Www.global-campaign.org Evolution in Community Involvement: The Changing Landscape Lori Heise Global...

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Evolution in Community

Involvement:

The Changing Landscape

Lori HeiseGlobal Campaign for Microbicides


Overview

• A short (and undoubtedly) incomplete history of community involvement

• Re-consideration of the CAB/CAG model

• Seismic shifts in the prevention trials landscape

• An introduction to on-going and planned initiatives


What is community involvement?

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History of Community Involvement in HIV Research

• US AIDS activists pushed for a advocate role in early days of HIV treatment research

• Community Advisory Boards (CABs) emerged in response; European treatment activists (TR5, EATG) and Big Pharma follow suit

• CAB model becomes institutionalized and is exported via NIH, ANRS, etc. to international research sites


GCM Community Involvement Dialogue Meeting, 2003

“It may be difficult to meet the diverse and complex challenges of community involvement through a single mechanism like a CAB or CAG.”

“Sites have begun to use other mechanisms to help educate, respond to, protect, collaborate with and seek ongoing input from communities.”

(Mobilization for Community Involvement in Microbicide Trials, SAMRI and GCM,’03)


Then...

• Activist-led

• Treatment trials- individual urgency

• Individuals educated, empowered, motivated to learn more

• Clearer understanding of community

• Community “PUSHED” researchers for involvement, defined parameters

In 2003...

• Researcher/Donor-led

• Prevention trials- less chance of immediate benefit

• Individuals marginalized, less powerful, less educated

• Less clear understanding of who is included in “community”

• Researchers “PULL” community into involvement, define parameters


Expectations and Challenges facing CABS

Expectations Realities?Represent community viewpoints

Channel for communication between researchers and community

Independent advice to researchers

Voluntary commitment of members over time

Provide input on trial design and protocol

Oversight/watchdog for the research

Co-opted or dominated by political or other agenda

Role confusion: should CAB members and CLO’s help recruit?

Ability to challenge the institution supporting the structure?

Competing priorities in resource-limited settings?

Power to influence research agenda? Accountability of CAB to community and research enterprise to CAB


Where should the efforts in CI be leading us to?

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Why Community Involvement?

• Improve ethical and scientific integrity of trials

• Increase transparency and accountability of the research to the community

• Maximize benefits and minimize risks for participants and for host community

• Strengthen local capacity and infrastructure


Issues of Power

• Power imbalances exist across multiple lines: PIs versus field staff, Northern researchers versus Southern; community versus research enterprise; within communities and CABs

• One goal of community involvement and microbicide advocacy is to work towards reduced power disparities.

• Pretending that power imbalances do not exist, however, breeds the worst form of tokenism.


Why Community Involvement? (RHRU, 2003)

• To inform community about the study

• To enable and increase recruitment into the study

• To maintain enrollment levels

• To develop strategies for the referral and support of women who test positive for HIV

• To solve problems arising from the study


2006 2008 2009

Female Barrier - Diaphragm

Male Circumcision - Susceptibility

20102007

Microbicides - Carraguard

Male Circumcision - Infectiousness

Microbicides• BG/Pro2000

• CS – 1• CS – 2

• Pro2000• TDF

Oral PrEP - IDU

HSV-2 Treatment - Infectiousness

HSV-2 Treatment –

Susceptibility

Oral PrEP• MSM

• Heterosexual

2012

IndexPartner

Treatment

Vaccines -Adenovirus1Adenovirus 2

Vaccines -Prime/Boost

Community VCT and HIV

Support

Oral PrEP -West Africa

Prevention Research Landscape, 2005

http://www.avac.org/timeline-website/index.htm

Micoribicides Saavy


r

““We will not let Cambodians be used as guinea pigs…” Cambodian prime

minister


Cameroon falls next


Consultations & Searching self-reflection

• Gates Foundation– Stakeholder consultation

on oral tenofovir trials• UNAIDS

– 3 regional consultations– Global meeting in Geneva

SOC

Research literacy

EthicalDebate

community


GCM Work plan & Response

• Case studies

– Cambodia

– Cameroon

• Manual and CI Tool Kit

– Shift to “community involvement plans”

• Field Test and Demonstration Project

– In collaboration with EDCTP project


Lessons Learned:Community Consultation

• Must extend beyond local trial community to include NGOs and other opinion leaders and stakeholders

• Requires adequate lead time and a specialized skill set;

• Must begin early when input can still effect change

• Demands separate line item in the budget

• Formative research cannot substitute for a consultative process


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http://www.avac.org/timeline-website/index.htm

The Revised Prevention Research Landscape November 2007

2006 2008 2009

Female Barrier Diaphragm

Male Circumcision – Susceptibility

20102007

Microbicides – Carraguard

Male Circumcision – Infectiousness

Microbicides• BG/Pro2000

•Pro2000• TDF

Oral PrEP – IDU

HSV-2 Treatment – Infectiousness

HSV-2 Treatment –

Susceptibility

Oral PrEP• MSM

• Heterosexual

2011+

IndexPartner

Treatment

Vaccine –VRC PAVE 100

Vaccines –Prime/Boost

Merck Adeno 1

Community VCT and HIV

Support

Oral PrEP – West Africa

Microbicides – CS-1CS-2

Vaccine –Merck Adeno 2

Micoribicides Saavy

?


• Grew out of2005 UNAIDS Global Consultation: “Creating Effective Partnerships for HIV Prevention Trials”

• Process jointly convened by UNAIDS and AVAC

• Objectives

• Establish clear, global standards for community participation and input in HIV prevention trials

• Publish guidelines with the intent of seeking eventual endorsement by ICH

Good Participatory Practice Guidelines


Normative DocumentsNormative Documents

Institutional/Internal GuidelinesInstitutional/Internal Guidelines

Resources/How To Resources/How To

Normative Guidance, Institutional Guidelines & Operational Tools

Normative Guidance, Institutional Guidelines & Operational Tools

Each Has A Distinct Role


NIH Division of AIDS (DAIDS)

• AIDS Clinical Trials Group (ACTG)

• HIV Prevention Trials Network (HPTN)

• HIV Vaccine Trials Network (HVTN)

• Adolescent AIDS Clinical Trials group (IMPAACT)

• Int’l Network for Strategic Initiatives in Global HIV

Trials (INSIGHT)

• Microbicides Trials Network (MTN)

Int’l Partnership for Microbicides (IPM)

(Up to 20 sites planned)

Stand Alone Sites: (Not part of a network)

• Family Health Int’l 6 site Truvada Study

• CAPRISATenofovir gel

• Population Council

•UCSF/CDC Prep Studies

• Lavalle-University (invisible condom study)

Universe Microbicide Trial Players

Microbicide Development Programme (MDP)

•University Teaching Hospital (Lusaka, Zambia)

•SA MRC & University of Natal (Durban, SA)

•RHRU/University of Witwatersrand

(Johannesburg, SA)

•AMREF/NIMR/LSHTM (Mwanza, Tanzania)

•Imperial College at St. Mary’s Hospital (London, UK)

•MRC/Uganda Virus Research Institute (Entebbe, Uganda)

•Africa Centre for Health & Population Studies

(Mtubatuba, SA)


Other initiatives

• ICASO Voices Project

• GCM Digital Stories Project

• Ethics, Society and Culture Gates Global Challenges Project

• MDS Civil Society Project

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