scholarly journals PO 8564 WHAT IS CLINICAL TRIAL QUALITY? A QUALITATIVE STUDY BASED ON INTERVIEWS WITH DIFFERENT STAKEHOLDERS CONDUCTING CLINICAL TRIALS IN SUB-SAHARAN AFRICA

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A54.1-A54
Author(s):  
Angela Lazarova ◽  
Claudia Fuchs ◽  
Christian Burri
Keyword(s):  
Clinical Trials ◽  
Qualitative Study ◽  
Web Search ◽  
Sub Saharan Africa ◽  
Quality Factors ◽  
Structured Interviews ◽  
Trial Quality ◽  
Resource Limited ◽  
Quality Aspects ◽  
Sub Saharan

BackgroundThere is no unified, broad definition for quality in clinical trials (CTs). Besides the explicit quality requirements in international guidelines and national legislation, however, there are broader factors to consider, including specific setting-related aspects influencing quality needs, quality perception and local implementation of guidelines. Our objective was to identify these factors from a resource-limited settings perspective (in this case, sub-Saharan Africa).MethodsIn March-April 2018, we conducted a qualitative study based on semi-structured interviews with participants from three stakeholder groups (monitors, sponsors, and investigators) conducting CTs in sub-Saharan Africa. We identified the interviewees either through CT registry platforms, a web search or by reference. We aimed to include 10–20 participants per stakeholder group. After consent, the interviews were held in person (via Skype or telephone), recorded, and transcribed verbatim. The interview questionnaire addressed a CT quality definition and quality factors during the CT process. We performed the analysis using the framework method.ResultsSo far, we included 21 participants (17 investigators, two sponsors, two monitors). Eight (8) (from sub-Saharan Africa) and 13 (not from sub-Saharan Africa) who contributed to CTs in 19 different countries in sub-Saharan Africa. Quality definitions mentioned so far were variable. A repeated statement was that the quality definition should be broad and include a system of multiple aspects and layers. We will interview more experts with sponsor and monitor experience in May 2018 and elaborate these quality aspects and layers. We will discuss these results with regards to a comprehensive quality framework for CTs currently under development for Northern countries by another Swiss research team.ConclusionCT quality was perceived in variable ways, as was the relevance of the aspects across different CT steps. Structuring the multifaceted layers of CT quality will facilitate appropriate and efficient CT quality management in sub-Saharan Africa.

scholarly journals "You can save time if…"—A qualitative study on internal factors slowing down clinical trials in Sub-Saharan Africa

PLoS ONE ◽  
2017 ◽  
Vol 12 (3) ◽  
pp. e0173796 ◽  
Author(s):  
Nerina Vischer ◽  
Constanze Pfeiffer ◽  
Manuela Limacher ◽  
Christian Burri
Keyword(s):  
Clinical Trials ◽  
Qualitative Study ◽  
Sub Saharan Africa ◽  
Internal Factors ◽  
Slowing Down ◽  
Sub Saharan

scholarly journals The conundrum of clinical trials and standard of care in sub-Saharan Africa – the research nurse perspective

2019 ◽  
Vol 24 (8) ◽  
pp. 649-660 ◽  
Author(s):  
Jane Frances Ndyetukira ◽  
Richard Kwizera ◽  
Florence Kugonza ◽  
Cynthia Ahimbisibwe ◽  
Carol Namujju ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Standard Of Care ◽  
Sub Saharan Africa ◽  
Research Nurse ◽  
Loss To Follow Up ◽  
Resource Limited ◽  
Research Nurses ◽  
Sub Saharan

Background Nurses form a very important part of the health workforce in sub-Saharan Africa. Research nurses are critical to the implementation of clinical trials. The duties and responsibilities of a research nurse are complex and continue to evolve as new practices and guidelines are formulated. Aims In this paper, we have highlighted the major contributions of research nurses in HIV clinical trials in sub-Saharan Africa from the unique perspective of Ugandan nurses. Methods The requirements and challenges of two multi-site, randomised cryptococcal meningitis clinical trials in Uganda were assessed from the perspective of research nurses conducting complex research in resource-limited settings. Results Over the course of 8 years, approximately 1739 participants were screened and 934 people were enrolled into the two trials. The nurses found that patient education and engagement were among the most important predictors of success in minimising loss to follow-up. Conclusions Research nurses played a key role in communicating clinical research goals to patients, obtaining informed consent, minimising loss to follow-up, and ensuring that research practices are translated and implemented into standard of care. However, there remains a need to integrate the same level of care provided in clinical research studies to non-study patients.

scholarly journals Connected diagnostics to improve accurate diagnosis, treatment, and conditional payment of malaria services in Kenya

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Shannen M. C. van Duijn ◽  
Angela K. Siteyi ◽  
Sherzel Smith ◽  
Emmanuel Milimo ◽  
Leon Stijvers ◽  
...  
Keyword(s):  
Clinical Performance ◽  
Healthcare Providers ◽  
Malaria Treatment ◽  
Sub Saharan Africa ◽  
Structured Interviews ◽  
National Guidelines ◽  
Private Providers ◽  
Provider Perspectives ◽  
Treatment Data ◽  
Sub Saharan

Abstract Background In sub-Saharan Africa, the material and human capacity to diagnose patients reporting with fever to healthcare providers is largely insufficient. Febrile patients are typically treated presumptively with antimalarials and/or antibiotics. Such over-prescription can lead to drug resistance and involves unnecessary costs to the health system. International funding for malaria is currently not sufficient to control malaria. Transition to domestic funding is challenged by UHC efforts and recent COVID-19 outbreak. Herewith we present a digital approach to improve efficiencies in diagnosis and treatment of malaria in endemic Kisumu, Kenya: Connected Diagnostics. The objective of this study is to evaluate the feasibility, user experience and clinical performance of this approach in Kisumu. Methods Our intervention was performed Oct 2017–Dec 2018 across five private providers in Kisumu. Patients were enrolled on M-TIBA platform, diagnostic test results digitized, and only positive patients were digitally entitled to malaria treatment. Data on socio-demographics, healthcare transactions and medical outcomes were analysed using standard descriptive quantitative statistics. Provider perspectives were gathered by 19 semi-structured interviews. Results In total 11,689 febrile patients were digitally tested through five private providers. Malaria positivity ranged from 7.4 to 30.2% between providers, significantly more amongst the poor (p < 0.05). Prescription of antimalarials was substantially aberrant from National Guidelines, with 28% over-prescription (4.6–63.3% per provider) and prescription of branded versus generic antimalarials differing amongst facilities and correlating with the socioeconomic status of clients. Challenges were encountered transitioning from microscopy to RDT. Conclusion We provide full proof-of-concept of innovative Connected Diagnostics to use digitized malaria diagnostics to earmark digital entitlements for correct malaria treatment of patients. This approach has large cost-saving and quality improvement potential.

scholarly journals Building sustainable research capacity at higher learning institutions in Tanzania through mentoring of the Young Research Peers

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Emmanuel Balandya ◽  
Bruno Sunguya ◽  
Daniel W. Gunda ◽  
Benson Kidenya ◽  
Tumaini Nyamhanga ◽  
...  
Keyword(s):  
Undergraduate Students ◽  
Professional Education ◽  
Research Training ◽  
Peer To Peer ◽  
Sub Saharan Africa ◽  
Ongoing Research ◽  
Scientific Presentation ◽  
Resource Limited ◽  
Sub Saharan ◽  
Young Researchers

Abstract Background Sustainability of research culture in Sub-Saharan Africa is threatened in part by the lack of a critical mass of young researchers with the requisite skills and interest to undertake research careers. This paper describes an intensive mentorship programme combining hierarchical (vertical) and peer-to-peer (horizontal) mentoring strategies among young researchers in a resource limited setting in Sub-Saharan Africa. Methods A consortium of three partnering large Tanzanian health training institutions (MUHAS, CUHAS and KCMUCo) and two collaborating US institutions (UCSF and Duke University) was formed as part of the five-year Transforming Health Professions Education in Tanzania (THET) project, funded by the NIH through Health Professional Education Partnership Initiative (HEPI). Within THET, the Community of Young Research Peers (CYRP) was formed, comprising of inter-professional and cross-institutional team of 12 Master-level Young Research Peers and 10 co-opted fellows from the former MEPI-Junior Faculty (MEPI-JF) project. The Young Peers received mentorship from senior researchers from the consortium through mentored research awards and research training, and in turn provided reciprocal peer-to-peer mentorship as well as mentorship to undergraduate students. Results At the end of the first 2 years of the project, all 12 Young Peers were proceeding well with mentored research awards, and some were at more advanced stages. For example, three articles were already published in peer reviewed journals and two other manuscripts were in final stages of preparation. All 12 Young Peers participated in CYRP-wide thematic training workshops on mentoring and secondary data analysis; 11 had undertaken at least three research training short courses in identified areas of need; 9 joined at least one other ongoing research project; 5 made at least one scientific presentation, and 5 participated in at least one submitted grant application. Half of the Young Peers have enrolled in PhD programmes. A collective total of 41 undergraduate students were actively mentored by the Young Peers in research. Conclusion The CYRP has demonstrated to be an effective model for dual vertical and horizontal mentorship in research to young investigators in resource-limited settings. This model is recommended to educators working on developing research competence of early career researchers, particularly in Sub-Saharan Africa.

scholarly journals Conducting clinical trials in sub-Saharan Africa: challenges and lessons learned from the Malawi Cryptosporidium study

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Neema Toto ◽  
Elaine Douglas ◽  
Markus Gmeiner ◽  
Lynn K. Barrett ◽  
Robert Lindblad ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Lessons Learned ◽  
Sub Saharan Africa ◽  
Sub Saharan

scholarly journals The inverse primary care law in sub-Saharan Africa: a qualitative study of the views of migrant health workers

2014 ◽  
Vol 64 (623) ◽  
pp. e321-e328 ◽  
Author(s):  
Shabir Moosa ◽  
Silvia Wojczewski ◽  
Kathryn Hoffmann ◽  
Annelien Poppe ◽  
Oathokwa Nkomazana ◽  
...  
Keyword(s):  
Primary Care ◽  
Qualitative Study ◽  
Health Workers ◽  
Migrant Health ◽  
Sub Saharan Africa ◽  
Sub Saharan

scholarly journals A metric-based assessment of flood risk and vulnerability of rural communities in the Lower Shire Valley, Malawi

2015 ◽  
Vol 370 ◽  
pp. 139-145 ◽  
Author(s):  
A. J. Adeloye ◽  
F. D. Mwale ◽  
Z. Dulanya
Keyword(s):  
Rural Communities ◽  
Spatial Variability ◽  
Flood Risk ◽  
Flood Hazard ◽  
Sub Saharan Africa ◽  
Structured Interviews ◽  
Adaptation Measures ◽  
Flood Depth ◽  
Inundation Area ◽  
Sub Saharan

Abstract. In response to the increasing frequency and economic damages of natural disasters globally, disaster risk management has evolved to incorporate risk assessments that are multi-dimensional, integrated and metric-based. This is to support knowledge-based decision making and hence sustainable risk reduction. In Malawi and most of Sub-Saharan Africa (SSA), however, flood risk studies remain focussed on understanding causation, impacts, perceptions and coping and adaptation measures. Using the IPCC Framework, this study has quantified and profiled risk to flooding of rural, subsistent communities in the Lower Shire Valley, Malawi. Flood risk was obtained by integrating hazard and vulnerability. Flood hazard was characterised in terms of flood depth and inundation area obtained through hydraulic modelling in the valley with Lisflood-FP, while the vulnerability was indexed through analysis of exposure, susceptibility and capacity that were linked to social, economic, environmental and physical perspectives. Data on these were collected through structured interviews of the communities. The implementation of the entire analysis within GIS enabled the visualisation of spatial variability in flood risk in the valley. The results show predominantly medium levels in hazardousness, vulnerability and risk. The vulnerability is dominated by a high to very high susceptibility. Economic and physical capacities tend to be predominantly low but social capacity is significantly high, resulting in overall medium levels of capacity-induced vulnerability. Exposure manifests as medium. The vulnerability and risk showed marginal spatial variability. The paper concludes with recommendations on how these outcomes could inform policy interventions in the Valley.

scholarly journals Effective strategies followed by multinational enterprises expanding into Africa

2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Zihné Coetzee ◽  
Henri Bezuidenhout ◽  
Gabriel Mhonyera
Keyword(s):  
Multinational Enterprises ◽  
Market Potential ◽  
Sub Saharan Africa ◽  
Retail Sector ◽  
International Expansion ◽  
Structured Interviews ◽  
International Partnerships ◽  
Managerial Implications ◽  
Sub Saharan ◽  
Value Add

Orientation: Retail sector multinational enterprises (MNEs) face challenges and follow diverse strategies when they expand into foreign markets.Research purpose: The major aim of this article is to determine how three well-established retail sector MNEs, namely, Walmart, Carrefour and Shoprite, addressed the challenges they faced and structured their market entry strategies in the African continent.Motivation for the study: While the opportunities in Africa are perpetual, breaking into the African market is not so straightforward. It is in this regard that the importance of determining the challenges faced by established retail MNEs in Africa and the valuable lessons that can be drawn by small and upcoming MNEs, from the experiences of these prominent MNEs studied, is exposed.Research approach/design and method: This article employs a mixed-method approach (i.e. case study and semi-structured interviews) to determine the challenges faced by Walmart, Carrefour and Shoprite when they expanded into Africa, and how they overcame those challenges.Main findings: The findings reveal that Walmart and Shoprite possess a substantial footprint in sub-Saharan Africa, while Carrefour enjoys a substantial footprint in North Africa and Francophone Countries of west Africa. Furthermore, Walmart follows a risk-averse approach when expanding into the African continent and only expands into new foreign markets based on the market potential and the ability to succeed. Carrefour’s main strategy is to achieve international expansion into Africa through the acquisition of international partnerships with local and regional firms. Shoprite, on the other hand, maintains that no written strategy was followed when the retail MNE expanded into Africa. It is also evident that external factors are significant for MNEs seeking to invest in Africa.Practical/managerial implications: Not all MNEs expanding into Africa have been successful. Accordingly, the practical value of this article rests upon the lessons that small and upcoming MNEs can learn from the experiences of MNEs that are now well established in African markets.Contribution/value-add: This article contributes to existing foreign direct investment (FDI) literature by identifying challenges that Walmart, Carrefour and Shoprite faced when they expanded into Africa. In addition, lessons that aspiring and small MNEs, specifically in the retail sector, can learn from these three retail MNEs that are now well established in African markets are drawn.

scholarly journals Rates and predictors of adherence and retention for antiretroviral therapy among HIV-positive adults in Enugu, Nigeria

2019 ◽  
Vol 31 (3) ◽  
pp. 202-211
Author(s):  
Onyinye Hope Chime
Keyword(s):  
Sub Saharan Africa ◽  
People Living With Hiv ◽  
Related Factors ◽  
Art Programs ◽  
Adherence To Medication ◽  
Behavioural Modification ◽  
Resource Limited ◽  
Sub Saharan ◽  
Living With Hiv ◽  
Predictors Of Adherence

BackgroundHIV infection and AIDS are majorpublic health challenges in Nigeria, a country with one of the highest rates of new infection in sub-Saharan Africa and the second largest HIV epidemic in the world.Non-adherence to medication and defaulting from treatment are the two major challenges faced by anti-retroviral therapy (ART) programs in resource-constrained settings. This study was undertaken to determine the rate and predictors of adherence to medication and retention among people living with HIVin Enugu State, Nigeria.MethodsThis was a cross-sectionalretrospective study conducted among adults living with HIV(PLHIV) receiving ARTs in eightcomprehensive health facilities in Enugu, Nigeria. We used self-reported adherence and recorded clinic visits to assess adherence and retention, respectively. Descriptive statistics (frequencies, proportions, mean and standard deviation) and regression analysis were then conducted to identify the association between adherence, retention and demographic and health-related factors. ResultsThe mean age of respondents was 38.5±9.8 years. Predictors of good adherence to medication includedbeing male(adjusted odds ratio [AOR]:2.08; 95% confidence interval [CI]:1.12–3.85), having been on anti-retroviral medications for more than 5 years (AOR:1.92; 95% CI: 1.17–3.16), the non-consumption of alcohol(AOR: 3.67; 95% CI: 2.01–6.70),not usingtraditional medicine (AOR: 2.76; 95% CI:1.33–5.73) and having a baseline CD4count exceeding 500 cells/μl (AOR: 5.67; 95% CI: 1.32–24.32).Adequate retention was predicted by being resident in the urban area (AOR: 1.90; 95% CI: 1.17–3.06). Being away from home (41.8%) and forgetfulness (35.0%) were reported as the major reasons for missing medication.ConclusionThe rates of adherence and retention found in this study were similar to those reported forother resource-limited settings. Health education and behavioural modification interventions should be intensified to reduce the consumption of alcohol and the use of traditional medicine by people living with HIV. Identifying other factors may help to design effective strategies to ensure that people living with HIV adhere to their medications and remain in care.

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