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Community
Participation
Community
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Regional
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Involvement Toolbox CORE CIP
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Community Participation
A key factor of the overall HIV Prevention Trials
Network (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 Network'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 CORE, at the sites
where research is to be implemented, and within the research communities. A
system of information sharing and resources helps ensure information is
exchanged between these levels of the Network. Information on these community
web pages provide information and guidance for site staff and the community
partners about community participation in the Network as well as how to develop
and sustain it in the HIV prevention research conducted at the sites.
HPTN Commitment
The HPTN's commitment to community participation in research is based on the
positive findings of research initiatives in the past that showed the research
produces outcomes that are more likely to be integrated into communities and
there is mutual benefit to the communities and the researchers when community is
involved in the process.
Understanding what is expected in the community
participation process is important. The Network proceeded with its community
program based on guidelines given to us by the Division of AIDS (DAIDS), US
National Institutes of Health (NIH), and was initiated during the HIVNET trials.
The mandate for community participation in the Network was also outlined in the
original request for the Network 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."
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 the research issues and
implications. An additional benefit to the collaborative effort is that 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 results of HIV vaccine research "…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)
HPTN Guidance
The HPTN provides guidance and resources to
Network participants to provide an outline for both community advisory board
members and site staff on what could and should be taking place to encourage
collaborative and participatory decision-making and educational activities. In
order to do this, some expectations need to be understood.
- At the community level, members of the
community need to know they can safely share their experiences and ideas
about what aspects of proposed research will and will not work in their
communities.
- At the site level, HPTUs must invest
appropriate resources in planning for and implementation of activities that
develop and sustain community participation at each stage and all levels of
the HPTN trials process while responding to community questions and concerns
in a timely fashion.
- At the Network level, there must
be willingness to respond to identified needs and concerns regarding
community involvement and decisions while facilitating the flow of this
information to all levels.
Additional guidance from the HPTN CORE in the
form of a document was provided for HPTN Year One activities to further clarify
the HPTN's commitment to a strong community involvement program.
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 at
each site. Site Community Education staff help with the site's community
commitment by facilitating the development of a written plan to actively
engage community participation.
- The site must identify ways to foster trust,
to ensure respect of social, cultural, and political realities of the
communities where recruitment will take place, and to 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 site operation plan.
- Community members need to be involved in early
discussions about prevention research priorities, particularly when the
research is in the design phase of the protocol development process.
Community input is important to a variety of issues including: research
design such as cohort selection criteria, questionnaire design, and
follow-up plans; informed consent procedures; risk-reduction interventions;
community education and outreach; and recruitment and retention planning and
implementation.
- A community advisory mechanism has been
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 Network, and for community representatives to be active partners in the
decision-making committees within the Network.
The HPTN CORE established a Community Working
Group (CWG) that meets on a regular
basis. Members from each research site will participate in conference calls and
be ensured representation at an annual retreat. The CWG meets to identify
cross-cutting issues for the site communities, advocate for resolution of
community issues within the Network, identify training needs, and facilitate
information exchange. Community representatives from the three Regional Working
Groups (RWGs) are on the CWG
where they exchange information and discuss issues from the sites.
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 facilitate
access to participation on science direction working groups and network
governance committees.
Science
Working Groups (SWGs)
Science Working Groups (SWGs) are where concepts for HIV prevention research in
the Network are developed. Two community representatives are on each of the
science working groups, one representative from a United States site and the
other from an international site. By having community representatives in each of
the SWGs, community perspectives are represented at the start of a research
topic before it becomes a protocol. Find more about the SWGs, including who is
representing the community on each of the groups, by going to the SWG page.
Protocol Teams
Protocol teams are where individual research concepts are developed into
protocols. The team has representation from each site that is interested in the
research concept in order to address site-specific research issues while the
protocol is developed and implemented. The CORE has advised that each site
involved in the protocol needs to include a community representative to
facilitate information exchange with the protocol team and the site's community
advisory members. A guidance document was issued in 2000 called "Community
Participation in Protocol Teams" that outlines the Network expectations of
including community perspectives on protocol teams.
Ethics
Working Group
Many of the issues associated with community involvement in HIV prevention
research are based in ethical questions. Two community representatives from the
CWG, one U.S. and one international, participate in the Ethics Working Group to
build a stronger connection between community efforts at the sites, as well as
CWG and Network efforts concerning ethics.
Network
Committees
To ensure a scientifically relevant research agenda that meets accepted ethical
considerations and community standards the Network has established oversight
committees. Community representatives (one International and one U.S.) have been
included in the following committees:
- Protocol
Review Committee (PRC) - reviews protocols before they go to the NIH for
approval and offers suggestions and comments to the team to help with the
final review.
- Network
Evaluation Committee (NEC) - responsible for the development and annual
review of Network measures to assess how well the Network is functioning and
meeting goals and objectives.
- Executive
Committee (EC) - responsible for leading and governing the Network
including setting research agenda, managing the budget, and addressing
issues of concern. The two community representatives on the EC are members
from the Community Working Group.
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