"If It's Not Working, Why Would They Be Testing It?": mental models of HIV vaccine trials and preventive misconception among men who have sex with men in India.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.