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School of Public Health
College of Health Sciences, Makerere University

Career Strengthening for Improved Randomised Controlled Trials in Uganda


The European and Developing Countries Clinical Trials Partnership (EDCTP)

Operational Time Range




 The Research Council of Norway through the Center for Intervention Science for Maternal and Child Health (CISMAC)


Acronym: BuildRCTBCG

Principal Investigator

Dr. Victoria Nankabirwa

Project Duration

60 Months

Project Summary

This research project aims to estimate the effects of BCG vaccination and timing on the risk of serious childhood illnesses such as lower respiratory tract infections, malaria and diarrhea in HIV-1 exposed uninfected (HEU) infants. HIV-1 exposure without infection of infants is becoming more and more common, and HEU children have a higher risk of illness and death from these highly prevalent childhood illnesses. Effective preventive interventions in these vulnerable children are urgently needed. Such interventions would contribute to sustainable improvement in health and, because HEU children are often from lower socio-economic strata, to health equity. This project, following the priorities of EDCTP, focuses on the third Sustainable Development Goal (SDG) that aims at ensuring healthy lives and the promotion of the well-being for all. We shall use a multidisciplinary approach that combines epidemiological, clinical and immunobiological methods, the latter to explain possible mechanisms behind observed effects of our intervention.

The project will also support the establishment of a clinical trials teaching clinic dedicated to the training of African graduate and postgraduate students in the practical aspects of randomized clinical trials and support these students to obtain their Masters and PhD theses. Further, it will establish a web-based/ online course on randomized clinical trials methodology which, although aimed at young scientists in SSA, will be freely accessible also to others who wish to take part. This will no doubt contribute to the pool of excellent researchers in Sub-Saharan Africa.

Specific project objectives-Research component

  1. To conduct an adequately powered randomized controlled trial whose primary objectives are to, in HIV-1 exposed uninfected infants, compare:
  •  the risk of severe illness (from malaria, diarrhea and lower respiratory tract infections) in the first 14 weeks of life between babies who receive early BCG and those who receive late BCG and
  • trained non-specific immunity and homologous and heterologous adaptive immunity between babies who receive early BCG and those who receive late BCG.
  1. To establish a clinical trial teaching clinic
  2. To develop at least one new web-based/online graduate level method’s course on clinical trials epidemiology
  3. To conduct one graduate/postgraduate level writing and analysis workshop per year

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