index
EDCTP portfolio: Clinical Research & Development Fellowships
EACCR: East African Consortium for Clinical Research
The EACCR network is building capacity for research into key poverty-related, neglected and emerging infectious diseases affecting East Africa.
The challenge
East Africa has a high burden of poverty-related infectious diseases and is at risk of outbreaks of Ebola and other viral haemorrhagic infections. The prevalence of TB, HIV/AIDS and malaria is high and co-infections are common; drug resistance is a growing threat.
Several countries in East Africa have well-established clinical research bases and strong links to European research collaborations. Networking provides opportunities to coordinate activities, share experiences, and build the capacities of less well-developed research sites.
The project
EACCR was established in 2009 with EDCTP funding, initially with 17 institutions in five countries. Its core focus was on capacity building, through long-term (master’s and PhD) and short-term training, as well as strengthening of laboratory capacities. Following needs assessments, EACCR completed infrastructure upgrades at more than 20 sites. It enabled more than 200 researchers to attend ten short-term courses, conducted a wide range of research skills workshops, and supervised 30 postgraduate research fellows.
EACCR also developed an innovative reciprocal monitoring scheme, generating a pool of experienced clinical trial monitors able to provide independent high-quality oversight of clinical trial activities. Trainee monitors are paired with experienced monitors so that they gain hands-on experience of clinical trial monitoring, raising awareness of quality management and increasing the pool of expertise able to perform monitoring activities in the region.
In follow-up EACCR2 funding, the network expanded to cover neglected infectious diseases as well as Ebola. It also grew in size, encompassing 23 African institutions in six countries and eight European partners from five countries. EACCR is also a part of the two EDCTP-funded epidemic preparedness consortia, ALERRT and PANDORA-ID-NET.
Thematic nodes of excellence have been established for malaria, TB, HIV/AIDS and neglected infectious diseases (primarily focusing on dengue, schistosomiasis, leishmaniasis, cysticercosis and Ebola), with a cross-cutting training node. Each area has a strong focus on collection of epidemiological, entomological and clinical data that will provide necessary background information to support interventional studies.
TB node partners successfully bid for EDCTP funding for the EXIT-TB project, which is exploring implementation of interventions to identify TB cases missed by conventional screening approaches. In addition, HIV node partners secured EDCTP funding for the EAPoC-VL study, which is exploring implementation of point-of-care viral load testing in young people with HIV. EDCTP funding was also secured for a career development fellow and a senior fellow. Collectively, EACCR2 partners obtained £20m additional funding from EDCTP and other sources.
Through its reciprocal monitoring scheme, the network trained 25 clinical research associates, who have monitored more than 30 clinical studies in the region. EACCR has supported four PhD projects associated with the Weltel trial, exploring the impact of weekly phone messaging on retention in a prevention of mother-to-child transmission trial. In total, 33 master’s students, five PhD students and five postdoctoral researchers have benefited from long-term training.
More than 35 people have been trained in 10 different short courses. Train-the-trainer courses in Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) have helped to cascade GCP and GCLP skills through the network. The network has more than 25 laboratories accredited to international GCLP standards. It has also established a data-sharing plan and data managers’ network to facilitate multisite studies.
Research studies funded through the EACCR3 grant will have a particular focus on the interaction between poverty-related infectious diseases and non-communicable diseases and with other infectious diseases, including COVID-19. The research studies will provide an opportunity for early-career researchers to get hands-on experience of clinical research. It will also work to strengthen ethical review capacities, working in partnership with the Pan-African Bioethics Institute (PABIN), and continue its training and mentorship programme. The network will also strengthen its links with other key institutes and networks in the regions, including ALERRT and PANDORA-ID-NET, Africa CDC, the East Africa Public Health Laboratory Network, and the WHO Regional Office for Africa.
Over the past decade the EACCR has strived to build capacity human resource capacity for clinical research among others, within the eastern African region. Despite these efforts still there is a gap in science for women capacity building in research and academia. EACCR developed a multidisciplinary PhD training programme known as Capacity Building for Female Scientists in East Africa (CaFe-SEA) to equip up to eight female scientists with skills and knowledge in the areas of epidemic preparedness, implementation science and health economics within the area of non-communicable and infectious diseases across Africa. The programme will also invite potential candidates from under-represented countries beyond the traditional partner states of EACCR like Seychelles, Burundi and South Sudan. Funding for this PhD fellowship program was awarded by the UK DHSC.
Impact
The EACCR3 project is supporting the development of clinical research capacity across a wide area in East Africa, facilitating the development of multicentre research projects. It is enabling a wider range of institutions to contribute to research into the poverty-related infectious diseases affecting East Africa, and providing a supportive environment for the training of a new generation of research leaders.
EDCTP portfolio: HIV & HIV-associated infections
The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.
Bringing antiretroviral drugs to children
“
test the safety and efficacy of this new formulation in young children
”
East Africa has a high burden of poverty-related infectious diseases and is at risk of outbreaks of Ebola and other viral haemorrhagic infections. The prevalence of TB, HIV/AIDS and malaria is high and co-infections are common; drug resistance is a growing threat.
Several countries in East Africa have well-established clinical research bases and strong links to European research collaborations. Networking provides opportunities to coordinate activities, share experiences, and build the capacities of less well-developed research sites.
The challenge
The later CHAPAS-3 trial compared the efficacy and safety of three fixed-dose combinations including two without stavudine (found to have some long-term side effects in adults, leading to a recommendation that its use be discontinued in children). The trial the first of its kind in Africa studied nearly 500 children at four sites in two African countries.
The project
EACCR was established in 2009 with EDCTP funding, initially with 17 institutions in five countries. Its core focus was on capacity building, through long-term (master’s and PhD) and short-term training, as well as strengthening of laboratory capacities. Following needs assessments, EACCR completed infrastructure upgrades at more than 20 sites. It enabled more than 200 researchers to attend ten short-term courses, conducted a wide range of research skills workshops, and supervised 30 postgraduate research fellows.
EACCR also developed an innovative reciprocal monitoring scheme, generating a pool of experienced clinical trial monitors able to provide independent high-quality oversight of clinical trial activities. Trainee monitors are paired with experienced monitors so that they gain hands-on experience of clinical trial monitoring, raising awareness of quality management and increasing the pool of expertise able to perform monitoring activities in the region.
In follow-up EACCR2 funding, the network expanded to cover neglected infectious diseases as well as Ebola. It also grew in size, encompassing 23 African institutions in six countries and eight European partners from five countries. EACCR is also a part of the two EDCTP-funded epidemic preparedness consortia, ALERRT and PANDORA-ID-NET.
Thematic nodes of excellence have been established for malaria, TB, HIV/AIDS and neglected infectious diseases (primarily focusing on dengue, schistosomiasis, leishmaniasis, cysticercosis and Ebola), with a cross-cutting training node. Each area has a strong focus on collection of epidemiological, entomological and clinical data that will provide necessary background information to support interventional studies.
TB node partners successfully bid for EDCTP funding for the EXIT-TB project, which is exploring implementation of interventions to identify TB cases missed by conventional screening approaches. In addition, HIV node partners secured EDCTP funding for the EAPoC-VL study, which is exploring implementation of point-of-care viral load testing in young people with HIV. EDCTP funding was also secured for a career development fellow and a senior fellow. Collectively, EACCR2 partners obtained £20m additional funding from EDCTP and other sources.
Through its reciprocal monitoring scheme, the network trained 25 clinical research associates, who have monitored more than 30 clinical studies in the region. EACCR has supported four PhD projects associated with the Weltel trial, exploring the impact of weekly phone messaging on retention in a prevention of mother-to-child transmission trial. In total, 33 master’s students, five PhD students and five postdoctoral researchers have benefited from long-term training.
More than 35 people have been trained in 10 different short courses. Train-the-trainer courses in Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) have helped to cascade GCP and GCLP skills through the network. The network has more than 25 laboratories accredited to international GCLP standards. It has also established a data-sharing plan and data managers’ network to facilitate multisite studies.
Research studies funded through the EACCR3 grant will have a particular focus on the interaction between poverty-related infectious diseases and non-communicable diseases and with other infectious diseases, including COVID-19. The research studies will provide an opportunity for early-career researchers to get hands-on experience of clinical research. It will also work to strengthen ethical review capacities, working in partnership with the Pan-African Bioethics Institute (PABIN), and continue its training and mentorship programme. The network will also strengthen its links with other key institutes and networks in the regions, including ALERRT and PANDORA-ID-NET, Africa CDC, the East Africa Public Health Laboratory Network, and the WHO Regional Office for Africa.
Over the past decade the EACCR has strived to build capacity human resource capacity for clinical research among others, within the eastern African region. Despite these efforts still there is a gap in science for women capacity building in research and academia. EACCR developed a multidisciplinary PhD training programme known as Capacity Building for Female Scientists in East Africa (CaFe-SEA) to equip up to eight female scientists with skills and knowledge in the areas of epidemic preparedness, implementation science and health economics within the area of non-communicable and infectious diseases across Africa. The programme will also invite potential candidates from under-represented countries beyond the traditional partner states of EACCR like Seychelles, Burundi and South Sudan. Funding for this PhD fellowship program was awarded by the UK DHSC.
Projects: Children with HIV in Africa Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS): CHAPAS-1 and -3
Project lead: Professor Chifumbe Chintu, University Teaching Hospital, Zambia (CHAPAS-1); Dr Veronica Mulenga, University Teaching Hospital, Zambia (CHAPAS-3)
Target population(s): Children with HIV
Sample size: 71 (CHAPAS-1); 480 (CHAPAS-3)
Countries involved: Ireland, the Netherlands, the UK, the USA, Zambia (CHAPAS-1); Uganda, Zambia (CHAPAS-3)
Project duration: 2005–2009 (CHAPAS-1); 2010 –2011 (CHAPAS-3)
EDCTP funding: €1.2M (CHAPAS-1); €4.6M (CHAPAS-3)
Total project funding: €1.2M (CHAPAS-1); €5.0M
L’homme RF et al. Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets. AIDS. 2008;22(5):557–65.
Mulenga V et al. Abacavir, zidovudine, or stavudine as paediatric tablets for African HIVinfected children (CHAPAS-3): an open-label, parallel-group, randomised controlled trial. Lancet Infect Dis. 2016;16(2):169–79.
WHO. Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2010.
WHO. Consolidated guidelines on the use of antiretroviral drugs
for treating and preventing
HIV infection: Recommendations for a public health approach
(second edition). 2016
Impact
ratios forfixed-dose combinations and on appropriatedosage according to weight.
The CHAPAS-3 trial confirmed the effectiveness of fixed-dose combinations, providing further impetus to the rollout of antiretrovirals to children. Its evidence on abacavir informed the WHO recommendation of abacavir-containing combinations for first-line therapy in children. Trial data have also been used to support applications for regulatory approval for new scored efavirenz tablets.
The EACCR3 project is supporting the development of clinical research capacity across a wide area in East Africa, facilitating the development of multicentre research projects. It is enabling a wider range of institutions to contribute to research into the poverty-related infectious diseases affecting East Africa, and providing a supportive environment for the training of a new generation of research leaders.