Trends in clinical trial registration in sub-Saharan Africa between 2010 and 2020: a cross-sectional review of three clinical trial registries.

OBJECTIVE: Prospective registration of clinical trials is an ethical, scientific, and legal requirement that serves several functions, including minimising research wastage and publication bias. Sub-Saharan Africa (SSA) is increasingly hosting clinical trials over the past few years, and there is limited literature on trends in clinical trial registration and reporting in SSA. Therefore, we set out to determine the trends in clinical trials registered in SSA countries between 2010 and July 2020. METHODS: A cross-sectional study design was used to describe the type of clinical trials that are conducted in SSA from 1 January 2010 to 31 July 2020. The registries searched were ClinicalTrials.gov (CTG), the Pan African Clinical Trials Register (PACTR), and the International Standard Randomized Controlled Trial Number (ISRCTN). Data were extracted into Excel and imported into STATA for descriptive analysis. RESULTS: CTG had the highest number of registered trials at 2622, followed by PACTR with 1501 and ISRCTN with 507 trials. Trials were observed to increase gradually from 2010 and peaked at 2018-2019. Randomised trials were the commonest type, accounting for at least 80% across the three registries. Phase three trials investigating drugs targeted at infections/infestations were the majority. Few completed trials had their results posted: 58% in ISRCTN and 16.5% in CTG, thus suggesting reporting bias. CONCLUSION: Despite the gradual increase in clinical trials registered during the period, recent trends suggest a drop in the number of trials registered across the region. Strengthening national and regional regulatory capacity will improve clinical trial registration and minimise reporting bias in completed clinical trials.

The use of a speaking book® to enhance vaccine knowledge among caregivers in The Gambia: A study using qualitative and quantitative methods.

OBJECTIVES: To measure the usefulness of a Speaking Book (SB) as an educational tool for enhancing knowledge, understanding and recall of key vaccine-related information among caregivers in The Gambia, as well as its acceptability and relevance as a health promotion tool for caregivers and healthcare workers. DESIGN AND SETTING: We developed a multimedia educational tool, the vaccine Speaking Book, which contained prerecorded information about vaccines provided in The Gambia's Expanded Programme on Immunization. Using qualitative and quantitative methods, we then conducted a sequential study assessing the use of this tool among caregivers andhealthcare workers in The Gambia.Participants200 caregivers attending primary healthcare centres in The Gambia for routine immunisation services for their infants, and 15 healthcare workers employed to provide immunisation services at these clinics. OUTCOME MEASURES: We calculated the median knowledge scores on vaccine-related information obtained at baseline, 1-month and 3-month follow-up visits. Wilcoxon's matched-pairs signed-rank test was used to compare the difference in the median knowledge scores between baseline and 1-month, and between baseline and 3-month follow-up visits. RESULTS: Of the 113 caregivers who participated, 104 (92%) completed all three study visits, 108 (95.6%) completed the baseline and 1-month follow-up visits, and 107 (94.7%) completed the baseline and 3-month follow-up visits. The median knowledge score increased from 6.0 (IQR 5.0-7.0) at baseline to 11.0 (IQR 8.0-14.0) at 1-month visit (p<0.001), and 15.0 (IQR 10.0-20.0) at 3-month visit (p<0.001). Qualitative results showed high acceptability and enthusiasm for the Speaking Book among both caregivers and healthcare workers. The Speaking Book was widely shared in the community and this facilitated communication with healthcare workers at the primary healthcare centres. CONCLUSIONS: Context-specific and subject-specific Speaking Books are a useful communication and educational tool to increase caregiver vaccine knowledge in low/middle-income countries.

A scorecard of progress towards measles elimination in 15 west African countries, 2001-19: a retrospective, multicountry analysis of national immunisation coverage and surveillance data.

BACKGROUND: The WHO Regional Office for the Africa Regional Immunization Technical Advisory Group, in 2011, adopted the measles control and elimination goals for all countries of the African region to achieve in 2015 and 2020 respectively. Our aim was to track the current status of progress towards measles control and elimination milestones across 15 west African countries between 2001 and 2019. METHODS: We did a retrospective multicountry series analysis of national immunisation coverage and case surveillance data from Jan 1, 2001, to Dec 31, 2019. Our analysis focused on the 15 west African countries that constitute the Economic Community of West African States. We tracked progress in the coverage of measles-containing vaccines (MCVs), measles supplementary immunisation activities, and measles incidence rates. We developed a country-level measles summary scorecard using eight indicators to track progress towards measles elimination as of the end of 2019. The summary indicators were tracked against measles control and elimination milestones. FINDINGS: The weighted average regional first-dose MCV coverage in 2019 was 66% compared with 45% in 2001. 73% (11 of 15) of the west African countries had introduced second-dose MCV as of December, 2019. An estimated 4 588 040 children (aged 12-23 months) did not receive first-dose MCV in 2019, the majority (71%) of whom lived in Nigeria. Based on the scorecard, 12 (80%) countries are off-track to achieving measles elimination milestones; however, Cape Verde, The Gambia, and Ghana have made substantial progress. INTERPRETATION: Measles will continue to be endemic in west Africa after 2020. The regional measles incidence rate in 2019 was 33 times the 2020 elimination target of less than 1 case per million population. However, some hope exists as countries can look at the efforts made by Cape Verde, The Gambia, and Ghana and learn from them. FUNDING: None.

Tracking coverage, dropout and multidimensional equity gaps in immunisation systems in West Africa, 2000-2017.

BACKGROUND: Several West African countries are unlikely to achieve the recommended Global Vaccine Action Plan (GVAP) immunisation coverage and dropout targets in a landscape beset with entrenched intra-country equity gaps in immunisation. Our aim was to assess and compare the immunisation coverage, dropout and equity gaps across 15 West African countries between 2000 and 2017. METHODS: We compared Bacille Calmette Guerin (BCG) and the third dose of diphtheria-tetanus-pertussis (DTP3) containing vaccine coverage between 2000 and 2017 using the WHO and Unicef Estimates of National Immunisation Coverage for 15 West African countries. Estimated subregional median and weighted average coverages, and dropout (DTP1-DTP3) were tracked against the GVAP targets of ≥90% coverage (BCG and DTP3), and ≤10% dropouts. Equity gaps in immunisation were assessed using the latest disaggregated national health survey immunisation data. RESULTS: The weighted average subregional BCG coverage was 60.7% in 2000, peaked at 83.2% in 2009 and was 65.7% in 2017. The weighted average DTP3 coverage was 42.3% in 2000, peaked at 70.3% in 2009 and was 61.5% in 2017. As of 2017, 46.7% of countries (7/15) had met the GVAP targets on DTP3 coverage. Average weighted subregional immunisation dropouts consistently reduced from 16.4% in 2000 to 7.4% in 2017, meeting the GVAP target in 2008. In most countries, inequalities in BCG, and DTP3 coverage and dropouts were mainly related to equity gaps of more than 20% points between the wealthiest and the poorest, high coverage regions and low coverage regions, and between children of mothers with at least secondary education and those with no formal education. A child's sex and place of residence (urban or rural) minimally determined equity gaps. CONCLUSIONS: The West African subregion made progress between 2000 and 2017 in ensuring that its children utilised immunisation services, however, wide equity gaps persist.