Risk behavior among women enrolled in a randomized controlled efficacy trial of an adenoviral vector vaccine to prevent HIV acquisition.
AIDS
; 27(11): 1763-70, 2013 Jul 17.
Article
em En
| MEDLINE
| ID: mdl-23807272
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Assunção de Riscos
/
Síndrome da Imunodeficiência Adquirida
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Vacinas contra a AIDS
Tipo de estudo:
Clinical_trials
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Etiology_studies
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Incidence_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Adolescent
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Adult
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Female
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Humans
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Middle aged
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Pregnancy
País/Região como assunto:
America do norte
/
America do sul
Idioma:
En
Revista:
AIDS
Assunto da revista:
SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS)
Ano de publicação:
2013
Tipo de documento:
Article
País de afiliação:
Estados Unidos
País de publicação:
Reino Unido