Objective: The effectiveness of leaf concentrate powder (LCP) as a nutritional supplement was established in trials conducted among adolescent girls and pregnant women in India. Here we evaluate LCP, compared with skimmed milk powder (SMP), as a supplement for antiretroviral-naïve children living with HIV in a sub-Saharan African country. Design: Randomized controlled, two-arm, 6-month trial comparing effects of isoproteic (5 g) LCP (10 g daily) and SMP (15 g daily) on HIV-1 viral load, CD4+ cell count/percentage, weight/height-for-age, general blood parameters, diarrhoea, respiratory and HIV-related opportunistic infections. . Children in the LCP group reported higher levels of appetite and overall health at 6 months. There were no differences in clinical events or any other outcome measures. LCP was less palatable than SMP to the children in this population, but there were few negative perceptions of appearance, texture and taste.Conclusions: LCP appears to be equivalent to SMP as a nutritional supplement in this population, despite slightly lower palatability. In relation to viral load and CD4 + count, equivalence may indicate no effect in either group. Effectiveness relative to no supplementation remains to be determined.
BackgroundCapacity in health research ethics review is key in Africa, given the increase in research activities, complexity, and use of advanced technologies. Harmonising ethics review frameworks can address challenges attributable to these complexities. Establishing an effective harmonised framework that is optimum or protection of the research subjects requires assessment of review capacity.The East African Health Research Commission commissioned a study to assess the capacity of Review Ethics Committees (RECs) in the East African Community (EAC) countries, as a step towards strengthening and harmonising the regions’ capacity and review frameworks.MethodsA desktop review of documentation (national and institutional guidelines, policies and SOPs) was conducted in five EAC countries. Semi-structured questionnaires were used to collect data from key informants. Qualitative interviews were used to collect views on stakeholders’ perception of benefits, opportunities and challenges of harmonisation.ResultsSixty-nine (69) accredited RECs were mapped. All countries had national ethics guidelines and National Research Regulatory Authorities, whose mandates varied across countries. 57% of RECs reviewed local and international research, 43% reviewed local studies only. On average, 91 protocols were reviewed annually across all RECs (range 15 to 200). Membership ranged from 6 to 22 members per REC, with age range of 29 to 75 years.Annual budget allocation ranged from $3000 to $2.9 million financed through review fees (84%) or/and institutional budget (14%). 71% of RECs had education policy but 41%had members with training in ethics. Review turn-around time ranged from 14 to 90 days. All RECs supported harmonisation and attributed it to improved efficiency, quality and standardised costs.ConclusionSimilarities and dissimilarities were noted in the EAC countries’ ethics review frameworks. Harmonisation should consider 1) harmonisation of policy frameworks and tools; 2) institutionalisation of regional joint review mechanisms, 3) standardisation of training and capacity strengthening, 4) Review of the REC operational and financing models.
BackgroundAccess to domestic financial resources is a pre-requisite for strengthening health research and development (R&D). Therefore, the East African Health Research Commission (EAHRC) commissioned a study to assess the financial needs of the East African Community (EAC) region and propose innovative domestic financing mechanisms for R and D in East Africa.MethodsThis study used a four-pronged approach as follows: a desk review of secondary data, followed by a survey to collect quantitative data from health R&D organisations and relevant ministries, followed by key informant interviews and, finally, a validation workshop. The study used 2014–2015 as the baseline year.ResultsOnly 51 out of 160 organisations responded to the survey. Using triangulation of desk reviews, national budgets documents and reported organisational budgets, the annual investment in health R&D in the EAC is estimated at USD 301.71 million of which 86% is financed from external sources. The share of health R&D financing in the GDP and health budget stood at 0.21% and 1.27% respectively, while the share of domestic financing of health R&D to GDP was as low as 0.03%The innovative domestic financing options suggested included: allocation of 10% of the USD 560 million of the sin-taxes collected; taxing 1% of the estimated USD 3 billion from inward remittances; fundraising for at least 2.5% of the USD 18.67 private sector investment in corporate social responsibility; issuing social impact bonds and the EAC Health Research Fund with an estimated annual performance of USD 20 million.ConclusionIn order to sustain health R&D investments in EAC, the EAHRC proposes to develop a 10 year domestic financing roadmap using a strategic mix of tax- and non-tax-based innovations.
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