpumalanga province (OR 2.32, 95%CI 1.04 to 5.18); compared to residence in the Free State province. Our findings suggest a high burden of MOV among children in South Africa and that MOV may be associated with individual and contextual factors. The findings also underscore the need for further exploration of the contextual factors contributing to MOV in South Africa.