From Research to Rollout: Comparing oral PrEP and the dapivirine ring

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Presentation transcript:

From Research to Rollout: Comparing oral PrEP and the dapivirine ring AVAC March 2018

Product Introduction Process: Research to rollout Develop Demonstrate Deliver Basic Pre clinical Clinical (Phase I, II, III) Post-Trial Access/OLE Implementation Research / Demonstration Projects Introduction Initiatives Scale-Up RESEARCH & DEVELOPMENT

Product Introduction Process: Moving a product to the “real world” Post-trial access After trial ends, intervention provided to participants, and sometimes their communities Open label extensions (OLE) Follow-on study, intervention available for specific time to participants from randomized controlled trial who know they are receiving active intervention/potential benefit Implementation research Research protocol enrolling new participants (not previously in trials/OLE), aiming to assess intervention in a more “real world” setting Demonstration projects Offer use of new intervention outside of clinical trial site; can address delivery infrastructure needs and ways individuals integrate it into daily activities & decision making Introduction initiatives Large-scale provision of an intervention, sometimes part of country rollout, aiming to learn and apply lessons from introducing an intervention at scale Scale-up Complex process of making new intervention widely available, includes mobilization of sufficient resources for procurement, distribution, delivery, worker training, etc.

Product Introduction Process: Comparing oral PrEP and Dapi Ring Phase III Efficacy 44% (iPrEx, 2010) 27% & 31% (ASPIRE & Ring Study, 2016) 50% (iPrEx OLE, 2014) 54% & 54% (HOPE & DREAM OLE, 2018) 86% (PROUD, 2015) ??? (design and funding pending) 62 distinct post-approval projects; 47 different organizations; projects ongoing, planned and completed in 30 different countries (As of Jan 2018) Open label extensions (OLE) Implementation research Demonstration projects Introduction initiatives Scale-up

Product Introduction Process: Comparing oral PrEP and Dapi Ring (MSM) (Heterosexual Men & Women) Dapivirine Ring 44% (iPrEx, 2010) 75% (Partners, 2011) 27% & 31% (ASPIRE & Ring Study, 2016) 50% (iPrEx OLE, 2014) 90% (Partners, 2014) 54% & 54% (HOPE & DREAM OLE, 2018) 86% (PROUD, 2015) 96% (Partners Demo, 2015) ??? (design & funding pending) 62 post-approval projects; ongoing, planned & completed in 30 countries with 47 different orgs (As of Jan 2018) Phase III Efficacy Open label extensions (OLE) Implementation research/ Demo Projects Introduction initiatives