Testing an HPV Vaccine Decision Aid for 27- to 45-Year-Old Adults in the United States: A Randomized Trial.

Background: In the United States, human papillomavirus (HPV) vaccination among 27- to 45-y-olds (mid-adults) is recommended based on shared clinical decision making with a health care provider. We developed a patient decision aid tool to support the implementation of this mid-adult HPV vaccination guideline. The purpose of this study was to evaluate the effect of a patient decision aid tool for HPV vaccination, HPV DECIDE, compared with an information fact sheet among mid-adults who have not received the HPV vaccine.

Method: Participants were recruited between December 2023 and January 2024. We used a randomized Solomon, 4-group, pretest/posttest design with mid-adults aged 27 to 45 y who were unvaccinated for HPV and balanced based on sex (n = 612). The primary outcome was decisional conflict. Intermediate outcomes included knowledge, behavioral expectancies, self-efficacy, and perceived risk. Variables were measured using validated scales. Pretest sensitization was not present; intervention and control groups were compared. Fixed-effects inverse-variance weighting was used to pool effect estimates and determine meta-analytic statistical significance across tests with and without pretest controls.

Results: Participants in the intervention group had significantly lower total decisional conflict scores (B = -3.58, P = 0.007) compared with the control group. Compared with the control group, participants in the intervention group showed higher knowledge (B = 0.48, P = 0.020), greater intention to receive (B = 0.196, P = 0.049) and discuss the HPV vaccine (B = 0.324, P ≤ 0.001), and greater self-efficacy about HPV vaccine decision making (B = 3.28, P = 0.043). There were no statistically significant results for perceived risks of HPV infection.

Conclusions: The HPV DECIDE tool for mid-adult HPV vaccination shows promise for immediate reductions in decisional conflict and improvement in knowledge, intentions, and self-efficacy about the HPV vaccine. Future studies are warranted to evaluate the effectiveness of this patient decision aid tool in real-world settings.

Highlights: Shared clinical decision making is recommended for HPV vaccination with mid-adults.A patient decision aid for HPV vaccination reduced decisional conflict for mid-adults.The HPV vaccine patient decision aid was acceptable to mid-adults.