Ellen, Jonathan M MD*; Wallace, Melissa BSoc, Sci(Hons), MSc, PhD†; Sawe, Fredrick K MBChB, MMED‡; Fisher, Kevin JD, MS§
As the HIV prevention community continues to pursue the discovery of effective biomedical strategies for preventing the acquisition and transmission of HIV, there has been a growing awareness of the importance of engaging communities in the development, testing, and eventual dissemination of these biomedical strategies. In the past, there was a tension between the desire of the basic and clinical scientist to pursue biomedical solutions to the HIV epidemic without interference from the lay community and a strong consumer advocacy best seen in the efforts of ACT-UP in the early days of the epidemic. This tension seems to be relaxing and there seems to be a growing acceptance of the need for early and on-going collaboration between scientists and communities in the development of biomedical HIV prevention clinical trials. This article is a discussion of the value and challenges of community engagement in the development of biomedical HIV prevention clinical trials with a particular focus on adolescents.
Mistrust of Researchers
There is a long history of mistrust of scientific researchers in communities in both developing and developed countries.1 Past experiences have created and reinforced this mistrust (eg, the Tuskegee syphilis study) within communities. Past research in Africa has seen researchers collecting data from people in impoverished communities without providing anything in return.2 This has led to increased vigilance in communities regarding access and the need to engage in consultation with local community and political structures to gain access.3 Power imbalances and cultural differences can be magnified in a developing country research context,3 and this imbalance may be even further enhanced when research participants are adolescents, a frequently disempowered group. As a group perceived as vulnerable, they are even more likely to be protected by the community, with access even further limited, making the need for careful community engagement even more pertinent.
Definition of Community and Community Engagement
A number of definitions of the word “community” exist in the context of clinical research, which is no doubt reflective of the fact that researchers find it increasingly difficult to define the limitations of who should be consulted to satisfy expectations of community involvement.4 Good Participatory Practice (GPP) defines community as “separate and overlapping groups of people who are infected and affected by HIV in various ways suggesting a shared identity for members of the same community.5” The National Institutes of Health-sponsored HIV/AIDS Clinical Trials Networks have long recognized the importance of community engagement. The HIV Vaccine Trials Network has defined it as the group of people who will participate in, are likely to be affected by, or have an influence on the conduct of research. Others have provided a far more comprehensive definition of community in relation to research6 asserting that features of a community include common culture and traditions; cannon of knowledge and history; comprehensiveness of culture; health-related common culture; legitimate political authority; representative group/individuals; mechanism for priority setting in health care; geographic localization; common economy/shared resources; communication; and self identification as community.
The term community engagement is also open to many interpretations. Tindana et al7 defines community engagement as “the process of working collaboratively with relevant partners who share common goals and interests.” Essentially, this involves “building authentic partnerships, including mutual respect and active inclusive participation; power sharing and equity; mutual benefit or finding the ‘win-win’ possibility” in the collaboration.8 Several key goals have been identified by different researchers, a number of which overlap. These include enhancing protection of the community and ensuring that community disruption is diminished; enhancing benefits to and avoiding exploitation of the community; creating legitimacy; and sharing responsibility.1,9 The Global Campaign for Microbicides has developed a multilevel framework to assist in defining the levels of community and stakeholder engagement in clinical trial research and the kinds of activities that might occur at each level. The personal level includes study participants and staff; the local level includes those individuals living in the area of the trial, local leaders, nongovernmental organizations representing them, and local community advisory boards (CABs); the national stakeholders include those involved in political, social, and scientific enterprise in relation to the product being studied and includes political decision makers, regulatory bodies, research ethics committees, donors, and funders. The type of engagement that occurs at each of these levels may be very different.
History of Community Engagement
Community engagement in HIV research has origins in the beginning of the epidemic. In the early days of research into new HIV treatments, activists pushed for the development of a community role. This movement led to the emergence of CABs representing diverse voices in the communities where research was taking place. This model became a global practice of community input and a requirement of US and European funders, as CABs were instituted in domestic and international HIV research sites. Initially, CABs were seen to exist mainly for the facilitation of research with a much smaller role in community engagement, but more recently, this approach has been met with criticism, and the view of the role of CABs has subsequently broadened to additionally include the promotion of community empowerment and greater shared decision making.10
Community engagement has since built upon the initial important work of CABs. Increasingly, researchers, funders, and implementers see the value in engaging the larger community. After United Nations AIDS guidelines in 2000, trials of HIV vaccine candidates and other HIV prevention options widely adopted a community engagement approach entitled GPP.5 The experience of a number of HIV prevention trials provided examples of community engagement that supports clinical trials development and later implementation. “Effective community engagement during the entire life cycle of a biomedical HIV prevention trial, and beyond, through genuine, transparent, meaningful participatory processes enhances both the quality and outcome of research.5” GPP is designed to provide guidance on the roles and responsibilities of trial sponsors and trial implementers toward participants and their communities. Community engagement is seen to have broader aims that include improvement of the ethical and scientific integrity of trials; increased transparency and accountability of the research to the community; the increase of benefits and decrease of risks for participants and the surrounding community; and the improvement of local capacity and infrastructure.
Benefits and Challenges of Community Engagement for Adolescent Biomedical HIV Prevention Trials
Although there are multiple benefits to community engagement on prevention trials mentioned throughout this article, two benefits merit discussion. First, community engagement in the early stages of the development of a biomedical prevention strategy would help scientists prioritize approaches that have a greater likelihood of facilitating acceptance and use by community members in the event that the strategy proves efficacious. That is, community engagement can increase both effectiveness and dissemination of new strategies.
A second benefit of community engagement is that it might improve participation in trials through community support and community referrals. The importance of community participation in adolescent trials becomes even more critical. Faced with the decision about whether to allow their child's participation in a clinical trial, parents are likely to look to members of their community that they trust. Another important aspect is explaining to stakeholders and communities at what stage they would be participating in the clinical trials: phase I, II, or III.11 Until the parents understand what their children are getting into, it is unlikely that they will support inclusion of adolescents in HIV prevention clinical trials.
Amidst the many benefits of engaging the community, there are some noteworthy challenges; there seems to be reluctance of some communities to acknowledge that their adolescents are having sex. Furthermore, there is sometimes the misguided belief that addressing adolescents sexual activities to make them safer will also make them more common. Risk compensation and disinhibition are other issues that need to be addressed before and after the clinical trials have started and are the focus of another review in this issue.12,13
Community engagement can also help scientists with the issue of informed consent by adolescent participants. Though not the focus of this review, it is important to note that community engagement can assist in the development of youth-specific materials and innovative strategies for imparting information to youth.12 Further research is needed on how best to present trial concepts to this age group.
Process of Community Engagement
All the stakeholders in the community, including peer leaders, gate keepers, opinion leaders, parents, religious leaders, youth groups, education officials, and politicians, should be engaged in the discussions and process. Community engagement that facilitates the participation of adolescents in HIV prevention trials can be best achieved through utilization of existing community infrastructure grounded in the larger community. Therefore, it is ideal that adolescent HIV prevention trials wrap around or scale up existing community HIV services, especially combination prevention interventions that have been shown to be most efficacious. The combination prevention interventions should be adapted to local situations and implemented on a scale that can make an impact in the community. These HIV prevention programs include for example comprehensive sex education, abstinence and “be faithful” programs, condom use, treatment of sexually transmitted diseases, male circumcision, and HIV counseling and testing that have been shown to work elsewhere.14-17 Various modes of communications can be used, including existing community structures, social gatherings, public forums, mass media, internet, and cell phones. HIV prevention activities can be further augmented by developing special youth friendly HIV prevention programs (that are largely managed and run as much as possible by the youth). These prevention programs can include other sexual and reproductive health services.
Connect to Protect®: An Example of Community Engagement
The urgency to find new prevention methods to target the HIV epidemic often means that community preparation and engagement receives insufficient funding and consideration. However, future clinical trials should be seen as an opportunity to test not only new biomedical interventions but to develop best practices for community engagement in clinical trials. One example of the investment by the US National Institutes of Health in community engagement science for biomedical prevention trials is Connect to Protect® (C2P).
Connect to Protect®
Partnerships for Youth Prevention Interventions is a multisite multiphase project developed by the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN), which is sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development.18 The overall goal of the project is to ultimately reduce HIV incidence and prevalence in youth 12-24 years old through a community mobilization intervention. Phase I (ATN 016a), now completed, consisted of the following: generating a youth HIV/AIDS epidemiological profile for each urban area in which an ATN/C2P site is located (Fig. 1); using the profiles to determine, within each city, high-risk geographic areas and a youth subpopulation on which to focus C2P efforts;19 and creating official partnerships with community-based organizations and agencies that can reach the designated youth “population of focus” and are located within or serve the identified high-risk geographic areas. Phase II (ATN 016b), also completed at some ATN/C2P sites, advances the project by describing the specific locations or venues within each city where the population of focus congregates. As an integral part of the process, HIV risk behaviors, social networking patterns, and HIV prevalence among 12-year to 24-year olds at these venues are being assessed. At a series of local meetings, staff from each ATN/C2P site and their Official Community Partners established in phase I are sharing input on venues, how to reach the population of focus, and other relevant topics. The objective of phase III, currently ongoing, is to initiate and complete a community mobilization intervention aimed at ultimately reducing HIV incidence and prevalence among youth. The intervention consists of guiding C2P coalitions through a strategic planning process that results in the development and implementation of a local action plan. The action plans focus on changing structural elements (eg, policies and practices of institutions and programs) of the affected communities that are believed to be associated with youth HIV acquisition and transmission.20 For assessing the overall efficacy of the community mobilization intervention, data are being collected and analyzed from ATN/C2P site staff, in the form of systematic documentation of the community mobilization process and accomplishments (eg, structural change achieved); and annual community assessment of risk and HIV prevalence in a subset of sites.
The South African Studies on HIV in Adolescents Project
Recently, the South African adolescent research community has begun to engage communities in preparation for HIV vaccine trials. The South African Studies on HIV in Adolescents project is a multisite national project funded by the European and Developing Countries Clinical Trials Partnership seeking to prepare for the running of HIV vaccine trials in adolescents. The project aims to identify and address obstacles to the conduct of such trials, and build site capacity for this purpose. It includes a study that is emulating an HIV vaccine trial, through the use of the licensed HPV vaccine, Gardasil (donated by Merck, Whitehouse Station, NJ), as a surrogate for an experimental HIV vaccine. One thousand four hundred adolescents will be enrolled across 7 sites and invited to decide along with parental/guardian consent, whether or not they would like to receive the vaccine. Both groups will be followed for a 9-month period and attend for 5 study visits. This study enables the exploration of a number of key ethicolegal and sociobehavioral questions, although building staff and site capacity to conduct trials with adolescents.
Importantly, the project includes a significant focus on community engagement. This has taken a multipronged comprehensive approach. Initial contact was made with key community gatekeepers including local education departments, health facilities, and other community leaders to inform them of the project and garner support. This step was vital in securing contact with local schools where information could be shared directly with adolescent students and teachers. Discussions often led to debate, and it was clear that adolescents were engaged on this topic.
It was also essential to engage and build trust within the parents of adolescents in the community. Stakeholders, parents, and adolescents were invited to participate in focus groups to explore community attitudes toward adolescents participating in adolescent HIV vaccine trials, barriers, and motivations for participation, and South African laws impacting on participation. Thus, findings from multisite focus groups will assist in informing the development and design of future prevention trials for adolescents, although participation in the study enabled relevant community members to increase their awareness, understanding of, and interest in adolescent HIV vaccine trials.
Before enrollment in the HPV vaccine study, vaccine discussion groups were held with both parents and adolescents to provide comprehensive information on the study. Parents and adolescents were provided with information as one group and then separated to provide the opportunity for questions and concerns to be raised independently.
In conjunction with consultation with local communities, simultaneous development of adolescent CABs took place. At each site, adolescents were recruited from local schools and youth centers and invited to participate in a CAB. The aim of the CABs is to form a link between the researchers and the local adolescent community, providing a structured mechanism for consultation between the two. CAB members are provided with education on HIV research and vaccine trials that they disseminate to peers, and in turn they have provided researchers with invaluable feedback on adolescent behavior and attitudes.
Study sites have also developed capacity to provide sexual health services to adolescents taking part in the study and others who may wish to utilize the service. Care has been taken that such services are sensitive to adolescent needs and concerns in terms of confidentiality, approachable nonjudgmental staff, and appropriate and relevant information. Services offered include HIV voluntary counseling and testing, pregnancy and sexually transmitted infection testing, information and advice, referral for termination, circumcision, and other required services.
In addition, sites have conducted community mapping to identify and make contact with key providers of other adolescent services, including health and psychosocial support, educational, recreational, and leisure, and skills development, community, and careers services for adolescents. Where appropriate, adolescents will be referred to these services, thus creating a community framework of support for adolescents and awareness of the project.
Communities need to be engaged and educated far in advance on the importance, need, and limitations of current available comprehensive HIV prevention, care, and research services for adolescents. Participation of adolescents in HIV biomedical prevention trials should be presented to the community as a continuum of the overall package addressing the problem of HIV in the community and the need to improve on them. All the various reasons (social, cultural, biological, behavioral, legal, and economic issues) that have been articulated elsewhere in this special review issue need to be explained to the wider communities in which trials are to be conducted in a manner that the community would be able to understand the challenges and want to do something about them. It is critical to have community support and buy-in of the HIV services being provided in general to adolescents and in particular involving adolescent HIV prevention research; otherwise, it will be very difficult to recruit and enroll adolescents in HIV prevention trials. Clinical trials can no longer simply provide information. Trials need to be anchored in the community and permit community monitoring. HIV prevention trials can be viewed as a continuum from the “conceptual (identification of a public health need and potential responses) to the experimental (development and implementation of research designs) to the applied (translation of research result into programs),8,10” and the community should be engaged throughout.
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