Manju Chatani, AMAG Anna Forbes, GCM

M2008 Pre-Conference Advocates Workshop24 February, 2008

Advocacy, Ethics and Advocacy, Ethics and Access: Access:

How civil society is shaping How civil society is shaping microbicide researchmicrobicide research

Where is microbicide advocacy?Generated at the intersection of women’s

health movement and AIDS activism

Need first expressed by grassroots women; AIDS and other leadership came later

15 years of sustained activism (since 1992)

Microbicide issue catalyzes joint action across

Sexual and reproductive health and rights

HIV/AIDS and other STIs

International development

LGBT and women’s rights

Trial Participan

t

Immediate community:

Participant’s family and friends

Surrounding community:

CBOs, religious institutions, traditional healers, schools/ universities, microbicide trial site staff, CAB…

Larger community:

NGOs, local policymakers, local media, medical professionals…

National community:

National NGOs, parliamentarians, Ministries of Health, media, regulatory bodies, ethical review committees…

Global community:

International NGOs, vaccine trial sponsors and networks, WHO/UNAIDS, other international organizations, international foundations, donors, funders…

BUTBUT end-users must always be the central focus!

Philosophically demand for microbicides is based on individual’s right to self-determination

Pragmatically microbicides are user-controlled technology

useless if not acceptable and accessible

trials impossible without major participant cooperation

Role of advocacy NGOsCreate tools and trainings to help build research literacy and advocacy capacity

Help pinpoint key issues -- provide background information and analysis to help frame discussions

Provide rapid information on breaking issues to keep everyone up to date

Create opportunities for training and strategizing

Facilitating networking and information-sharing

Current Political Environment

Shaky support among some donors and governments

Backlash against NPT advocacy and focus on “things that don’t exist yet”

Heightened scrutiny because of recent microbicide and vaccine trial failures

Civil society engagementIn microbicides, generates action across sectors among:

Governments and policy makers

Researchers and other scientists

Funders, trial sponsors and research institutions

The media

Enables stake-holders to have a productive impact in the scientific process

Requires the conscious creation of effective mechanisms for engagement

The First 55 Steps: A report of the Microbicide Development

Strategy’s Civil Society Working Group

“a blueprint for bridging the gap between where we are now

(with minimal, scatter-shot and under-resourced civil society participation)

to where we need to be

(with civil society engaging as a full partner).”

Good Participatory Practice Guidelines

Guidance on the responsibilities

of trial sponsors and researchers

towards participants and their communities

Builds engagement among stakeholders which

• minimizes controversy and risk of disruption• informs essential acceptability and access work

Global CampaignGlobal Campaign for Microbicidesfor Microbicides works to

Advance dialogue and debate between civil society and researchers on key issues

Provide tools and capacity-building for researchers and communities

Advocate for approaches that emphasize development and empowerment (not just participation or involvement)

Document and disseminate lessons learned

What does it take?

“scientific literacy”Helping communities learn how clinical trials

work and why

“community literacy”Helping researchers learn communities

work and how to engage with them

transparency and trust-buildingOvercoming historically justified suspicion

The tools we use are… Training, technical support and resources to local

partners to advance work with their own communities

CD Rom – an electronic text book

Microbicides Media and Communications Initiative – to facilitate rapid flow of accurate, objective

information about trials

Exploring and advancing work on key trial ethics questions

Cultivating joint advocacy to help research ratchet up health care infrastructure

African Microbicides Advocacy Group

African Regional Network

Coordinated African engagement in setting and moving forward the microbicides advocacy and research agenda.

Over 500 advocates and researchers from 30 countries across Africa and beyond

“With over 30 clinical trials in Africa, 100s of African researchers and advocates, and 1000s of African trial participants – it is time to amplify realities and needs on the ground.”

AMAG’s focal areas…Facilitating…

Information sharing, communication & networking

Enabling environment for ethical research

Enabling environment for access

Engaging… Social: Strengthening local, national and regional level advocacy leadership

Political: Demand for women’s HIV prevention options on regional agendas.

Resource mobilisation to support advocacy, especially in Africa

“How do we empower communities – future users, African researchers and NGOs, women - to be active in this research – to own it, to critique it, to use it?”

Tools and platforms for action…

Collaboration with partner groups

Mapping exercises

Eforum as platform for dialogue and visibility of emerging issues

Meetings and training opportunities

Amplifying & highlighting issues/work of local, national groups

Ensuring linkages to advocates on the ground

Partnerships support efficient science and human rights, too!

Trials unlikely to be shut down due to community opposition

Trial participants more candid re: adherence, preferences, behaviors, etc.

End product more likely to be what target communities want and need

Communities more inclined to host, and benefit from, future trials

Advocacy successes so far..Increased Resources for the Field

Adequate Standard of Care in trialsincluding contraception at microbicide trial sites

& sexual health care for participants

On-going access to care forHIV positive people screen out of trial& those who seroconvert during a trial

Improved Informed Consent processes

Place at the table for advocates

Relationships between researchers and advocates on the ground

Working with media around trial results

Championing emerging issuesCare of trial site counsellors and outreach; communication challenges; local researcher voices; trial participant voices

Reshaping advocacy… Different levels/kinds of advocacy - different information, different players, different strategies

Advocates for the need for new options – to keep the ground-based demand visible,

Advocates for ethical prevention research – to engage, support and critique research and move forward changing paradigm

Advocates for eventual access – to focus on how microbicides (and other products) will eventually come into the hands of women

Advocacy issues pending…Who are advocates?

Messaging – managing expectations, keeping hope alive

“Keeping the faithful faithful” - long haul interest and advocacy?

Managing information – complexity, trial results, confusions, disappointment

Coordination between groups & honest appraisal of partnerships

Raising voices of trial participants

Integrating microbicides advocacy into existing agendas

Holistic approach - other HIV prevention research?

Ethics issues pending…Pregnancy in trials – care of foetus/mother, access to RH options

ARV-microbicides – resistance, 2nd line treatment drugs, HIV+ women

Ensuring dynamic pipeline

Strengthening IRBs and ethics committees – whose role is it?

Trials with multiple prevention options – feasible? ethical?

What about research needs of “vulnerable populations”?

Sex workers, Adolescents, HIV positive women, People needing rectal microbicides

Access Issues Pending…

Preferential access to participants

Gov’t support to ensuring access

Regulatory issues

Intellectual property issues

Who pays for products?

Industrial level use of products?

Access during Phase 4 trials…

Thank you

Aluta Continua…..