Frew Paula M, Mulligan Mark J, Hou Su-I, Chan Kayshin, del Rio Carlos
Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia, USA.
Open Access J Clin Trials. 2010 Sep 1;2010(2):149-156. doi: 10.2147/OAJCT.S11915.
This study examines whether men-who-have-sex-with-men (MSM) and transgender (TG) persons' attitudes, beliefs, and risk perceptions toward human immunodeficiency virus (HIV) vaccine research have been altered as a result of the negative findings from a phase 2B HIV vaccine study. DESIGN: We conducted a cross-sectional survey among MSM and TG persons (N = 176) recruited from community settings in Atlanta from 2007 to 2008. The first group was recruited during an active phase 2B HIV vaccine trial in which a candidate vaccine was being evaluated (the "Step Study"), and the second group was recruited after product futility was widely reported in the media. METHODS: Descriptive statistics, t tests, and chi-square tests were conducted to ascertain differences between the groups, and ordinal logistic regressions examined the influences of the above-mentioned factors on a critical outcome, future HIV vaccine study participation. The ordinal regression outcomes evaluated the influences on disinclination, neutrality, and inclination to study participation. RESULTS: Behavioral outcomes such as future recruitment, event attendance, study promotion, and community mobilization did not reveal any differences in participants' intentions between the groups. However, we observed greater interest in HIV vaccine study screening (t = 1.07, P < 0.05) and enrollment (t = 1.15, P < 0.05) following negative vaccine findings. Means on perceptions, attitudes, and beliefs did not differ between the groups. Before this development, only beliefs exhibited a strong relationship on the enrollment intention (β = 2.166, P = 0.002). However, the effect disappeared following negative trial results, with the positive assessment of the study-site perceptions being the only significant contributing factor on enrollment intentions (β = 1.369, P = 0.011). CONCLUSION: Findings show greater enrollment intention among this population in the wake of negative efficacy findings from the Step Study. The resolve of this community to find an HIV vaccine is evident. Moreover, any exposure to information disseminated in the public arena did not appear to negatively influence the potential for future participation in HIV vaccine studies among this population. The results suggest that subsequent studies testing candidate vaccines could be conducted in this population.
本研究旨在探讨男男性行为者（MSM）和跨性别者（TG）对人类免疫缺陷病毒（HIV）疫苗研究的态度、信念和风险认知是否因一项2B期HIV疫苗研究的阴性结果而发生改变。设计：我们于2007年至2008年在亚特兰大社区招募了176名MSM和TG人群进行横断面调查。第一组是在一项正在评估候选疫苗的2B期HIV疫苗试验的活跃阶段招募的（“Step研究”），第二组是在产品无效性被媒体广泛报道后招募的。方法：进行描述性统计、t检验和卡方检验以确定两组之间的差异，并进行有序逻辑回归分析上述因素对一个关键结果（未来参与HIV疫苗研究）的影响。有序回归结果评估了对研究参与的不情愿、中立和倾向的影响。结果：诸如未来招募、活动参与、研究推广和社区动员等行为结果并未显示两组参与者意图上的任何差异。然而，我们观察到在疫苗阴性结果公布后，参与者对HIV疫苗研究筛查（t = 1.07，P < 0.05）和入组（t = 1.15，P < 0.05）的兴趣更高。两组在认知、态度和信念方面的均值没有差异。在此之前，只有信念与入组意愿呈现出强烈关系（β = 2.166，P = 0.002）。然而，阴性试验结果公布后这种效应消失了，对研究地点的积极评价是入组意愿的唯一显著影响因素（β = 1.369，P = 0.011）。结论：研究结果表明，在“Step研究”出现阴性疗效结果后，该人群的入组意愿更高。这个群体寻找HIV疫苗的决心是明显的。此外，在公共领域传播的任何信息暴露似乎都没有对该人群未来参与HIV疫苗研究的可能性产生负面影响。结果表明后续可以在该人群中开展测试候选疫苗的研究。
