Contact with or exposure to human immunodeficiency virus
Conditions
Interventions
All participants will be included in only 1 group. In this unique group, throughout the duration of the study, individuals can participate in up to four different stages. In Step 1, choosing between o
Month 1, Month 3, Month 5, Month 7, Month 9, Month 11, Month 13
D27.505.954.122.388.077.088
Sponsors
Instituto Nacional de Infectologia Evandro Chagas - INI/Fiocruz
Fundação Oswaldo Cruz
Ministério da Saúde
Eligibility
Age
18 Years to 30 Years
Inclusion criteria
Inclusion criteria: Cisgender, non-binary (assigned male at birth) or transvestite men, transgender men and women; Report of anal sex in the past six months with a person who was assigned male at birth (Persons born female who have had sex only with people born female are excluded); Age from 18 to 30 years old; Report to the study center looking for PrEP; PrEP-naïve with CAB LA or oral PrEP with TDF/FTC; Willing and able to provide written informed consent and adhere to study requirements; Non-reactive/negative HIV test results, including rapid HIV tests and an undetectable HIV RNA test at enrollment for individuals who choose injectable CAB-LA; No reports of liver dysfunction. Applicants who report liver disease will have their enrollment visit postponed until laboratory results of liver function tests are available. See Section 7 (Study Procedures - Inclusion Visit); Willing to undergo all necessary study procedures.
Exclusion criteria
Exclusion criteria: One or more reactive or positive HIV test results at the enrollment visit, even if HIV infection is not confirmed; Currently participating in a PrEP agent intervention trial, HIV vaccine trial, or experimental medication trial; Positive pregnancy test, breastfeeding or intent to become pregnant during study enrollment (for trans men); Previous participation in studies with Cabotegravir; History or presence of allergy to study drug components; Past participation in an HIV vaccine trial. An exception will be made for participants who can provide documentation of placebo receipt (non-active arm); Planning to relocate outside the area during the study period; Injected or surgically placed buttock implants or fillers, by self-report; Have a dermatological/inflammatory skin condition overlying the buttock region which, in the opinion of the study investigator, in consultation with the Clinical Study Coordination (CSC), may interfere with the interpretation of injection site reactions; Active or planned use of a contraindicated co-administered drug for which significant decreases in plasma concentrations of Cabotegravir may occur due to uridine diphosphate glucuronosyltransferase (UGT1A1): • Anticonvulsants: Carbamazepine, Oxcarbazepine, Phenobarbital, Phenytoin • Antimycobacterial: Rifampicin, Rifapentine; Current or anticipated need for chronic systemic anticoagulation or history of known or suspected bleeding disorder, including history of prolonged bleeding; History of severe liver failure (including, but not limited to, history of liver failure or hospitalization for liver disease, history of hepatocellular carcinoma or near liver transplant); Individuals with advanced Hepatitis C; Other medical conditions that, in the opinion of the study investigator, interfere with the conduct of the study (eg, provided by self-report or found by the physician).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to identify facilitators and barriers to the integration of CAB-LA (cabotegravir - long acting) in public health services in Brazil, evaluating the effectiveness of PrEP (pre-exposure prophylaxis) with CAB-LA (cabotegravir - long acting) in reducing the risk of acquiring HIV in a cohort of study participants in a context in which that they exercise choice of their HIV prevention method (i.e., PrEP (pre-exposure prophylaxis) with CAB-LA (cabotegravir - long acting)or daily oral PrEP (pre-exposure prophylaxis)), assess the effectiveness of PrEP with CAB-LA in reducing the risk of acquiring HIV in a cohort of study in a context where they exercise choice of their HIV prevention method (i.e., PrEP (pre-exposure prophylaxis) with CAB-LA (cabotegravir - long acting) or daily oral PrEP (pre-exposure prophylaxis)), by estimating HIV incidence in participants who select CAB-LA (cabotegravir - long acting) for HIV prevention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected. | — |
Countries
Brazil
Contacts
Public ContactBeatriz Grinsztejn
Insituto Nacional de Infectologia Evandro Chagas/Instituto de Pesquisa Clinica Evandro Chagas
Outcome results
None listed