Implementation Research Methods in Recently-Funded HIV Studies By the Nih: A Deep Dive into Their Aims, Study Design, Primary Outcomes, and Stage of Investigation

Introduction. The field of HIV has the necessary interventions to significantly reduce, if not eliminate, new infections. With effective tools in hand, achieving the goal of zero new infections becomes an issue of implementation. The NIH currently supports a broad portfolio of HIV-related research—a small proportion of which is implementation research (IR). This study sought to examine the IR methods being used in recently-funded HIV research by the NIH with a focus on the rigor of these methods and the stage of IR, which varies by the maturity of the evidence-based intervention but can be an indicator of the state of IR in HIV.

Methods. We conducted a scoping review in April 2018 of studies in NIH RePORTER of studies funded since 2013 that were both focused on prevention and treatment of HIV and were also addressing an IR question. We extracted the methodologic characteristics from the 216 studies that met inclusion criteria—being related to both HIV and IR—which included the study aims/intent, study design, and IR outcomes (e.g., acceptability, appropriateness, feasibility, adoption, fidelity, reach, cost, sustainability). We then characterized the stage of IR using the coding of the aims, design, and outcomes into 3 primary types: implementation preparation, testing of a single strategy, and comparative implementation.

Results. Concerning the aims/intent, 28% of studies were evaluating the impact of an implementation strategy or bundle of strategies; 22% were examining barriers and facilitators; and 14% were developing or adapting an implementation strategy. The majority of studies (54%) did not specifically mention inclusion of an IR outcome. Of those that specified an IR outcome, 74% mentioned only 1 or 2 outcomes (21% had 3 or 4, and 6% had 5 or more). Almost half of studies used an RCT design with individual patient randomization despite in some cases testing site level implementation strategies; 22% used within-, between-, or within- and between-site designs.

Conclusions. The results of this scoping review are useful for improving the specification, rigor, conduct, and reporting of IR studies in the field of HIV and have elucidated a number of potential opportunities to gather implementation outcomes and inform where additional IR efforts are needed in this field. The total proportion of HIV IR is small in the NIH portfolio with a good deal of attention on earlier stage IR despite robust evidence for the interventions, suggesting a need for more advanced IR. A limitation of this review is the reliance on project descriptions from NIH RePORTER and not complete articles—a future direction.