Sub-Saharan Africa (SSA) has the world’s highest prevalence of HIV infection, which contributes substantially to the high childhood mortality in the region. WHO recommends that mothers of HIV-exposed infants, who can hygienically prepare formula feeds, exclusively formula feed their infants. However, formula feeding in disadvantaged communities carries substantial health risks for infants and formula feeding increases the incidence rates of diarrhoea and pneumonia.

The aim of this project is to increase the capacity of researchers in SSA in the conduct of randomised clinical trials (RCT). Moreover, the research, primarily RCTs, aim to improve survival opportunities of HIV-exposed infants.

Specific objectives:
SP1. Provided nutritional surveys* indicate high prevalence of micronutrient deficiencies, an RCT will measure the efficacy of routine micronutrient supplementation to HIV- exposed formula fed infants in reducing incidence of severe diarrhoea and pneumonia.

SP2. An RCT to measure the degree to which promoting the use of a specially designed feeding cup (versus the commonly used feeding bottle) will reduce the risk of diarrhoea in HIV-exposed formula fed infants.

SP3. Establishment of an advanced course in clinical and field trials methodology for SSA.

*A prerequisite for the undertaking SP1 is that surveys far more extensive than those described in the application submitted to NUFU reveal considerable deficiency of folate, cobalamin and/or zinc in Eastern Cape and/or Gauteng and that sufficient collateral funding can be procured for the RCTs. The need for collateral funding stems from the required substantial expansion of the surveys.

This project will strengthen UWC as a regional leader in public health research training, and increase the impact of UWC short-course and post-graduate distance-learning programmes in building capacity in SSA to conduct high quality research to improve child health.

We hypothesize that micronutrient supplementation to formula fed HIV exposed infants decreases the incidence of diarrhoea and pneumonia and that using a cup rather than a feeding bottle to these infants decreases their diarrhoea burden. The outcomes of the trials will contribute to make informed decisions on whether to incorporate micronutrient supplementation and/or cup feeding for formula fed HIV exposed infants in the national (South African) infant feeding policy. The information will also be shared with other SSA policy makers.

Two female PhD students and three female Masters students will graduate after completion of the studies. Several health care field workers and technicians will be trained to assist in the execution of the trials. The aim is to submit two PHD theses, three Masters theses and several publications in accredited journals.

The development of an advanced course in RCT methodology will improve the quality of trials conducted in SSA. We aim to train up to 15 participants from SSA countries every year, thereby building capacity in these countries to execute clinical trials efficiently. The course will contribute to competence building at UWC School of Public Health (SoPH) and SoN, as junior faculty will be trained to facilitate the course. Learners will also be taught how to write proposals and reports/manuscripts for publication.