Contact With or Exposure to Human Immunodeficiency Virus
Conditions
Brief summary
The goal of this study is to learn how well long-acting lenacapavir works to prevent human immunodeficiency virus (HIV) infection in people at higher risk of getting HIV in Brazil. The study will also learn about safety, continued use over time, and whether people prefer this option compared to daily oral pre- exposure prophylaxis (PrEP). The main questions it aims to answer are: How many participants get HIV while using long-acting lenacapavir? How safe is long-acting lenacapavir in real-world health services? How many participants continue using their chosen prevention method over time? What factors help or make it harder for participants to stay on prevention? Researchers will compare two HIV prevention options to understand how they work in routine care: Long-acting lenacapavir, given as an injection under the skin every 6 months, Daily oral pre-exposure prophylaxis (PrEP), taken as a pill containing tenofovir disoproxil fumarate and emtricitabine, Participants will choose the prevention option they prefer after receiving counseling. This is not a randomized study. Researchers will follow participants for up to 2 years. Participants will: Receive either an injection every 6 months or take a daily pill, Visit the clinic regularly for HIV testing and health checkups, Receive testing and treatment for sexually transmitted infections, Answer questions about their health, medication use, and experiences, Receive prevention counseling and condoms. This study will help health services understand how to offer long-acting HIV prevention in Brazil and how to better support people who want to prevent HIV infection.
Interventions
Approximately 1200 participants who choose long acting Lenacapavir will receive an oral loading dose consisting of 600 milligrams on Day 1 and 600 milligrams on Day 2, followed by 300 milligrams on Day 8, according to the clinical protocol, followed by subcutaneous administration of Lenacapavir at a dose of 927 milligrams per injection, administered at the enrollment visit and repeated every six months, totaling up to four administrations during the follow up period, combined with regular clinical visits for safety assessment, human immunodeficiency virus testing, monitoring of adverse events and serious adverse events, evaluation of injection site reactions, combined prevention counseling, screening and management of sexually transmitted infections, hepatitis B and hepatitis C, and monitoring of adherence to the injection schedule
Approximately 300 participants who choose oral human immunodeficiency virus pre exposure prophylaxis will receive oral tenofovir disoproxil fumarate 300 milligrams combined with emtricitabine 200 milligrams in a fixed dose combination administered once daily on a continuous basis, with regular medication dispensing, periodic clinical follow up, serial human immunodeficiency virus testing, monitoring of adverse events, assessment of self reported adherence, combined prevention counseling, and screening and management of sexually transmitted infections and viral hepatitis, for up to 24 months of follow up
Sponsors
Oswaldo Cruz Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who remain persistent on Lenacapavir pre-exposure prophylaxis at 24 months | From enrollment to 24 months of follow-up | Persistence will be defined as the proportion of participants who initiate Lenacapavir pre-exposure prophylaxis and continue receiving scheduled Lenacapavir injections according to the recommended dosing schedule during the follow-up period. Participants will be considered non-persistent if they permanently discontinue Lenacapavir or fail to receive a scheduled injection within the allowable visit window. Persistence will be assessed using study clinic records documenting administration of Lenacapavir injections. |
| Time to discontinuation of Lenacapavir pre-exposure prophylaxis | Up to 24 months | Time from initiation of Lenacapavir pre-exposure prophylaxis to permanent discontinuation of Lenacapavir. Discontinuation will be defined as failure to receive a scheduled injection within the allowable visit window or documented decision to stop Lenacapavir. |
Countries
Brazil
Contacts
CONTACTBeatriz Grinsztejn, PhD
CONTACTValdiléa Veloso, PhD
Outcome results
None listed