Title: New Prevention Technologies Workshop
1www.icad-cisd.com
- New Prevention Technologies Workshop
- Module 4
- Whos Who
2Overview of Role of Various Players
3Who?
Ethical Research
4Who 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
5Academic 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
6Community 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
7Private 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
8Government 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
9Health 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
10Community engagement
11Locating 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
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13Trial 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.
14Host 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)
15National 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.
16International 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.
17Community 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
18Community 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
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20- Why is so much blood taken?
- What do you do with the left over blood?
- Are the needles safe/clean?
21Authentic 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
- Global Campaign for Microbicides
22International and National Organizations
23www.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.
24www.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 optionsespecially 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.
25www.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.
26www.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.
27www.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.
28www.iavi.org
To support the development of safe and effective
preventative HIV vaccines that are accessible for
use throughout the world.
29www.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.
30www.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.
31www.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.
32www.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.
33www.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.