MDP301An 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

2009.

16,000 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 2008. 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 leadersMoH, Ethics, NAC, MinistriesThe Field

The World

MoH, Ethics, NAC, MinistriesLocal Leaders and the Field

The World

Communities, participants

PLANNING DISSEMINATIONFROM PAPER TO REALITIES

Aug 08

•Kick off Dissemination Meeting

•Dissemination Working Group

Feb 09

•Results Dissemination Plan

Q3 - 09

•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 www.mdp.mrc.ac.uk

Q1-Q2

2010

•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.

USA

UK

AfricaZambia

Mazabuka

Ppts Partners

HIV Prevention

ADV.

MDPADV.

+ +

DISSEMINATION OF CLINICAL TRIAL RESULTS IN A CONNECTED WORLD 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