The data reported here describe a diversity of perspectives about HIV vaccine trial participation. Rather than eliciting dichotomous views regarding being willing or unwilling, respondents’ views were complex, and a range of issues factored into decision-making with the potential that women would opt out at various points. Many motivators and deterrents were similar to those found in other studies regarding participation in HIV vaccine [3
], suggesting that many groups have similar considerations overall, though the degree to which these considerations ultimately influence participation may differ. Most held positive views of the study’s recruitment procedures, and mentioned various motivators for participating. However, the majority were ultimately deterred by concerns about research procedures, potential consequences of participation, and/or their ability to attend study appointments.
Our findings show that women in this sample think carefully about enrolling in HIV vaccine trials given the structural constraints within which they live. Uncertainties about unforeseen consequences of participation may be particularly important among women with few economic or social resources to fall back on if they experience a medical problem. Poor women may be particularly concerned about the potential for illness that may lead to a loss of ability to support their selves and/or fulfill their familial responsibilities [4
] in the short or long term. Perhaps this figured into their far-sighted thinking about potential future consequences of trial participation. Participants in previous trials have experienced negative social impacts related to personal relationships, and even areas with high AIDS case rates may not have high community-level knowledge about HIV vaccine research [31
]. Several respondents said they would talk about participating with loved ones before making up their minds, but unfortunately many women’s comments implied the presence of research distrust and/or misinformation among their social networks.
Though these women’s decisions about research participation appeared largely to be in line with current standards of autonomy, in some cases motivations were based on false assumptions or alternative interpretations of study procedures. A minority were motivated to participate by the hope that the investigational vaccine could help prevent them from getting infected with HIV. This has been reported to be an issue in previous HIV vaccine trials [19
]. Though the informed consent process for screening explicitly stresses that it is not known if the trial vaccine will prevent HIV or not, those who only behaviorally screened may not have had as detailed of discussions. In addition, several people perceived that there were social services to be gained from engagement with the vaccine trial. Though informed consent emphasizes that participants “receive no direct benefit” from participating, some women believe that research interactions do benefit them. Being motivated to participate in an HIV vaccine trial by potential personal benefits has been reported as more frequent among women, people of color, those with lower educational attainment, and those reporting unprotected anal or vaginal intercourse in the last 6 months [19
]; it was also reported as a motivator among non-Black MSM [20
The fact that these women perceive that they need to take part in research to obtain information, support, or social services may belie a lack of comprehensive HIV/AIDS information, as well as other available services which they feel comfortable accessing, in their communities and/or the difficulties of maintaining supportive relationships in a drug-using context. The degree to which poor women may rely on research to fill in for absent public services raises questions about the voluntary nature of research participation. As Colfax et al. have argued, public health efforts to ensure that potential HIV vaccine trial participants have access to HIV prevention services and medical care outside of clinical trials may alleviate such tensions [19
While several participants asserted that they were not solely motivated to take part in the study by money, in some cases, the way they talked about the compensation suggests that it was significant in their lives, and may have been difficult to turn down. For example, when women talked about having money to eat with or to cook a child’s birthday meal, this small compensation becomes quite meaningful. Many of these comments were specific to the compensation received for a short pre-screening interview in a community-based location. Judging from the relatively low rates of follow-up, the various considerations involved in participating further in the HIV vaccine trial may have outweighed the influence of compensation on participation.
Limitations in this study include the small sample. Results cannot represent all women eligible to participate in the HIV vaccine trial. Interviewees were recruited, in most cases, when it was not clear whether they would continue, or be eligible to continue, participating in the vaccine trial; therefore, the perspectives of women who screened and enrolled, as well as people who did not participate in trial activities at all, are not well represented. Member checking was not conducted, which is also a limitation. However, per our study aims, results provide rich data on the beliefs and understandings with which women consider participation in HIV vaccine trials. Although the questions asked in this study were not directed at understanding WTP in trials of other biomedical HIV prevention interventions, it is likely that similar factors could apply to women’s WTP in other biomedical intervention trials.
Understanding factors which influence vaccine research participation among women at ‘high risk’ can aid sites to tailor recruitment procedures to local contexts. The goal is not to convince unwilling women to take part, rather to address concerns and barriers to make clinical research better understood and more convenient to women at risk for HIV acquisition. Concerns about future reactions can be addressed through sustained community education and informed consent which continues to address safety and side-effects of relevant HIV vaccine studies. Convenience barriers can be ameliorated by providing rides to office visits when necessary, and/or conducting clinical study visits in more accessible neighborhood locations. While distrust did not preclude most respondents from learning more about the study, it remains salient among African-American women and their social networks and must continually be addressed in clinical trials, as well as future vaccine rollout if and when a safe and effective HIV vaccine is found.
Further research is needed regarding community-level influences on WTP in HIV vaccine research and the structural factors which influence personal agency and individuals’ thinking about research participation, particularly in light of the tenuous financial situations that the women in this study were living in. Researchers must continue to interrogate the ethical dimensions of recruitment practices and research participation when recruiting impoverished and socially marginalized people into research.