Using Implementation Science to Better Integrate Novel Long-Acting Injectable Therapy Into Routine HIV Care.

Abstract

The key to maximizing the value of implementation science data is to get the learnings early. A critical contributor to early clinical research data is the biopharmaceutical industry. In partnership with the implementation research community, industry has an opportunity to play a major role to increase the value of implementation research data through earlier integration of implementation questions in the development continuum. This article suggests that by using more hybrid implementation-effectiveness study designs in phase III trials, researchers can accelerate the availability of implementation data closer to the initial introduction of novel treatments into community settings. The biopharmaceutical industry is uniquely poised to lead or collaborate on these trials. The first LAI HIV medications are being studied for both HIV prevention and treatment. This paradigm shift in the provision of HIV care is an opportunity to blend implementation research into clinical trials earlier so that the public health community is armed with tested implementation strategies to maximize access and impact when these new medications become available. CUSTOMIZE, a novel phase IIIB-hybrid III implementation-effectiveness trial-is the first-of-its-kind study to examine different implementation strategies to overcome challenges of delivering a LAI antiretroviral medication in various types of HIV clinical settings the US health care system. Industry can play a complimentary and additive role by partnering with implementation science researchers to understand the implementation strategies sooner in the development pipeline. These collaborations may allow for earlier, more informed, and strategic HIV public health programs in the future.