RELEVANCE: The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates that there were 1.7 million new HIV infections in 2019, despite efforts to improve HIV testing, linkage to treatment, and prevention. Persistent disparities exist in ongoing HIV incidence in Black, Hispanic/LatinX MSM and TGW populations, with the greatest disparities in Black transgender women in the U.S. and with continued low uptake of PrEP in these disproportionately affected populations globally. These barriers clearly highlight the need for additional PrEP options that may address disparities to PrEP uptake.

DESCRIPTION: Twice a year injections of the medication Lenacapavir have the potential to provide an additional option for populations at risk of HIV acquisition. Lenacapavir can help address substantial existing PrEP barriers including requirements for daily adherence, stigma and concerns about disclosure and discrimination or other social harms, oral medication-associated adverse events, and challenges with access to health care providers in overburdened health systems or in geographical PrEP deserts. Thus, it has the potential to increase the uptake of, adherence to, and thereby the scalability of PrEP in those populations most disproportionately affected by HIV, which will contribute to the overarching goal of ending the epidemic. The primary objective of this study is to evaluate the efficacy of Lenacapavir in preventing the risk of HIV infection.

STATUS: This study is no longer enrolling new participants.