scholarly journals Prospective validation of host transcriptomic biomarkers for pulmonary tuberculosis by real-time PCR

2021 ◽  
Author(s):  
Simon C Mendelsohn ◽  
Stanley Kimbung Mbandi ◽  
Andrew Fiore-Gartland ◽  
Adam Penn-Nicholson ◽  
Munyaradzi Musvosvi ◽  
...  
Keyword(s):  
South African ◽  
Active Case Finding ◽  
Target Product Profile ◽  
Prognostic Accuracy ◽  
Product Profile ◽  
Host Blood ◽  
Weighted Prevalence ◽  
Triage Test ◽  
Hiv Negative

We tested performance of host-blood transcriptomic tuberculosis (TB) signatures for active case-finding. Among 20,207 HIV-uninfected and 963 HIV-infected adults screened; 2,923 and 861 were enrolled from five South African communities. Eight signatures were measured by microfluidic RT-qPCR and participants were microbiologically-investigated for pulmonary TB at baseline, and actively surveilled for incident disease through 15 months. Diagnostic AUCs for 61 HIV-uninfected (weighted-prevalence 1.1%) and 10 HIV-infected (prevalence 1.2%) prevalent TB cases for the 8 signatures were 0.63-0.79 and 0.65-0.88, respectively. Thereafter, 24 HIV-uninfected and 9 HIV-infected participants progressed to incident TB (1.1 and 1.0 per 100 person-years, respectively). Prognostic AUCs through 15-months follow-up were 0.49-0.66 and 0.54-0.81, respectively. Prognostic performance for incident TB occurring within 6-12 months in HIV-negative participants was higher for all signatures. None of the signatures met WHO Target Product Profile criteria for a triage test to diagnose asymptomatic TB; most signatures met the criteria for symptomatic TB. Prognostic accuracy of most signatures for incident TB within six months of testing met the criteria for an incipient TB test.

Quality by Design: Concept to Applications

2019 ◽  
Vol 16 (3) ◽  
pp. 240-250 ◽  
Author(s):  
Suryakanta Swain ◽  
Rabinarayan Parhi ◽  
Bikash Ranjan Jena ◽  
Sitty Manohar Babu
Keyword(s):  
Quality By Design ◽  
Pharmaceutical Products ◽  
Assessment Tools ◽  
Basic Knowledge ◽  
Target Product ◽  
Target Product Profile ◽  
Critical Material ◽  
Novel Approach ◽  
Product Profile ◽  
Performance Report

Background: Quality by Design (QbD) is associated with a modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also lead to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to fulfill the predefined manufactured goods or final products quality characteristics. It is quite essential to identify the desired and required product performance report, such as Target Product Profile, typical Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQA). Methods: This review highlighted the concepts of QbD design space, for critical material attributes (CMAs) as well as the critical process parameters that can totally affect the CQAs within which the process shall be unaffected thus, consistently manufacturing the required product. Risk assessment tools and design of experiments are its prime components. Results: This paper outlines the basic knowledge of QbD, the key elements; steps as well as various tools for QbD implementation in pharmaceutics field are presented briefly. In addition to this, quite a lot of applications of QbD in numerous pharmaceutical related unit operations are discussed and summarized. Conclusion: This article provides a complete data as well as the roadmap for universal implementation and application of QbD for pharmaceutical products.

What Matters to South African Bank Customers? A Case Study of four Main South African Banks

2015 ◽  
Vol 6 (1and2) ◽  
Author(s):  
Kingstone Mutsonziwa
Keyword(s):  
Customer Satisfaction ◽  
South African ◽  
Language Usage ◽  
Face To Face ◽  
Bank Resolution ◽  
African Context ◽  
Key Drivers ◽  
Investment Advice

This paper is a follow-up article based on the first article titled Customers speak for themselves: A case of Customer Satisfaction in the four Main South African Banks. Customer satisfaction within the banking industry is very important in the South African context. Although banks are trying their best to give their customers the best service, it is important to continuously measure customer satisfaction and identify service attributes that contribute to overall customer satisfaction for the banks. The data used in the analysis is based on a quantitative survey of 500 randomly selected customers in Pretoria, Johannesburg, Durban and Cape Town were interviewed using a face to face methodology. The key drivers of overall customer satisfaction based on regression analysis for the different banks were helpfulness and innovativeness (ABSA), helpfulness, innovativeness of the bank, resolution of problems and investment advice (FNB), language usage and friendliness of service consultants (Nedbank), innovativeness of the bank, investment advice and use of language (Standard bank). These attributes were important to the overall customer satisfaction and need to be closely monitored by the management of these banks.

scholarly journals Longitudinal Event-Level Sexual Risk and Substance Use among Gay, Bisexual, and Other Men Who Have Sex with Men

2021 ◽  
Vol 18 (6) ◽  
pp. 3183
Author(s):  
Jordan M. Sang ◽  
Zishan Cui ◽  
Paul Sereda ◽  
Heather L. Armstrong ◽  
Gbolahan Olarewaju ◽  
...  
Keyword(s):  
Substance Use ◽  
Sexual Risk ◽  
Health Study ◽  
Anal Sex ◽  
Study Objective ◽  
Condomless Anal Sex ◽  
Gamma Hydroxybutyrate ◽  
Sex With Men ◽  
Hiv Negative

(1) Background: Condomless anal sex and substance use are associated with STI risk among gay, bisexual, and other men who have sex with men (gbMSM). Our first study objective was to describe event-level sexual risk and substance use trends among gbMSM. Our second study objective was to describe substances associated with event-level sexual risk. (2) Methods: Data come from the Momentum Health Study in Vancouver, British Columbia and participants were recruited from 2012–2015, with follow-up until 2018. Stratified by self-reported HIV status, we used generalized estimating equations to assess trends of sexual event-level substance use and assessed interactions between substance use and time period on event-level higher risk sex defined as condomless anal sex with an HIV serodifferent or unknown status partner. (3) Results: Event-level higher risk anal sex increased across the study period among HIV-negative/unknown (baseline prevalence: 13% vs. study end prevalence: 29%) and HIV-positive gbMSM (baseline prevalence: 16% vs. study end prevalence: 38%). Among HIV-negative/unknown gbMSM, event-level erectile drug use increased, while alcohol use decreased over the study period. Overall, interactions between substance use and time on higher risk anal sex were not statistically significant, regardless of serostatus. However, we found a number of time-specific significant interactions for erectile drugs, poppers, Gamma-hydroxybutyrate (GHB), crystal methamphetamine and ecstasy/MDMA use among HIV-negative/unknown gbMSM. (4) Conclusion: Significant differences in substance use trends and associated risks exist and are varied among gbMSM by serostatus. These findings provide a more comprehensive understanding of the effects of event-level substance use on sexual risk through longitudinal follow-up of nearly six years.

scholarly journals Teaching Mathematics during the COVID-19 Lockdown in a Context of Historical Disadvantage

2021 ◽  
Vol 11 (4) ◽  
pp. 177
Author(s):  
Brantina Chirinda ◽  
Mdutshekelwa Ndlovu ◽  
Erica Spangenberg
Keyword(s):  
South Africa ◽  
South African ◽  
Mathematics Teachers ◽  
Education System ◽  
Teaching And Learning ◽  
Face To Face ◽  
Global Pandemic ◽  
Education Community ◽  
South African Education

The COVID-19 global pandemic widely affected education across the world and engendered unprecedented scenarios that required expeditious responses. In South Africa, the pandemic came on top of pre-existing inequalities in the education system. Using a qualitative research method of exploratory and descriptive nature, this study engaged a social justice framework to explore the teaching and learning of mathematics during the COVID-19 lockdown in a context of historical disadvantage. A sample of twenty-three Grade 12 mathematics teachers at various public secondary schools in Gauteng, South Africa was used in the study. The teachers were selected through purposive sampling. A Google-generated open-ended questionnaire and follow-up telephonic interviews were used to collect data. Data were analysed thematically in five steps. The findings revealed that the WhatsApp platform is a valuable tool that can support the teaching and learning of mathematics beyond the classroom in the contexts of historical disadvantage. The findings also provided insights into how mathematics teachers became learners themselves during emergency remote teaching (ERT) as they had to adapt to digital teaching, find solutions to unfamiliar problems and acquire knowledge from a larger mathematics education community around the globe. The article discusses these findings and teachers’ challenges of transitioning from traditional face-to-face classrooms to ERT and how they were addressed. At the time of publishing the article, most learners in South Africa had started going to school on a rotational basis. Nonetheless, the study reported in this article is of importance as ERT in the context of historical disadvantage has foregrounded issues of inequality in the South African education system that must be dealt with urgently.

scholarly journals Loss to follow-up in a cohort of HIV-negative men who have sex with men: Project Horizonte

2017 ◽  
Vol 51 (0) ◽  
Author(s):  
Ana Paula Silva ◽  
Marília Greco ◽  
Maria Arlene Fausto ◽  
Mariângela Carneiro
Keyword(s):  
Loss To Follow Up ◽  
Sex With Men ◽  
Hiv Negative

scholarly journals The target product profile as a tool for regulatory communication: advantageous but underused

2017 ◽  
Vol 16 (3) ◽  
pp. 156-156 ◽  
Author(s):  
Adria Tyndall ◽  
Wenny Du ◽  
Christopher D. Breder
Keyword(s):  
Target Product ◽  
Target Product Profile ◽  
Product Profile

What’s the Regulatory Value of a Target Product Profile?

2017 ◽  
Vol 35 (7) ◽  
pp. 576-579 ◽  
Author(s):  
Christopher D. Breder ◽  
Wenny Du ◽  
Adria Tyndall
Keyword(s):  
Target Product ◽  
Target Product Profile ◽  
Product Profile

scholarly journals Efficacy and safety of a combined treatment of sodium stibogluconate at 20mg/kg/day with upper maximum daily dose limit of 850mg and Paromomycin 15mg/kg/day in HIV negative visceral leishmaniasis patients. A retrospective study, northwest Ethiopia

2021 ◽  
Vol 15 (8) ◽  
pp. e0009713
Author(s):  
Aschalew Tamiru ◽  
Rezika Mohammed ◽  
Saba Atnafu ◽  
Girmay Medhin ◽  
Asrat Hailu
Keyword(s):  
Visceral Leishmaniasis ◽  
Adverse Events ◽  
Combined Treatment ◽  
Daily Maximum ◽  
Sodium Stibogluconate ◽  
Efficacy And Safety ◽  
African Countries ◽  
Treatment Interruptions ◽  
Hiv Negative

Background Visceral leishmaniasis (VL) is one of the most neglected tropical infectious diseases. It is fatal if left untreated. The objective of this study was to assess the efficacy and safety of 17-day injections of combined regimen of sodium stibogluconate and paromomycin (SSG/PM) in HIV-negative VL patients. Methods A retrospective analysis of medical records of VL patients treated in the University of Gondar Hospital during period 2012–2019 was carried out. Results A total of 2836 patients were treated for VL from 2012 to 2019. Of these 1233 were treated with SSG-PM, and 1000 of them were included in the study. Initial cure was achieved in 922 (92.2%) patients. The frequency of treatment failure, treatment interruptions, default and deaths respectively were 30 (3%), 20 (2%), 13 (1.3%) and 15 (1.5%). Among 280 patients who completed 6-month follow up, the final cure was 93.9% (263/280), 4 (1.4%) relapsed and 13 (4.6%) developed post-kala-azar dermal leishmaniasis (PKDL). The most common adverse events (AEs) were raised liver transaminases (35.1%; 351 patients), injection site pain (29.1%, 291 patients) and raised serum alpha-amylase (29.1%, 291 patients). Factors associated with poor treatment outcomes were sepsis, pneumonia, and adverse events. Conclusion A combination of SSG at 20mg/kg with upper daily maximum dose of 850mg and PM was effective for achieving initial cure at end of treatment and safe for treatment of HIV negative VL patients in northwestern Ethiopia. Our data are consistent with previous reports and confirms effectiveness of SSG/PM treatment regimen in the Eastern African countries. Efficacy at 6-months (93.9%) was estimated on data derived from patients who completed follow up and needs to be interrogated by future studies.

scholarly journals Analysis of HIV-related mortality data in a tertiary South African neurology unit, 2006- 2012

2013 ◽  
Vol 14 (3) ◽  
pp. 121-124
Author(s):  
Clara Maria Schutte
Keyword(s):  
South African ◽  
Neurological Complications ◽  
Mortality Data ◽  
Hiv Positive ◽  
Steady Increase ◽  
Number Of Patients ◽  
High Prevalence ◽  
Living With Hiv ◽  
Related Mortality ◽  
Hiv Negative

Background. South Africa (SA) has a high prevalence of HIV infection with almost 11% of the population aged >2 years living with HIV. At the Steve Biko Academic Hospital, Pretoria, the Neurology Department has seen a steady increase in HIV-related neurology patients.Objective. To evaluate the mortality data of this unit as it relates to HIV infection.Methods. The study was a retrospective analysis of records. Patient mortality statistics for 2006, 2008, 2010 and 2012 were analysed regarding cause of death, sex, age and HIV status.Results. During 2006, 85 patients died: 33% were HIV-positive, 13% were HIV-negative and 54% had not tested for HIV. By 2010, these figures were 50%, 22% and 28%, respectively, changing little in 2012 (48%, 28% and 24%, respectively). Causes of death in the HIV-positive group were meningitis in 58% – with tuberculous meningitis the most common aetiology – followed by strokes (14%), space-occupying lesions (8%) and status epilepticus (7%). Among HIV-positive patients aged 20 - 30 years, a larger proportion of young women died than men. In the combined untested and HIV-negative group, strokes accounted for the vast majority of deaths.Conclusion. Neurological complications of HIV remain common in SA and contribute significantly to the overall mortality in our tertiary neurology unit, with TB posing a serious threat. A strong corps of clinical neurologists with training in infective neurology is needed urgently in the coming years to care for this growing number of patients. 

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