RESUMO
OBJECTIVE: To evaluate novel eligibility criteria and outreach methods to identify and recruit women at high risk of HIV-1 infection in the Caribbean. METHODS: A prospective cohort study was conducted in 2009-2012 among 799 female commercial sex workers in the Dominican Republic, Haiti, and Puerto Rico. Minimum eligibility criteria included exchange of sex for goods, services, or money in the previous 6 months and unprotected vaginal or anal sex with a man during the same period. Sites used local epidemiology to develop more stringent eligibility criteria and recruitment strategies. Participants were asked questions about HIV/AIDS and their level of concern about participating in an HIV vaccine trial. Logistic regression modeling was used to assess predictors of prevalent HIV infection and willingness to participate in a future HIV vaccine study. RESULTS: HIV prevalence at screening was 4.6%. Crack cocaine use [odds ratio (OR) = 4.2, 95% confidence interval (CI) (1.8-9.0)] was associated with and having sex with clients in a hotel or motel [OR = 0.5, CI (0.3-1.0)] was inversely associated with HIV infection. A total of 88.9% of enrolled women were definitely or probably willing to participate in a future HIV vaccine trial. CONCLUSIONS: This study indicated that local eligibility criteria and recruitment methods can be developed to identify and recruit commercial sex workers with higher HIV prevalence than the general population who express willingness to join an HIV vaccine trial.
Assuntos
Ensaios Clínicos como Assunto/métodos , Infecções por HIV/epidemiologia , Doenças Profissionais/epidemiologia , Seleção de Pacientes , Profissionais do Sexo , Vacinas contra a AIDS , Adolescente , Adulto , Atitude Frente a Saúde , Cultura , República Dominicana/epidemiologia , Feminino , Soroprevalência de HIV , Haiti/epidemiologia , Humanos , Consentimento Livre e Esclarecido , Pessoa de Meia-Idade , Estudos Prospectivos , Porto Rico/epidemiologia , Risco , Assunção de Riscos , Profissionais do Sexo/psicologia , Comportamento Sexual , Parceiros Sexuais , Fatores Socioeconômicos , Adulto JovemRESUMO
OBJECTIVE: To evaluate novel eligibility criteria and outreach methods to identify and recruit women at high risk of HIV-1 infection in the Caribbean. METHODS: A prospective cohort study was conducted in 2009-2012 among 799 female commercial sex workers in the Dominican Republic, Haiti, and Puerto Rico. Minimum eligibility criteria included exchange of sex for goods, services, or money in the previous 6 months and unprotected vaginal or anal sex with a man during the same period. Sites used local epidemiology to develop more stringent eligibility criteria and recruitment strategies. Participants were asked questions about HIV/AIDS and their level of concern about participating in an HIV vaccine trial. Logistic regression modeling was used to assess predictors of prevalent HIV infection and willingness to participate in a future HIV vaccine study. RESULTS: HIV prevalence at screening was 4.6%. Crack cocaine use [odds ratio (OR) = 4.2, 95% confidence interval (CI) (1.8-9.0)] was associated with and having sex with clients in a hotel or motel [OR = 0.5, CI (0.3-1.0)] was inversely associated with HIV infection. A total of 88.9% of enrolled women were definitely or probably willing to participate in a future HIV vaccine trial. CONCLUSIONS: This study indicated that local eligibility criteria and recruitment methods can be developed to identify and recruit commercial sex workers with higher HIV prevalence than the general population who express willingness to join an HIV vaccine trial.
OBJETIVO: Evaluar nuevos criterios de selección y métodos extrainstitucionales encaminados a detectar y captar a las mujeres con alto riesgo de contraer la infección por virus de la inmunodeficiencia humana (VIH) en el Caribe. MÉTODOS: Del 2009 al 2012, se llevó a cabo un estudio prospectivo de cohortes de 799 mujeres profesionales del sexo en la República Dominicana, Haití y Puerto Rico. Los requisitos mínimos de selección fueron el intercambio de relaciones sexuales por bienes, servicios o dinero en los últimos 6 meses y las relaciones sexuales vaginales o anales sin protección con un hombre durante el mismo período. En cada centro se aplicaron criterios de selección y estrategias de captación más restrictivos, en función de las características epidemiológicas locales. Se formularon a las participantes preguntas acerca de la infección por el VIH/sida y su motivación para participar en un estudio clínico sobre la vacuna contra el VIH. Se usó un modelo de regresión logística con el fin de analizar los factores pronósticos de prevalencia de infección por el VIH y la voluntad de participar en un estudio futuro sobre la vacuna contra el virus. RESULTADOS: La prevalencia de infección por el VIH en el momento del tamizaje fue 4,6%. El consumo de crack se asoció con la infección por el VIH (razón de posibilidades [OR]: 4,2; intervalo de confianza [IC] de 95%: 1,8-9,0) y la práctica de relaciones sexuales con clientes en un hotel o un motel se asoció inversamente con esta infección (OR: 0,5; IC 95%: 0,3-1,0). El 88,9% de las mujeres inscritas manifestó una disposición decidida o probable de participar en un estudio futuro sobre la vacuna contra el VIH. CONCLUSIONES: Los resultados del estudio indican que es posible formular criterios de selección e introducir métodos de captación locales con el propósito de detectar y captar a las mujeres profesionales del sexo, que presentan una prevalencia de infección por el VIH mayor que la población general y manifiestan una buena disposición de participar en un ensayo clínico sobre la vacuna contra el VIH.
Assuntos
Humanos , Feminino , Adolescente , Adulto , Pessoa de Meia-Idade , Adulto Jovem , Ensaios Clínicos como Assunto/métodos , Infecções por HIV/epidemiologia , Doenças Profissionais/epidemiologia , Seleção de Pacientes , Profissionais do Sexo , Vacinas contra a AIDS , Atitude Frente a Saúde , Cultura , República Dominicana/epidemiologia , Soroprevalência de HIV , Haiti/epidemiologia , Consentimento Livre e Esclarecido , Estudos Prospectivos , Porto Rico/epidemiologia , Risco , Assunção de Riscos , Profissionais do Sexo/psicologia , Comportamento Sexual , Parceiros Sexuais , Fatores SocioeconômicosRESUMO
OBJECTIVES: Report of risk behavior, HIV incidence, and pregnancy rates among women participating in the STEP study, which is a phase IIB trial of MRKAd5 HIV-1 gag/pol/nef vaccine in HIV-negative individuals who were at high risk of HIV-1. DESIGN: Prospective multicenter, double-blinded, placebo-controlled trial. METHODS: Women were from North American, and from Caribbean and South America (CSA) sites. Risk behavior was collected at screening and 6-month intervals. Differences in characteristics between groups were tested with chi-square, two-sided Fisher's exact tests, and Wilcoxon rank-sum tests. Generalized estimating equation models were used to assess behavioral change. RESULTS: Among 1134 enrolled women, the median number of male partners was 18; 73.8% reported unprotected vaginal sex, 15.9% unprotected anal sex and 10.8% evidence of a sexually transmitted infection in the 6 months prior to baseline. With 3344 person-years of follow-up, there were 15 incident HIV infections: incidence rate was 0.45 per 100 person-years [95% confidence interval (CI) 0.25, 0.74]. Crack cocaine use in both regions [relative risk (RR) 2.4 (1.7, 3.3)] and in CSA, unprotected anal sex [RR 6.4 (3.8, 10.7)], and drug use [RR 4.1 (2.1, 8.0)] were baseline risk behaviors associated with HIV acquisition. There was a marked reduction in risk behaviors after study enrollment with some recurrence in unprotected vaginal sex. Of 963 nonsterilized women, 304 (31.6%) became pregnant. CONCLUSION: Crack cocaine use and unprotected anal sex are important risk criteria to identify high-risk women for HIV-efficacy trials. Pregnancy during the trial was a common occurrence and needs to be considered in trial planning for prevention trials in women.
Assuntos
Vacinas contra a AIDS/imunologia , Síndrome da Imunodeficiência Adquirida/prevenção & controle , Assunção de Riscos , Vacinas contra a AIDS/administração & dosagem , Síndrome da Imunodeficiência Adquirida/epidemiologia , Síndrome da Imunodeficiência Adquirida/imunologia , Adenovírus Humanos/genética , Adolescente , Adulto , Região do Caribe , Método Duplo-Cego , Portadores de Fármacos/administração & dosagem , Feminino , Humanos , Incidência , Pessoa de Meia-Idade , América do Norte , Placebos/administração & dosagem , Gravidez , Comportamento Sexual , América do Sul , Transtornos Relacionados ao Uso de SubstânciasAssuntos
Infecções por HIV , Síndrome da Imunodeficiência Adquirida , Vacinas contra a AIDS , Profissionais do Sexo , Região do Caribe , República Dominicana , Haiti , Porto Rico , Infecções por HIV , Síndrome da Imunodeficiência Adquirida , Vacinas contra a AIDS , Profissionais do Sexo , Região do Caribe , República Dominicana , Ensaios Clínicos como Assunto , Cultura , Consentimento Livre e Esclarecido , Porto Rico , Risco , Comportamento Sexual , Parceiros Sexuais , Infecções por HIV , Doenças Profissionais , Seleção de Pacientes , Profissionais do Sexo , Vacinas contra a AIDS , Atitude Frente a Saúde , Soroprevalência de HIV , Estudos Prospectivos , Assunção de Riscos , Fatores SocioeconômicosRESUMO
BACKGROUND: The first multicenter, international National Institutes of Allergy and Infectious Diseases (NIAID)-sponsored HIV vaccine trial took place in Brazil, Haiti, Peru and Trinidad. This randomized, double-blind, placebo-controlled, phase 2 trial evaluated the safety and immunogenicity of a clade B-derived, live canarypox HIV vaccine, vCP1452. vCP1452 was administered alone or with a heterologous boost of MN rgp120 glycoprotein. The trial was pivotal in deciding whether these vaccines advanced to phase 3 efficacy trials. METHODS: Forty seronegative volunteers per site were randomized to ALVAC alone, ALVAC plus MN rgp120, or placebo in a 0, 1, 3, and 6 month schedule. Immunogenicity was assayed by chromium-release cytotoxic T lymphocyte (CTL) responses; interferon-gamma (IFN-gamma) enzyme-linked immunosorbent spot assays (ELISpot); lymphocyte proliferation assays (LPA); neutralization; and enzyme-linked immunosorbent assays (ELISA). RESULTS: Enrollment and follow-up were excellent. Both vaccines were well tolerated. Neutralizing antibody to the laboratory-adapted MN strain was detected. Cellular immune responses, as measured by CTL, ELISpot, and LPA, did not differ between vaccines and placebos. CONCLUSIONS: 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.