Multivitamin supplementation in HIV infected adults initiating antiretroviral therapy in Uganda: the protocol for a randomized double blinded placebo controlled efficacy trial.

BACKGROUND: Use of multivitamin supplements during the pre-HAART era has been found to reduce viral load, enhance immune response, and generally improve clinical outcomes among HIV-infected adults. However, immune reconstitution is incomplete and significant mortality and opportunistic infections occur in spite of HAART. There is insufficient research information on whether multivitamin supplementation may be beneficial as adjunct therapy for HIV-infected individuals taking HAART. We propose to evaluate the efficacy of a single recommended daily allowance (RDA) of micronutrients (including vitamins B-complex, C, and E) in slowing disease progression among HIV-infected adults receiving HAART in Uganda. METHODS/DESIGN: We are using a randomized, double-blind, placebo-controlled trial study design. Eligible patients are HIV-positive adults aged at least 18 years, and are randomized to receive either a placebo; or multivitamins that include a single RDA of the following vitamins: 1.4 mg B1, 1.4 mg B2, 1.9 mg B6, 2.6 mcg B12, 18 mg niacin, 70 mg C, 10 mg E, and 0.4 mg folic acid. Participants are followed for up to 18 months with evaluations at baseline, 6, 12 and 18 months. The study is primarily powered to examine the effects on immune reconstitution, weight gain, and quality of life. In addition, we will examine the effects on other secondary outcomes including the risks of development of new or recurrent disease progression event, including all-cause mortality; ARV regimen change from first- to second-line therapy; and other adverse events as indicated by incident peripheral neuropathy, severe anemia, or diarrhea. DISCUSSIONS: The conduct of this trial provides an opportunity to evaluate the potential benefits of this affordable adjunct therapy (multivitamin supplementation) among HIV-infected adults receiving HAART in a developing country setting. TRIAL REGISTRATION: Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01228578

A software tool for estimation of burden of infectious diseases in Europe using incidence-based disability adjusted life years

The burden of disease framework facilitates the assessment of the health impact of diseases through the use of summary measures of population health such as Disability- Adjusted Life Years (DALYs). However, calculating, interpreting and communicating the results of studies using this methodology poses a challenge. The aim of the Burden of Commu

Climate Risk Management in Agricultural Extension for Ethiopia 2nd Edition

The Climate Risk Management in Agricultural Extension (CRMAE) for Ethiopia Reference Guide 2nd Edition is an accompaniment to the abridged CRMAE Handbook, with new and updated content following demand from Ethiopia's Agricultural Technical Vocational Education and Training (ATVET) colleges. Both the Reference Guide and Handbook are training and reference materials intended to be used during implementation of the Climate Risk Management in Agricultural Extension course in Ethiopia. The Reference Guide was designed for Ethiopia’s subject matter specialists (SMS) and extension staff, including development agents (DAs). It may also be used by other actors, such as non-governmental organizations (NGOs) or community-based organizations (CBOs), who work closely with farmers and those who support them. It aims to provide foundational knowledge on climate and agricultural decision making and practical tools to analyze climate-related risks, use appropriate weather and climate information to support agricultural decisions, communicate complex climate information effectively with farmers, and integrate climate services into agricultural extension activities

Climate Risk Management in Agricultural Extension for Ethiopia 2nd Edition: Facilitators' Guide

The 2nd Edition of the Climate Risk Management in Agricultural Extension for Ethiopia Facilitators’ Guide is an accompaniment to curricular materials presented in the Climate Risk Management in Agricultural Extension (CRMAE) Reference Guide and Handbook, with new and updated content following demand from Ethiopia's Agricultural Technical Vocational Education and Training (ATVET) colleges. It is intended to be used during implementation of the CRMAE course targeting Ethiopia’s subject matter specialists (SMS) and extension staff, including development agents (DAs). This includes, but is not limited to, teachers of Ethiopia’s Agricultural Technical Vocational Education and Training (ATVET) program and its associated colleges. This Facilitators’ Guide was designed to ensure that all of the learning objectives are addressed effectively in the time allotted for each of the four modules that comprise the CRMAE course. It provides facilitators with a roadmap and step-by-step instructions for each of the modules and their sub-components, including each session’s agenda, presentations, activities, and worksheets

Climate Risk Management in Agricultural Extension for Ethiopia 2nd Edition Handbook

The 2nd Edition Climate Risk Management in Agricultural Extension (CRMAE) for Ethiopia Handbook is an accompaniment and concise summary of the more comprehensive CRMAE Reference Guide, with new and updated content following demand from Ethiopia's Agricultural Technical and Vocational Education and Training (ATVET) colleges. Both the Handbook and Reference Guide are training and reference materials intended to be used during implementation of the CRMAE course designed for Ethiopia’s subject matter specialists (SMS) and extension staff, including development agents (DAs). It may also be used by other actors, such as non-governmental organizations (NGOs) or community-based organizations (CBOs), who work closely with farmers and those who support them. This Handbook aims to provide foundational knowledge on climate and agricultural decision making; and practical tools to analyze climate-related risks, use appropriate weather and climate information to support agricultural decisions, communicate complex climate information effectively with farmers, and integrate climate services into agricultural extension activities

Reference Intervals in Healthy Adult Ugandan Blood Donors and Their Impact on Conducting International Vaccine Trials

BACKGROUND: Clinical trials are increasingly being conducted internationally. In order to ensure enrollment of healthy participants and proper safety evaluation of vaccine candidates, established reference intervals for clinical tests are required in the target population. METHODOLOGY/PRINCIPAL FINDINGS: We report a reference range study conducted in Ugandan adult blood bank donors establishing reference intervals for hematology and clinical chemistry parameters. Several differences were observed when compared to previously established values from the United States, most notably in neutrophils and eosinophils. CONCLUSIONS/SIGNIFICANCE: In a recently conducted vaccine trial in Uganda, 31 percent (n = 69) of volunteers screened (n = 223) were excluded due to hematologic abnormalities. If local reference ranges had been employed, 83% of those screened out due to these abnormalities could have been included in the study, drastically reducing workload and cost associated with the screening process. In addition, toxicity tables used in vaccine and drug trial safety evaluations may need adjustment as some clinical reference ranges determined in this study overlap with grade 1 and grade 2 adverse events

Impact of infectious diseases on population health using incidence-based disability-adjusted life years (DALYs)

Background and aims: The Burden of Communicable Diseases in Europe (BCoDE) study aimed to calculate disability-adjusted life years (DALYs) for 31 selected diseases in the European Union (EU) and European Economic Area (EEA). Methods: DALYs were estimated using an incidence-based and pathogen-based approach. Incidence was estimated through assessment of data availability and quality, and a correction was applied for under-estimation. Calculation of DALYs was performed with the BCoDE software toolkit without applying time discounting and age-weighting. Results: W

Measuring underreporting and under-ascertainment in infectious disease datasets: a comparison of methods

Gibbons CL, Mangen M-JJ, Plaß D, et al. Measuring underreporting and under-ascertainment in infectious disease datasets: a comparison of methods. BMC Public Health. 2014;14(1): 147.Background: Efficient and reliable surveillance and notification systems are vital for monitoring public health and disease outbreaks. However, most surveillance and notification systems are affected by a degree of underestimation (UE) and therefore uncertainty surrounds the 'true' incidence of disease affecting morbidity and mortality rates. Surveillance systems fail to capture cases at two distinct levels of the surveillance pyramid: from the community since not all cases seek healthcare (under-ascertainment), and at the healthcare-level, representing a failure to adequately report symptomatic cases that have sought medical advice (underreporting). There are several methods to estimate the extent of under-ascertainment and underreporting. Methods: Within the context of the ECDC-funded Burden of Communicable Diseases in Europe (BCoDE)-project, an extensive literature review was conducted to identify studies that estimate ascertainment or reporting rates for salmonellosis and campylobacteriosis in European Union Member States (MS) plus European Free Trade Area (EFTA) countries Iceland, Norway and Switzerland and four other OECD countries (USA, Canada, Australia and Japan). Multiplication factors (MFs), a measure of the magnitude of underestimation, were taken directly from the literature or derived (where the proportion of underestimated, under-ascertained, or underreported cases was known) and compared for the two pathogens. Results: MFs varied between and within diseases and countries, representing a need to carefully select the most appropriate MFs and methods for calculating them. The most appropriate MFs are often disease-,country-, age-, and sex-specific. Conclusions: When routine data are used to make decisions on resource allocation or to estimate epidemiological parameters in populations, it becomes important to understand when, where and to what extent these data represent the true picture of disease, and in some instances (such as priority setting) it is necessary to adjust for underestimation. MFs can be used to adjust notification and surveillance data to provide more realistic estimates of incidence

A Single-Blind randomized controlled trial to evaluate the effect of extended counseling on uptake of pre-antiretroviral care in eastern uganda

<p>Abstract</p> <p>Background</p> <p>Many newly screened people living with HIV (PLHIV) in Sub-Saharan Africa do not understand the importance of regular pre-antiretroviral (ARV) care because most of them have been counseled by staff who lack basic counseling skills. This results in low uptake of pre-ARV care and late treatment initiation in resource-poor settings. The effect of providing post-test counseling by staff equipped with basic counseling skills, combined with home visits by community support agents on uptake of pre-ARV care for newly diagnosed PLHIV was evaluated through a randomized intervention trial in Uganda.</p> <p>Methods</p> <p>An intervention trial was performed consisting of post-test counseling by trained counselors, combined with monthly home visits by community support agents for continued counseling to newly screened PLHIV in Iganga district, Uganda between July 2009 and June 2010, Participants (N = 400) from three public recruitment centres were randomized to receive either the intervention, or the standard care (the existing post-test counseling by ARV clinic staff who lack basic training in counseling skills), the control arm. The outcome measure was the proportion of newly screened and counseled PLHIV in either arm who had been to their nearest health center for clinical check-up in the subsequent three months +2 months. Treatment was randomly assigned using computer-generated random numbers. The statistical significance of differences between the two study arms was assessed using chi-square and t-tests for categorical and quantitative data respectively. Risk ratios and 95% confidence intervals were used to assess the effect of the intervention.</p> <p>Results</p> <p>Participants in the intervention arm were 80% more likely to accept (take up) pre-ARV care compared to those in the control arm (RR 1.8, 95% CI 1.4-2.1). No adverse events were reported.</p> <p>Conclusions</p> <p>Provision of post-test counseling by staff trained in basic counseling skills, combined with home visits by community support agents had a significant effect on uptake of pre-ARV care and appears to be a cost-effective way to increase the prerequisites for timely ARV initiation.</p> <p>Trial registration</p> <p>The trial was registered by Current Controlled Trials Ltd C/OBioMed Central Ltd as <a href="http://www.controlled-trials.com/ISRCTN94133652">ISRCTN94133652</a> and received financial support from Sida and logistical support from the European Commission.</p