RESUMO
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 SubstânciasRESUMO
Women are the fastest growing segment of the adult population acquiring HIV, and most women infected with HIV are in their reproductive years. The success of HAART is highly dependent upon the ability and willingness of the individual to adhere to complex antiretroviral regimens. Improved adherence among HIV-infected pregnant women will delay disease progression in the mother and should also reduce HIV transmission to the baby. Modified directly observed therapy (MDOT), may benefit this population. MDOT has been shown to be an acceptable and feasible intervention among HIV substance users; however, no-one has yet evaluated the use of MDOT in pregnant and postpartum women. Based on semi-structured interviews with 17 Latina women with HIV infection, we explored women's adherence patterns and barriers to adherence and their perceptions of a hypothetical MDOT program. The vast majority of women positively appraised the MDOT program as an effective means to increase and reinforce adherence to demanding drug regimens. Respondents cited the face-to-face contact, the supportive nature of the relationship, and the practical approach of the program as the primary reasons for the effectiveness of MDOT. Results indicate that MDOT could be an acceptable intervention for pregnant and postpartum Latina women to improve adherence to HAART.