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Project details

Enhancing clinical research during outbreaks

The ACT-PREP project aims to strengthen capacity for conducting clinical trials in sub-Saharan Africa, with a particular focus on research during outbreaks.

The challenge

Countries in sub-Saharan Africa face a multitude of infectious disease challenges, including a high risk of outbreaks of epidemic-prone pathogens. At the same time, countries typically have weak healthcare systems, limited surveillance capacity, and underdeveloped capacity for detecting and responding to outbreaks. 

In particular, countries rarely have the capacity to integrate research activities into outbreak responses to generate evidence that strengthens control activities and response effectiveness. 

Nevertheless, some countries in the region have built strong surveillance, outbreak response and research capacities, and have achieved significant successes in preventing outbreaks from turning into major health crises. There are opportunities for such countries to share their expertise and experience with other countries in the region. 

The project

The goal of the ACT-PREP project is to institutionalise clinical trial preparedness within national public health systems, as part of broader efforts to strengthen outbreak detection and response. It has a particular focus on HIV/AIDS, malaria, neglected tropical diseases and TB, alongside emerging and re-emerging infections. 

The project is providing an extensive range of short- and long-term training opportunities to strengthen research capacity for researchers, healthcare professionals, clinical trials support staff, and undergraduate and postgraduate students. This will be based on interactive workshops and online courses, use of massive open online courses (MOOCs), and placements at trial sites and within ongoing trials or surveillance activities. The project partners will provide access to real-life datasets for supervised training exercises.

In particular, the project is training more than 700 senior researchers in advanced methodologies and techniques, setting up mentorship programmes, and developing exchange programmes. It will support the work of 15 PhD students and 10 postdoctoral scientists. In addition, a further 80 clinical trial monitors will be trained. 

Capacity for preparedness and rapid response will be built across the network, leveraging existing high-performing sites. In addition to research, it aims to ensure that new tools, such as AI technologies, are integrated into outbreak responses. 

Standardised research protocols will be developed so that research studies can be rapidly launched at the onset of outbreaks, supported by training and simulation exercises for responders. Surveillance activities will be enhanced by integrating surveillance data with existing DHIS2 health informatics systems. Community engagement will be strengthened to build trust and support for research activities during outbreaks. 

To facilitate the rapid launch of high-quality research during outbreaks, training workshops and benchmarking visits will be organised for ethics review committee members and representatives of regulatory authorities. Guidelines will be updated based on research conducted during outbreaks and epidemics. To improve efficiency, digital systems will be introduced where they are not already used by regulators and ethics review bodies.

Laboratory infrastructure and data management systems will also be upgraded, with a focus on sites in countries with less well-developed clinical research capacity. At least five laboratories will be upgraded during the project. 

Collaborations will be strengthened across academia, public health bodies and ministries of health, with the project also working closely with the Africa Centre for Disease Control and Prevention (Africa CDC). The project will create a platform for sharing resources, data and protocols, and establish an extensive community of practice for researchers and health workers delivering trials during outbreaks.

Impact

The ACT-PREP project will strengthen regional capacity to detect, prevent and manage infectious disease outbreaks. It will

  • Strengthen capacity to launch clinical trials rapidly when outbreaks occur.
  • Streamline regulatory and ethics review processes to enable rapid launch of clinical studies while safeguarding participants’ interests.
  • Build a highly trained workforce able to be deployed to different sites when outbreaks occur.

Collectively, these activities will ensure that more research can be carried out during outbreaks, generating more evidence to support more effective responses, and thereby leading to better control and prevention of future outbreaks.

Consortium map

Coordinator

EUROPEAN & DEVELOPING COUNTRIES CLINICAL TRIALS PARTNERSHIP

Location
Den Haag, Netherlands
EU contribution
€0,98

Scientific project leader

MAKERERE UNIVERSITY

Location: Kampala, Uganda

Beneficiaries

SOMALI NATIONAL UNIVERSITY

Location
MOGADISHU, Somalia
EU contribution
€500 024,21

UNIVERSITE DE KINSHASA

Location
KINSHASA, Democratic Republic of the Congo
EU contribution
€1 140 737,38

MAKERERE UNIVERSITY

Location
Kampala, Uganda
EU contribution
€4 022 279,53

MINISTRY OF HEALTH

Location
Kampala, Uganda
EU contribution
€1 117 348,53

AFRICA CENTRES FOR DISEASE CONTROL AND PREVENTION

Location
Addis Ababa, Ethiopia
EU contribution
€901 724,99

MAKERERE UNIVERSITY LUNG INSTITUTE

Location
KAMPALA, Uganda
EU contribution
€427 999,99

UNIVERSITY OF GLOBAL HEALTH EQUITY UGHE LTD

Location
Kacyiru, Rwanda
EU contribution
€900 750,01

UNIVERSITE CHEIKH ANTA DIOP

Location
DAKAR FANN, Senegal
EU contribution
€511 262,37

Partners

UNIVERSITY OF JUBA

Location
Juba, South Sudan