scholarly journals Assessing clinical investigators’ perceptions of relevance and competency of clinical trials skills: An international AIDS Malignancy Consortium (AMC) study

2020 ◽  
pp. 1-6
Author(s):  
Jeannette Y. Lee ◽  
Shelly V Lensing ◽  
Maria T. Botello-Harbaum ◽  
Rebecca Medina ◽  
Meredith Zozus
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Task Force ◽  
Perceived Competence ◽  
Sub Saharan Africa ◽  
People Living With Hiv ◽  
Specimen Collection ◽  
Average Proportion ◽  
Sub Saharan ◽  
Safety Considerations

Abstract Introduction: The AIDS Malignancy Consortium (AMC) conducts clinical trials of therapeutic and prevention strategies for cancer in people living with HIV. With its recent expansion to Sub-Saharan Africa and Latin America, there was a need to increase the competence of clinical investigators (CIs) to implement clinical trials in these regions. Methods: AMC CIs were invited to complete a survey to assess role-relevance and self-perceived competence based on the Joint Task Force for Clinical Trials Competency domains. Results: A total of 40 AMC CIs were invited to complete the questionnaire and 35 responded to the survey. The data management and informatics and engaging with communities’ domains were lowest in the average proportion of CIs rating themselves high (scores of 3–4) for self-perceived competency (46.6% and 44.2%) and role-relevance (61.6% and 67.5%), whereas, the ethical and participant safety considerations domain resulted in the highest score for competency (86.6%) and role-relevance (93.3%). In the scientific concepts and research design domain, a high proportion rated for competency in evaluating study designs and scientific literature (71.4% and 74.3%) but a low proportion for competency for designing trials and specimen collection protocols (51.4% and 54.3%). Conclusions: Given the complexity of AMC clinical research, these results provide evidence of the need to develop training for clinical research professionals across domains where self-perceived competence is low. This assessment will be used to tailor and prioritize the AMC Training Program in clinical trial development and management for AMC CIs.

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 Clinical Trials for Treatment and Prevention of HIV-Associated Malignancies in Sub-Saharan Africa: Building Capacity and Overcoming Barriers

2020 ◽  
pp. 1134-1146 ◽  
Author(s):  
Lilie L. Lin ◽  
David S. Lakomy ◽  
Elizabeth Y. Chiao ◽  
Robert M. Strother ◽  
Meg Wirth ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cervical Dysplasia ◽  
Kaposi Sarcoma ◽  
Sub Saharan Africa ◽  
Current Status ◽  
People Living With Hiv ◽  
Non Hodgkin Lymphoma ◽  
Treatment And Prevention ◽  
Sub Saharan ◽  
Living With Hiv

PURPOSE The aim of this study was to review the current status of clinical trials for HIV-associated malignancies in people living with HIV in sub-Saharan Africa (SSA) and efforts made by the AIDS Malignancy Consortium (AMC) to build capacity in SSA for HIV malignancy research. METHODS All malignancy-related clinical trials in 49 SSA countries on ClinicalTrials.gov were reviewed and evaluated for inclusion and exclusion criteria pertaining to HIV status. Additional studies by AMC in SSA were compiled from Web-based resources, and narrative summaries were prepared to highlight AMC capacity building and training initiatives. RESULTS Of 96 cancer trials identified in SSA, only 11 focused specifically on people living with HIV, including studies in Kaposi sarcoma, cervical dysplasia and cancer, non-Hodgkin lymphoma, and ocular surface squamous neoplasia. Recognizing the increasing cancer burden in the region, AMC expanded its clinical trial activities to SSA in 2010, with 4 trials completed to date and 6 others in progress or development, and has made ongoing investments in developing research infrastructure in the region. CONCLUSION As the HIV-associated malignancy burden in SSA evolves, research into this domain has been limited. AMC, the only global HIV malignancy-focused research consortium, not only conducts vital HIV-associated malignancies research in SSA, but also develops pathology, personnel, and community-based infrastructure to meet these challenges in SSA. Nonetheless, there is an ongoing need to build on these efforts to improve HIV-associated malignancies outcomes in SSA.

scholarly journals PO 8538 STRENGTHENING SOCIAL STRATEGIES TO ENGAGE SUB-SAHARAN AFRICAN SOCIETIES TO VALUE CLINICAL RESEARCH: THE EXPERIENCE IN CONDUCTING CLINICAL TRIALS IN LAMBARéNé

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A51.1-A51
Author(s):  
Pamela C Angoissa Minsoko ◽  
Selidji T Agnandji
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Community Engagement ◽  
Sub Saharan Africa ◽  
Social Meaning ◽  
Willingness To Participate ◽  
The Social ◽  
Social Meanings ◽  
Sub Saharan ◽  
Social Components

BackgroundOver the last two decades, clinical research activities have increased significantly in sub-Saharan Africa but societal engagement to make research socially and economically valuable is limited. Thus, engaging communities when designing clinical research and promoting social impacts of research are becoming key objectives among stakeholders involved in clinical research in sub-Saharan Africa. However, there is a need to define concepts and indicators to assess the strength of community engagement as well as the social impacts of clinical research.Here, we hypothesised that the social meanings of willingness to participate and compliance to clinical trial procedures are relevant indicators to assess community engagement.MethodsWe conducted a retrospective, prospective case study of clinical trials conducted in CERMEL between 1995 and 2017. We performed a social meaning framework analysis of the following processes: protocol design, ethical and regulatory clearance, informed consent and medical study procedures. We identified the social meanings of each procedure according to the involvement of social components (actors, ideas, communication strategies).ResultsA total of 42 clinical trials were identified in the ClinicalTrials.gov and Pan-African Clinical Trials Registry databases and confirmed by the top management of CERMEL. Between 1995 and 2004, there was little social meaning connected to trial procedures. This period was associated with poor compliance to study procedures. Between 2005 and 2017, compliance to study procedures improved. Detailed results will be presented during the meeting.ConclusionThe rise in willingness to participate in clinical research and improved compliance with study procedures were associated with the introduction of social components to medical procedures. Both indicators may be relevant to assess the strength of community engagement.

scholarly journals Pandemics and Burden of Stroke and Epilepsy in Sub-Saharan Africa: Experience from a Longstanding Health Programme

2021 ◽  
Vol 18 (5) ◽  
pp. 2766
Author(s):  
Massimo Leone ◽  
Fausto Ciccacci ◽  
Stefano Orlando ◽  
Sandro Petrolati ◽  
Giovanni Guidotti ◽  
...  
Keyword(s):  
Neurological Disorders ◽  
Combined Treatment ◽  
Cerebrovascular Disorders ◽  
Sub Saharan Africa ◽  
Noncommunicable Diseases ◽  
People Living With Hiv ◽  
Sub Saharan ◽  
Health Programme ◽  
Excess Deaths ◽  
Hiv Aids

Eighty percent of people with stroke live in low- to middle-income nations, particularly in sub-Saharan Africa (SSA) where stroke has increased by more than 100% in the last decades. More than one-third of all epilepsy−related deaths occur in SSA. HIV infection is a risk factor for neurological disorders, including stroke and epilepsy. The vast majority of the 38 million people living with HIV/AIDS are in SSA, and the burden of neurological disorders in SSA parallels that of HIV/AIDS. Local healthcare systems are weak. Many standalone HIV health centres have become a platform with combined treatment for both HIV and noncommunicable diseases (NCDs), as advised by the United Nations. The COVID-19 pandemic is overwhelming the fragile health systems in SSA, and it is feared it will provoke an upsurge of excess deaths due to the disruption of care for chronic diseases such as HIV, TB, hypertension, diabetes, and cerebrovascular disorders. Disease Relief through Excellent and Advanced Means (DREAM) is a health programme active since 2002 to prevent and treat HIV/AIDS and related disorders in 10 SSA countries. DREAM is scaling up management of NCDs, including neurologic disorders such as stroke and epilepsy. We described challenges and solutions to address disruption and excess deaths from these diseases during the ongoing COVID-19 pandemic.

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 Aging, Health, and Quality of Life for Older People Living With HIV in Sub-Saharan Africa: A Review and Proposed Conceptual Framework

2017 ◽  
Vol 31 (1) ◽  
pp. 109-138 ◽  
Author(s):  
Mark J. Siedner
Keyword(s):  
Quality Of Life ◽  
Conceptual Framework ◽  
Care Delivery ◽  
Sub Saharan Africa ◽  
People Living With Hiv ◽  
Sub Saharan ◽  
Living With Hiv ◽  
The Impact

Objective: The number of people living with HIV (PLWH) over 50 years old in sub-Saharan Africa is predicted to triple in the coming decades, to 6-10 million. Yet, there is a paucity of data on the determinants of health and quality of life for older PLWH in the region. Methods: A review was undertaken to describe the impact of HIV infection on aging for PLWH in sub-Saharan Africa. Results: We (a) summarize the pathophysiology and epidemiology of aging with HIV in resource-rich settings, and (b) describe how these relationships might differ in sub-Saharan Africa, (c) propose a conceptual framework to describe determinants of quality of life for older PLWH, and (d) suggest priority research areas needed to ensure long-term gains in quality of life for PLWH in the region. Conclusions: Differences in traditional, lifestyle, and envirnomental risk factors, as well as unique features of HIV epidemiology and care delivery appear to substantially alter the contribution of HIV to aging in sub-Saharan Africa. Meanwhile, unique preferences and conceptualizations of quality of life will require novel measurement and intervention tools. An expanded research and public health infrastructure is needed to ensure that gains made in HIV prevention and treamtent are translated into long-term benefits in this region.

scholarly journals The Kaposi’s Sarcoma-Associated Herpesvirus (KSHV) gH/gL Complex Is the Predominant Neutralizing Antigenic Determinant in KSHV-Infected Individuals

Viruses ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 256 ◽  
Author(s):  
Yasaman Mortazavi ◽  
Salum J. Lidenge ◽  
Tara Tran ◽  
John T. West ◽  
Charles Wood ◽  
...  
Keyword(s):  
Antigenic Determinant ◽  
Neutralizing Antibodies ◽  
Kaposi's Sarcoma ◽  
Kaposi’S Sarcoma ◽  
Sub Saharan Africa ◽  
People Living With Hiv ◽  
Viral Glycoproteins ◽  
Kaposi's Sarcoma Associated Herpesvirus ◽  
Sub Saharan ◽  
Kaposi’S Sarcoma Associated Herpesvirus

Kaposi’s sarcoma-associated herpesvirus (KSHV) is the etiological agent of Kaposi’s sarcoma (KS), one of the most prevalent cancers of people living with HIV/AIDS in sub-Saharan Africa. The seroprevalence for KSHV is high in the region, and no prophylactic vaccine against the virus is available. In this study, we characterized the antigenic targets of KSHV-specific neutralizing antibodies (nAbs) in asymptomatic KSHV-infected individuals and KS patients with high nAbs titers. We quantified the extent to which various KSHV envelope glycoproteins (gB, ORF28, ORF68, gH, gL, gM, gN and gpK8.1) adsorbed/removed KSHV-specific nAbs from the plasma of infected individuals. Our study revealed that plasma from a majority of KSHV neutralizers recognizes multiple viral glycoproteins. Moreover, the breadth of nAbs responses against these viral glycoproteins varies among endemic KS, epidemic KS and asymptomatic KSHV-infected individuals. Importantly, among the KSHV glycoproteins, the gH/gL complex, but neither gH nor gL alone, showed the highest adsorption of KSHV-specific nAbs. This activity was detected in 80% of the KSHV-infected individuals regardless of their KS status. The findings suggest that the gH/gL complex is the predominant antigenic determinant of KSHV-specific nAbs. Therefore, gH/gL is a potential target for development of KSHV prophylactic vaccines.

scholarly journals Stigmatising Attitudes Towards Co-workers with HIV in the Workplace of a Metropolitan State, Southwestern Nigeria

2017 ◽  
Vol 11 (1) ◽  
pp. 67-75 ◽  
Author(s):  
Idongesit Godwin Utuk ◽  
Kayode Omoniyi Osungbade ◽  
Taiwo Akinyode Obembe ◽  
David Ayobami Adewole ◽  
Victoria Oluwabunmi Oladoyin
Keyword(s):  
Sampling Technique ◽  
Sub Saharan Africa ◽  
Good Knowledge ◽  
People Living With Hiv ◽  
Cross Sectional Survey ◽  
Southwestern Nigeria ◽  
Cross Sectional ◽  
Sub Saharan ◽  
Living With Hiv ◽  
Hiv Aids

Background:Despite demonstrating global concerns about infection in the workplace, very little research has explored how co-workers react to those living with HIV in the workplace in sub-Saharan Africa. This study aimed to assess the level of stigmatising attitude towards co-workers living with HIV in the workplace.Methods:The study was a descriptive cross-sectional survey involving 403 respondents. They were recruited from selected companies through a multistage sampling technique. Survey was carried out using pre-tested semi-structured questionnaires. Data were analyzed using the Statistical Package for the Social Sciences to generate frequencies, cross tabulations of variables at 5% level of significance. Logistic regression model was used to determine the predictors at 95% confidence intervals.Results:Mean age of respondents was 32.9 ± 9.4 years with 86.1% being females. Overall, slightly below two-third (63.0%) had good knowledge on transmission of HIV/AIDS while 218 (54.1%) respondents had a high stigmatising attitude towards co-workers with HIV in the workplace. More female respondents (69.6%) demonstrated high stigmatising attitudes towards co-workers with HIV in the workplace (p = 0.012). Female workers were twice more likely to have high stigmatising attitudes towards co-worker with HIV [OR 2.1 (95% CI: 1.13 – 3.83)].Conclusion:Stigma towards people living with HIV/AIDs is still very persistent in different settings. Good knowledge amongst our participants about HIV/AIDs did not translate to low stigmatising attitudes among workers. Concerted efforts and trainings on the transmission of HIV/AIDs are essential to reduce stigma that is still very prevalent in workplace settings.

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