PROJECT SUMMARY
Southern and East Africa is home to 54% of the world’s people living with HIV, with Southern Africa remaining
as the epicenter of the global HIV pandemic. The proposed Aurum South and East African Clinical Trials Unit
(ASEA CTU) brings together a unique South–South partnership led by three internationally recognized
investigators and including five clinical research sites (CRSs) (three in South Africa, one in Zambia, and one in
Uganda) experienced in conducting HIV and TB treatment and prevention trials. The ASEA CTU has a strong
centralized management structure, well-developed CRSs, access to the required study populations, and
experience conducting HIV and TB treatment and prevention trials. While there have been advances in treating
and preventing HIV and TB, we need to develop new treatment and prevention tools to control HIV and end the
TB epidemic. The ASEA CTU’s primary goal is to use its collective scientific leadership, infrastructure,
experience, and strong community relationships to partner with three Networks to meet the following aims: AIM
1: Conduct trials of HIV vaccines and antibodies for HIV prevention. We need a safe, effective HIV vaccine that
can be delivered at scale to combat HIV; antibodies that could be delivered through passive infusion or induced
by vaccination would complement taking antiretroviral therapy (ART) before possible HIV exposure to prevent
becoming infected with HIV. AIM 2: Conduct trials of HIV and TB therapeutics, and TB preventive therapy and
vaccines. In order to end the TB epidemic, we need shorter, more potent combinations of drugs to treat TB
disease or infection that is susceptible or resistant to the currently available TB drugs, and effective vaccines to
prevent disease or re-occurrence of TB once treated. Despite great advances in the treatment of HIV, adherence
to and retention in care remain problems; we need new, safe, simple, effective, and long-lasting forms of ART
that will promote uptake and address adherence challenges. AIM 3: Participate in studies of novel long acting
antiretrovirals, multipurpose technologies, and integrated strategies for HIV prevention. Our experience suggests
that more targeted and individually tailored interventions are required to overcome adherence challenges with
existing prevention options. Rates of sexually transmitted infections (STIs) and unplanned pregnancy remain
high and underscores the need for technologies that can prevent HIV and other conditions at the same time,
such as STIs and pregnancy.