Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Ability to understand and sign the Informed Consent Form, which must be obtained before the initiation of any study procedures, and willingness to comply with the protocol requirements
Be a cisgender man, a non-binary person designated male at birth, or a transgender woman or transgender man
Report having engaged in anal sex with a person designated male at birth within the last six months
Be between 16 and 30 years of age
Have a body weight equal to or greater than 35 kilograms
Seek care at a participating study clinic for human immunodeficiency virus testing or initiation of human immunodeficiency virus pre-exposure prophylaxis, either spontaneously or through peer invitation
Have a non-reactive result on a rapid test for human immunodeficiency virus
Be an individual without prior use of human immunodeficiency virus pre-exposure prophylaxis, or an individual with prior use who remains in a situation of vulnerability, characterized by:
a history of oral human immunodeficiency virus pre-exposure prophylaxis with at least two prior dispensations without return for a new pickup in the six months preceding the enrollment visit, or
a history of long-acting cabotegravir use with a delay of at least one scheduled reload dose
Exclusion criteria
Known hypersensitivity to the study medication, its metabolites, or formulation excipients
Severe hepatic impairment or a history or current clinical condition of decompensated liver cirrhosis, such as ascites, encephalopathy, or variceal bleeding
Known or suspected severe active infection, such as active tuberculosis
Need for continuous use of contraindicated concomitant medications
Any clinical or psychosocial condition, or prior treatment, that in the opinion of the investigator makes the participant unsuitable for the study or unable to comply with dosing requirements
Confirmed or suspected infection with the human immunodeficiency virus
Plans to move outside the study area during the follow-up period
Prior participation in a clinical study using Lenacapavir in the PURPOSE study
Prior participation in a human immunodeficiency virus vaccine study, except in cases where the participant provides documentation demonstrating receipt of placebo and not the active product
Current participation in another interventional human immunodeficiency virus prevention study that, in the opinion of the investigator, may interfere with the conduct of this study
