Contact with or exposure to human immunodeficiency virus
Conditions
Interventions
This is a prospective, open label cohort study with a type two hybrid effectiveness implementation design, conducted without randomization and without masking, in which approximately 1500 eligible par
Sponsors
Insituto Nacional de Infectologia Evandro Chagas/Instituto de Pesquisa Clinica Evandro Chagas
Insituto Nacional de Infectologia Evandro Chagas/Instituto de Pesquisa Clinica Evandro Chagas
Eligibility
Age
16 Years to 30 Years
Inclusion criteria
Inclusion criteria: Ability to understand and sign the Informed Consent Form, which must be obtained before the initiation of any study procedures, and agree 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 be an individual with prior use of human immunodeficiency virus pre exposure prophylaxis and remain 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
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 other 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 |
|---|---|
| Evaluate the persistence of Lenacapavir among study participants in a context in which participants exercise choice of their methods of human immunodeficiency virus pre exposure prophylaxis | — |
Secondary
| Measure | Time frame |
|---|---|
| Describe organizational capacity, facilitators, and barriers to the integration of Lenacapavir into existing public health services in Brazil;Evaluate the effectiveness of a network based client engagement strategy on reach, equity, and retention in human immunodeficiency virus pre exposure prophylaxis when availability expands to include Lenacapavir;Evaluate the efficacy of Lenacapavir for the prevention of human immunodeficiency virus in a cohort of participants in a context in which they exercise choice of their human immunodeficiency virus prevention method in a real world setting;Evaluate the prevalence of human immunodeficiency virus, identify acute and recent human immunodeficiency virus infections, and estimate the incidence of human immunodeficiency virus among participants at study screening;Describe pre exposure prophylaxis uptake;Describe choice, adherence, and continuation of human immunodeficiency virus pre exposure prophylaxis;Evaluate self reported adherence to the oral loading dose of Lenacapavir;Describe adherence to injection visits among participants who chose Lenacapavir;Evaluate the safety and tolerability of Lenacapavir, including, for example, injection site pain and serious adverse events;Assess product switch, restarts and discontinuation among all participants ;Characterize human immunodeficiency virus infections, including drug resistance, human immunodeficiency virus viral load and human immunodeficiency virus diagnostic test results among those diagnosed with human immunodeficiency virus infection after receiving Lenacapavir injections;Evaluate coverage of human immunodeficiency virus pre exposure prophylaxis using oral tenofovir disoproxil fumarate combined with emtricitabine or Lenacapavir among participants without prior use and with prior use of human immunodeficiency virus pre exposure prophylaxis, including tenofovir disoproxil fumarate combined with emtricitabine or long acting cabotegravir, who choose to initiate or resume human | — |
Countries
Brazil
Contacts
Public ContactBeatriz Grinsztejn
Instituto Nacional de Infectologia Evandro Chagas
Outcome results
None listed