Pre-Exposure Prophylaxis
Conditions
Interventions
Prospective multicenter study on the Implementation of PrEP modalities in a cohort of aHSH, aNBH, aMTG, and aHTG aged 15 to 19 using a mixed-methods Design with quantitative and qualitative techniques
and counseling + financial incentive) and will be compared to regular clinical practice regarding the number of partners notified and reinfection rates. This component will also assess the acceptance
Sponsors
Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo
Instituto de Saúde Coletiva, Universidade Federal da bahia
Faculdade de Medicina, Universidade Federal de Minas Gerais
Eligibility
Age
15 Years to 19 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and profile of adolescents who acquired HIV infection during follow-up, measured by a 4th-generation rapid test and qualitative molecular examination. ;Number of incident STI episodes among participants undergoing CAB-LA PrEP and oral PrEP, assessed through signs, symptoms, and/or laboratory tests;Frequency of adverse events among CAB-LA PrEP users and oral PrEP users by subpopulations, assessed through clinical consultations and/or laboratory tests.;Total costs of CAB-LA PrEP intervention compared to oral PrEP intervention, assessed through the recording of procedures and supplies used in clinical care;Number, proportion, and profile of participants using and exhibiting good acceptability of adherence and retention strategies, assessed through a quarterly questionnaire;Number and proportion of adherence among CAB-LA PrEP users and oral PrEP users by age and subpopulations, assessed through the medication withdrawal/application frequency and self-report;Continuation rate among CAB-LA PrEP users and oral PrEP users by age and subpopulations, assessed through pharmaceutical records | — |
Secondary
| Measure | Time frame |
|---|---|
| Barriers and facilitators characterizing the use of CAB-LA PrEP among adolescents from the perspective of healthcare professionals and stakeholders, assessed through in-depth interviews;Number and proportion of participants who adhered to the CAB-LA discontinuation protocol among those who discontinued its use during the study period, assessed through clinical and pharmaceutical records;Number of delayed detections of recent HIV infection, resulting in the administration of CAB-LA PrEP injections to participants after infection, assessed through retrospective laboratory tests;Number and proportion of participants initiating CAB-LA PrEP according to each demand creation strategy, assessed through a first-visit form | — |
Countries
Brazil
Contacts
Public ContactAlexandre;Inês Grangeiro;Dourado
Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo;Instituto de Saúde Coletiva, Universidade Federal da bahia
Outcome results
None listed