The case for prioritizing implementation strategy fidelity measurement: Benefits and challenges

Implementation strategies are systematic approaches to improve the uptake and sustainability of evidence-based interventions. They frequently focus on changing provider behavior through the provision of interventions such as training, coaching, and audit-and-feedback. Implementation strategies often impact intermediate behavioral outcomes like provider guideline adherence, in turn improving patient outcomes. Fidelity of implementation strategy delivery is defined as the extent to which an implementation strategy is carried out as it was designed. Implementation strategy fidelity measurement is under-developed and under-reported, with the quality of reporting decreasing over time. Benefits of fidelity measurement include the exploration of the extent to which observed effects are moderated by fidelity, and critical information about Type-III research errors, or the likelihood that null findings result from implementation strategy fidelity failure. Reviews of implementation strategy efficacy often report wide variation across studies, commonly calling for increased implementation strategy fidelity measurement to help explain variations. Despite the methodological benefits of rigorous fidelity measurement, implementation researchers face multi-level challenges and complexities. Challenges include the measurement of a complex variable, multiple data collection modalities with varying precision and costs, and the need for fidelity measurement to change in-step with adaptations. In this position paper, we weigh these costs and benefits and ultimately contend that implementation strategy fidelity measurement and reporting should be improved in trials of implementation strategies. We offer pragmatic solutions for researchers to make immediate improvements like the use of mixed methods or innovative data collection and analysis techniques, the inclusion of implementation strategy fidelity assessment in reporting guidelines, and the staged development of fidelity tools across the evolution of an implementation strategy. We also call for additional research into the barriers and facilitators of implementation strategy fidelity measurement to further clarify the best path forward

Comparing a standard and tailored approach to scaling up an evidence-based intervention for antiretroviral therapy for people who inject drugs in Vietnam: Study protocol for a cluster randomized hybrid type III trial

Background: People who inject drugs (PWID) bear a disproportionate burden of HIV infection and experience poor outcomes. A randomized trial demonstrated the efficacy of an integrated System Navigation and Psychosocial Counseling (SNaP) intervention in improving HIV outcomes, including antiretroviral therapy (ART) and medications for opioid use disorder (MOUD) uptake, viral suppression, and mortality. There is limited evidence about how to effectively scale such intervention. This protocol presents a hybrid type III effectiveness-implementation trial comparing two approaches for scaling-up SNaP. We will evaluate the effectiveness of SNaP implementation approaches as well as cost and the characteristics of HIV testing sites achieving successful or unsuccessful implementation of SNaP in Vietnam. Methods: Design: In this cluster randomized controlled trial, two approaches to scaling-up SNaP for PWID in Vietnam will be compared. HIV testing sites (n = 42) were randomized 1:1 to the standard approach or the tailored approach. Intervention mapping was used to develop implementation strategies for both arms. The standard arm will receive a uniform package of these strategies, while implementation strategies for the tailored arm will be designed to address site-specific needs. Participants: HIV-positive PWID participants (n = 6200) will be recruited for medical record assessment at baseline; of those, 1500 will be enrolled for detailed assessments at baseline, 12, and 24 months. Site directors and staff at each of the 42 HIV testing sites will complete surveys at baseline, 12, and 24 months. Outcomes: Implementation outcomes (fidelity, penetration, acceptability) and effectiveness outcomes (ART, MOUD uptake, viral suppression) will be compared between the arms. To measure incremental costs, we will conduct an empirical costing study of each arm and the actual process of implementation from a societal perspective. Qualitative and quantitative site-level data will be used to explore key characteristics of HIV testing sites that successfully or unsuccessfully implement the intervention for each arm. Discussion: Scaling up evidence-based interventions poses substantial challenges. The proposed trial contributes to the field of implementation science by applying a systematic approach to designing and tailoring implementation strategies, conducting a rigorous comparison of two promising implementation approaches, and assessing their incremental costs. Our study will provide critical guidance to Ministries of Health worldwide regarding the most effective, cost-efficient approach to SNaP implementation. Trial registration: NCT03952520 on Clinialtrials.gov. Registered 16 May 2019