1. New Prevention Technologies Workshop Module 4: Who’s Who
New Prevention Technologies Workshop
Module 4:
Who’s Who

2. Overview of Role of Various Players

3. Who? Ethical Research Ethics Committees and Review Boards
Community and Advocates
Researchers and Sponsors
Ethical Research

4. Who are the Players in HIV NPT Research?
Academic researchers and universities
Community members and organizations, community advisory boards
Private sector – pharmaceutical and biotech companies
Government funders and regulators
Health care providers

5. Academic Researchers Basic Researchers
lead the scientific discovery and development of NPT candidate concepts and products
Clinical Researchers
lead the clinical testing of candidate NPT products, testing efficacy as well as issues of acceptance and accessibility
establish and maintain the highest standards of ethical conduct of clinical trials
Social Researchers
conduct research on acceptability, preparedness, access and delivery issues
work alongside clinical research to understand usability and acceptance of NPTs

6. Community Roles develop community acceptance and preparedness for NPTs
raise awareness about the role community based organizations can play before, during and after trials
facilitate clinical trial recruitment
incorporate NPTs into prevention education and training programs for specific vulnerable populations
develop strategies for promoting and distributing NPTs once available
advocate for investment in NPT research and development

7. Private Sector
invest in research and development, manufacturing and production
technical innovation
establish clinical infrastructure (e.g., epidemiological laboratories, trials infrastructure) during the pre-clinical development of the NPT that will be needed in clinical research
translational research: generate data, clinical materials

8. Government Funders and Regulators
provide funding for NPT research programs, academic researchers, conferences
coordinate domestic and global efforts
ensure that adequate clinical research facilities exist
ensure availability of properly trained staff
help build public awareness and support for research and development
achieve speedy and appropriate access once a NPT becomes available

9. Health Care Providers
monitoring, prevention and control of HIV/AIDS and STIs
help with NPT delivery, education and access
With ARV-based NPTs, may need to be prescribers

10. Community engagement

11. Locating Community
When we talk about community, it is important to frame the discussion in terms of:
Who is included in the particular “community” we are discussing?
And distinguish which “level” we are referring to

13. “Trial Participants & Study Staff”
refers to the individuals directly participating in the trial, in some instances their partner(s), and study staff working at the trial site.

14. “Host Community”
refers to the individuals living in the area of the trial, their leaders, and community-based organizations that serve or represent them directly. This can also include traditional healers, local radio, and other community structures (including CABs)

15. “National Stakeholders”
describes anyone who has a role to play in the political, scientific, and social enterprise of microbicide development in the larger, national community.
It includes political decision-makers, MoH, regulatory bodies, ethical review committees, national NGOs, donors, national media, etc.

16. “International Civil Society”
refers to non-profit, organized, citizen-led movements or groups interested in the goals, process, and outcomes of microbicide research, and/or in the rights of communities or research participants. Civil society includes international or regional NGOs (GCM/UNAIDS), international or media.

17. Community Involvement Strategies
Community advisory structures (CABs, CAGs, CACs, participant representatives)
Community preparedness
Community mappings
Radio & local media
Dramas and community events
Network community working groups
Cross-network community involvement
Researchers are using a lot of creative strategies to try to achieve meaningful community involvement.

18. Community Advisory Groups
Also Community Advisory Boards (CABs)
CAGs are now required by many research sponsors and trial networks
A CAG is a group of volunteers from the general public and from the diverse communities affected by a condition like HIV/AIDS
A CAG is organized to assist and advise researchers within a given network or site

19. This is an example of a community mapping exercise done by women in Mwanza, Tanzania before a trial starts

20. Why is so much blood taken?
What do you do with the left over blood?
Are the needles safe/clean?
MDP Mwanza example of how they dealt with community rumors/concerns about taking blood as part of the trial…
The trial personnel invited community members to visit the laboratory / clinic to understand exactly what is done with the blood samples.

21. Authentic Community Involvement
Evolution of Norms for Community Involvement in Research
Partnership and Mobilization
Research implementation exists alongside specific process goals that strengthen the role and capacity of community to articulate and address its own development needs including future research priorities.
Advisory
Community representatives provide input into specific areas of the study as requested by the research team
Collaborative
Community representatives and research team cooperate in developing and implementing the research
Historical
No involvement of community except as pool from which to draw research participants
This vision looks at community involvement in research not as an outcome but a process, leading to increasingly shared influence over how research is conceptualized, implemented, and applied in affected communities and wider society.
Community involvement in research has both instrumentalist and philosophical goals: it enhances the quality and effectiveness of the research, it seeks to create cooperation and mutual trust in an atmosphere of possible controversy, and it empowers affected communities to influence their own pathways toward improved health, quality of life, and social justice. When we speak of community involvement as a desirable goal, we mean that we want to create an authentic partnership between researchers and research institutions and communities and civil society. An authentic partnership is one in which:
Partners share a common vision, sense of purpose, and are committed to collaborating to meet a mutually beneficial set of goals
Partners are committed to joint decision-making honest, transparent communication
Partners have all the information and skills they need to represent their interests effectively
Partners have equal ability to express concerns, articulate their point of view, and problem-solve.
Partners are active participants in a process that is increasingly owned by the community.
~ Global Campaign for Microbicides

22. International and National Organizations

23.
AVAC uses education, policy analysis, advocacy and community mobilization to accelerate the ethical development and eventual global delivery of HIV vaccines and other new HIV prevention options.

24.
A civil society organization that works to ensure the ethical and accelerated development and widespread access to new and existing HIV-prevention options—especially for women. GCM works to ensure that as research proceeds, the rights and interests of women, potential end-users, trial participants and communities are represented and respected.

25.
AMAG is a coalition of microbicides advocates from organisations and institutions based in/or working in various African countries, working to ensure that a coordinated African voice is engaged in setting and moving forward the microbicides advocacy agenda.

26.
IRMA works to advance a robust rectal microbicide research and development agenda. IRMA works to confront the institutional, socio-cultural and political stigma around the public health need for rectal microbicide research, and to increase funding and commitment within this field of inquiry.

27.
The Enterprise is a working group of scientists, researchers, funders,
government and industry representatives, and advocates from around the world to mobilize significant funding and resources in order to accelerate the development of an effective and safe preventive HIV vaccine.

28.
To support the development of safe and effective preventative HIV vaccines that are accessible for use throughout the world.

29.
HVTN is an international collaboration of scientists and educators searching for an effective and safe HIV vaccine through well-designed clinical research trials, which objectively and ethically address all the critical questions in all phases of clinical trials.

30.
IPM is a non-profit product development partnership (PDP) established to prevent HIV transmission by accelerating the development, availability and delivery of safe and effective microbicides for use by women in developing countries.

31.
MTN is a worldwide collaborative clinical trials network focused on preventing the sexual transmission of HIV through the development and evaluation of products that reduce the transmission of HIV.

32.
The overall goal of the CHVI is to support a coordinated Canadian domestic and international contribution to global efforts to accelerate the development of a safe, effective, affordable and globally accessible HIV vaccine.
NOTE to Facilitators: you will want to replace the last two slides with profiles of relevant national organizations.

33.
ICAD helps Canadians contribute to international HIV/AIDS work and ensures that the lessons learned from the global response to HIV/AIDS are utilized by Canadian organizations to improve prevention, care, treatment and support work in Canada.