UAB - Center for Clinical and Translational Science

The main inclusion criteria include but are not limited to the following: - Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results - Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person - Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening - Weighs ≥35 kg

The main exclusion criteria include but are not limited to the following: - Has hypersensitivity or other contraindication to any component of the study interventions - Has evidence of acute or chronic hepatitis B infection - Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ anal or cervical cancers - Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time - Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration - Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1 - Is expecting to donate eggs at any time during the study