Country and community preparedness: Community Involvement in Clinical Trials Global Campaign for Microbicides

Microbicide Introduction? Copyright Jim Mclaren

Definitions Activities and mechanisms that promote partnership between communities and research teams in decision-making, problem- solving and program implementation Efforts to engage a wide range of stakeholders in decision-making about the research and its implementation

History of Community Involvement in HIV Research AIDS activists pushed for a role in early days of HIV treatment research. Institution of CABs emerged. Recognition of “Community involvement” as a part of ethical clinical trials, especially in prevention trials in vulnerable populations. –Exportation of CAB model to developing country research sites –Invoking community involvement as a response to ethical dilemmas

In the North... Activist-driven Treatment trials- individual urgency Individuals educated, empowered, motivated to learn more Clearer under- standing of community Community “PUSH” researchers for involvement In the South.. Researcher/Donor- driven 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

Special Challenges of Microbicides Research “SEX” Specific gender orientation Potential tension in involving/empowering “the community” and involving/empowering women specifically Need to communicate complex messages about partial effectiveness

“Partnership Continuum” 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 research process. Mobilization Engagement in the research process strengthens com- munity capacity to analyze and address its own health and development priorities.

Global Campaign Initiative on Community Involvement Goal: to support researchers and communities in building effective partnerships –Advance the dialogue and debate –Provide tools and capacity-building for researchers and communities –Advocate for new approaches that emphasize development and empowerment (not just participation or involvement) –Document and disseminate lessons learned Project: ‘Dialogue in Southern Africa’

Goals of Community Involvement Entrée and trust building Promote exchange of information Maintain scientific validity and ethical integrity of trial Contribute to community capacity and development

Critical Reflections: Information With electronic communication, more people  need to know  want to know  consider themselves stakeholders Information management, therefore, has to:  assure accuracy and transparency  provide opportunities for dialogue  Enable participants to prepare for meaningful dialogue by developing research literacy skills

Critical Reflections: Accountability Once community and civil society actors demand accountability, what is the researchers/donors responsibility? How are community/civil society actors held accountable for accuracy, transparency, etc.? What are the consequences of failure? We are making the path by walking….