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HIV vaccine efficacy trials require the enrolment of large numbers of HIV-negative individuals and thus it is necessary to engage with communities where HIV incidence is high. We identify some of the caveats and pitfalls associated with researching community engagement in the context of HIV vaccine trials. These are as follows: the lack of consensus of what community engagement is and how it is practiced, the sometimes paradoxical role of community advisory boards as community representatives and challenges associated with information dissemination in communities. We identify a set of considerations for community engagement practitioners, trial investigators and social scientists when conducting community engagement.

It is vital that enough participants are willing to participate in clinical trials to test HIV vaccines adequately. It is, therefore, necessary to explore what affects peoples' willingness to participate (WTP) in such trials. Studies have only examined individual factors associated with WTP and not the effect of messages about trial participation on potential participants (e.g., whether losses or gains are emphasized, or whether the outcome is certain or uncertain). This study explores whether the effects of message framing on WTP in a hypothetical HIV vaccine trial are consistent with Prospect Theory. This theory suggests that people are fundamentally risk averse and that (1) under conditions of low risk and high certainty, gain-framed messages will be influential (2) under conditions of high risk and low certainty, loss-framed messages will be influential. This cross-sectional study recruited 283 HIV-negative students from a South African university who were given a questionnaire that contained matched certain gain-framed, certain loss-framed, uncertain gain-framed, and uncertain loss-framed statements based on common barriers and facilitators of WTP. Participants were asked to rate how likely each statement was to result in their participation in a hypothetical preventative HIV vaccine trial. Consistent with Prospect Theory predictions, for certain outcomes, gain-framed messages were more likely to result in WTP than loss-framed messages. Inconsistent with predictions, loss-framed message were not more likely to be related to WTP for uncertain outcomes than gain-framed messages. Older students were less likely to express their WTP across the different message frames. Recruitment for HIV vaccine trials should pay attention to how messages about the trial are presented to potential participants.

HIV vaccine clinical research occurs within a context where biomedical science and social issues are interlinked. Previous HIV vaccine research has considered behavioral and social issues, but often treated them as independent of clinical research processes. Systematic attention to the intersection of behavioral and social issues within a defined clinical research framework is needed to address gaps, such as those related to participation in trials, completion of trials, and the overall research experience. Rigorous attention to these issues at project inception can inform trial design and conduct by matching research approaches to the context in which trials are to be conducted. Conducting behavioral and social sciences research concurrent with vaccine clinical research is important because it can help identify potential barriers to trial implementation, as well as ultimate acceptance and dissemination of trial results. We therefore propose a conceptual framework for behavioral and social science in HIV vaccine clinical research and use examples from the behavioral and social science literature to demonstrate how the model can facilitate identification of significant areas meriting additional exploration. Standardized use of the conceptual framework could improve HIV vaccine clinical research efficiency and relevance., (Published by Elsevier Ltd.)

Social and behavioral science research is integral to the conduct of HIV vaccine trials, especially because the vaccine targets an infection laden with sensitive human issues. Although social and behavioral sciences have played a larger role in HIV vaccine clinical trials than other vaccine clinical trials to date, this role should be expanded. Fortunately, related publications, conference coverage and research proposals are on the rise; community engagement is receiving more attention during the earlier stages of product development; and collaboration between HIV vaccine scientists and social and behavioral scientists is being fostered. Greater attention to social and behavioral science issues could not only facilitate accrual, but also improve research efficiency and relevance. In this review, gaps in the literature on social and behavioral science issues in HIV vaccine clinical research, including barriers and facilitators to trial participation, enhancing feasibility of trial success, health systems, policy and monitoring social and behavioral issues, are identified and directions are suggested for filling those gaps. Development of a safe, efficacious and acceptable HIV vaccine will be nurtured by addressing the gaps through interdisciplinary collaborations.

Recent data indicate that the worldwide rate of HIV infection in adolescents is steadily increasing. Internationally, more than 7000 youths between 15 and 24 years of age are infected with HIV daily, resulting in more than 2.5 million new infections annually. Almost two thirds (1.7 million) of these new infections occur in Africa. Estimates in 2000 showed that the number of South Africans between 15 and 49 years of age infected with HIV was 4.7 million. This number equates to a prevalence rate of 15.4% in those younger than 20 years. Adolescents form an important target group not only for preventative efforts but also for HIV vaccine trials. This article focuses on the social and psychological factors that affect adolescent decision making by considering adolescent risk-taking behaviors, problems associated with predicting adolescent behavior, peer relationships and decision making, sexual disinhibition, and the role of family relationships in adolescent decision making.

Social and behavioral science research is integral to the conduct of HIV vaccine trials, especially because the vaccine targets an infection laden with sensitive human issues. Although social and behavioral sciences have played a larger role in HIV vaccine clinical trials than other vaccine clinical trials to date, this role should be expanded. Fortunately, related publications, conference coverage and research proposals are on the rise; community engagement is receiving more attention during the earlier stages of product development; and collaboration between HIV vaccine scientists and social and behavioral scientists is being fostered. Greater attention to social and behavioral science issues could not only facilitate accrual, but also improve research efficiency and relevance. In this review, gaps in the literature on social and behavioral science issues in HIV vaccine clinical research, including barriers and facilitators to trial participation, enhancing feasibility of trial success, health systems, policy and monitoring social and behavioral issues, are identified and directions are suggested for filling those gaps. Development of a safe, efficacious and acceptable HIV vaccine will be nurtured by addressing the gaps through interdisciplinary collaborations. [ABSTRACT FROM AUTHOR]

Adolescents form an important target group for HIV vaccine trials for a number of reasons. These include the high HIV prevalence and incidence rates amongst adolescents, early sexual debut,multiple sexual partners, and other high-risk sexual behaviours. It has therefore been argued that the focus of HIV vaccination attempts should be on early adolescents younger than 15 years of age. Indeed, vaccination of adolescents prior to their sexual debut has been argued to have the potential to be one of the most effective ways to curb the HIV pandemic. While the biological and epidemiological arguments for vaccination of adolescents have been elucidated, this article offers some insight into the cognitive aspects of decision making in adolescence that may inform strategies vaccine trial sites might employ when dealing with adolescent participants. After a brief overview of the educational, biological, and relationship changes that occur during adolescence, this article explores some of the more pertinent cognitive changes that occur during adolescence. More specifically, this article explores the cognitive changes during adolescence that affect decision making, such as differences between younger and older adolescents in (a) choice, (b) comprehension, (c) creativity, (d) compromise, (e) consequentiality, (f) correctness, (g) credibility, (h) consistency, and (i) commitment. Research findings relating to the above changes are discussed, creating an argument for the exclusion of early adolescents in vaccine trials and the concomitant active engagement with middle adolescents. [ABSTRACT FROM AUTHOR]

We present the findings of a qualitative investigation into the factors that may enable or inhibit participation in a future HIV vaccine trial. Thirty-seven semi-structured interviews and two focus groups were conducted with trial site community members who had attended HIV vaccine education workshops conducted by the community involvement programme of the South African AIDS Vaccine Initiative (SAAVI). Our findings indicate that enablers and inhibitors to participation in HIV vaccine trials may be further classified as either abstract or concrete. Each sub-theme was classified as an abstract inhibitor, abstract enabler, concrete inhibitor, or concrete enabler. Abstract inhibitors were fear of illness or death, lack of information about HIV/AIDS and HIV vaccines, and an HIV vaccine trial's association with HIV/AIDS. Abstract enablers were participants' reported sense of altruism and quality of life issues, such as protection from becoming infected with HIV. Concrete inhibitors were the monetary costs associated with participation, fear of being tested for HIV and receiving test results, negative reactions from family and community members, time delays between receiving trial participation information and actual enrolment, and a general mistrust of researchers. Concrete enablers were practicalities and convenience, financial rewards, a safe testing environment, positive family reactions to trial participation, the different levels of participation available to different members of the community, the salience of HIV in communities, positive community reactions to vaccine trials, and the presence of role models. In addition to these quadrants, the enablers and inhibitors have also been located within a contextual framework that includes the individual, family, community, and societal levels. Our research contributes to an understanding of the concerns of potential HIV vaccine trial participants within the South African context. Our findings illustrate the applicability of international research to proposed vaccine trial activities in South Africa and should, therefore, inform the development and implementation of successful community preparedness activities. [ABSTRACT FROM AUTHOR]