Clinical Research Site Community Activities & Research
Community involvement at the site level has a common purpose throughout the HPTN, yet there is tremendous diversity in how CRS guarantee community participation. Although CRS may be working on common protocols, the partnership with the community at each CRS may be very different.
Sharing information about what communities and CRSes are doing is an important way to support innovative and productive community participation throughout the HPTN.
The key to successful community participation is the development and implementation of community education activities and establishment of a community advisory process. Each site in the HPTN is required to develop a community involvement work plan (CIWP) and is given the authority to create an advisory process appropriate to the research topic and communities where the research will be conducted.
Community Involvement
Including community members at all stages and levels of the research process helps build trust and mutual understanding. This ensures values and cultural differences among participants are respected. Creating and supporting a community advisory process with an established structure and methods of governance is the foundation for creating a solid, collaborative relationship between the community and the CRS.
Stakeholders are important to developing community involvement and engagement plans. Stakeholders are people or organizations affected by the outcome of a proposed action, intervention, or research effort in their community. Stakeholders are also individuals who can affect the outcome the proposed activities.
Stakeholders may be directly impacted by the action or may only have indirect interests related to what happens to those directly affected. The distinction between both a "direct stakeholder" and an "indirect stakeholder" becomes very important when community input is needed about a potential research effort
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Direct Stakeholders: Individuals or groups immediately affected by a research effort and who stand to personally benefit or lose from the research in their communities. Usually the direct stakeholders will be the target population of the study itself. Marginalized and stigmatized community members are often among this group, and are often perceived as the most difficult to identify and involve in participatory efforts.
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Indirect Stakeholders: Individuals, groups, or organizations that are removed from the immediate involvement of the HIV prevention research efforts, but may be linked in some way to those who are directly affected. Such stakeholders may include Non-Governmental Organizations (NGOs), intermediary organizations, private sector businesses, political organizations, family members of direct stakeholders, employers of direct stakeholders, and the general community affected by the issues and concerns of direct stakeholders.
When developing a community advisory process, a CRS must establish and maintain a process for affected communities to:
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Receive culturally appropriate study information.
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Be given the opportunity to offer their opinions on the research.
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Make decisions about research issues affecting them.
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Have an impact on the research process.
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Have autonomy regarding their involvement in the research.
Advisory Structures
In HIV research the advisory process has traditionally been ensured through the creation of a Community Advisory Board (CAB). Respect for social and cultural structures of local communities has lead to the need for some CRS to develop alternative advisory structures to guarantee direct stakeholder input. Alternative advisory structures to CABs require innovative methods for gathering input from the community so that opinions can be exchanged.
Community advisory structures are established through different methods depending on varying factors at the CRS. Examples of community advisory structures include:
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Site-coordinated process that supports communication with direct stakeholders and community members through regular processes without an advisory group (for example, conducting focus groups, coordinate a community meeting, conducting street outreach surveys, working with existing support groups).
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CAB made up of indirect stakeholders and a system of regular communication with direct stakeholder communities (for example, conducting focus groups, conducting street outreach surveys, working with existing support groups).
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Site CAB with both direct and indirect stakeholders.
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Site CAB with direct stakeholders only.
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Coordinating CAB advising on multiple studies with formalized system of communication with issue-focused stakeholder groups (sub-CABs).
