MDP301 An international multi-centre, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of 0.5% and 2% PRO 2000/5 gels for the prevention of vaginally acquired HIV infection Funded by UK MRC and DFID Mini Oral Presentation Disseminating the MDP301 Results A Critical Approach to the Dissemination of Trial Results in a Connected World Roger Tatoud, Ph.D.

MDP 301 Phase 3 trial conducted in 16 centres across South-Eastern Africa between 2005 and ,000 women screened and 9,400 enrolled in an efficacy study investigating the candidate microbicide PRO2000 for the prevention of vaginal HIV acquisition. PRO2000 had previously been been trialled by the MTN in the Phase 2 HPTN035 and showed promising result in February 2009 (30% reduction in risk, not statistically significant) This result was not confirmed by the MDP 301 in December 2009 which demonstrated that the PRO 2000 gel was ineffective. The MDP dissemination work started as early as August In March 2009 expectations where high and work was already well advanced on the dissemination of a number of scenarios. How to disseminate results across many different countries and stakeholders? How to manage a failed hope from HPTN 035 to MDP301?

Participants Community, local leaders MoH, Ethics, NAC, Ministries The Field The World MoH, Ethics, NAC, Ministries Local Leaders and the Field The World Communities, participants P LANNING D ISSEMINATION F ROM PAPER TO REALITIES Aug 08 Kick off Dissemination Meeting Dissemination Working Group Feb 09 Results Dissemination Plan Q Advance Messages Key Messages Backgrounders Dec 09 Appointments with MoH Call with Researchers and Advocates Events for participants 14 Dec 09 Public release of results All document available online Q1-Q Follow up events “This is simply sanctioned murder (Grievous Bodily Harm) FROM THE WEST, in the name of scientific research, by the Medical Research Council and DFID at a cost of £40 million to infect ONLY one hundred and twenty-three (123) simple, cheap, black, AFRICAN women's lives in Uganda, Tanzania, South Africa and Zambia. The lead researcher says, "IT IS DISHEARTENING!" No it is MURDER!” Dr. Edwin Mapara, London. Diaspora voices, Yahoo Group. “This is simply sanctioned murder (Grievous Bodily Harm) FROM THE WEST, in the name of scientific research, by the Medical Research Council and DFID at a cost of £40 million to infect ONLY one hundred and twenty-three (123) simple, cheap, black, AFRICAN women's lives in Uganda, Tanzania, South Africa and Zambia. The lead researcher says, "IT IS DISHEARTENING!" No it is MURDER!” Dr. Edwin Mapara, London. Diaspora voices, Yahoo Group.

USA UK Africa Zambia Mazabuka Ppts Partners HIV Prevention ADV. MDP ADV. + +

D ISSEMINATION OF C LINICAL T RIAL R ESULTS IN A C ONNECTED W ORLD Research does not happen in a vacuum Political context (we do research, not politics, but should we?) Cultural and social context (North/South tension, Women in society, Science & Society) What do we communicate How? To whom? When? Identify & acknowledge Networks and their overlaps (or lack thereof) Limitations of what can be done Long term planning Systemic and systematic approach to dissemination The Internet Your Best Friends and Worst Enemies