This study is for Cisgender Men (CGM), Transgender Women (TGW), Transgender Men (TGM) & Gender Non-binary people (GNB) who have sex with male partners and who are at risk for HIV infection.

The study will test the experimental drug Lenacapavir (LEN) for the prevention of HIV infection, also known as Pre-Exposure Prophylaxis (PrEP). This study will also compare the effectiveness of LEN to Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF; Truvada®), which has already been approved in several countries for use as PrEP.

Adult patients (18 years and older) who receive treatment for HIV in the MUSC Infectious Diseases Clinic will be offered participation in this study. This study will asses whether receipt of injectable HIV therapy at home with a Home Health provider is as safe and effective as receiving treatment in clinic. Participants receiving injectable HIV therapy prescribed by their primary HIV physician will choose to receive the injections once a month or once every two months at home or in a clinic setting and will have the option to change where they receive treatment at any time. A post-administration satisfaction survey, either once a month or once every two months. Participation in the study is expected to last approximately one year.

The purpose of this study is to evaluate the safety and efficacy of an investigational drug in adults with a clinical diagnosis of Human Immunodeficiency Virus (HIV). This study aims to determine if receipt of a one-time infusion or sub-cutaneous (under the skin) administration of the study drug results in a longer lasting response against HIV. The study drug will be given in addition to the standard of care treatment. The study of this investigational drug represents a novel approach to the treatment of this condition. Participation in the study will involve a minimum of 10 visits to the study clinic over a period of 1 month, followed by initiation of standard of care treatment.