Pre-exposure and postexposure prophylaxes and the combination HIV prevention methods (The Combine! Study): protocol for a pragmatic clinical trial at public healthcare clinics in Brazil

Alexandre Grangeiro, Márcia Thereza Couto, Maria Fernanda Peres, Olinda Luiz, Eliana Miura Zucchi, Euclides Ayres de Castilho, Denize Lotufo Estevam, Rosa Alencar, Karina Wolffenbüttel, Maria Mercedes Escuder, Gabriela Calazans, Dulce Ferraz, Éri


Few results from programmes based on combination prevention methods are available. We propose to analyse the degree of protection provided by postexposure prophylaxis (PEP) for consensual sexual activity at healthcare clinics, its compensatory effects on sexual behaviour; and the effectiveness of combination prevention methods and pre-exposure prophylaxis (PrEP), compared with exclusively using traditional methods.

Methods and analysis 

A total of 3200 individuals aged 16 years or older presenting for PEP at 5 sexually transmitted disease (STD)/HIV clinics in 3 regions of Brazil will be allocated to one of two groups: the PEP group—individuals who come to the clinic within 72 h after a sexual exposure and start PEP; and the non-PEP group—individuals who come after 72 h but within 30 days of exposure and do not start PEP. Clinical follow-up will be conducted initially for 6 months and comprise educational interventions based on information and counselling for using prevention methods, including PrEP. In the second study phase, individuals who remain HIV negative will be regrouped according to the reported use of prevention methods and observed for 18 months: only traditional methods; combined methods; and PrEP. Effectiveness will be analysed according to the incidence of HIV, syphilis and hepatitis B and C and protected sexual behaviour. A structured questionnaire will be administered to participants at baseline and every 6 months thereafter. Qualitative methods will be employed to provide a comprehensive understanding of PEP-seeking behaviour, preventive choices and exposure to HIV.

Ethics and dissemination 

This study will be conducted in accordance with the resolution of the School of Medicine Research Ethics Commission of Universidade de São Paulo (protocol no. 251/14). The databases will be available for specific studies, after management committee approval. Findings will be presented to researchers, health managers and civil society members by means of newspapers, electronic media and scientific journals and meetings.

September 2, 2015
Year of publication
Resource types
Journal and research articles
combination prevention methods, HIV prevention, research, post-exposure prophylaxis (PEP), pre-exposure prophylaxis (PrEP)

Similar Resources

Men who have sex with men (MSM) have been affected disproportionately by the global HIV pandemic. Rates of consistent condom-use are low and there is a need for further biomedical prevention interventions to prevent new HIV infections.

Home-based HIV counselling and testing (HBHCT) has the potential to increase HIV testing uptake in sub-Saharan Africa (SSA), but data on linkage to HIV care after HBHCT are scarce. We conducted a systematic review of linkage to care after HBHCT in SSA.

To mark the 9th IAS Conference on HIV Science, the Lancet journals have made a selection of content free that reflects some of the breadth and diversity of clinical, epidemiological, and operational HIV research produced by the tireless global HIV community.

Introduction: HIV incidence remains high among young women in sub-Saharan Africa in spite of scale-up of HIV testing, behavioural interventions, antiretroviral treatment and medical male circumcision.

The prevalence of HIV in young South African women aged 20–24 years is three times higher than that in their male counterparts.

New data from the PROUD pre-exposure prophylaxis (PrEP) study have identified the characteristics of the gay and other men who have sex men (MSM) who are most likely to benefit from PrEP. Study participants were randomised to receive immediate or deferred PrEP.

Oral pre-exposure prophylaxis (PrEP) using the antiretroviral drug emtricitabine/tenofovir disoproxil fumarate (Truvada) has been shown to dramatically reduce the risk of HIV acquisition for women at higher risk of infection if taken daily.


The MSM population in Kenya contributes to 15% of HIV incidence. This calls for innovative HIV prevention interventions. Pre-exposure prophylaxis (PrEP) has been efficacious in preventing HIV among MSM in trials.

Strategic framing of public messages about HIV pre-exposure prophylaxis (PrEP) may influence public support for policies and programs affecting access.