Motivations for participating in an HIV vaccine efficacy trial
Motivations for participating in an HIV vaccine efficacy trial
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DOI：
10.1097/01.qai.0000152039.88422.ec
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发表时间：
2005-07-01
影响因子：
3.6
通讯作者：
Bartholow, B
中科院分区：
文献类型：
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作者：
Colfax, G;Buchbinder, S;Bartholow, B
了解人们为什么参加HIV疫苗有效性试验对于试验招募和教育工作至关重要。我们评估了参与者加入VaxGen VAX 004研究的动机，这是一项随机、双盲、安慰剂对照、III期多中心试验。在5417名参与者中，94%是男男性行为者（MSM），6%是有异性传播艾滋病毒风险的女性大多数参与者给出了参与试验的利他主义原因：99%的人报告说加入是为了帮助寻找艾滋病毒疫苗，98%的人报告说加入是为了帮助他们的社区。一些人给出了更多的个人原因：56%的人加入是为了减少风险行为，46%的人加入是为了获得艾滋病毒的保护。多因素Logistic回归分析显示，女性参与者参加试验的动机明显高于男性参与者（P均<0. 05）。在入组前6个月内有13名或更多性伴侣的参与者比那些性伴侣较少的参与者更有可能报告参加试验是为了保护，但不太可能参加试验是为了减少风险行为（均P < 0.05）。由于许多参与者报告个人保护免受艾滋病毒感染是他们加入的原因，疫苗试验风险降低咨询应继续强调安慰剂对照试验设计和试验产品的未知功效，特别是对于女性和有大量性伴侣的人。由于相当一部分参与者报告说，参加试验是为了获得艾滋病毒信息、艾滋病毒检测和财务报销，因此需要在研究试验之外提供艾滋病毒预防服务，并进行监测，以确保参与者不因经济利益而参加试验。
Understanding why people join HIV vaccine efficacy trials is critical for trial recruitment and education efforts. We assessed participants' motivations for joining the VaxGen VAX004 study, a randomized, double-blind, placebo-controlled, phase 3 multicenter trial. Of 5417 participants, 94% were men who have sex with men (MSM) and 6% were women at risk for heterosexual transmission of HIV Most participants gave altruistic reasons for trial participation: 99% reported having joined to help find an HIV vaccine, and 98% reported having joined to help their community. Some gave more personal reasons: 56% joined to reduce risk behavior and 46% joined to get protection from HIV Additional reasons related to receiving services or compensation included to obtain information about HIV (75%), to receive free HIV testing (34%), and for financial reimbursement (14%). Multivariate logistic regression analysis showed that female participants were significantly more motivated than male participants to join the trial for protection and to receive services or compensation (all P < 0.05). Participants with 13 or more sex partners in the 6 months before enrollment were more likely than those with fewer sex partners to report having joined the trial for protection but less likely to have joined to reduce risk behavior (both P < 0.05). Because many participants reported personal protection from HIV as their reason for joining, vaccine trial risk-reduction counseling should continue to emphasize the placebo-controlled trial design and unknown efficacy of the test product, particularly for women and persons with large numbers of sex partners. Because a significant minority of participants reported joining to receive HIV information, HIV testing, and financial reimbursement, a need is indicated for provision of HIV prevention services outside research trials and for monitoring to ensure that participants are not motivated to join trials for financial gain.