Study on the implementation of Long-Action Injectable Pre-exposure Prophylaxis in male adolescents who have sex with men and transgender individuals, aged 15 to 19, in Brazil. PrEP 15-19 Study
- Conditions
- Pre-Exposure ProphylaxisB20.8
- Registration Number
- RBR-104736f4
- Lead Sponsor
- Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Self-identified men who have sex with men, non-binary assigned as male at birth, and transgender people; age between 15 and 19 years; HIV negative status (including HIV-rapid test for oral PrEP and HIV-viral load for CAB-LA PrEP) at screening/enrollment; at high risk for sexually acquiring HIV infection (condomless receptive or insertive anal intercourse in the 6 months prior to screening/enrollment, condomless vaginal intercourse in the last 6 months, any STI episode in the last 6 months, post-exposure prophylaxis (PEP) use at least once in the last 6 months, frequent use of alcohol or drugs before or during sexual intercourse, transactional or commercial sex); PrEP request by the participant who shows vulnerability and/or increased risk of HIV infection, based on risk management counseling and vulnerability context assessment by the research team
Weight under 35 Kg; currently participating in another interventional trial of PrEP agents, experimental medication or HIV vaccine trial; participant shows, according to a specialized psychological assessment, mental and/or intellectual impairment that do not allow PrEP use; only applicable for CAB-LA PrEP: surgically-placed buttock implants, including injected silicon, or fillers, per self-report; diagnosis of chronic hepatitis B2 with indication for antiviral treatment, alanine aminotransferase, ALT > 2 times the upper limit of normal, ULN; total bilirubin > 2.5 times ULN; Current or chronic history of liver disease, e.g., non-alcoholic or alcoholic steatohepatitis, or known hepatic or biliary abnormalities, with the exception of Gilbert's syndrome, asymptomatic gallstones, or cholecystectomy; any known coagulopathy that contraindicates receiving intramuscular injections; use of carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin and/or rifapentine; plan to relocate out of the area during the study period; a history or presence of allergy to the cabotegravir or its components; Only applicable for oral PrEP: estimated glomerular filtration rate, eGFR < 60 mL/min/1.73m2; history of spontaneous bone fracture
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method