General

  1. What is community engagement?

  2. What is a community educator?

  3. What is community education?

  4. What are the roles and responsibilities of investigators and study staff in community engagement?

  5. What are some examples of how the community can be involved in the research?

  6. What is the difference between community education and recruitment?

  7. What should a community expect by participating in a research project?

 

Terminology

  1. What does "community" mean?

  2. What is "informed consent?"

  3. What are "community advisory" functions?

  4. What is a Community Advisory Board?

  5. What is the Community Involvement Work Plan (CIWP)?

  6. At what point should the study community get involved?

 

HPTN-Specific

  1. Why is community participation critical to the HPTN research ethics discussion?

  2. Must every HPTN site have a CAB?

  3. What measures have been established for community involvement in the HPTN?

  4. What is meant by "community participation" or "community involvement" in the HPTN?

  5. How is "community" defined in the context of research and the HPTN?

 

 

1. Community engagement focuses on the development and/or maintenance of partnerships and quality relationships with various stakeholders. Community engagement works to cultivate trust and engage stakeholders in a shared vision that is mutually beneficial to all parties

 

2. Community educators have diverse roles and responsibilities depending upon their CRS affiliation. Some of the responsibilities community educators have include:

  • Raising the level of awareness about HIV prevention research in the community 
  • Engaging communities in ongoing dialogue about the research conducted by the site 
  • Building positive working relationships with other organizations involved in HIV/AIDS related activities

 

3. Community education involves mobilization, sensitization, and engagement of communities into which HPTN research will be introduced. This includes facilitation of awareness of HPTN research among local and national opinion leaders to build trust, acceptance, and willingness to participate. Educational priorities, strategies and messages must be tailored to and determined with input by the target communities and based on needs identified by the community. Community education is effective only when there is ownership over the problem and involvement in the action taken to address it.

 

4. The primary role is to develop a true partnership between the research project and the community in all aspects of research design, implementation, and dissemination. Research staff is responsible for ensuring sustained two-way communication and information exchange between community members and themselves.

 

5. Some examples include:

  • Project goals and objectives
  • Needs assessment of community education needs
  • Identification of target audience
  • Selection of interventions / channels of communication
  • Implementation schedule
  • Evaluation indicators

 

6. Community education and recruitment are complementary activities. Effective community education increases community understanding of HIV prevention research. Recruitment refers to engaging community members with the purpose of enrollment into the research study. Community education helps to lay the foundation for recruitment and ongoing dialogue between community members and research.

 

7. Expectations about participation can vary between communities and research projects, but there are some basic things that can be expected:

  • To be treated with respect and dignity
  • That an official method is available for community members to receive information about the study, provide information about needs and concerns of the community to the study staff, and to have meaningful impact on decisions that affect the community
  • Full disclosure of the study concepts, impact, methods of implementation, responsibilities to the community after the research study is completed that is described in an appropriate and understandable way 
  • Possible harm from participation is prevented as fully as possible.
  • Referral to care and compensation if harm does occur

 

8. Community can be described in many different ways. One definition is: One or many groups of people who share common identity on the basis of location, ethnicity, occupation, sexual orientation / behavior, or common interest or activity.

 

9. Informed consent refers to the process of ensuring that individual study participants fully understand the purpose, facts, risks, and benefits of the research before deciding to participate. Informed consent is an on-going process that ends when the participant leaves the study.

 

10. This refers to the ways that a community provides and receives information while working with the HIV prevention activities in the HPTN. The HPTN recognizes that the level of community input affects the quality of final research results. In order to support community participation, methods to receive advice from the community on all aspects of the research and its impact on the community need to be established and maintained. These systems of information exchange make up the community advisory functions.

 

11. Community advisory boards (CABs) serve as a voice for the community and local study participants. CABs provide input into study design and local study procedures. CABs work to ensure that research strategies acknowledge and respect the values and cultural/ethnic differences among participants. Members of a CAB vary according to locale and situation. Membership may include community members who share characteristics of study participants (or study participants themselves), representatives of local agencies working with HIV-related services or programs, religious or community leaders, and professionals with relevant research and/or scientific expertise.

 

12. The community involvement work plan describes the CRS’s community education program planning cycle. Each CIWP should include:

  • Project goals and objectives
  • Needs assessment of community education needs
  • Identification of target audience
  • Selection of interventions / channels of communication
  • Implementation schedule
  • Evaluation indicators

 

13. Ideally the community should be involved at the very beginning of the planning of the research. The priority placed on a specific HIV prevention project by the community may be very different than the partnering research team. A joint partnership based on trust and shared experiences established early in the research process will make for better results for both the community and the research team.

 

14. The HPTN EWG focuses on the conduct of clinical trials ensuring participants’ human rights are protected. Community members are best able to provide insights about particular conditions that might increase the vulnerability of trial participants, as well as identify factors that might be considered coercive to participation.

 

15. The HPTN encourages each CRS to have a community advisory structure. The HPTN recognizes that the partnerships between a community and a research project can develop in many different ways over time. As a result, the ways a research project receives guidance from the community and shares information about research activities can happen in different ways as well.

 

16.

  • Representation in governance and key scientific committees
  • Mandate/support for community programs at each CRS
  • Representation on protocol development and review teams

 

17. Community participation or involvement in the HPTN refers to ensuring community input in the research process (e.g. conceptualization, design, implementation and dissemination). The HPTN has developed a system that ensures community representatives can express opinions and concerns that may influence the research.

 

18. For the purposes of HPTN research, a community is the group of people who will participate in, are likely to be affected by or have an influence on the conduct of the research.