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Article ; Online: The European & Developing Countries Clinical Trials Partnership (EDCTP) Knowledge Hub

Samuel Driver / Shan Gray / Welile Sikhondze / Ken Awuonda / Helena Wilcox / Alexis Segrt / Lara Pandya / Johanna Roth / Michael Makanga / Trudie Lang

Trials, Vol 23, Iss 1, Pp 1-

developing an open platform for facilitating high-quality clinical research

2022 Volume 7

Abstract: Abstract There is stark global inequity in health research in terms of where studies happen, who leads the research and the ultimate beneficiaries of the results generated. Despite significant efforts made, limited research ideas are conceptualised and ... ...

Abstract	Abstract There is stark global inequity in health research in terms of where studies happen, who leads the research and the ultimate beneficiaries of the results generated. Despite significant efforts made, limited research ideas are conceptualised and implemented in low-resource settings to tackle diseases of poverty, and this is especially true in sub-Saharan Africa. There is strong evidence to show that the barriers to locally led research do not vary largely between disease, study type and location and can be largely solved by addressing these common gaps. The European & Developing Countries Clinical Trials Partnership (EDCTP) was established in 2003 as a European response to the global health crisis caused by the three main poverty-related diseases HIV, tuberculosis and malaria. EDCTP has established a model of long-term sustainable capacity development integrated into clinical trials which addresses this lack of locally led research in sub-Saharan Africa, supporting the development of individual and institutional capacity and research outputs that change the management, prevention and treatment of poverty-related and neglected infectious diseases across Africa. In recognition of emergent data on what the barriers and enablers are to long-term, sustainable capabilities to run studies, EDCTP formed a new collaboration with The Global Health Network (TGHN) in September 2017, with the aim to make a set of cross-cutting tools and resources to support the planning, writing and delivery of high-quality clinical trials available to research staff wherever they are in the world, especially those in low- and middle-income countries (LMICs) via TGHN platform. These new resources developed on the ‘EDCTP Knowledge Hub’ are those identified in the mixed method study described in this commentary as being key to addressing the gaps that the research community report as the most limiting elements in their ability to design and implement studies. The Knowledge Hub aims to make these tools freely available to any ...
Keywords	Capacity development ; Research resources ; Research methodology ; Research leadership ; African research leaders ; Medicine (General) ; R5-920
Subject code	306
Language	English
Publishing date	2022-05-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Leveraging tuberculosis case relative locations to enhance case detection and linkage to care in Swaziland

Marie Brunetti / Sathyanath Rajasekharan / Piluca Ustero / Katherine Ngo / Welile Sikhondze / Buli Mzileni / Anna Mandalakas / Alexander W. Kay

Global Health Research and Policy, Vol 3, Iss 1, Pp 1-

2018 Volume 6

Abstract: Abstract Background In Swaziland, as in many high HIV/TB burden settings, there is not information available regarding the household location of TB cases for identifying areas of increased TB incidence, limiting the development of targeted interventions. ...

Abstract	Abstract Background In Swaziland, as in many high HIV/TB burden settings, there is not information available regarding the household location of TB cases for identifying areas of increased TB incidence, limiting the development of targeted interventions. Data from “Butimba”, a TB REACH active case finding project, was re-analyzed to provide insight into the location of TB cases surrounding Mbabane, Swaziland. Objective The project aimed to identify geographical areas with high TB burdens to inform active case finding efforts. Methods Butimba implemented household contact tracing; obtaining landmark based, informal directions, to index case homes, defined here as relative locations. The relative locations were matched to census enumeration areas (known location reference areas) using the Microsoft Excel Fuzzy Lookup function. Of 403 relative locations, an enumeration area reference was detected in 388 (96%). TB cases in each census enumeration area and the active case finders in each Tinkhundla, a local governmental region, were mapped using the geographic information system, QGIS 2.16. Results Urban Tinkhundla predictably accounted for most cases; however, after adjusting for population, the highest density of cases was found in rural Tinkhundla. There was no correlation between the number of active case finders currently assigned to the 7 Tinkhundla surrounding Mbabane and the total number of TB cases (Spearman rho = −0.57, p = 0.17) or the population adjusted TB cases (Spearman rho = 0.14, p = 0.75) per Tinkhundla. Discussion Reducing TB incidence in high-burden settings demands novel analytic approaches to study TB case locations. We demonstrated the feasibility of linking relative locations to more precise geographical areas, enabling data-driven guidance for National Tuberculosis Programs’ resource allocation. In collaboration with the Swazi National Tuberculosis Control Program, this analysis highlighted opportunities to better align the active case finding national strategy with the TB disease burden.
Keywords	Mapping ; Geospatial ; Relative location ; Active case finding ; Public aspects of medicine ; RA1-1270
Subject code	910
Language	English
Publishing date	2018-02-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Situating trade-offs

Muthoni Mwaura / Kekeletso Kao / Jesse Wambugu / Andre Trollip / Welile Sikhondze / Eunice Omesa / Sindi Dlamini / Nompumelelo Mzizi / Muyalo Dlamini / Busizwe Sibandze / Brian Dlamini / Heidi Albert / Wybo Dondorp / Nora Engel

PLoS ONE, Vol 15, Iss 2, p e

Stakeholder perspectives on overtreatment versus missed diagnosis in transition to Xpert MTB/RIF Ultra in Kenya and Swaziland.

2020 Volume 0228669

Abstract: Implementing new diagnostics in public health programs can involve difficult trade-off decisions between individual patient benefits and public health considerations. Such decision-making processes are often not documented and may not include engagement ... ...

Abstract	Implementing new diagnostics in public health programs can involve difficult trade-off decisions between individual patient benefits and public health considerations. Such decision-making processes are often not documented and may not include engagement of affected communities. This paper examines the perspectives of stakeholders on the trade-off between over-treatment and missed diagnosis captured during decision-making workshops on the transition from use of Xpert MTB/RIF to diagnose tuberculosis to Xpert MTB/RIF Ultra in Kenya and Swaziland. Xpert MTB/RIF Ultra has an overall increase in sensitivity but a decrease in specificity when compared to its predecessor. We conducted a qualitative study using four focus group discussions with a total of 47 participants and non-participant observation. The analysis reveals how participants deemed Xpert MTB/RIF Ultra's reduced specificity vis-à-vis its increased sensitivity to be an acceptable trade-off. The way participants assessed this trade-off was shaped by their experiences with the general uncertainty of all diagnostic tests, alternative testing options, historical evolution of diagnostic practices, epidemiological factors and resource constraints. In assessing the trade-off community and individual benefit and harm was frequently discussed together. Qualitative research on stakeholder engagement activities for diagnostic development and implementation can identify everyday experiences and situate assessments and perspectives of key stakeholders and as such aid in decision-making, improving implementation as well as patient outcomes. Further research is needed on the intended and unintended consequences of such engagement activities, how findings are being incorporated by decision-makers, and the impact on programmatic implementation.
Keywords	Medicine ; R ; Science ; Q
Subject code	360
Language	English
Publishing date	2020-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Rapid molecular diagnostics of tuberculosis resistance by targeted stool sequencing

Genome Medicine, Vol 14, Iss 1, Pp 1-

2022 Volume 11

Abstract: Abstract Background Stool is an important diagnostic specimen for tuberculosis in populations who struggle to provide sputum, such as children or people living with HIV. However, the culture of Mycobacterium tuberculosis (M. tuberculosis) complex strains ...

Abstract	Abstract Background Stool is an important diagnostic specimen for tuberculosis in populations who struggle to provide sputum, such as children or people living with HIV. However, the culture of Mycobacterium tuberculosis (M. tuberculosis) complex strains from stool perform poorly. This limits the opportunity for phenotypic drug resistance testing with this specimen. Therefore, reliable molecular methods are urgently needed for comprehensive drug resistance testing on stool specimens. Methods We evaluated the performance of targeted next-generation sequencing (tNGS, Deeplex® Myc-TB) for the detection of mutations associated with M. tuberculosis complex drug resistance on DNA isolated from stool specimens provided by participants from a prospective cohort of patients treated for tuberculosis in Eswatini (n = 66; 56 with and 10 participants without M. tuberculosis complex DNA detected in stool by real-time quantitative PCR), and an independent German validation cohort of participants with culture-confirmed tuberculosis (n = 21). Results The tNGS assay detected M. tuberculosis complex DNA in 38 of 56 (68%) samples; for 28 of 38 (74%) samples, a full M. tuberculosis complex drug resistance prediction report was obtained. There was a high degree of concordance with sputum phenotypic drug susceptibility results (κ = 0.82). The ability to predict resistance was concentration-dependent and successful in 7/10 (70%), 18/25 (72%), and 3/21 (14%) of samples with stool PCR concentration thresholds of > 100 femtogram per microliter (fg/μl), 1 to 100 fg/μl, and < 1 fg/μl, respectively (p = 0.0004). The German cohort confirmed these results and demonstrated a similarly high concordance between stool tNGS and sputum phenotypic drug susceptibility results (κ = 0.84). Conclusions tNGS can identify drug resistance from stool provided by tuberculosis patients. This affords the opportunity to obtain critical diagnostic information for tuberculosis patients who struggle to provide respiratory specimens.
Keywords	Tuberculosis ; Drug resistance ; Feces ; Medicine ; R ; Genetics ; QH426-470
Subject code	572
Language	English
Publishing date	2022-05-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: BUTIMBA

Anna Maria Mandalakas / Katherine Ngo / Pilar Alonso Ustero / Rachel Golin / Florence Anabwani / Bulisile Mzileni / Welile Sikhondze / Robert Stevens

PLoS ONE, Vol 12, Iss 1, p e

Intensifying the Hunt for Child TB in Swaziland through Household Contact Tracing.

2017 Volume 0169769

Abstract: Limited data exists to inform contact tracing guidelines in children and HIV-affected populations. We evaluated the yield and additionality of household contact and source case investigations in Swaziland, a TB/HIV high-burden setting, while prioritizing ...

Abstract	Limited data exists to inform contact tracing guidelines in children and HIV-affected populations. We evaluated the yield and additionality of household contact and source case investigations in Swaziland, a TB/HIV high-burden setting, while prioritizing identification of childhood TB.In partnership with 7 local TB clinics, we implemented standardized contact tracing of index cases (IC) receiving TB treatment. Prioritizing child contacts and HIV-affected households, screening officers screened contacts for TB symptoms and to identify risk factors associated with TB. We ascertained factors moderating the yield of contact tracing and measured the impact of our program by additional notifications.From March 2013 to November 2015, 3,258 ICs (54% bacteriologically confirmed; 70% HIV-infected; 85% adults) were enrolled leading to evaluation of 12,175 contacts (median age 18 years, IQR 24-42; 45% children; 9% HIV-infected). Among contacts, 196 TB cases (56% bacteriologically confirmed) were diagnosed resulting in a program yield of 1.6% for all forms of TB. The number needed to screen (NNS) to identify a bacteriologically confirmed TB case or all forms TB case traced from a child IC <5 years was respectively 62% and 40% greater than the NNS for tracing from an adult IC. In year one, we demonstrated a 32% increase in detection of bacteriologically confirmed child TB. Contacts were more likely to have TB if <5 years (OR = 2.0), HIV-infected (OR = 4.9), reporting ≥1 TB symptoms (OR = 7.7), and sharing a bed (OR = 1.7) or home (OR = 1.4) with the IC. There was a 1.4 fold increased chance of detecting a TB case in households known to be HIV-affected.Contact tracing prioritizing children is not only feasible in a TB/HIV high-burden setting but contributes to overall case detection. Our findings support WHO guidelines prioritizing contact tracing among children and HIV-infected populations while highlighting potential to integrate TB and HIV case finding.
Keywords	Medicine ; R ; Science ; Q
Subject code	360
Language	English
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Sustainable clinical laboratory capacity for health in Africa

Justine Davies / Alash'le Abimiku / Moses Alobo / Zoë Mullan / Rachel Nugent / Miriam Schneidman / Welile Sikhondze / Philip Onyebujoh

The Lancet Global Health, Vol 5, Iss 3, Pp e248-e

2017 Volume 249

Keywords	Public aspects of medicine ; RA1-1270
Language	English
Publishing date	2017-03-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: BUTIMBA

Anna Maria Mandalakas / Katherine Ngo / Pilar Alonso Ustero / Rachel Golin / Florence Anabwani / Bulisile Mzileni / Welile Sikhondze / Robert Stevens

PLoS ONE, Vol 12, Iss 1, p e

Intensifying the Hunt for Child TB in Swaziland through Household Contact Tracing.

2017 Volume 0169769

Abstract	Limited data exists to inform contact tracing guidelines in children and HIV-affected populations. We evaluated the yield and additionality of household contact and source case investigations in Swaziland, a TB/HIV high-burden setting, while prioritizing identification of childhood TB.In partnership with 7 local TB clinics, we implemented standardized contact tracing of index cases (IC) receiving TB treatment. Prioritizing child contacts and HIV-affected households, screening officers screened contacts for TB symptoms and to identify risk factors associated with TB. We ascertained factors moderating the yield of contact tracing and measured the impact of our program by additional notifications.From March 2013 to November 2015, 3,258 ICs (54% bacteriologically confirmed; 70% HIV-infected; 85% adults) were enrolled leading to evaluation of 12,175 contacts (median age 18 years, IQR 24-42; 45% children; 9% HIV-infected). Among contacts, 196 TB cases (56% bacteriologically confirmed) were diagnosed resulting in a program yield of 1.6% for all forms of TB. The number needed to screen (NNS) to identify a bacteriologically confirmed TB case or all forms TB case traced from a child IC <5 years was respectively 62% and 40% greater than the NNS for tracing from an adult IC. In year one, we demonstrated a 32% increase in detection of bacteriologically confirmed child TB. Contacts were more likely to have TB if <5 years (OR = 2.0), HIV-infected (OR = 4.9), reporting ≥1 TB symptoms (OR = 7.7), and sharing a bed (OR = 1.7) or home (OR = 1.4) with the IC. There was a 1.4 fold increased chance of detecting a TB case in households known to be HIV-affected.Contact tracing prioritizing children is not only feasible in a TB/HIV high-burden setting but contributes to overall case detection. Our findings support WHO guidelines prioritizing contact tracing among children and HIV-infected populations while highlighting potential to integrate TB and HIV case finding.
Keywords	Medicine ; R ; Science ; Q
Subject code	360
Language	English
Publishing date	2017-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Upholding Tuberculosis Services during the 2014 Ebola Storm

Nimer Ortuno-Gutierrez / Rony Zachariah / Desalegn Woldeyohannes / Adama Bangoura / Gba-Foromo Chérif / Francis Loua / Veerle Hermans / Katie Tayler-Smith / Welile Sikhondze / Lansana-Mady Camara

PLoS ONE, Vol 11, Iss 8, p e

An Encouraging Experience from Conakry, Guinea.

2016 Volume 0157296

Abstract: Ten targeted health facilities supported by Damien Foundation (a Belgian Non Governmental Organization) and the National Tuberculosis (TB) Program in Conakry, Guinea.To uphold TB program performance during the Ebola outbreak in the presence of a package ... ...

Abstract	Ten targeted health facilities supported by Damien Foundation (a Belgian Non Governmental Organization) and the National Tuberculosis (TB) Program in Conakry, Guinea.To uphold TB program performance during the Ebola outbreak in the presence of a package of pre-emptive additional measures geared at reinforcing the routine TB program, and ensuring Ebola infection control, health-workers safety and motivation.A retrospective comparative cohort study of a TB program assessing the performance before (2013) and during the (2014) Ebola outbreak.During the Ebola outbreak, all health facilities were maintained opened, there were no reported health-worker Ebola infections, drug stockouts or health staff absences. Of 2,475 presumptive pulmonary TB cases, 13% were diagnosed with TB in both periods (160/1203 in 2013 and 163/1272 in 2014). For new TB, treatment success improved from 84% before to 87% during the Ebola outbreak (P = 0.03). Adjusted Hazard-ratios (AHR) for an unfavorable outcome was alwo lower during the Ebola outbreak, AHR = 0.8, 95% CI:0.7-0.9, P = 0.04). Treatment success improved for HIV co-infected patients (72% to 80%, P<0.01). For retreatment patients, the proportion achieving treatment success was maintained (68% to 72%, P = 0.05). Uptake of HIV-testing and Cotrimoxazole Preventive Treatment was maintained over 85%, and Anti-Retroviral Therapy uptake increased from 77% in 2013 to 86% in 2014 (P<0.01).Contingency planning and health system and worker support during the 2014 Ebola outbreak was associated with encouraging and sustained TB program performance. This is of relevance to future outbreaks.
Keywords	Medicine ; R ; Science ; Q
Subject code	796
Language	English
Publishing date	2016-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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