Sobieszczyk Magdalena E, Xu Guozhen, Goodman Krista, Lucy Debbie, Koblin Beryl A
Department of Medicine, Division of Infectious Diseases, Columbia University College of Physicians and Surgeons, New York, NY 10032, USA.
J Acquir Immune Defic Syndr. 2009 Jun 1;51(2):194-201. doi: 10.1097/qai.0b013e3181990605.
African Americans (AAs) and Latinos in United States bear a disproportionate burden of HIV infection, yet remain underrepresented in HIV vaccine trials. The success in engaging and enrolling AAs and Latinos in phase 1 and phase 2 vaccine trials at 2 research sites in New York City is described.
A retrospective analysis of 1683 HIV-uninfected individuals who completed > or = 1 stage of the screening process from 2002 to 2006. Data on sociodemographic, behavioral characteristics, medical eligibility, and enrollment in National Institutes of Health-sponsored vaccine trials were collected.
7.5% of screening participants completed enrollment; 33% were AAs, 24% Latinos. The proportion of enrollees did not differ significantly by race/ethnicity. Low-risk vs. high-risk AAs (49% vs. 23%, P = 0.006) and high-risk vs. low-risk Latinos (31% vs. 13%, P = 0.006) were more likely to enroll. Among them, loss to follow-up was the most common reason for not completing screening. In multivariate analysis, older participants, high-risk men, and high-risk women were more likely to complete enrollment.
Once potential minority participants are identified and engaged in the screening process, it is possible to enroll them at rates comparable to white participants. Experience at these sites suggests that the challenge in achieving high rates of minority participation is in increasing the initial pool of candidates prescreening for HIV vaccine studies.
美国非裔美国人和拉丁裔承受着不成比例的艾滋病毒感染负担，但在艾滋病毒疫苗试验中的代表性仍然不足。本文描述了在纽约市的2个研究地点让非裔美国人和拉丁裔参与1期和2期疫苗试验并进行入组的成功经验。
对2002年至2006年期间完成≥1个筛查阶段的1683名未感染艾滋病毒的个体进行回顾性分析。收集了社会人口统计学、行为特征、医学资格以及参与美国国立卫生研究院资助的疫苗试验入组情况的数据。
7.5%的筛查参与者完成了入组；33%为非裔美国人，24%为拉丁裔。入组者的比例在种族/族裔方面无显著差异。低风险与高风险的非裔美国人（49%对23%，P = 0.006）以及高风险与低风险的拉丁裔（31%对13%，P = 0.006）更有可能入组。其中，失访是未完成筛查的最常见原因。在多变量分析中，年龄较大的参与者、高风险男性和高风险女性更有可能完成入组。
一旦识别出潜在的少数族裔参与者并让其参与筛查过程，就有可能以与白人参与者相当的比例让他们入组。这些研究地点的经验表明，实现少数族裔高参与率的挑战在于增加艾滋病毒疫苗研究预筛查的初始候选人群。
