Each year, 6.2 million persons are newly infected with human papillomavirus (HPV) and 26,000 new HPV- related cervical, genital, and or pharyngeal cancers are diagnosed, resulting in >$4 billion in annual medical costs. Despite US guidelines for vaccinating all adolescents starting at age 11 with 3 doses of HPV vaccine, in 2012 only 53% of 13-17y females had >1 dose and 35% had 3 doses; 21% of teen males had a vaccination. The most effective strategy for improving vaccination rates is patient reminder/recall (R/R), in which providers send reminder messages by telephone, mail or other modalities to parents of children or teens who are eligible for vaccinations, or recall messages for vaccines that are overdue. Yet few practices use reminder/recall for any vaccinations because of costs and lack of personnel time; very few use reminder/recall for HPV vaccine. Statewide immunization information systems (IISs) now exist in 49 states to track childhood vaccinations, but they have not been used for reminder/recall for HPV vaccinations. We have united two leading immunization research groups (Rochester, NY and Denver, CO) for this dissemination/implementation project to determine whether IIS-based reminder/recall is more effective/cost-effective than practice- based reminder/recall in increasing HPV vaccination rates in adolescents. Our study has 4 aims.
Aim 1 is to adapt R/R procedures used for children (protocols, clinical decision support, and message content) for state IISs to conduct reminder/recall for HPV vaccinations.
Aim 2 is to assess the impact and cost-effectiveness of auto dialer (phone) IIS R/R in increasing HPV#1 and HPV#3 vaccination rates in adolescents 11-17 years. We will use a population-level, pragmatic comparative effectiveness trial, and randomizing counties to IIS R/R versus practice-based R/R training. We will apply the RE- AIM framework to evaluate the reach, effectiveness/cost-effectiveness, adoption and implementation of IIS R/R.
Aim 3 is to assess the additional benefit and cost-effectiveness of adding mailed IIS R/R to auto dialer R/R for those with wrong or disconnected phone numbers or if no response to phone IIS R/R. This will involve a second pragmatic RCT, performed simultaneously with Aim 2, and also assessed using the RE-AIM framework.
Aim 4 is to disseminate IIS R/R across New York and Colorado, develop a toolkit, and work with 4 other IISs and a technical advisory group to develop a sustainable IIS R/R system for the US. By the end of the study we will have a feasible, sustainable, cost-effective model for HPV vaccination reminders that can be used nationally to prevent cervical cancer and other HPV-related cancers.
Despite US guidelines for HPV vaccination of all adolescents starting at age 11 with 3 doses of HPV vaccine, only one-third of girls and less than one-tenth of boys are fully vaccinated, leading to many cases of HPV- related cancers. A major barrier is that families are not reminded about the need for their adolescents to receive HPV vaccinations. This dissemination/implementation project will evaluate the impact of patient reminder/recall (R/R) performed by state immunization information systems (immunization registries) to improve HPV vaccination rates. Using two concurrent randomized clinical trials within two states, we will assess the impact and cost-effectiveness of centralized immunization-registry driven auto dialer (phone) R/R in increasing receipt of HPV vaccine among teens and assess the additional benefit and cost-effectiveness of adding mailed R/R to autodialer R/R if the registries have no phone number, a wrong phone number, or no response to phone R/R. We will assess the impact of IIS reminders on subgroups at high risk for HPV related cancers. We will fine-tune the reminder-recall intervention so that it can be disseminated to all states to improve HPV vaccination rates and reduce HPV-related cancers.
