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.
RCT Entities:
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.
Authors: Quarraisha Abdool Karim; Ayesha B M Kharsany; Janet A Frohlich; Lise Werner; May Mashego; Mukelisiwe Mlotshwa; Bernadette T Madlala; Fanelesibonge Ntombela; Salim S Abdool Karim Journal: Int J Epidemiol Date: 2010-11-03 Impact factor: 7.196
Authors: Mary H Latka; Tracey E Wilson; Judith A Cook; Melanie C Bacon; Jean L Richardson; Nancy Sohler; Mardge H Cohen; Ruth M Greenblatt; Evie Andreopoulis; David Vlahov Journal: J Subst Abuse Treat Date: 2005-12
Authors: G R Seage; S E Holte; D Metzger; B A Koblin; M Gross; C Celum; M Marmor; G Woody; K H Mayer; C Stevens; F N Judson; D McKirnan; A Sheon; S Self; S P Buchbinder Journal: Am J Epidemiol Date: 2001-04-01 Impact factor: 4.897
Authors: J Justman; M Befus; J Hughes; J Wang; C E Golin; A A Adimora; I Kuo; D F Haley; C Del Rio; W M El-Sadr; A Rompalo; S Mannheimer; L Soto-Torres; S Hodder Journal: AIDS Behav Date: 2015-07
Authors: Elise D Riley; Martha Shumway; Kelly R Knight; David Guzman; Jennifer Cohen; Sheri D Weiser Journal: Drug Alcohol Depend Date: 2015-05-27 Impact factor: 4.492
Authors: Marie M Deschamps; Barbara Metch; Cecilia A Morgan; Carmen D Zorilla; Yeycy Donastorg; Edith Swann; Dadaille Taina; Joseph Patrice; William J Pape Journal: J Acquir Immune Defic Syndr Date: 2016-01-01 Impact factor: 3.731
Authors: James Stannah; Romain Silhol; Jocelyn Elmes; Branwen Owen; Barbara L Shacklett; Peter Anton; Ian McGowan; Ariane van der Straten; Dobromir Dimitrov; Rebecca F Baggaley; Marie-Claude Boily Journal: AIDS Behav Date: 2020-03