Building Partnerships for prevention research: New Models

1. Building Partnerships for prevention research: New Models Quarraisha Abdool Karim, PhD Head: CAPRISA Women & AIDS Programme UNAIDS Consultation on Creating effective partnerships for clinical trials, June 20-21, 2005, Geneva

2. Overview Epidemiology Research Context Scientific Accountability Partnerships

3. Global burden of HIV Infection in 2004 *(conservative estimate) Source: Joint UNAIDS and WHO AIDS epidemic update December 2004

4. Geographical distribution of HIV infection in 2004 Eastern Europe & Central \Asia 1.4 milion IDU Western Europe 610 000 MSM, IDU North America 1.0 million HSex,MSM, IDU East Asia 1.1 mil HSex,IDU, MSM North Africa & Middle East 540 000 HSex, IDU Caribbean 440 000 HSex, MSM South & South-East Asia 7.1 million HSex, IDU Sub Saharan Africa 25.4 million HSex Latin America 1.7 million HSex,MSM, IDU Oceania 35 000 MSM HSex = heterosexual transmission IDU = transmission through injecting drug use MSM = sexual transmission among men who have sex with men Source: Joint UNAIDS and WHO AIDS epidemic update December 2004

5. 350 300 250 1996-1998 1999-2000 200 PERCENTAGE OF 1985-1990 AVERAGE 150 100 50 0 15-19 20-24 25-29 30-34 35-39 40-44 45-49 50-54 55-59 60-64 65-69 AGE Temporal changes in adult mortality rate for men in SA Source: Dorrington R, Bradshaw D, et al. Medical Research Council

6. 350 300 250 1996-1998 1999-2000 200 PERCENTAGE OF 1985-1990 AVERAGE 150 100 50 0 15-19 20-24 25-29 30-34 35-39 40-44 45-49 50-54 55-59 60-64 65-69 AGE Temporal changes in adult mortality rate for women in SA Source: Dorrington R, Bradshaw D, et al. Medical Research Council

7. Public Health Challenge • + 16 000 infections per day • >70% in Sub-Saharan Africa • 10-15% of adults infected with HIV • 2000 person prevention trial (4 sites) • 200-300 screen positive • 50-75 positive per site • 66 become infected • +16 per site

8. 100000 80000 60000 AIDS deaths 40000 AIDS cases 20000 0 1993 1995 1997 1999 2001 Impact of HAART on morbidity and mortality 43% decrease in deaths from 1995 to 1997 Source: CDC Report 2001 and Palella et al

9. Research Context • Need for research • Concerns of exploitation vs 2 standards (research participants and non) • Local vs Externally sponsored research • Single site vs muliti site, 1 site with multiple trials • Numerous guidelines, documents + revisions

10. Epidemiological and Research Context • Global inequalities • Disparities in access to health and health infrastructure

11. Accountability in Science • ? societal contribution/value • investment of public funds -- ? tangible benefits to society • Beyond publications -- ? impact on health outcomes • Research vs service delivery • Advocacy for increased funding • Public opinion on utility of research • Communication with Public - ?Media • UK MRC, Welcome Trust and AMS Initiative

12. Public Access to Data on Trials • International Committee of Medical Journal Editors • Database of planned trials • Accountability • Registered before enrolment of first patient • WHO guide – minimal registration data to be submitted • ? Phase I - III trials; Co-ordination

13. time COMMUNITY BENEFIT (Facilitated by policy makers) SPONSORS Public Sector/ Industry Private individuals RESEARCHERS Research outputs Publications, posters, presentations Irony: Limited public access Growing mistrust MEDIA activism Public time Health Science and Technology- Civil society Not uniform acceptance Acceptance dependent on personal circumstances including value system. Issues can be highly politicised (stem cell, GM foods, IVF) Current model of researcher’s link to civil society

14. Research Challenges • Sponsor demands – GCP, retention rates, incidence rates • Ethics and Regulatory – host and sponsor country • Research naïve populations, infrastructure and local research capacity • Delays in initiating trials • Miscommunication to public

15. Whose interests • Research imperative fuelled equally by a commitment to progress and the persistence of hope in desperate communities can easily tip the balance away from the best interest of research participants toward the pursuit of knowledge for the sake of others. • How do we maintain the balance between the best interests of research participants with social benefits of science

16. Partnerships – procedural fairness • What constitutes effective partnerships • When dialogue should be initiated • Who should be included • Parameters of engagement

17. Partners/Stakeholders • Scientists • Community • Civil Society • Sponsors • Government • IRBs and Regulatory Bodies

18. Community Advisory Boards • Geographical Restriction • Involvement in research process • Informed Consent Processes • Recruitment and Retention • Issues during Implementation

19. Civil Society • Broader interests • Increasing morbidity & mortality • Urgency and immediacy • Co-ownership of research • Advocacy – GRIPP • Public Accountability

20. Effective Partnerships • Mutual trust, • Participatory management, • Mutual ownership of the research process, • Common sense of purpose and goals, • Varied and differentiated roles based on stakeholder expertise and skills, • Development of national research capacity, • Translation of research findings into policy and practice. • Resolution of disputes/conflicts between scientists and civil society

21. Synergy between Activism and Science • ARV Drug development • HIVNET 012 • ARV Treatment access

22. GRIPP • Ultimate goal of research – improve quality of care • Practice falls short • Successful trials undertaken in RCS yet to benefit these countries --- Exploitative research? • Overly simplistic to suggest that research is unethical unless post-trial access assured • Wide array of factors – policy decision, licensure, production, • Not all decision-making is evidence based • Complex political process • Research – set stage for advocacy --- partnership with civil society

23. Hans Josef, 1970 • “Let us all remember that a slower progress in the conquest of disease would not threaten society…..but that society would indeed be threatened by the erosion of those moral values whose loss, possibly caused by too reckless a pursuit of scientific progress, would make its most dazzling triumphs not worth having.”

24. Acknowledgements • HPTN Ethics Working Group • Steve Wakefield, HVTN • Vivek Naranbhai, University of KwaZulu-Natal • CAPRISA and Fogarty AITRP