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www.icad-cisd.com. New Prevention Technologies Workshop Module 4: Who’s Who. Overview of Role of Various Players. Who?. Ethical Research. Who are the Players in HIV NPT Research?. Academic researchers and universities Community members and organizations, community advisory boards

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  1. www.icad-cisd.com New Prevention Technologies Workshop Module 4: Who’s Who

  2. Overview of Role of Various Players

  3. Who? 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

  12. “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.

  13. “Host Community” refers tothe 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)

  14. “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.

  15. “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.

  16. 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

  17. 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

  18. Why is so much blood taken? • What do you do with the left over blood? • Are the needles safe/clean?

  19. Authentic Community Involvement ~ Global Campaign for Microbicides 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

  20. International and National Organizations

  21. www.avac.org 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.

  22. www.global-campaign.org 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.

  23. www.global-campaign.org/amag.htm 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.

  24. www.rectalmicrobicides.org 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.

  25. www.hivvaccineenterprise.org 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.

  26. www.iavi.org To support the development of safe and effective preventative HIV vaccines that are accessible for use throughout the world.

  27. www.hvtn.org 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.

  28. www.ipmglobal.org 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.

  29. www.mtnstophiv.org 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.

  30. www.chvi-icvv.gc.ca 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.

  31. www.icad-cisd.com 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.

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