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.
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.