ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention

Prior treatment

• 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
• 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

Other illness

• 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
• Confirmed or suspected infection with the human immunodeficiency virus

Other

• Plans to move outside the study area during the follow-up period
• 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

• 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