Increasing the adoption of evidence-based communication practices for HPV vaccination in primary care clinics: The HPV ECHO study protocol for a cluster randomized controlled trial.

BACKGROUND: The safe, highly-effective human papillomavirus (HPV) vaccine remains underused in the US. The Announcement Approach Training (AAT) has been shown to effectively increase HPV vaccine uptake by training providers to make strong vaccine recommendations and answer parents' common questions. Systems communications, like recall notices, can further improve HPV vaccination by reducing missed clinical opportunities for vaccination. Never tested in supporting HPV vaccination, the ECHO (Extension for Community Healthcare Outcomes) model is a proven implementation strategy to increase best practices among healthcare providers. This trial uses a hybrid effectiveness-implementation design (type II) to evaluate two ECHO-delivered interventions intended to increase HPV vaccination rates. METHODS: This 3-arm cluster randomized controlled trial will be conducted in 36 primary care clinics in Pennsylvania. Aim 1 evaluates the impact of HPV ECHO (AAT to providers) and HPV ECHO+ (AAT to providers plus recall notices to vaccine-declining parents) versus control on HPV vaccination (≥1 dose) among adolescents, ages 11-14, between baseline and 12-month follow-up (primary outcome). Using a convergent mixed-methods approach, Aim 2 evaluates the implementation of the HPV ECHO and HPV ECHO+ interventions. Aim 3 explores exposure to and impact of vaccine information from providers and other sources (e.g., social media) on secondary acceptance among 200 HPV vaccine-declining parents within 12 months. DISCUSSION: We expect to demonstrate the effectiveness and evaluate the implementation of two highly scalable interventions to increase HPV vaccination in primary care clinics. Our study seeks to address the communication needs of both providers and parents, increase HPV vaccination, and, eventually, prevent HPV-related cancers. TRIAL REGISTRATION: ClinicalTrials.govNCT04587167. Registered on October 14, 2020.

Support for HPV vaccine school-entry requirements in the United States: The role of exemption policies.

In the United States (U.S.), only five states or territories require human papillomavirus (HPV) vaccination for school attendance, even though almost all U.S. jurisdictions have debated adopting this type of policy. In this U.S. based study, we sought to estimate the level of support for HPV vaccine school-entry requirements with varying exemption policies and documentation procedures to obtain exemptions. Between July and August 2019, we conducted a web-based survey with a national sample of 1,109 U.S. parents of 11- to 17-year-olds. The survey assessed support for four school-entry vaccine requirement policies: without exemption or with exemption for medical, religious or philosophical reasons. Analyses used multivariable logistic regression to assess correlates of support for each policy. Overall, 38% of parents agreed with laws requiring HPV vaccination for school attendance without exemptions. When including exemption provisions, agreement increased to 45% for philosophical reasons, 50% for religious reasons, and 59% for medical reasons. Parents more often agreed on requirements without any exemptions if they were female (OR = 1.37, 95% CI:1.01-1.87), their child had initiated HPV vaccination (OR = 2.05, 95% CI:1.50-2.87), reported high levels of vaccine confidence (OR = 2.41, 95% CI:1.77-3.27), or reported having values similar to those of the people in their community (OR = 1.85, 95% CI:1.39-2.47). Parents more often agreed with requirements that included religious or philosophical exemptions if they reported having values similar to their community or high levels of psychological reactance (all p <.05). Many parents also supported requiring a written notice signed by a health care provider (40%) or religious leader (49%) to obtain a medical or religious exemption, respectively. In conclusion, exemption policies greatly increase parent support of school-entry requirements for HPV vaccination but may decrease their impact in practice. A large number of U.S. parents support strict documentation to obtain exemptions, signaling a promising area of policymaking to strengthen vaccine policies for school attendance.

Pharmacogenomic testing for mental health (Part II): qualitative analysis of early adopter prescriber perceptions.

Aim: We sought to explore how early adopters use pharmacogenomic (PGx) testing for treating depression and attention-deficit/hyperactivity disorder. Patients & methods: Prescribers of the Informed PGx (Progenity, Inc., Ann Arbor, MI 48108, USA) test completed a phone survey assessing use of PGx testing for different scenarios. We conducted a qualitative thematic text analysis of transcribed audio recordings of open-ended responses (n = 62). Results: PGx testing was used when treating multiple comorbidities or resistant disease, and to ease patients' concerns with future therapy. Use of PGx testing is influenced by insurance coverage, interpretability of results and results turnaround time. Conclusion: Prescribers used PGx tests to modify medications for complex patients with depression, attention-deficit/hyperactivity disorder and other disorders to alleviate concerns related to adverse effects and lack of effectiveness.

Using Pharmacogenomic Testing in Primary Care: Protocol for a Pilot Randomized Controlled Study.

BACKGROUND: Antidepressants are used by primary care providers to treat a variety of conditions, including (but not limited to) depression and anxiety. A trial-and-error approach is typically used to identify effective therapy, as treatment efficacy and safety can vary based on the response, which is affected by certain gene types. Pharmacokinetic pharmacogenomic (PGx) testing provides phenotypic classification of individuals as poor, intermediate, extensive, and ultrarapid CYP450 metabolizers, providing information for optimal drug selection. OBJECTIVE: The objective of this pilot study is to examine the feasibility, acceptability, and preliminary effectiveness of PGx testing when used after starting a new antidepressant medication. METHODS: We are conducting a pilot study with physicians from 6 Department of Family Medicine clinics at the University of Michigan who are willing to use PGx test results to manage antidepressant medication use. From enrolled physicians, patients were recruited to participate in a 6-month randomized, wait-list controlled trial in which patient participants newly prescribed an antidepressant had PGx testing and were randomized equally to have the results released to their primary care physician as soon as results were available or after 3 months. Patients were excluded if they had been taking the antidepressant for more than 4 weeks or if they had undergone PGx testing in the past. Physician participants completed a baseline survey to assess demographics, as well as knowledge, feasibility, and acceptability of PGx testing for this population. At the conclusion of the study, physician participants will complete a survey to assess knowledge, satisfaction, feasibility, acceptability, perceived effectiveness, and barriers to widespread adoption of PGx testing. Patient participants will complete a baseline, 3-month, and 6-month assessment, and control patient participants will have an additional 9-month assessment. Data collected will include the reason for antidepressant use, self-reported medication adherence, side effects, patient health questionnaire 8-item depression scale, generalized anxiety disorder 7-item scale, 12-Item Short-Form Health Survey, work status or changes, and physician and emergency department visits. PGx knowledge and perceptions (including acceptability and feasibility) as well as demographic information will also be obtained. RESULTS: We recruited 23 physician participants between November 2017 and January 2019, and 52 patient participants between January 2018 and April 2019. Currently, all physician and patient participants have been recruited, and we expect data collection to conclude in January 2020. CONCLUSIONS: This study will examine the preliminary effectiveness of PGx testing after treatment initiation and determine the feasibility and acceptability of PGx testing for use in primary care. Through this study, we expect to demonstrate the benefit of PGx testing and lay the foundation for translating this approach into use within primary care. TRIAL REGISTRATION: ClinicalTrials.gov NCT03270891; https://clinicaltrials.gov/ct2/show/NCT03270891. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/13848.

Perceived risk of cervical cancer in Appalachian women.

OBJECTIVE: To examine perceptions of cervical cancer risk in elevated-risk Appalachians. METHODS: Appalachian women (n=571) completed interviews examining self-regulation model factors relevant to perceived risk of cervical cancer. RESULTS: Women with good/very good knowledge of cervical cancer, greater worry, and history of sexually transmitted infection had higher odds of rating their perceived risk as somewhat/much higher than did other women. Former smokers, compared to never smokers, had lower risk perceptions. CONCLUSIONS: Self-regulation model factors are important to understanding perceptions of cervical cancer risk in underserved women. The relationship of smoking and worry to perceived risk may be a target for intervention.