14 research outputs found
Entrenching internationalisation in African Higher Education Institutions
In this paper, an attempt was made to locate the role of internationalisation in African Higher Education Institutions (HEIs). It is argued that comprehensive international, intercultural, and global dimensions in the affairs of African tertiary institutions provide for a more nuanced and diversified higher education landscape. Through a desk study approach, dwelling mainly on existing literature, the paper examines the issues of internationalisation from the perspectives of diversity and inclusion, as well as the roles of the relevant key players within those institutions to practically deliver internationalisation strategies that will put the institution on a global pedestal while remaining locally and regionally relevant. More importantly, strategies for achieving comprehensive internationalisation are discussed drawing inferences from literature and documentary sources. The interrogation of these sources in relation to the expectations of the current and future HEIs to remain socially relevant and sustainable is carried out. HEIs in Africa must contribute to socio-economic change and engage with their quad-helix and eco-system partners to ensure that high end skills training, knowledge production, entrepreneurship and innovation are accelerated. In so doing, African HEIs must embrace diversity in its fullness including welcoming differences in gender, race, culture, nationality and providing platforms of engagement that allow for inclusion, and breaking silos to allow for a nuanced agenda of internationalisation
Ethical considerations in implementing a biometric coenrolment prevention system in clinical trials in South Africa
Preventing co-enrolment in clinical trials ensures participant safety and data integrity. To facilitate co-enrolment checks, a novel biometric coenrolment prevention system (BCEPS) was developed and implemented in 2010 by the HIV Prevention Research Unit (HPRU) in collaboration with the South African Medical Research Council’s (SAMRC) Information Technology Services Division. The use of this web-based system to capture participant’s identification details in real time was approved by the SAMRC Ethics Committee. BCEPS was implemented at 13 other research organisations conducting clinical trials in South Africa (SA). Participants who screened at the clinical research sites (CRSs) had their names, SA identity or passport number and fingerprints captured onto BCEPS after comprehensive education and discussion. This information was verified at all study visits. If a participant attempted to screen or co-enrol at multiple CRSs, the system flagged this as a potential coenrolment.By addressing the ethical concerns around participant consent and rights, participant confidentiality and privacy, data securityand access, and data management and storage, we were able to successfully implement BCEPS within the clinical trials conducted at HPRU,while adhering to the principles of good clinical practice (GCP), including respect for persons, beneficence and justice
Hen egg white bovine colostrum supplement reduces symptoms of mild/moderate COVID-19: a randomized control trial
Aim: The ability of a hen egg white bovine colostrum supplement to prevent severe COVID-19 was tested in a double-blind randomized control study. Methods: Adults with mild/moderate COVID-19, risk factors for severe disease, and within 5 days of symptom onset were assigned to the intervention (n = 77) or placebo (n = 79) arms. Symptoms were documented until day 42 post-enrollment and viral clearance was assessed at 11–13 days post-symptom onset. Results: One participant developed severe COVID-19. The severe-type symptom score was lower in the active arm at 11–13 days post-symptom onset (p = 0.049). Chest pain, fever/chills, joint pain/malaise, and sore throat were significantly less frequent in the active arm. No differences in viral clearance were observed. Conclusion: The intervention reduced symptoms of mild/moderate COVID-19. Clinical Trial Registration: DOH-27-062021-9191 (South African National Clinical Trials Register
Characteristics of Women Enrolled into a Randomized Clinical Trial of Dapivirine Vaginal Ring for HIV-1 Prevention.
Women in sub-Saharan Africa are a priority population for evaluation of new biomedical HIV-1 prevention strategies. Antiretroviral pre-exposure prophylaxis is a promising prevention approach; however, clinical trials among young women using daily or coitally-dependent products have found low adherence. Antiretroviral-containing vaginal microbicide rings, which release medication over a month or longer, may reduce these adherence challenges.ASPIRE (A Study to Prevent Infection with a Ring for Extended Use) is a phase III, randomized, double-blind, placebo-controlled trial testing the safety and effectiveness of a vaginal ring containing the non-nucleoside reverse transcriptase inhibitor dapivirine for prevention of HIV-1 infection. We describe the baseline characteristics of African women enrolled in the ASPIRE trial.Between August 2012 and June 2014, 5516 women were screened and 2629 HIV-1 seronegative women between 18-45 years of age were enrolled from 15 research sites in Malawi, South Africa, Uganda, and Zimbabwe. The median age was 26 years (IQR 22-31) and the majority (59%) were unmarried. Nearly 100% of participants reported having a primary sex partner in the prior three months but 43% did not know the HIV-1 status of their primary partner; 17% reported additional concurrent partners. Nearly two-thirds (64%) reported having disclosed to primary partners about planned vaginal ring use in the trial. Sexually transmitted infections were prevalent: 12% had Chlamydia trachomatis, 7% Trichomonas vaginalis, 4% Neisseria gonorrhoeae, and 1% syphilis.African HIV-1 seronegative women at risk of HIV -1 infection were successfully enrolled into a phase III trial of dapivirine vaginal ring for HIV-1 prevention
Hen egg white bovine colostrum supplement reduces symptoms of mild/moderate COVID-19: a randomized control trial: Supplementary files
Aim: The ability of a hen egg white bovine colostrum supplement to prevent severe COVID-19 was tested
in a double-blind randomized control study. Methods: Adults with mild/moderate COVID-19, risk factors
for severe disease, and within 5 days of symptom onset were assigned to the intervention (n = 77) or
placebo (n = 79) arms. Symptoms were documented until day 42 post-enrollment and viral clearance was
assessed at 11–13 days post-symptom onset. Results: One participant developed severe COVID-19. The
severe-type symptom score was lower in the active arm at 11–13 days post-symptom onset (p = 0.049).
Chest pain, fever/chills, joint pain/malaise, and sore throat were significantly less frequent in the active
arm. No differences in viral clearance were observed. Conclusion: The intervention reduced symptoms of
mild/moderate COVID-19.</p
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Social harms in female-initiated HIV prevention method research: state of the evidence.
ObjectivesAssessment of safety is an integral part of real-time monitoring in clinical trials. In HIV prevention research, safety of investigational products and trial participation has been expanded to include monitoring for 'social harms', generally defined as negative consequences of trial participation that may manifest in social, psychological, or physical ways. Further research on social harms within HIV prevention research is needed to understand the potential safety risks for women and advance the implementation of prevention methods in real-world contexts.MethodsSecondary analysis of quantitative data from three randomized, double-blind, placebo-controlled trials of microbicide candidates in sub-Saharan Africa was conducted. Additionally, we assessed data from two prospective cohort studies that included participants who became HIV-positive or pregnant during parent trials.ResultsSocial harms reporting was low across the largest and most recent microbicide studies. Social harm incidence per 100 person-years ranged from 1.10 (95% CI 0.78-1.52) to 3.25 (95% CI 2.83-3.74) in the phased trials. Reporting differed by dosing mechanism (e.g. vaginal gel, oral tablet, ring) and study, most likely as a function of measurement differences. Social harms were most frequently associated with male partners, rather than, for example, experiences of stigma in the community.ConclusionMeasurement and screening for social harms is an important component of conducting ethical research of novel HIV prevention methods. To date, social harm incidence reported in microbicide trials has been relatively low (<4% per 100 person-years), and the majority have been partner-related events. However, any incidence of social harm within the context of HIV prevention is important to capture and understand for the safety of individuals, and for the successful impact of prevention methods in a real-world context
Recommended from our members
Social harms in female-initiated HIV prevention method research: state of the evidence.
ObjectivesAssessment of safety is an integral part of real-time monitoring in clinical trials. In HIV prevention research, safety of investigational products and trial participation has been expanded to include monitoring for 'social harms', generally defined as negative consequences of trial participation that may manifest in social, psychological, or physical ways. Further research on social harms within HIV prevention research is needed to understand the potential safety risks for women and advance the implementation of prevention methods in real-world contexts.MethodsSecondary analysis of quantitative data from three randomized, double-blind, placebo-controlled trials of microbicide candidates in sub-Saharan Africa was conducted. Additionally, we assessed data from two prospective cohort studies that included participants who became HIV-positive or pregnant during parent trials.ResultsSocial harms reporting was low across the largest and most recent microbicide studies. Social harm incidence per 100 person-years ranged from 1.10 (95% CI 0.78-1.52) to 3.25 (95% CI 2.83-3.74) in the phased trials. Reporting differed by dosing mechanism (e.g. vaginal gel, oral tablet, ring) and study, most likely as a function of measurement differences. Social harms were most frequently associated with male partners, rather than, for example, experiences of stigma in the community.ConclusionMeasurement and screening for social harms is an important component of conducting ethical research of novel HIV prevention methods. To date, social harm incidence reported in microbicide trials has been relatively low (<4% per 100 person-years), and the majority have been partner-related events. However, any incidence of social harm within the context of HIV prevention is important to capture and understand for the safety of individuals, and for the successful impact of prevention methods in a real-world context