Expert Review of Vaccines

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Advancing community stakeholder engagement in biomedical HIV prevention trials: principles, practices and evidence Peter A Newman & Clara Rubincam To cite this article: Peter A Newman & Clara Rubincam (2014) Advancing community stakeholder engagement in biomedical HIV prevention trials: principles, practices and evidence, Expert Review of Vaccines, 13:12, 1553-1562 To link to this article: http://dx.doi.org/10.1586/14760584.2014.953484

Published online: 01 Sep 2014.

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Advancing community stakeholder engagement in biomedical HIV prevention trials: principles, practices and evidence Expert Rev. Vaccines 13(12), 1553–1562 (2014)

Peter A Newman* and Clara Rubincam Factor-Inwentash Faculty of Social Work, University of Toronto, 246 Bloor Street West, Toronto, Ontario, M5S 1V4, Canada *Author for correspondence: Tel.: +1 416 946 8611 Fax: +1 416 978 7072 [email protected]

Community stakeholder engagement is foundational to fair and ethically conducted biomedical HIV prevention trials. Concerns regarding the ethical engagement of community stakeholders in HIV vaccine trials and early terminations of several international pre-exposure prophylaxis trials have fueled the development of international guidelines, such as UNAIDS’ good participatory practice (GPP). GPP aims to ensure that stakeholders are effectively involved in all phases of biomedical HIV prevention trials. We provide an overview of the six guiding principles in the GPP and critically examine them in relation to existing social and behavioral science research. In particular, we highlight the challenges involved in operationalizing these principles on the ground in various global contexts, with a focus on low-income country settings. Increasing integration of social science in biomedical HIV prevention trials will provide evidence to advance a science of community stakeholder engagement to support ethical and effective practices informed by local realities and sociocultural differences. KEYWORDS: clinical trials • community engagement • community participation • ethics • HIV prevention • HIV vaccines • low-income countries • mistrust • social sciences • stakeholder engagement

As biomedical HIV prevention trials continue to be mounted globally to respond to the most devastating epidemic of modern times, the complexities as well as the importance of community stakeholder engagement is increasingly evident. Leading international AIDS organizations have taken up the task of responding to diverse global challenges in achieving meaningful and effective community stakeholder engagement in HIV prevention trials. UNAIDS/AVAC has spearheaded these efforts in publishing a series of good participatory practice (GPP) guidelines for community participation in HIV clinical trials, hereafter referred to as GPP [1,2]. GPP guidelines are organized according to six principles that ‘constitute the foundation for positive, collaborative and mutually beneficial relationships that trial funders, sponsors and implementers can foster with other

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stakeholders’ (p. 22 [2]). These principles are respect, mutual understanding, integrity, transparency, accountability and community stakeholder autonomy. Such guiding principles are, by their nature, broadly worded in order to provide a systemic framework for GPP that transcend specific cultural, social and economic contexts. Overarching guidelines and principles alone, however, may fail to address the significant gaps between espoused best practices and implementation that have frequently been documented in global health research [3–7]. The authors briefly review the guiding principles of GPP and then interface these guidelines with emerging social and behavioral science research. The objective of the authors is to highlight specific challenges as well as emerging solutions in operationalizing these guidelines in diverse global contexts. Given the

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preponderance of clinical trials in low-income country settings, the majority of existing empirical research is appropriately based in these locations, which forms the focus of this review. By constructively engaging with principled conceptual guidelines and evolving empirical evidence, we aim to advance an emerging science of community stakeholder engagement in HIV vaccine and other biomedical HIV prevention trials [8]. Foundational to an analysis of community stakeholder engagement and its challenges is how one defines the terms themselves. ‘Community’ has been defined on the basis of geographic proximity, special interests or shared identities and experiences [9,10]. An individual, therefore, can belong to a number of different communities on the basis of different localities, interests, identities and experiences [6], and can, over time, adopt and discard identification with a particular community as circumstances, geographic location and values change [11]. A synthesis of social scientists’ and communitybased researchers’ perspectives concludes that a ‘community’ must contain ‘sufficient social interaction, structure and permanence’ to enable an individual to identify as part of that community [9]. The emphasis on an individual’s own identification with a community is key, as definitions of community by members and non-members, such as researchers, may be substantially different and translate into divergent priorities for ‘community engagement’ [10]. UNAIDS guidelines indicate that the term ‘community stakeholders’ refers to both ‘individuals and groups that are ultimately representing the interests of people who would be recruited to or participate in a trial’ as well as ‘others locally affected by a trial’ (p. 14 [2]). In practice, this definition encompasses the range of definitions of community membership identified above, including geography (people living in the area of the study), illness group (people living with HIV in the area) and special interests (people affected by the HIV epidemic, local non-governmental organizations, community groups and community-based organizations), as well as externally-defined groups (those targeted for trial recruitment) [2]. The fact that communities are shifting, multiple and overlapping can complicate the process of defining ‘community engagement’ [6,11]. In defining ‘stakeholder engagement’, GPP guidelines refer to processes through which those responsible for implementing trials build ‘transparent, meaningful, collaborative and mutually beneficial relationships’ with ‘interested or affected’ individuals or groups with the ultimate aim of ‘shaping research collectively’ (p. 16 [2]). This definition situates itself at the upper end of a ‘ladder of participation’, which ranges from dissemination of information about planned research initiatives to community members to a more intensive process of sharing power over decision-making [4,6,12]. Operationalizing these definitions of ‘community’ and ‘engagement’ requires clarity as to who constitutes ‘interested or affected’ individuals, as well as understanding of the processes and activities required to shape a collective research endeavor. One challenge in operationalizing ‘community’ is the fact that ‘interested and affected’ individuals or groups may or 1554

may not predate the initiation of a trial; furthermore, community engagement activities initiated at the outset of a research project can themselves create a new sense of community among some individuals or disrupt an existing community identity [13,14]. Similarly, challenges in operationalizing stakeholder engagement can include determining the extent to which community members have a veto on decisions surrounding the trial [4,9]. Awareness of the different, overlapping and dynamic parameters that may define community, and the importance of individuals’ self-defined community identifications, helps to inform understanding of the challenges in implementing GPP guidelines on the ground; it also serves to highlight the importance of the processes of engagement themselves. Respect

GPP guidelines suggest that respect within a research team is demonstrated when ‘stakeholders communicate and act in ways that value and honor each other’s perspectives and realities’ (p. 22 [2]). Trust within the research team is built when community stakeholders are made to feel that their expertise is recognized and respected. Among the challenges in bringing together distinct perspectives, experiences and methodologies are reconciling backgrounds, priorities and styles of research that are founded on vastly different epistemological premises. These distinctions create tension even among research professionals from different academic disciplines. Economists and anthropologists, for example, even as both disciplines are classified as social sciences, remain ‘divided on their views of human agency, on what constitutes data, on how to interpret their respondents’ words and on what counts as an adequate explanation’ (p. 3 [15]). Significant epistemological differences exist among researchers within the health sciences, such as medicine, nursing and social work, as well as between these researchers and community workers who may be guided primarily by a social justice perspective [3]. Even in cases when stakeholders are able to reconcile epistemic and methodological divergences, differences in skills and abilities may constitute a barrier for stakeholders to participate equally in all aspects of a research endeavor. Community members involved in community-based research, for instance, are more likely to participate in data collection and dissemination of research findings than in actual data analysis [15,16]. In recognition of how community members can be excluded by the perception that data analysis is technical, complex and/or requires quantitative expertise [17], researchers are developing opportunities for various community stakeholders to participate in all aspects of a research endeavor. These strategies range from translating quantitative data into percentages or graphic form [16] to finding creative ways for community members to participate in qualitative analysis [18]. Research by the authors suggests that respect may be challenged by entreaties to community stakeholders to engage in ways that are not commensurate with their expertise and availability [19]. Mere participation in team meetings, for example, Expert Rev. Vaccines 13(12), (2014)

Advancing community stakeholder engagement in biomedical HIV prevention trials

that are not designed to engage community input, may be rightly perceived as tokenism rather than meaningful engagement. Respect may require striking a balance that entails affording opportunities, including technical support and training for community stakeholders, in order to more meaningfully participate in the science, while acknowledging limitations in competencies, time and interest. Respect, therefore, also necessitates training for researchers and site staff in understanding and appropriately responding to community stakeholder concerns that are grounded in local contexts and social relationships [14].

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Mutual understanding

In recognition of the need to cultivate a common understanding of trial objectives, GPP guidelines suggest that stakeholders should ‘develop competency in both socio-cultural issues and research processes’ (p. 22 [2]). Developing understanding of both the scientific processes of doing research as well as the ‘norms, practices, and beliefs of relevant local cultures’ [2] represents a significant challenge for clinical trial teams. In the case of the former, researchers need to ensure that all members of the team understand basic elements such as how a research question is developed, how trials are designed and how data are to be collected, analyzed and disseminated. A systematic review of levels of understanding in the context of informed consent, however, indicates that prospective participants from various communities frequently did not understand the information that was disclosed to them in the informed consent process [20]. Assessments of understanding of clinical trial concepts also appear to be contingent on the tools used to measure informed consent [21]. Academic researchers are confronted with challenges of communicating about complex technical concepts, such as ‘vaccine-induced seropositivity’ or ‘placebo’, with community members who may lack scientific training and expertise [22]. This is particularly the case in trial locations and populations in which chronic underinvestment in education and skills development has meant that the local community is relatively ‘research-naı¨ve’ [23]. Social science investigations reveal how pre-existing mental models – simplified cognitive representations of complex external realities – can influence how scientific concepts are perceived by a particular community. In a study the authors conducted among low socioeconomic status men who have sex with men in India, local research staff reported difficulties in explaining the concepts of ‘placebo’ and ‘randomization’ to community members. Even after explaining in lay language how trial volunteers would be randomly assigned to one of two groups, participants still greatly overestimated their likelihood of being in the experimental vaccine group rather than the placebo group, as well as conflating a vaccine trial with a preventive intervention [22]. Several informants construed doubleblind, placebo-controlled trials as constituting a form of ‘cheating’. Beyond the ethical considerations, trials that proceed without first ensuring that community stakeholders understand these foundational concepts may be more liable to encounter difficulties in implementation as well as early termination [8]. informahealthcare.com

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Moreover, historically grounded mistrust between local communities and government or medical researchers can hinder communication [24]. In sites where HIV vaccine trials were stopped early due to unanticipated adverse events, with some vaccinees being made more susceptible to HIV infection, trial participants and local community stakeholders interpreted the news about early cessation through the lens of historical exclusion and marginalization. In Canada, an African/Caribbean woman wondered, ‘Why didn’t they use college girls? Why did they use sex trade workers?’, while an Aboriginal key informant suggested, ‘Our people don’t trust the government anymore because we’ve been cheated so many times. The Whites brought polio to our people, other diseases. It’s the government telling us, ‘take it, it will not hurt you’ (p. 1754 [25]). In South Africa, a key informant observed, ‘I think you know the previous trials haven’t really left a positive mark…So that also contributes negatively in communities not really wanting to participate’ (p. 1251 [26]). These experiences constitute the ‘local vaccination cultures’ of each community [27], encompassing past experiences with vaccine delivery programs and collective observations about the efficacy and fairness of health and vaccine-related interventions [28,29]. GPP guidelines acknowledge that while members of the research team from outside the study community may have high levels of formal research competency, they may lack expertise regarding the sociocultural competencies required in various study locales to conduct a trial. Addressing these challenges means that biomedical and clinical scientists on the research team have to step outside of their usual roles and engage with issues (and experts) outside of the traditional remit of biomedical research; rather, the latter challenges constitute the primary expertise of social scientists [30]. In the case of HSV/HIV intervention trials in South Africa, this meant responding ‘to the legacies of apartheid, that is the lack of knowledge, the lack of skill and the lack of trust in science’ among the study population (p. 6 [23]). Researchers used drama, music, radio and community events to generate awareness of and interest in the research process. Incorporating locally meaningful images, concepts and languages also may help to increase community members’ understanding of research concepts [31]. In a US study, the use of a culturally-derived metaphor to explain the process of randomization in cancer clinical trials yielded significantly higher intentions to participate [32]. An innovative intervention study with US adolescents found that two-sided messaging (i.e., a ‘myth’ and ‘fact’ sheet) improved understanding of difficult trial concepts without compromising willingness to participate in an HIV vaccine trial [33] among this critical constituency for biomedical HIV prevention research. Thus, several studies illustrate methods for advancing evidence to address the challenges of attaining ‘mutual understanding’ as well as the value of integrating social science with biomedical research to support clinical trial implementation. Rather than trial and error attempts fueled by good intentions, evidence-informed approaches may help to bridge some of the real-world challenges in implementing clinical trials in 1555

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resource-limited settings [8]. Qualitative and mixed method studies conducted before and during trials may guide effective strategies for addressing specific cultural and socioeconomic circumstances that require tailoring and formative work on the ground. Lessons learned from the field also underscore the limitations of approaches that are too formulaic or rigid, highlighting the need to ‘take social relationships seriously’ [14] in addressing what are context-specific social interactions and ethical challenges [4] that are foundational to GPP.

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Integrity

GPP guidelines urge adherence to ‘the highest standards of scientific and ethical integrity’ as a fundamental component of ‘achieving the scientific goals of a biomedical HIV prevention trial, maximizing benefits for community stakeholders, and advancing global HIV prevention science’ (p. 24 [2]). While scientific integrity is maintained through adherence to rigorous scientific standards and processes, ethical integrity ‘requires consideration of broader societal and ethical issues as well as adherence to universal ethical principles that include respect for persons, beneficence and justice’ (p. 24 [2]). In practice, this means going beyond what is technically, legally or scientifically required in the conduct of a trial to consider local community members’ priorities and constraints. A common ethical challenge has been to define what obligations, if any, research teams have to address the needs of research participants above and beyond the scientific requirements of conducting the trial. Navigating this challenge requires distinguishing obligatory care from ancillary care. Ancillary care is care that is not necessary to ensure the scientific validity of a study, to ensure a trial’s safety or to address research-related harms [34]. While the provision of free HIV testing in the context of an HIV vaccine trial, for example, is not ancillary care, the latter might include providing broader sexual and reproductive health services. In practice, the distinction between obligatory and ancillary care remains unclear and, moreover, controversial [35,36]. A critical overview of ethical parameters guiding ancillary care indicates the lack of specific guidelines and argues for a ‘middle position’ between responsibilities of a ‘personal physician’ and a ‘mere scientist’: ‘Researchers do not owe their subjects the same level of care that physicians owe patients, but they owe more than merely what the research protocol stipulates’ [37]. In particular, expanded responsibilities exist in resource-limited settings and circumstances in which the researcher’s discretionary actions would have the greatest impact on participants’ health [37], including sustainable improvements in standards of care [38]. However, researchers may feel constrained in balancing the provision of ancillary care in the form of expansive healthcare services with avoidance of undue inducement for community members to participate in a trial [36]. Challenges around ethical integrity are a poignant concern in HIV clinical trials in resource-limited settings where HIV healthcare services, much less basic healthcare, may not otherwise be available and accessible to trial participants [39]. 1556

Community stakeholders who become engaged in a trial as members of a Community Advisory Board (CAB) may feel particularly driven to maximize the ancillary care services provided to members of their constituent community. Although there are clearly limits to what level of ancillary care is feasible for researchers and sponsors to bear, a recent review of ancillary care provision in South Africa found that descriptions of ancillary services in HIV prevention trial protocols were only partially in line with ethical guideline recommendations, including the GPP [40]. For one, when ancillary care is outsourced through referrals and linkages to the broader healthcare system, participants’ needs may be unevenly or inadequately addressed [40,41]. Even in cases where particular services are ostensibly available in local communities, as revealed in the authors’ own research with men who have sex with men and transgender people in India and Thailand, pervasive discrimination in healthcare settings creates formidable barriers to the use of services from HIV testing to government-subsidized antiretroviral medications among key populations who might be engaged in HIV clinical trials [42,43]. A critical related issue is the extent to which medical researchers have an ethical obligation to provide post-trial services, particularly in cases in which the trial supports the efficacy of the candidate vaccine or product tested. Several previous investigations indicate that trial participants strongly endorse the provision of a product found to be efficacious in a trial to the study population. In an international HIV clinical trial, 98% of participants indicated that the trial had an obligation to provide an efficacious study drug to trial participants [39]. In the authors’ own research conducted among low socioeconomic status men who have sex with men in India, access to the candidate HIV vaccine for free if found to be efficacious in the trial was the highest rated characteristic among 10 features of a hypothetical trial, with 93% endorsement [44]. Yet a review of protocols and informed consent forms from major Phase III and IV antiretroviral trials noted the absence of stipulations about post-trial medications and medical care [45]. An alternative to making an efficacious product ‘reasonably available’ to the host population after a trial emphasizes that researchers should provide a ‘fair benefit’ to participants [46]. The fair benefit literature suggests a number of other compensatory activities that could contribute to the host population, such as training of healthcare personnel and building healthcare facilities [46,47]. However, in the absence of community stakeholder engagement in decision-making and clarity regarding a trial’s intention to provide post-trial services or other activities that could constitute a fair benefit, community members may feel manipulated or deceived by researchers. In sum, the demands of scientific integrity in the conduct of clinical trials, an essential component of GPP, are generally clear, with mechanisms for accountability built into the trial process. However, ethical integrity, while widely agreed upon as a conceptual ‘good’, brings with it many unmet challenges and subjectivities in practice; and these are dependent in part on the local geography and resource availability of particular Expert Rev. Vaccines 13(12), (2014)

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trial sites. Further empirical research in the context of HIV clinical trials, and guidelines based on this research along with mechanisms to evaluate the effectiveness of related interventions, will help to advance and ensure high standards of ethical integrity in biomedical HIV prevention trials. Although clinical trials cannot be expected to address all unmet medical needs in trial settings, lest many trials not proceed at all due to unfeasibility, mechanisms including articulation of what may be competing claims within research teams and between researchers and community stakeholders, identification of clear benefits for the study population, and mutual understanding between trial investigators and local communities can help to mete out ethical integrity in practice. Transparency

GPP guidelines recommend ‘open, honest, timely and clear communication’ between stakeholders and researchers about the objectives and processes of a trial (p. 24 [2]). However, communication about particular issues of concern to community stakeholders may be vaguely worded in study documents or not present at all. In a review of trial practices and research protocols submitted to ethics committees in South Africa, although trial practices generally met or exceeded ethical guidelines in terms of the provision of ancillary care services, there was less adherence to guidelines about description of these practices in trial protocols [40]. This was attributed, in part, to researchers’ desire to preserve ‘flexible, nimble care responses’, which could be impeded by formal commitments in protocols. To address this challenge, Slack [40] recommends placing descriptions of ancillary care services in clearly marked ‘ethical considerations’ sections of protocols that can be revised and adjusted as needed. A similar challenge exists in relation to communication about post-trial availability of efficacious products. The overwhelming majority of participants in an HIV clinical trial believed that the trial had a duty to provide an efficacious study drug to trial participants [39]. Yet, a systematic review found that less than 50% of trial documents reviewed for HIV antiretroviral trials mentioned post-trial medications or medical care [45]. In light of the gap between the expectations of participants and the stated commitments of researchers, greater attention to implementing clear and transparent communication is needed. Open discussion of what products and services will be made available to study participants may help to guard against the potential for participants to decide to participate in a trial based on inaccurate expectations of post-trial care [45]. In contrast to the important value of transparency, in practice formal descriptions in study protocols of researchers’ obligations or commitments for ancillary care and post-trial care may be partial at best. In order to maintain transparent communication between researchers and community stakeholders, steps need to be taken to ensure that clear discussions of what is provided by a trial are ongoing and that community leaders are in an informed position to explain potential benefits (and risks) of the research to their constituents. informahealthcare.com

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Accountability

GPP guidelines state that ‘community stakeholders and other relevant stakeholders are accountable for ensuring that their input into the research process is fair and constructive, respects the scientific process, and is in the best self-identified interests of community stakeholders’ (p. 25 [2]). This, in turn, relies on community stakeholders’ possessing sufficient knowledge and understanding of study concepts and objectives to participate meaningfully in trial design and implementation. Research teams are often responsible for building research literacy among community stakeholders; thus care must be taken to ensure that this training does not constrain the ability of stakeholders to speak openly about their concerns. In a study of stakeholder concerns about HIV clinical trials conducted with the South African research partners of the authors, a key informant described challenges around the impartiality of community members who have received training from researchers, ‘because when it’s done by the researchers, it looks like social marketing and all you want to do is make sure people accept your research, rather than coming from a neutral perspective’ (p. 8 [19]). Another key informant cautioned, ‘I also think the CAB’s being constituted by the research community and being sustained by the research community introduces some bias to what they do’ (p. 8 [19]). GPP guidelines recognize the importance of maintaining the perception and practices of those on CABs as an ‘independent advisory voice that is free to express concerns about proposed or ongoing research’ (p. 31 [2]), and caution against overlap between CAB members and those conducting research. In practice, however, communities may have a finite number of highly trusted, interested and qualified individuals who end up participating in both the community advisory mechanisms as well as on-the-ground trial implementation activities, such as participant recruitment. This overlap may create tensions among community stakeholders with regard to their primary task as accountable liaisons between researchers and other stakeholders [5]. In a study by the authors of willingness to participate in HIV vaccine trials in India, community stakeholders articulated hesitations about explaining the possibility of vaccine-induced seropositivity to community members as they feared this concept would be conflated with actual HIV infection, which might deter people from participating in the trial [22]. In short, though trial literacy activities are essential to ensuring that community stakeholders comprehend relevant trial concepts, formal training activities have the potential to bias stakeholders toward researchers’ priorities, thereby reducing their accountability to the community. Measures to support community stakeholder accountability to local communities include allocating sufficient resources for in-depth and balanced training of community stakeholders, remaining mindful of the very real potential for research teams to introduce bias that impedes this accountability, and seeking participation from a broad and diverse range of community members. Such measures may help to mitigate likely challenges to community 1557

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stakeholders’ ability to effectively advocate for local concerns and, if necessary, to hold trial researchers accountable.

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Community stakeholder autonomy

GPP guidelines describe ‘community stakeholders’ right to support or refuse proposals to conduct research in a particular area, depending on the community stakeholders’ self-identified interests and desires’. They highlight the importance of ‘maximizing the opportunity for stakeholders to understand the local, national and global benefits of a specific trial and to make informed decisions regarding the appropriateness of a proposed trial’ (p. 25 [2]). Stakeholders’ abilities to make informed decisions rely heavily on the extent to which they understand relevant trial concepts such as placebo and randomization, comprehend the trial’s stated obligations for ancillary care and post-trial services, and are clear about the possibilities of trial-related harms. GPP guidelines further acknowledge that ‘different stakeholder groups may well have different perspectives on the relevance or appropriateness of a specific trial, adding complexity to the situation’ (p. 25 [2]). The International AIDS Vaccine Initiative’s (p. 12 [48]), Guidance Tool for CABs provides examples of further complexity in that ‘prominent members of the local society, such as religious leaders, lawyers and representatives of local government, will be serving alongside representatives from vulnerable groups’ The latter might include marginalized (and criminalized in many settings) populations, such as sex workers, men who have sex with men, people who inject drugs, and others likely to be involved as volunteers or affected communities, as well as people living with HIV. Imperatives around community stakeholder autonomy make it clear how essential it is for those considered ‘community stakeholders’ to be broadly representative of the trial community. However, given the varied definitions of what constitutes ‘community’ in the community engagement literature [4,6,9,36], the degree of representativeness of community advisory mechanisms is not always easy to assess from an outsider’s perspective. Even in cases in which individuals are able to clearly identify their communities, they may not be able to easily identify spokespeople for their community [9]. Furthermore, even those people viewed as spokespeople may not be invested with surrogate decision-making status on behalf of community members in all circumstances [9]. In light of the discretionary power of a stakeholder group to support or refuse trial proposals, there exists real potential for a relatively small group of influential individuals in a community to ‘capture’ these decision-making processes if research teams are not sufficiently knowledgeable about local power dynamics and mindful about addressing this risk [49–51]. Accordingly, a central feature of formative research toward establishing successful community engagement in a research program in Kenya involved an extensive survey of all active community-based organizations—with 569 groups identified—serving a high poverty area with 240,000 residents, with the goal of providing ‘balanced and accurate community representation’ [4]. 1558

It is important to acknowledge that external researchers are almost always beholden to someone in the local research context for guidance. GPP guidelines suggest that ‘formative research activities’ can help determine ‘which groups or individuals are relevant stakeholders and why’ (p. 31 [2]), although in a somewhat circular fashion, these formative activities are themselves reliant on ‘community stakeholders’ for assistance in gathering relevant information. In short, while community stakeholders need to be mindful of the extent to which they are seen as trustworthy and accountable to the local community they serve, so too must researchers be aware of the need to ensure balanced representation and the potential for the consultative process to be captured or diverted by community members who do not necessarily represent the best interests of the whole. Expert commentary

Stakeholder engagement remains a priority for funders, researchers, civil society organizations, local community-based organizations and community members involved in HIV vaccine and other biomedical HIV prevention research [52]. The GPP guidelines provide broad, systemic principles that serve as ‘the foundation of the relationships among trial funders, sponsors and implementers and other stakeholders’ in these endeavors (p. 10 [2]). Importantly, UNAIDS/AVAC [2] acknowledges that the GPP guidelines are dynamic and subject to revision based on ongoing empirical investigations. Based on a critical evaluation of some of the key challenges in the implementation of GPP guidelines vis-a`-vis empirical research and clinical trial practices, the authors have identified the following as important areas for further research and evaluation: • Ensuring understanding among community stakeholders and participants of complex trial concepts, particularly in trial locations and populations with lower levels of education and experience with clinical research; • Addressing the multifaceted challenges of historically-based mistrust in local communities; • Exploring how trials can best meet obligations aligned with the principle of ethical integrity, particularly in relation to ancillary care services and post-trial services that enhance standards of care in resource-limited settings; • Ensuring that communication between researchers and trial participants, as well as other community stakeholders, is clear and transparent so that research participation is based on ethically valid informed consent and community leaders are able to explain benefits and risks to their constituents; and, • Balancing the need for training, support, and collaboration with community stakeholders with the importance of maintaining their independence and autonomy within the community. Five-year view

Even with its relatively short history, HIV and its various stakeholders have been agents of change, sometimes agents Expert Rev. Vaccines 13(12), (2014)

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provocateurs, across social, public health and biomedical domains. Among the most significant challenges are substantial systemic shifts in traditional, often hierarchical, relationships – between patients and healthcare providers, community stakeholders and scientific experts, researchers and participants, marginalized communities and the social mainstream, prevention and treatment, social scientists and biomedical scientists, civil society organizations and government policymakers, and high-income and low- and middle-income countries [53,54]. All of these relationship shifts are brought to bear in the domain of emerging biomedical HIV prevention technologies, including HIV vaccine clinical trials. In their focus on community stakeholder engagement, a critical facet of the evolving changes in social relationships in medical research, the authors see the imperative of meaningful stakeholder engagement in biomedical HIV prevention trials as, increasingly, an accepted norm. The primary questions then shift away from a preoccupation with the ifs of stakeholder engagement to the hows. As it has become increasingly evident that we cannot divorce the social and behavioral from the biomedical domains of HIV, whether in clinical trials or post-trial implementation of new products, the authors foresee an escalating focus and interest in applying empirical research to bring our best science to bear on the challenges of stakeholder engagement in biomedical HIV prevention trials. Accordingly, the authors see the next 5 years as bringing increased awareness of the importance and impact of cultural and economic differences between trial sponsor nations and trial sites, as well as such differences within trial locales. In conjunction with an increased research focus, this should lead to greater refinement and specificity of ethical guidance documents for HIV clinical trials, particularly in highlighting tested solutions from international teams on the ground. The authors also expect that community stakeholders will become increasingly more aware of and involved in the research design process, as well as in consultation about ethically challenging decisions that remain somewhat subjective, as more information is made available publicly online, including through open access publications. Various community stakeholders, including marginalized subpopulations as well as civil society organizations, will also be better equipped and empowered to bring their issues of concern to bear through learning from other stakeholders’ experiences globally. At the same time, as a result of successes in the development of more prevention options, the task of engaging community stakeholders and trial participants will be challenged by the increasing complexity and informational needs in implementing HIV prevention trials [55]. Researchers and site staff will need to be able to explain the range of prevention options to community stakeholders and deal with associated ethical issues based in part on what technology is available and licensed in each study site, in addition to addressing uneven access to these technologies across countries and even within the same country. Advancing empirical evidence will also support more effective means of building and assessing trial literacy, as well as ethically informahealthcare.com

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rigorous informed consent, to enhance the ethical conduct of HIV clinical trials. Additionally, a recent trend is for pharmaceutical companies to cut costs in drug research and development by hiring clinical research organizations to manage the process of clinical trials, including recruitment of participants [56]. An investment research firm recently estimated that 33% of all drug development was outsourced in this manner in 2012; that number is expected to rise to 50% by 2022 [56]. In these instances, the responsibility for community stakeholder engagement activities are likely to be transferred to private for-profit organizations, meaning that the ethical obligation to effectively engage with community stakeholders may not be overseen by research ethics boards at academic research institutions. Furthermore, the weight of ethical obligations to provide ancillary services, fair benefits and independent community oversight may be seriously constrained with increasing weight given to the financial bottom line. These developments make it all the more essential that community stakeholder engagement responsibilities, and assessment of their implementation and effectiveness, are clearly elaborated in internationally accepted guidance documents. Finally, the authors expect to see in the next 5 years the increasing meaningful integration of social scientists as independent investigators on HIV vaccine and other biomedical HIV prevention trial teams. This entails being engaged and funded from the protocol development stage onward, as well as operating outside the domain of specific clinical trials, and tasked with examining the crucial social and behavioral factors that affect stakeholder engagement, the success of trial implementation and the impact on community trial sites, thereby adding to the social science evidence base to support future trial implementation. The hard lessons of HIV prevention trial shutdowns and promising prevention products whose efficacy is undercut by unaddressed social and behavioral challenges evoke Jonathan Mann’s pioneering advocacy three decades ago. The crucial need to address HIV as a social as well as a biomedical disease [57] reverberates in the increasing centrality of community stakeholder engagement to the successful implementation of biomedical HIV prevention research. Acknowledgements

The authors wish to thank their research collaborators in India (Venkatesan Chakrapani) and South Africa (Graham Lindegger and Catherine Slack) for helpful insights regarding the content of this article. Financial & competing interests disclosure

This work was supported by Canadian Institutes of Health Research (THA-118570). PA Newman is also supported by the Canada Foundation for Innovation and the Canada Research Chairs Program. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript. 1559

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Key issues • Ethical guidelines for stakeholder engagement in clinical HIV prevention trials emphasize the importance of respect, mutual understanding, integrity, transparency, accountability and community stakeholder autonomy. • Social and behavioral science research suggests broad and pervasive challenges to community stakeholder engagement, including: – bringing together diverse perspectives and experiences between researchers and community members; – ensuring a common understanding of the research design, implementation and analysis process; – addressing mistrust between local communities and medical researchers based on personal experience and historical discrimination; and, – developing a shared understanding and agreement about what health services will be provided to participants during and after a trial. • Social science research can provide clinical researchers with insights into the multifaceted ethical and practical implications of conducting trials in various locales and with diverse community stakeholders. • Trial research teams need to be fully aware of the broad array of community engagement challenges so that they do not begin

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implementing a clinical trial without adequately considering how to address common stakeholder concerns.

pre-exposure prophylaxis trial site, 2009. Available from: www.global-campaign.org/ clientfiles/Cameroon.pdf [Last accessed 29 July 2014]

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Expert Rev. Vaccines 13(12), (2014)

Advancing community stakeholder engagement in biomedical HIV prevention trials

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Expert Rev. Vaccines 13(12), (2014)

Advancing community stakeholder engagement in biomedical HIV prevention trials: principles, practices and evidence.

Community stakeholder engagement is foundational to fair and ethically conducted biomedical HIV prevention trials. Concerns regarding the ethical enga...
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