Nicolette Naidoo

This session highlighted considerations for future HIV prevention trial design as the range of prevention options expand. Presentations covered regulatory perspectives on trial design and potential surrogate endpoints, and study perspectives and considerations for the standard of HIV prevention in trials.

Jeff Murray outlined the current trial designs but questioned the feasibility for HIV prevention. He presents a proof of concept correlating STI (rectal GC) with HIV incidence; noting that validation is required. Deborah Donnell indicated that a prevention mosaic effectiveness trial design presents the most promising option for studying long acting prevention methods. In settings with low HIV incidence, larger trials will be needed but HIV risk in these communities could supplement safety and efficacy data. Yunda Huang provided critical insight on vaccine and mABs HIV prevention efficacy trials designs, presenting a promising approach to examining correlates of protection resulting in candidates which could target the features of break-through HIV virus thus conferring prevention efficacy. Definate Nthamo emphasized the need to make prevention sexy, involve communities in product development, deliver comprehensive package of care underpinned by implementation science to ensure swift transition from research to scale.

This session clearly demonstrated that HIV prevention poses new challenges and opportunities for engagement, collaboration, optimization of trial design and identification of populations most in need. However, questions remain on the role of the research community in advocating for equitable access and distribution to effective prevention products.