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The effectiveness of HIV preventive methods in Brazilian health service

Pre- and post-exposure prophylaxes and the combination HIV prevention methods: protocol for a pragmatic clinical trial at public healthcare clinics in Brazil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-2qfjpv
Enrollment
Unknown
Registered
2016-01-13
Start date
2015-09-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Interventions

In the first component, the protective effect of PEPsexual will be evaluated. Therefore, individuals (estimated total of 3200), with 16 years or more, without HIV infection who are sexually exposed an
• Non-PEPsexual group: 1600 individuals who come to the clinic more than 72 hours and less than 30 days after exposure and do not start PEPsexual. The individuals who have not developed HIV infecti
Group 2) exclusive use of traditional methods (estimated 1360 individuals): condoms and/or sexual practices without vaginal or anal sex
and Group 3) PrEP (estimated 544 individuals), independent of a
Drug
Device
Behavioural
N02.421.726.755
N02.421.726.758.655
E07.190.270.150

Sponsors

Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo
Lead Sponsor
SAE Vila dos Comerciários - SMS de Porto Alegre
Collaborator
COAS da SMS de Curitiba
Collaborator
Centro de Referência e Treinamento em DST e Aids da SES de São Paulo
Collaborator
Centro de Referência em Especialidade Central da SMS de Ribeirão Preto
Collaborator
Hospital São José de Doença Infecciosa
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Seek care in service for the use of PEPsexual or report sexual exposure to HIV in a consensual relationship in the last 30 days in accordance to the criteria defined by the Health Ministry for use of prophylaxis; 16 years of age or over; Negative anti-HIV test at the time when the clinic is sought, or positive anti-HIV serological test with negative/indeterminate western blot; Having started PEPsexual at the clinic or having been referred for clinical follow-up soon after the initial attendance at an emergency service, provided that information on serological status, sexual exposure and prescribed therapy is available; Having signed the free and informed consent statement.

Exclusion criteria

Exclusion criteria: Having sought PEPsexual for the purpose of assisted reproduction or due to occupational exposure or sexual violence;

Design outcomes

Primary

MeasureTime frame
Difference in the occurrence of infection, verified through semi-annual screening laboratory tests with positive results (ELISA or rapid test) and confirmed by western blot, immunofluorescence or a second rapid test.

Secondary

MeasureTime frame
Difference in the occurrence of unprotected sexual practices for HIV infection, reported in semi-annual questionnaires, characterized by not using any preventive method in sexual intercourse;

Countries

Brazil

Contacts

Public ContactAlexandre Grangeiro

Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo

ale.grangeiro@gmail.com551130617976

Outcome results

None listed

Source: REBEC (via WHO ICTRP)