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.

PROJECT NARRATIVE The Aurum South and East African Clinical Trials Unit (ASEA CTU) will implement a comprehensive, integrated strategy to address the HIV and TB pandemics. Our approach is to test new HIV and TB prevention strategies, novel HIV and TB therapeutic agents, and combination and multipurpose prevention interventions, to generate the empirical data to guide future development and implementation of effective HIV and TB strategies.