Text and Talk: A Multi-level Intervention to Increase Provider HPV Vaccine Recommendation Effectiveness - Part 4: Randomized Controlled Trial

Random Assignment: The study will test the hypotheses with a doubly randomized, two-level nested design for testing two nested implementation factors. Randomization will occur at two levels: the clinic and patient/parent. A group randomized trial forms the basis of randomization.

The study will randomly assign a fixed number of 30 clinics (and the providers within each clinic) equally to one of three provider trainings: (1) bundled training (n=10 clinics), (2) benefits training (n=10 clinics), and (3) no training (n=10 clinics). All providers in each clinic will be invited to participate in the assigned training. The investigators anticipate an average of 2 providers per clinic. The study will stratify by baseline vaccination rates to ensure balance across the three groups. The investigators chose to assign provider trainings at the clinic level because it is more feasible to conduct one training at each clinic and it limits the potential for contamination between providers.

The second level of randomization will occur among patients/parents. The investigators anticipate between 70-100 adolescents per clinic. The study will randomly assign parents (nested within clinic) equally to one of three text message groups: (1) bundled (n=30), (2) benefits (n=30), and (3) no messages (n=30). Inclusion criteria are: 10 , 11 , and 12-year-olds, attended the clinic in the past two years, and do not have records of changing providers or receiving the adolescent vaccines. Randomization will include 10-year-olds because text messages will be sent just prior to the adolescents' 11th birthday. The study will stratify text message assignment by patient biologic sex because of large differences in HPV vaccination and possible differential effectiveness of text messages. To ensure auditability, separate SAS programs will be written for the two levels of randomization.

Delivery of interventions: At each clinic randomized to training, providers will be invited to participate in a group-based training occurring over Zoom. Each training will last one-hour and providers will receive continuing medical education (CME) credit for participating. Trainings will focus on increasing the providers' intention to recommend the vaccine. Following best practices, each provider training will have a combination of activities (presentation, concrete skills development, role-play, and feedback), will be learner-centered, and engaging. Training will include: (A) presentation of HPV vaccination background; (B) the approach explanation, script, and a video-recorded example of a provider talking to a parent; (C) practicing prepared role play scenarios in small groups; and (D) an explanation of the follow-up, audio-recorded trainings. For part B, the bundled training will include existing nationally endorsed materials.

The study will audio-record thee visits with each provider to give individual feedback, to offer boosters (e.g., script review or barrier discussions) to providers who are lower than 80% adherent, and to evaluate provider adherence to assigned approaches. To increase the trialability, providers will be encouraged to use a standardized form to record their vaccine recommendations with their next ten patients and compare the HPV vaccination rates to their preceding ten patients.