WILL PREVENTIVE HIV VACCINE EFFICACY TRIALS BE POSSIBLE WITH FEMALE INJECTION-DRUG USERS

This article examines whether preventive HIV vaccine trials will be vi able among female injection drug users (IDUs). Of the 137 women who co mpleted baseline serologic and behavioral assessments, 121 (88%) were seronegative; all enrolled in Project Jumpstart in Philadelphia (PA, U .S.A.), a vaccine preparedness initiative cosponsored by NIAID and NID A. Subjects were seen every 3 months for risk and vaccine opinion asse ssment, risk reduction counseling, and HIV antibody testing. The basel ine prevalence rate of HIV infection was 12% (16 of 137) with an annua l incidence rate of 3.5% (4 of 114) during the first year. Of the 121 baseline seronegative women, 28% shared needles and 52% engaged in unp rotected intercourse. Sixty percent of the baseline seronegative women reported being willing to be one of the first people to try an HIV va ccine. According to logistic regression, needle sharers were 12.8 time s more likely, women who engaged in sex for drugs or money 6.6 times m ore likely, out-of-treatment women 3.5 times more likely, and those wh o believed that vaccines can prevent disease acquisition 3 times more likely to report willingness to try an HIV vaccine than their respecti ve counterparts. At 1-year postbaseline assessment, 98% of the women h ad behavioral data collected and 95% had serologic specimens collected , Given that seroconversions occur and that these women engage in risk behaviors, report willingness to try an HIV vaccine, and can be retai ned for longitudinal assessment, they appear to be suitable participan ts for preventive HIV vaccine efficacy trials. Nonetheless, work is re quired to insure that these women make informed and knowledgeable deci sions regarding trial enrollment.