Communication Strategy to PROMOTE HPV Vaccination in Pharmacies: PROMOTE Study

OUTLINE:

AIM 1: Participants participate in a semi-structured interview in-person or via phone over 90 minutes about barriers/facilitators of HPV vaccination in pharmacies.

AIM 2: Participants provide feedback on survey questions via cognitive testing. Pharmacy staff complete an online survey over 10-15 minutes to assess the acceptability, appropriateness, and feasibility of providing HPV vaccination to children aged 9-17 in their pharmacies. Pharmacy staff then attend two, 60-minute vaccine communication training sessions, consisting of identifying vaccine-eligible children and recommending HPV and other vaccines. Pharmacy staff employ the new communication strategy in their pharmacy up to 6 months, and then complete an online survey over 10-15 minutes.

Pharmacies of which the pharmacy staff participants work undergo an environmental scan to characterize the pharmacy's environment, vaccination workflow, and team dynamics.

Additionally, pharmacy audits will be conducted from the pharmacy electronic records to assess adoption of HPV vaccination, and the impact of the communication strategy on adoption of other adolescent vaccines (e.g., tetanus, diphtheria, acellular pertussis; meningococcal conjugate; influenza).

• Communication Intervention (Other): Undergo communication strategy intervention
• Communication Skills Training (Other): Undergo communication training sessions
• Healthcare Activity (Behavioral), also known as Health Care Activity, Healthcare: Participate in interview
• Healthcare Activity (Behavioral), also known as Health Care Activity, Healthcare: Undergo environmental scan
• Survey Administration (Other): Complete survey

Primary outcomes

• Acceptability of Providing HPV Vaccination to Children and of the Proposed Communication Strategy to Support HPV Vaccination [Up to 6 months after baseline survey and communication training]: The survey was developed by study researchers based upon the Implementation Outcomes Questionnaire (IOQ) (Livet M, et al. 2021.). It was used to capture change of participants' perceptions pre/post training. There are five answers to each survey question and each answer is given a score from 1 to 5, with 1 being strongly disagree and 5 being strongly agree. Higher numerical scores on the 5-point Likert scale indicate greater level of agreement that the intervention was acceptable to support HPV vaccination delivery to children ages 9-17. We calculated the average scale based on numeric scores. For questions that were asked in a reverse fashion, we reversed the score accordingly.
• Appropriateness of Providing HPV Vaccination to Children and of the Proposed Communication Strategy to Support HPV Vaccination [Up to 6 months after baseline survey and communication training]: The survey was developed by study researchers based upon the Implementation Outcomes Questionnaire (IOQ) (Livet M, et al. 2021.). It was used to capture change of participants' perceptions pre/post training. There are five answers to each survey question and each answer is given a score from 1 to 5, with 1 being strongly disagree and 5 being strongly agree. Higher numerical scores on the 5-point scale indicate greater level of agreement that the intervention was appropriate to support HPV vaccination delivery to children ages 9-17. We calculated the average scale based on numeric scores. For questions that were asked in a reverse fashion, we reversed the score accordingly.
• Feasibility of Providing HPV Vaccination to Children and of the Proposed Communication Strategy to Support HPV Vaccination [Up to 6 months after baseline survey and communication training]: The survey was developed by study researchers based upon the Implementation Outcomes Questionnaire (IOQ) (Livet M, et al. 2021.). It was used to capture change of participants' perceptions pre/post training. There are five answers to each survey question and each answer is given a score from 1 to 5, with 1 being strongly disagree and 5 being strongly agree. Higher numerical scores on the 5-point scale indicate greater level of agreement that the intervention was feasible to support HPV vaccination delivery to children ages 9-17. We calculated the average scale based on numeric scores. For questions that were asked in a reverse fashion, we reversed the score accordingly.
• Self-efficacy of Providing HPV Vaccination [Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention)]: The survey was developed by study researchers and included validated measures from a 31-item medication therapy management (MTM) efficacy scale (Martin B, et al. 2010) and a statewide survey of healthcare providers (McRee AL, et.al. 2014). It was used to capture change of participants' perceptions pre/post training. For this outcome there were five answers to each survey question reflecting how confident the respondent is in performing tasks related to providing HPV vaccinations to children, and each answer is given a score from 1 to 5, with 1 being not at all confident/strongly disagree and 5 being completely confident/strongly agree. Higher numerical scores on the 5-point scale reflect higher levels of self-efficacy or confidence in personal ability to complete vaccination process actions. We calculated the average scale based on numeric scores.
• Adoption of HPV Vaccination [Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention)]: Will conduct audits of the pharmacy electronic records to assess adoption of HPV vaccination, measured as the total sum (count) of HPV vaccinations administered by all eligible Aim 2 pharmacists.
• Adoption of Other Adolescent Vaccines [Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention)]: Will conduct audits of the pharmacy electronic records to assess adoption of other adolescent vaccination, measured as the total sum (count) of adolescent vaccinations administered by all eligible Aim 2 pharmacists.

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* AIM 1 (PARENTS/GUARDIANS): Individuals with children between the ages of 9-17 in their care who are English speakers, live in Washington state, and have access to a telephone or computer with internet access (up to 12 parents)
* AIM 1 (PHARMACY STAFF): Employed at a Western Washington Bartell Drugs pharmacy sites and have access to a telephone or computer with internet access
* AIM 2: Pharmacy staff employed at up to four independent pharmacies in western Washington state who speak English and have access to a computer with internet access

Exclusion Criteria:

* AIM 1 (PARENTS/GUARDIANS): Those who object to having their interview audio recorded
* AIM 1 and AIM 2 (PHARMACY STAFF): Floaters/per diem. Those who object to having their interview audio recorded

Participant flow

Outcome results

• Acceptability of Providing HPV Vaccination to Children and of the Proposed Communication Strategy to Support HPV Vaccination (Primary), Mean, units on a scale: PROMOTE Intervention (Aim 2) 4.1 +/- 0.664
• Appropriateness of Providing HPV Vaccination to Children and of the Proposed Communication Strategy to Support HPV Vaccination (Primary), Mean, units on a scale: PROMOTE Intervention (Aim 2) 4.0 +/- 0.502
• Feasibility of Providing HPV Vaccination to Children and of the Proposed Communication Strategy to Support HPV Vaccination (Primary), Mean, units on a scale: PROMOTE Intervention Aim 2 4.1 +/- 0.529
• Self-efficacy of Providing HPV Vaccination (Primary), Mean, units on a scale: PROMOTE Intervention (Aim 2) 4.2 +/- 0.893
• Adoption of HPV Vaccination (Primary), Number, sum of vaccine doses administered: PROMOTE Intervention 2
• Adoption of Other Adolescent Vaccines (Primary), Number, sum of vaccine doses administered: PROMOTE Intervention 75

Adverse events

Time frame: Adverse events were not collected/assessed.

• Study Protocol and Statistical Analysis Plan (PDF, 2022-12-05)
• Informed Consent Form (PDF, 2022-12-05)

• Parth Shah, Principal investigator, Fred Hutch/University of Washington Cancer Consortium

NIH grants: P30CA015704