PEP was safe and did not appear to be associated with increases in reported high-risk behavior in our cohort. Ready access to PEP did not appear to substantially affect HIV transmission, suggesting a limited public health impact of this intervention.

Evaluation of HIV vaccines requires high-risk individuals willing to participate in a vaccine trial. We investigated the willingness to participate in HIV vaccine trials of initially HIV-seronegative homosexual men enrolled in an HIV seroincidence cohort study. Of 815 initially HIV-seronegative participants, 569 (69.8%) reported willingness to participate in an HIV vaccine trial. Altruism was the primary reason given for wanting to participate. Fear of HIV infection from the study's immunizations and a vaccine-induced positive HIV test result were the main reasons for not wanting to participate. Of the 34 study subjects who eventually had HIV seroconversion, 29 (85%) had indicated a willingness to participate. In a univariate analysis, factors associated with willingness to participate included HIV seroconversion during follow-up (odds ratio [OR]. 2.6; p =.04), low educational level (OR, 1.6; p =.005), low family income (p =.02), and exchanging sex for housing, food, or clothing (OR 6.1; p =.005). Students were less likely to be willing to participate in a trial (OR, 0.7; p = .03), as well as those who reported sex at the first encounter (OR, 0.7; p = .05). In a multivariate analysis, low education level, infection with Condyloma, and exchanging sex for housing, food, or clothing were positively associated with willingness to participate, whereas being a student and reporting sex at first encounter were negatively associated. In general, factors indicative of high-risk of HIV infection were associated with a higher willingness. These data demonstrate that this high-risk homosexual male cohort has a high willingness to participate in HIV vaccine trials.

The observation of disappointing immunogenicity in this and a parallel domestic study has informed future vaccine development. Equally important, challenges to doing an integrated trial across countries, cultures, languages, and differing at-risk populations were overcome. The identification of specific safety, ethical, logistic, and immunological issues in this trial established the foundation for current larger international studies.

Resumo Introdução O uso e a prescrição inadequados de antimicrobianos e a pressão da indústria farmacêutica para a sua utilização transformaram a resistência bacteriana a esses medicamentos em um problema mundial de saúde pública. Objetivo O objetivo do estudo foi analisar o processo de implantação da Resolução da Diretoria Colegiada (RDC) da Agência Nacional de Vigilância Sanitária (Anvisa) de nº 20/2011, que dispõe sobre o controle dos antimicrobianos. Método Utilizou-se o Modelo de Múltiplos Fluxos de Kingdon para examinar a inserção do tema do controle dos antimicrobianos na agenda governamental e sua posterior conformação em política pública. Foram empregadas diversas estratégias metodológicas, como a revisão bibliográfica, a análise de documentos, a busca de notícias veiculadas na mídia e informações advindas de entrevistas com informantes-chave. Conclusão Apesar da existência de legislações e regulamentações sobre o uso e a prescrição de antimicrobianos, além da ampliação do acesso da população aos profissionais de saúde para evitar a automedicação e promover o uso correto, esforços como a educação sanitária para profissionais e a população e o reforço da fiscalização sanitária devem ser efetivamente implementados, não apenas para alcançar o uso racional, mas também para diminuir a resistência aos antimicrobianos.

An HIV seroincidence study was conducted to identify a high-risk population for HIV prevention trials. Inclusion criteria were male gender, homosexual behavior, age between 18 and 50 years, and negative HIV serostatus; 862 study subjects were screened and 753 were enrolled and observed during follow-up for a mean of 1.5 years. In this population, 34 people had HIV seroconversions for an overall annual seroincidence of 3.1% (95% confidence interval [CI], 2.1%-4.1%). Among study subjects <20 years old, annual incidence was 8.4% (95% CI, 1.7%-15%). Independent risk factors for seroconversion were age <25 years (p = .01), hepatitis B core antibody seropositivity (p > .01), sex at first encounter in the preceding 6 months (p = .11), and a history of gonorrhea or condyloma in the 6 months before seroconversion (p = .04 and p = .08, respectively). At enrollment, 85% of the eventual seroconverters said they would participate in a vaccine trial; all agreed to participate when told there would be a placebo arm. Follow-up rates were 97%, 91%, and 88% at 6, 12, and 18 months, respectively. The HIV-1 subtype was B for each of the first 17 seroconverters. These data demonstrate the suitability of this cohort for HIV prevention trials, based on high HIV incidence and retention rates, and a willingness to participate in such trials.