Study Participation Information

Community Participation

A key factor of the overall HPTN strategy is the commitment to community participation at all levels of research. Directed by Federal guidelines, the HPTN has committed to community participation and collaboration as a key component in the HPTN's goal of effective public health research. As a result, a partnership of people who are affected and infected by the HIV epidemic will have input into the ideas that are developed, how the studies are designed, and the implementation of the actual research.

To ensure movement toward this goal, community participation must be facilitated to occur within the HPTN Coordinating and Operations Center (CORE), at the clinical research sites (CRS) and within the communities where the research is to be implemented. A system of information sharing and resources helps ensure information is exchanged between these various levels.

HPTN Commitment to Community Participation

The HPTN's commitment to community participation is based on study results that show research produces outcomes that are more likely to be integrated into communities when the community is involved throughout the research process.

Understanding what is expected in the community participation process is important. The HPTN established its community program based on guidelines given by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH) .  The mandate for community participation in the HPTN was also outlined in the original request for the HPTN proposal in 1999; the NIH Request for Application (RFA) for the HPTN stated that applicants must "… ensure community input into the research process and to foster a partnership between researchers and the community, particularly the population served by the individual unit and/or research study."

The HPTN is committed to:

  • Conducting ethical research of the highest scientific quality that is supported and informed by local community input

  • Supporting local community education and building community partnerships at HPTN CRS, including the provision of regular and ongoing scientific updates

  • Supporting activities and infrastructure to build and sustain the community-research partnership

  • Developing leadership, through the CWG, to advise the HPTN on crosscutting community issues

  • Providing technical assistance and support to HPTN and CRS community activities through CORE (FHI) Community Program staff

  • Ensuring community consultation and input into the research agenda, beginning with concept and protocol development through the dissemination of study results

  • Responding to concerns and misconceptions arising from study participants and communities, as needed

Community participation in decision-making ensures that research participants and the community feel ownership of the research and have an interest in its success. Collaborations and partnerships encourage trust and mutual understanding of research issues and implications. Additionally, the prevention research developed will be based on respect for cultural and ethnic differences among participants. "Where there is community participation in research, human capacity is built, with the ultimate results being self-determination, self-reliance, and a high self-esteem." (Janet Frohlich, HPTN CWG Co-Chair)

Community representatives should be involved in an early and sustained manner in the design, development, implementation and distribution of research results "…in order to ensure the ethical and scientific quality of the proposed research, its relevance to the affected community, and its acceptance by the affected community." (UNAIDS)

Community and Site-based Participation

Local community advisory processes in the HPTN incorporate some common elements and must work together to create a solid working relationship that invites community participation. Site staff work to support the process locally to ensure these elements are in place.

  • Clinical trials of HIV prevention interventions are most likely to succeed when all the parties concerned - researchers, government, manufacturers, and community - regard the trials as a collaborative process. Community members, particularly potential trial volunteers and people from the populations from which volunteers will be recruited, can and should play an integral role in advising on research trials.
  • Sustained relationships and communication with community members are the responsibility of the Principal Investigator (PI) at each site. Site Community Education (CE) staff facilitate the site's community commitment by facilitating the development of a written community involvement work plan (CIWP) to actively engage community members. The community involvement work plan guidance document and a sample CIWP are available in the Community Involvement Tool Box.
  • The CRS must identify ways to foster trust, to ensure respect of social, cultural, and political realities of the communities where recruitment will take place.  The CRS must also maximize opportunities for dialogue about the implementation of research trials. This involvement and participation of community members will be supported as an integral part of the CRS operation plan.
  • Community members need to be involved in early discussions about prevention research priorities. Community input is important to a variety of issues including: research design; informed consent procedures; risk-reduction interventions; community education and outreach; and recruitment and retention planning and implementation.
  • A community advisory mechanism should be established at each of the HPTN sites. The most common way to do this has been to create a Community Advisory Board (CAB). Each site's advisory structure may vary based on local needs and direction.

Network-Based Participation

Creating a network that integrates community perspective requires participation in the leadership bodies of the HPTN. The strategy employed is two-fold:

  • Create a self-governing working group to assess and advocate for community issues in the HPTN.

  • Ensure that community representatives are active partners in the decision-making committees within the HPTN.

The HPTN CORE established a Community Working Group (CWG) that meets on a regular basis. Representatives from each CRS participate in conference calls and meetings. The CWG meets to identify cross-cutting issues for the site communities, advocate for resolution of community issues within the HPTN, identify training needs, and facilitate information exchange.

The HPTN CORE is responsible for outlining steps to develop, maintain, support, and encourage the full participation of community representatives in all phases of the research process. This includes plans for community education, training, recruitment, ongoing orientation, and participation on protocol teams and governance committees.

 

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

  • 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.

  • 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:

  • Receive culturally appropriate study information.
  • Be given the opportunity to offer their opinions on the research.
  • Make decisions about research issues affecting them.
  • Have an impact on the research process.
  • 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:

  • 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).
  • 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).
  • Site CAB with both direct and indirect stakeholders.
  • Site CAB with direct stakeholders only.
  • Coordinating CAB advising on multiple studies with formalized system of communication with issue-focused stakeholder groups (sub-CABs).