Lessons learnt from communicating the results of the four HSV trials conducted in South Africa Sinead Delany-Moretlwe

Introduction Increased emphasis from donors to communicate research results to policy makers. Randomised controlled trials prove whether interventions are effective yet by there nature are uncertain Researchers must balance planning for a positive outcome with the knowledge that outcomes could be positive, negative or equivocal

Policy makers need evidence Researchers provide evidence Patient advocates use evidence to lobby for change Policy changes

In South Africa, challenges to this model… Apartheid history has led to mistrust of researchers Recent history of AIDS denialism highlights tension between western biomedicine and indigenous knowledge systems Insufficient skills at all levels of government to interpret evidence Communities are research naïve. Harbour suspicion of research yet recognise huge need to respond to HIV Media is unable to contribute or assist the debate

Researchers drawn into mediating these tensions –Need to build trust and address stereotype –Need to explain science and mediate expectations –Need to anticipate outcomes and support policy makers to do the same –Recognise and work within the context of an ailing health service

Case study Four HIV prevention trials 1.Episodic acyclovir to improve ulcer healing 2.Suppressive acyclovir to reduce infectiousness in HIV positive 3.Suppressive acyclovir to reduce HIV acquisition in HIV negatives 4.Suppressive acyclovir to reduce HIV transmission in HIV serodiscordant couples First results available in early 2007; most recent results May 2009

Inner City Johannesburg

Station Orange Farm

Process Approach to research dissemination has been an organic process Shaped by several formative events –Male circumcision trials –Early closure of CS microbicide trial Shifted focus from policymakers at start of trial to participants and communities during trial and then all for results dissemination Anticipated the implications of a positive result and conducted additional research

Process-2 Iterative Communication with participants, community groups and policy makers Pre-release of results to key stake- holders using variety of methods Workshop format for dissemination events with a main event which brings all players together Use of local and national media Unblinding visits for participants Documentation of responses which have been integrated into the next plan

What is the evidence telling us? Episodic therapy improves ulcer healing Suppressive therapy does not prevent HIV acquisition Suppressive therapy is able to reduce infectiousness But this is not sufficient to prevent HIV transmission Suppressive therapy reduces HIV plasma viral load which leads to modest delays in disease progression but more research is needed before policy can be changed

No change in HIV prevention policy required Possibly changes in STI treatment policy HIV treatment and care policy But more research is needed…

Practical lessons learnt Research dissemination is an ongoing process that requires sufficient resources throughout the research process from inception to completion Prepare for a positive result and do the research to support policy and practice change if needed, but plan for all possible outcomes and be prepared for any results Prepare staff and communities for any possible outcome; a trained community advisory board is an asset Learn to anticipate results which may not be straightforward & be prepared to communicate a clear message Repetition is good; unblinding visit is another dissemination opportunity

Was it worth it..? Demonstrated that research is necessary to provide evidence for policy Supported key structures to anticipate results and use the evidence Brought actors together to discuss implications Built a greater understanding of the research process in communities – managed uncertainty and sustained hope Built trust and with that a more enabling environment for research to take place