Chakrapani Venkatesan, Newman Peter A, Singhal Neeti, Nelson Ruban, Shunmugam Murali
Factor-Inwentash Faculty of Social Work, University of Toronto, 246 Bloor Street West, Toronto, Ontario M5S 1V4 Canada.
BMC Public Health. 2013 Aug 7;13:731. doi: 10.1186/1471-2458-13-731.
Informed consent based on comprehension of potential risks and benefits is fundamental to the ethical conduct of clinical research. We explored mental models of candidate HIV vaccines and clinical trials that may impact on the feasibility and ethics of biomedical HIV prevention trials among men who have sex with men (MSM) in India.
A community-based research project was designed and implemented in partnership with community-based organizations serving MSM in Chennai and Mumbai. We conducted 12 focus groups (n=68) with diverse MSM and 14 key informant interviews with MSM community leaders/service providers using a semi-structured interview guide to explore knowledge and beliefs about HIV vaccines and clinical trials. Focus groups (60-90 minutes) and interviews (45-60 minutes) were conducted in participants' native language (Tamil in Chennai; Marathi or Hindi in Mumbai), audio-taped, transcribed and translated into English. We explored focus group and interview data using thematic analysis and a constant comparative method, with a focus on mental models of HIV vaccines and clinical trials.
A mental model of HIV vaccine-induced seropositivity as "having HIV" resulted in fears of vaccine-induced infection and HIV stigma. Some participants feared inactivated vaccines might "drink blood" and "come alive". Pervasive preventive misconception was based on a mental model of prevention trials as interventions, overestimation of likely efficacy of candidate vaccines and likelihood of being assigned to the experimental group, with expectations of protective benefits and decreased condom use. Widespread misunderstanding and lack of acceptance of placebo and random assignment supported perceptions of clinical trials as "cheating". Key informants expressed concerns that volunteers from vulnerable Indian communities were being used as "experimental rats" to benefit high-income countries.
Evidence-informed interventions that engage with shared mental models among potential trial volunteers, along with policies and funding mechanisms that ensure local access to products that demonstrate efficacy in trials, may support the safe and ethical implementation of HIV vaccine trials in India.
基于对潜在风险和益处的理解的知情同意是临床研究道德行为的基础。我们探究了候选HIV疫苗和临床试验的心智模式，这些模式可能会影响印度男男性行为者（MSM）中生物医学HIV预防试验的可行性和伦理学。
与在金奈和孟买为男男性行为者服务的社区组织合作，设计并实施了一项基于社区的研究项目。我们使用半结构化访谈指南，对不同的男男性行为者进行了12个焦点小组访谈（n = 68），并对男男性行为者社区领袖/服务提供者进行了14次关键 informant访谈，以探究关于HIV疫苗和临床试验的知识与信念。焦点小组访谈（60 - 90分钟）和访谈（45 - 60分钟）以参与者的母语进行（金奈为泰米尔语；孟买为马拉地语或印地语），进行录音、转录并翻译成英语。我们使用主题分析和持续比较法探究焦点小组访谈和访谈数据，重点关注HIV疫苗和临床试验的心智模式。
将HIV疫苗诱导的血清阳性视为“感染了HIV”的心智模式导致了对疫苗诱导感染和HIV污名化的恐惧。一些参与者担心灭活疫苗可能会“吸血”并“复活”。普遍存在的预防性误解基于将预防试验视为干预措施的心智模式，高估了候选疫苗的可能疗效以及被分配到实验组的可能性，期望获得保护益处并减少避孕套的使用。对安慰剂和随机分配的广泛误解和不接受支持了将临床试验视为“欺骗”的看法。关键 informant表示担心来自印度弱势群体的志愿者被用作“实验鼠”以使高收入国家受益。
基于证据的干预措施，与潜在试验志愿者中共享的心智模式相结合，以及确保当地能够获得在试验中证明有效的产品的政策和资金机制，可能有助于在印度安全且符合伦理地开展HIV疫苗试验。
