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EDCTP portfolio: Clinical Research & Development Fellowships

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The SCINE-U project is enhancing the capacity of community advisory boards to feed into ethics review processes.

Strengthening community engagement in Uganda

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Increasing numbers of clinical trials are being conducted in sub-Saharan Africa, making it ever more important that the interests of participants and wider communities are protected. 

Through various initiatives, the ethics review capacities of the Uganda National Council for Science and Technology (UNCST) and institutional research ethics committees have been significantly strengthened in recent years. However, one area that has not been addressed to date is community engagement, for example through community advisory boards. There is currently limited guidance on engagement with such boards, so activities are dependent on the commitment of individual researchers. 

The challenge

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The SCINE-U project is supporting activities to enhance community input into national ethics review processes in Uganda. A situational analysis is being undertaken across the 19 institutions carrying out clinical research in Uganda to identify the routes through which communities currently feed into ethical review of research proposals. Consultations will take place with community advisory boards, participants, research ethics committees, national ethics regulators, researchers and other key stakeholders.

Based on the findings of the situational analysis, as well as a review of similar documentation used in other settings and interviews with key stakeholders, policies and guidelines on engagement with community advisory boards and operating manuals for such bodies will be developed.

The project will also develop an education programme and training materials to build the capacity of community advisory boards to provide input into ethics review activities, with training and mentoring of board members.  An online management information system will also be developed so that the UNCST can keep track of the involvement of community advisory boards in ethics review activities nationally. A monitoring and evaluation framework will be developed so that the functionality of boards can be tracked over time.

The project

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The SCINE-U project will close a key gap in ethics review activities in Uganda, strengthening links between national research oversight bodies and community advisory boards. It will also build the capacity of community advisory boards to play a meaningful role in clinical research ethics review and project monitoring activities. This will ensure that community advisory boards are better able to protect the interests of local communities and ensure that research adheres to sound ethical practices.

Impact

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test the safety and efficacy of this new formulation in young children

Bringing antiretroviral drugs to children

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The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.

EDCTP portfolio: HIV & HIV-associated infections

The challenge

Increasing numbers of clinical trials are being conducted in sub-Saharan Africa, making it ever more important that the interests of participants and wider communities are protected. 

Through various initiatives, the ethics review capacities of the Uganda National Council for Science and Technology (UNCST) and institutional research ethics committees have been significantly strengthened in recent years. However, one area that has not been addressed to date is community engagement, for example through community advisory boards. There is currently limited guidance on engagement with such boards, so activities are dependent on the commitment of individual researchers. 

watermark

The SCINE-U project is supporting activities to enhance community input into national ethics review processes in Uganda. A situational analysis is being undertaken across the 19 institutions carrying out clinical research in Uganda to identify the routes through which communities currently feed into ethical review of research proposals. Consultations will take place with community advisory boards, participants, research ethics committees, national ethics regulators, researchers and other key stakeholders.

Based on the findings of the situational analysis, as well as a review of similar documentation used in other settings and interviews with key stakeholders, policies and guidelines on engagement with community advisory boards and operating manuals for such bodies will be developed.

The project will also develop an education programme and training materials to build the capacity of community advisory boards to provide input into ethics review activities, with training and mentoring of board members.  An online management information system will also be developed so that the UNCST can keep track of the involvement of community advisory boards in ethics review activities nationally. A monitoring and evaluation framework will be developed so that the functionality of boards can be tracked over time.

The project

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 SCINE-U project will close a key gap in ethics review activities in Uganda, strengthening links between national research oversight bodies and community advisory boards. It will also build the capacity of community advisory boards to play a meaningful role in clinical research ethics review and project monitoring activities. This will ensure that community advisory boards are better able to protect the interests of local communities and ensure that research adheres to sound ethical practices.

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.

Impact

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

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