Practice facilitation to implement stepped care for unhealthy alcohol use in HIV clinics: study protocol for a type III hybrid effectiveness-implementation study

Despite availability of evidence-based alcohol reduction interventions (EBIs), unhealthy alcohol use (UAU) remains a barrier to HIV medication adherence, viral suppression, and retention in HIV care. While translation of alcohol EBIs into HIV clinical practice is important for comprehensive HIV care, their implementation in HIV settings is impeded by resource constraints, workflow challenges, and negative perceptions of alcohol-related care. Guided by the Consolidated Framework for Implementation Research and Reach, Effectiveness, Adoption, Implementation and Maintenance frameworks, we will conduct a Hybrid Type 3 effectiveness-implementation study testing whether external practice facilitation increases reach, adoption, implementation, and maintenance of stepped care for UAU in three Center for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) HIV clinics in the United States. We will secondarily test whether practice facilitation is associated with clinical outcomes. We will first conduct a mixed methods formative evaluation to tailor delivery of practice facilitation (including the tools, technical assistance, and content expertise offered) based on each site’s context and needs (Aim 1). We will then deliver practice facilitation across the three sites sequentially to implement a stepped-care model of alcohol treatment to patients with UAU. Stepped care, where non-responders to alcohol EBIs are offered a more intensive therapy, will specifically include person- or computer-delivered brief alcohol intervention, on-line cognitive behavioral therapy, and linkages to alcohol pharmacotherapy. Clinical outcomes will include: (1) clinic-level implementation outcomes of stepped care EBIs for alcohol use including reach, adoption, maintenance, using mixed methods (Aim 2a) and (2) patient-level outcomes using interrupted time series analysis with synthetic controls (Aim 2b). Finally, we will use summative evaluation to describe barriers and facilitators to implementation of the interventions at each site to describe maintenance and inform widespread sustainable implementation (Aim 3). This trial tests an implementation strategy to improve the delivery of stepped care, an evidence-based treatment approach for UAU in HIV clinics. Practice facilitation has shown promise for implementing evidence-based care for UAU in primary care but use of practice facilitation for this purpose in HIV clinics is novel. Results from this implementation study may support broader implementation of alcohol evidence-based practices in HIV care. The trial is registered with Clinicaltrials.gov, identifier NCT05241990 Date of submission 2/16/2022.