ABSTRACT The University of Pennsylvania HIV Clinical Trials Unit (Penn HIV CTU) will build on its current infrastructure and further its commitment to provide scientific leadership to advance the science of HIV treatment and prevention within three HIV Clinical Research Networks, the Adult AIDS Clinical Trials Group (ACTG), the HIV Vaccine Trials Group (HVTN), and the HIV Prevention Trials Group (HPTN). The Penn HIV CTU features an integrated, efficient clinical trials organization with two clinical research sites (CRS), the Penn Therapeutics CRS, located on the Penn School of Medicine (PSOM) campus, that conducts ACTG trials; and the Penn Prevention CRS, separately located on the Penn campus, that conducts HVTN and HPTN supported trials. Penn investigators will continue to contribute to the scientific agendas of these Networks through participation on network committees and through submission of protocols and membership on protocol teams. In addition, the Penn HIV CTU will advance the research agendas of these Networks through the cost efficient implementation of clinical trials to improve the lives of people living with HIV infection and to prevent it among those at risk. The leadership of the Penn HIV CTU will mentor the next generation of clinical investigators by involving junior investigators at our site and elsewhere in activities at that promote their career development at both the Network and site level. Penn investigators will engage the local community affected by HIV when formulating priorities, we will inform the community about opportunities to participate in research, and educate the community about medical advances and opportunities to access them. Penn investigators have contributed to important advances in HIV therapeutics through the evaluation of strategies designed to control HIV replication in the absence of antiretrovirals and purge the latent reservoir, testing of novel agents to inhibit HIV replication, and by improving treatments and prevention of co-morbid conditions associated with HIV infection. Penn investigators have also contributed to advances in HIV prevention through the testing of HIV vaccines, long-acting antiretrovirals and monoclonal antibodies for pre-exposure prophylaxis, and through behavioral interventions designed to modify risk behaviors. It is our goal to make these advances available to all populations living with or at-risk for HIV infection, including men who have sex with men, cisgender women, transgender and gender non-conforming individuals, and persons who inject drugs. Given the resources, vision, and commitment of Penn investigators, the Penn HIV CTU is well positioned to support the initiative for Ending the HIV Epidemic in Philadelphia, a priority city, through achievements in HIV prevention, diagnosis, treatment.

PROJECT NARRATIVE Despite recent breakthroughs in HIV treatment and prevention, many obstacles remain. The Penn HIV Clinical Trials Unit will test new strategies that will improve HIV treatment and advance the goal of curing people living with HIV infection. We will also test novel, long-acting strategies to prevent HIV infection.