Cholera vaccine clinical trials: A cross-sectional analysis of clinical trials registries.

Cholera has been one of the world's biggest public health challenges for centuries. The presence of this disease brings into focus the social determinants of health in different parts of the world. Research and development efforts to find safe and effective Cholera vaccines are critical to decreasing the disease burden from Vibrio cholerae. We searched the International Clinical Trials Registry Platform (ICTRP) and Cochrane Central Register of Controlled Trials (CENTRAL) on 5 March 2023. We included all registered randomized trials studying Cholera vaccines. We used Microsoft Excel to perform a descriptive analysis of the source registry, geographic distribution, recruitment status, phase of trials, and type of trial sponsor and presented the findings using tables and graphs. The search of ICTRP yielded 84 trials, and 315 trials were identified from CENTRAL. Seventy-four trials were included in the analysis. Most of the trials (66%, n = 49) were registered in ClinicalTrials.gov, followed by Clinical Trials Registry - India (9%, n = 7) and the Cuban Public Registry of Clinical Trials (8%, n = 6). The geographical distribution of the trials indicates that 48% (n = 36) of the trials were conducted in Asia, followed by 23% (n = 17) in North America, 15% (n = 11) in Africa, and 11% (n = 8) in Europe. Results further indicate that 81% (n = 60) of trials have a recruitment status "Not recruiting," followed by 12% (n = 9) with a status "recruiting." With the recent surge in Cholera cases and the limited supply of Cholera vaccines, research indicates the need for Cholera vaccine trials to ensure the availability of vaccines, especially in populations affected.

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.

Strengthening the Health System as a Strategy to Achieving a Universal Health Coverage in Underprivileged Communities in Africa: A Scoping Review.

Universal health coverage (UHC) is defined as people having access to quality healthcare services (e.g., treatment, rehabilitation, and palliative care) they need, irrespective of their financial status. Access to quality healthcare services continues to be a challenge for many people in low- and middle-income countries (LMICs). The aim of this study was to conduct a scoping review to map out the health system strengthening strategies that can be used to attain universal health coverage in Africa. We conducted a scoping review and qualitatively synthesized existing evidence from studies carried out in Africa. We included studies that reported interventions to strengthen the health system, e.g., financial support, increasing work force, improving leadership capacity in health facilities, and developing and upgrading infrastructure of primary healthcare facilities. Outcome measures included health facility infrastructures, access to medicines, and sources of financial support. A total of 34 studies conducted met our inclusion criteria. Health financing and developing health infrastructure were the most reported interventions toward achieving UHC. Our results suggest that strengthening the health system, namely, through health financing, developing, and improving the health infrastructure, can play an important role in reaching UHC in the African context.

Interventions for vaccine hesitancy.

Despite overwhelming evidence of the effectiveness and safety of vaccinations, a growing number of people are reluctant to receive recommended vaccinations or refuse them altogether. Vaccination currently prevents 2-3 million deaths a year and a further 1.5 million deaths could be avoided if global coverage of vaccinations improved. However, recently vaccine hesitancy has led to a resurgence of preventable diseases. There is heterogeneity in vaccine hesitant individuals and a diversity of situations in which vaccine hesitancy can arise, thus requiring that interventions to address vaccine hesitancy be context-specific and problem-specific.

Implementation research approaches to promoting universal health coverage in Africa: a scoping review.

BACKGROUND: Implementation research has emerged as part of evidence-based decision-making efforts to plug current gaps in the translation of research evidence into health policy and practice. While there has been a growing number of initiatives promoting the uptake of implementation research in Africa, its role and effectiveness remain unclear, particularly in the context of universal health coverage (UHC). Hence, this scoping review aimed to identify and characterise the use of implementation research initiatives for assessing UHC-related interventions or programmes in Africa. METHODS: The review protocol was developed based on the methodological framework proposed by Arksey and O'Malley, as enhanced by the Joanna Briggs Institute. The review is reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR). MEDLINE, Scopus and the Cochrane Library were searched. The search also included a hand search of relevant grey literature and reference lists. Literature sources involving the application of implementation research in the context of UHC in Africa were eligible for inclusion. RESULTS: The database search yielded 2153 records. We identified 12 additional records from hand search of reference lists. After the removal of duplicates, we had 2051 unique records, of which 26 studies were included in the review. Implementation research was used within ten distinct UHC-related contexts, including HIV; maternal and child health; voluntary male medical circumcision; healthcare financing; immunisation; healthcare data quality; malaria diagnosis; primary healthcare quality improvement; surgery and typhoid fever control. The consolidated framework for implementation research (CFIR) was the most frequently used framework. Qualitative and mixed-methods study designs were the commonest methods used. Implementation research was mostly used to guide post-implementation evaluation of health programmes and the contextualisation of findings to improve future implementation outcomes. The most commonly reported contextual facilitators were political support, funding, sustained collaboration and effective programme leadership. Reported barriers included inadequate human and other resources; lack of incentives; perception of implementation as additional work burden; and socio-cultural barriers. CONCLUSIONS: This review demonstrates that implementation research can be used to achieve UHC-related outcomes in Africa. It has identified important facilitators and barriers to the use of implementation research for promoting UHC in the region.

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.

Protocol for a scoping review of implementation research approaches to universal health coverage in Africa.

INTRODUCTION: Implementation research has emerged as part of evidence-based decision-making efforts to plug current gaps in the translation of research evidence into health policy and practice. While there has been a growing number of institutions and initiatives promoting the uptake of implementation research in Africa, their role and effectiveness remain unclear, particularly in the context of universal health coverage (UHC). This review aims to extensively identify and characterise the nature, facilitators and barriers to the use of implementation research for assessing or evaluating UHC-related interventions or programmes in Africa. METHODS AND ANALYSIS: This scoping review will be developed based on the methodological framework proposed by Arksey and O'Malley and enhanced by the Joanna Briggs Institute. It will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. A comprehensive search of the following electronic databases will be conducted: Medline (via PubMed), Scopus and the Cochrane Library. Relevant grey literature and reference lists will also be searched. All publications describing the application of implementation research in the context of UHC will be considered for inclusion. Findings will be narratively synthesised and analysed using a predefined conceptual framework. Where applicable, quantitative evidence will be aggregated using summary statistics. There will be consultation of stakeholders, including UHC-oriented health professionals, programme managers, implementation researchers and policy-makers; to provide methodological, conceptual and practical insights. ETHICS AND DISSEMINATION: The data used in this review will be sourced from publicly available literature; hence, this study will not require ethical approval. Findings and recommendations will be disseminated to reach a diverse audience, including UHC advocates, implementation researchers and key health system stakeholders within the African region. Additionally, findings will be disseminated through an open-access publication in a relevant peer-reviewed journal.

Cochrane corner: video calls for reducing social isolation and loneliness in older people.

The occurrence of social isolation and loneliness has increased with the implementation of social distancing measures in multiple countries to contain the COVID-19 pandemic. Social isolation and loneliness are associated with considerable morbidity and mortality. Numerous interventions addressing social isolation and loneliness have been studied, including social facilitation using video calls. A Cochrane review, published in May 2020, assessed the effectiveness of video calls for preventing social isolation and loneliness in the elderly. The authors conducted a comprehensive electronic search and found three eligible studies, none of which was conducted during the COVID-19 pandemic. The review provides limited and uncertain evidence regarding the effectiveness of video call interventions to reduce loneliness in the elderly. Given the need for social distancing among the elderly, even when social distancing measures are lifted in African countries, there is a need for further research on the effectiveness of video calls in reducing social isolation and loneliness among older people.

Sequential Cross-Sectional Surveys in Orange Farm, a Township of South Africa, Revealed a Constant Low Voluntary Medical Male Circumcision Uptake among Adults despite Demand Creation Campaigns and High Acceptability.

BACKGROUND: WHO recommends a male circumcision (MC) prevalence rate higher than 80% to have a substantial impact on the HIV-AIDS epidemic in Eastern and Southern Africa. Orange Farm, a township in South Africa, has a free-for-service voluntary medical male circumcision (VMMC) clinic in operation since 2008. Following an intense campaign from 2008 to 2010, MC prevalence rate increased to 55.4% (ANRS-12126). Ongoing and past VMMC campaigns focused on youths, through school talks, and adults at a community level. The main objective of the study was to assess the change in MC prevalence rate among adults aged 18-19 and 18-49 years in the past 5 years. METHODS: A cross-sectional survey (ANRS-12285) was conducted among a random sample of 522 adult men in 2015. MC status and characteristics of participants were collected through a genital examination and a face-to-face questionnaire. RESULTS: MC prevalence rate among young adult men aged 18-19 years increased markedly from 61.2% (95%CI: 57.4% to 65.0%) in 2010 to 87.5% (76.0% to 94.6%) in 2015 (p<0.001). In the same period, among men aged 18-49 years, MC prevalence rate varied slightly from 55.4% (53.6% to 57.1%) to 56.7% (52.4% to 60.9%). In 2015, 84.9% (79.2% to 89.5%) of uncircumcised adult men reported that they were willing to be circumcised. However, we estimated that only 4.6% (11/237; 2.5% to 7.9%) of the uncircumcised men underwent circumcision in 2015, despite 117/185 (63.2%; 95%CI: 56.1% to 69.9%) who reported that they were definitely willing to become circumcised. CONCLUSIONS: In Orange Farm, VMMC campaigns were successful among the youth and led to a sufficiently high MC prevalence rate to have a substantial impact in the future on the HIV-AIDS epidemic. However, despite high acceptability and a free VMMC service, VMMC campaigns since 2010 have failed to increase MC prevalence rate among adults to above 80%. These campaigns should be revisited.