Meyers K, Metzger D S, McLellan A T, Navaline H, Sheon A R, Woody G E
University of Pennsylvania/Philadelphia Veterans Medical Center, Center for Studies of Addiction, USA.
J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Dec 15;10(5):577-85.
This article examines whether preventive HIV vaccines trials will be viable among female injection drug users (IDUs). Of the 137 women who completed 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 NIDA. Subjects were seen every 3 months for risk and vaccine opinion assessment, risk reduction counseling, and HIV antibody testing. The baseline prevalence rate of HIV infection was 12% (16 of 137) with an annual 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 unprotected intercourse. Sixty percent of the baseline seronegative women reported being willing to be one of the first people to try an HIV vaccine. According to logistic regression, needle sharers were 12.8 times more likely, women who engaged in sex for drugs or money 6.6 times more likely, out-of-treatment women 3.5 times more likely, and those who believed that vaccines can prevent disease acquisition 3 times more likely to report willingness to try an HIV vaccine than their respective counterparts. At 1-year postbaseline assessment, 98% of the women had 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 retained for longitudinal assessment, they appear to be suitable participants for preventive HIV vaccine efficacy trials. Nonetheless, work is required to insure that these women make informed and knowledgeable decisions regarding trial enrollment.
本文探讨了预防性HIV疫苗试验在女性注射吸毒者中是否可行。在完成基线血清学和行为评估的137名女性中，121名（88%）血清学检测呈阴性；她们均参加了美国宾夕法尼亚州费城的“启动计划”项目，该项目是由美国国立过敏与传染病研究所（NIAID）和美国国立药物滥用研究所（NIDA）共同发起的疫苗准备计划。每3个月对受试者进行一次风险和疫苗意见评估、降低风险咨询以及HIV抗体检测。HIV感染的基线患病率为12%（137人中16人），第一年的年发病率为3.5%（114人中4人）。在121名基线血清学检测呈阴性的女性中，28%共用针头，52%有未采取保护措施的性行为。60%的基线血清学检测呈阴性的女性表示愿意成为首批尝试HIV疫苗的人群之一。根据逻辑回归分析，与各自的对照组相比，共用针头者报告愿意尝试HIV疫苗的可能性高12.8倍，以性换毒品或金钱的女性高6.6倍，未接受治疗的女性高3.5倍，认为疫苗可预防感染疾病的女性高3倍。在基线评估后1年时，98%的女性收集了行为数据，95%的女性收集了血清学标本。鉴于这些女性出现了血清转化，且她们有危险行为、表示愿意尝试HIV疫苗并可被保留进行纵向评估，她们似乎是预防性HIV疫苗疗效试验的合适参与者。尽管如此，仍需开展工作以确保这些女性在参与试验方面做出明智和知情的决定。
