Understanding Differences in Enrollment Outcomes Among High-Risk Populations Recruited to a Phase IIb HIV Vaccine Trial
Understanding Differences in Enrollment Outcomes Among High-Risk Populations Recruited to a Phase IIb HIV Vaccine Trial
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DOI：
10.1097/qai.0b013e3181945eec
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发表时间：
2009-03-01
影响因子：
3.6
通讯作者：
Mulligan, Mark J.
中科院分区：
文献类型：
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作者：
Frew, Paula M.;del Rio, Carlos;Mulligan, Mark J.
背景：Step研究是一项II期B HIV疫苗概念验证研究，在进化枝B区域招募了约3000人。亚特兰大研究中心试图招募多样化的人群。这项前瞻性队列研究探讨了与参与者enrollment.Methods相关的关键因素：我们获得了参与者的信息（例如，社会人口统计学，医疗），并遵循2005年至2007年的结果。在810名潜在的“Step Study”参与者中，对340个案例进行了分析。结果：招募策略引起了少数族裔的强烈兴趣，预筛选后有37%符合资格，但只有25%的少数族裔参加了。然而，白人的比例从62%合格（预筛选样本）增加到75%。教育程度是入学预测因素（P = 0.0023）。那些至少有学士学位的人比那些有K-12教育或一些大学的人更有可能入学（比值比= 2.424，95%置信区间= 1.372至4.281，P < 0.01）。白色人种也是一个显著因素（优势比= 2.330; 95%可信区间= 1.241 ~ 4.375，P < 0.01）。不同招募方式的受试者入组率无差异，Pearson χ（2）（2）（n = 336）= 5.286，P = 0.07。结论：本研究结果表明，女性、少数民族和低文化程度的人不太可能参加本中心的HIV疫苗效果研究。研究结果强调了健康知识在维持合格少数群体参与艾滋病毒疫苗试验中的作用方面的重要考虑。
Background: The Step Study, a Phase IIb HIV vaccine proof of concept study, enrolled approximately 3000 persons in clade B regions. The Atlanta site sought to enroll a diverse Population. This prospective cohort study examined key factors associated with participant enrollment.Methods: We obtained participant information (eg, sociodemographic, medical) and followed outcomes from 2005 to 2007. Of the 810 potential "Step Study" participants, 340 cases were analyzed.Results: The recruitment strategy generated strong interest among minorities with 37% eligible after prescreening, yet 25% of the minorities enrolled. However, the percentage of whites increased from 62% eligible (prescreened sample) to 75% enrolled. The regression model was significant with educational level being an enrollment predictor (P = 0.0023). Those with at least a bachelor's degree were more likely to enroll compared with those with a K-12 education or some college (odds ratio = 2.424, 95% confidence interval = 1.372 to 4.281, P < 0.01). White race was also a significant factor (odds ratio = 2.330; 95% confidence interval = 1.241 to 4.375, P < 0.01). No difference in enrollment was observed among recruitment approaches, Pearson chi(2) (2) (n = 336) = 5.286, P = 0.07.Conclusions: The results from this study indicate that women, minorities, and those with lower educational attainment were less likely to enroll in an HIV vaccine efficacy study at our site. The findings highlight an important consideration on the role of health literacy to sustain participation of eligible minorities in HIV vaccine trials.