Implementation and Dissemination of Evidence-Based Interventions to Improve PrEP Care Continuum Outcomes Among Women in Community Health Clinics in the Southern U.S.

Research Design After the investigators have adapted the POWER-Up strategies for use in the new setting, the investigators will conduct a hybrid type II trial within the framework of a cluster randomized, cross-sectional stepped wedge study. The investigators will use the RE-AIM framework for evaluation. The investigators will utilize a cluster randomized, cross-sectional stepped wedge trial, including sites in the South and the Midwest. This study design will allow us to roll out the intervention across diverse geographic areas and assess the change in clinical and implementation outcomes from the pre-intervention (control) and the post intervention (intervention) periods. The cluster, or unit of analysis, is each CHC, N=12 (8 in the South, 4 in the Midwest). In a stepped wedge study, each cluster contributes both time and observations to the control condition (usual care) and the intervention condition (strategies to increase PrEP use). Every cluster switches from the control to the intervention at regular time intervals ("steps"), but at different points in calendar time. More than one cluster may start the intervention at a step, but the step at which a cluster switches from control to intervention is randomized. The design is cross-sectional as outcomes are obtained from the subset of patients seen during each time period at each clinic rather than following individually recruited patients over time. This use of clinics under both intervention and control conditions improves precision when intra-cluster correlation is high, which is likely among the CHCs the investigators have chosen.

In our stepped wedge design, each step is 6 months long, and there are 4 waves of intervention implementation (three sites begin the intervention at the same step, a mix from the South and the Midwest, N=12). Three CHC sites will be randomized to each step occurring at 6-month intervals. Each cluster also undergoes a 6-month transition period when the individual clinics will prepare to implement the intervention package.

Although the investigators hypothesize that the effect of this intervention will increase PrEP uptake among participants, the investigators powered this study to ensure that the investigators could detect a range of intervention effectiveness. The investigators used the R statistical package swCRTdesign V3.1 to verify that a sample of 50 participants at 6 different times ("steps") each lasting 6 months, at the 12 CHC sites ("clusters") provides adequate power (>80%) to detect a change from a baseline of 1% of eligible participants receiving prescriptions for PrEP to 2% with an ICC of 0.2 and a CAC of 0.80.60. This minimum sample size per time interval is one that can easily be met by all of the clinics used as sites in this study (100 eligible participants per calendar year).

A key element of the research infrastructure will be AllianceChicago's uniform EMR system, which is distinguished by the integration of evidence-based practice recommendations into the end user interface to provide clinical decision support at the point of care. AllianceChicago's information technology (IT) team will create a study specific fields to measure study outcomes. The IT team will build custom reports in their data warehouse to access and validate in real-time. Reports will be built to pull data (ICD, CPT/HCPCS, and RXNORM codes, laboratory results, demographic characteristics) from the medical record and billing claims, and will be used to determine implementation success for the RE-AIM outcomes of effectiveness and maintenance. The investigators will utilize the Health Catalyst Tool which already has reports built to monitor PrEP care continuum outcomes. Additional reports will be built to monitor: 1) Participants who receive HIV risk assessment 2) participants who receive PrEP education; 3) participants who receive PrEP navigation; 4) PrEP prescriptions among eligible participants.

Implementation Patient education: CHC staff will perform HIV risk assessment for participants who present at the CHCs for care. HIV risk assessment will consist of asking questions regarding PrEP indications adapted from the USHS guidelines for PrEP (e.g., sexual partners, recent STIs, condom use, drug use, etc). For participants who meet criteria of "PrEP eligibility," patient education regarding PrEP will be provided. Patient education occurs at each clinic visit.