Human Papillomavirus Infection
Conditions
Brief summary
This trial investigates how a communication strategy works in increasing human papillomavirus (HPV) vaccines in community pharmacies among adolescents. Although pharmacies are vaccine providers, low vaccination rates are persistent as a result of low awareness of pharmacy services and poor engagement by pharmacy staff with adolescents about vaccines. The purpose of this study is to test a communication strategy that identifies vaccine-eligible children and teaches pharmacy staff how to effectively communicate with them about HPV vaccination in order to increase HPV vaccination rates.
Detailed description
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).
Interventions
OTHERSurvey Administration
Complete survey
OTHERCommunication Intervention
Undergo communication strategy intervention
Undergo communication training sessions
BEHAVIORALHealthcare Activity
Participate in interview
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PROMOTE Aim 1 Interviews: Pharmacy Staff Participants in the key informant interview phase (Aim 1) whose goal was to adapt an existing electronic forecasting system and behavioral counseling framework to match barriers and facilitators to HPV vaccination in pharmacies, administered by the Principal Investigator. Participants are pharmacy staff and in Western Washington.
Key informant interviews were conducted with the participants described above using semi-structured interview techniques and guided by theoretical domain framework.
Interviews were conducted by trained study staff members over the phone and lasted approximately 90 minutes. The interview included demographic survey questions. | 11 |
| PROMOTE Aim 1 Interviews: Parents Participants in the key informant interview phase (Aim 1) whose goal was to adapt an existing electronic forecasting system and behavioral counseling framework to match barriers and facilitators to HPV vaccination in pharmacies, administered by the Principal Investigator. Participants are parents/guardians of children aged 9-17 in Western Washington.
Key informant interviews were conducted with the participants described above using semi-structured interview techniques and guided by theoretical domain framework.
Interviews were conducted by trained study staff members over the phone and lasted approximately 90 minutes. The interview included demographic survey questions. | 13 |
| PROMOTE Aim 2 Intervention Participants in the intervention group an adapted multi-modal communication strategy to support HPV vaccination in pharmacies administered by the Principal Investigator. Participants are pharmacy staff in Western Washington.
The intervention consists of a multi-modal strategy that includes adapting an existing electronic forecasting system to identify vaccine eligible children who are due for vaccination and communication training for pharmacy staff to effectively recommend HPV vaccination.
The intervention was delivered in one 60-minute session recorded and available online as a continuing education training that covered five modules: 1) educational overview of adolescent vaccination, 2) overview of the communication strategy, 3) process for integrating the strategy into clinical workflow, 4) training on communication strategy, and 5) pharmacy staff practice of the strategy. | 18 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| PROMOTE Intervention (Aim 2) | Lost to Follow-up | 0 | 0 | 5 |
Baseline characteristics
| Characteristic | PROMOTE Aim 1 Interviews: Pharmacy Staff | Total | PROMOTE Aim 2 Intervention | PROMOTE Aim 1 Interviews: Parents |
|---|---|---|---|---|
| Age, Continuous | 31 years STANDARD_DEVIATION 8.6 | 39.89 years STANDARD_DEVIATION 7.7 | 44.17 years STANDARD_DEVIATION 13.01 | 44.5 years STANDARD_DEVIATION 5.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 13 Participants | 3 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 29 Participants | 15 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 11 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 27 Participants | 13 Participants | 9 Participants |
| Region of Enrollment United States | 11 participants | 42 participants | 18 participants | 13 participants |
| Role Parents | 0 Participants | 13 Participants | 0 Participants | 13 Participants |
| Role Pharmacist | 0 Participants | 10 Participants | 10 Participants | 0 Participants |
| Role pharmacist-in-charge | 3 Participants | 3 Participants | 0 Participants | 0 Participants |
| Role Pharmacy assistant | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Role pharmacy director | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Role Pharmacy technician | 4 Participants | 9 Participants | 5 Participants | 0 Participants |
| Role Staff pharmacist | 4 Participants | 4 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Sex, Female | 6 Participants | 30 Participants | 11 Participants | 13 Participants |
| Sex/Gender, Customized Sex, Male | 5 Participants | 11 Participants | 6 Participants | 0 Participants |
| Sex/Gender, Customized Sex, Unknown | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Years in practice (pharmacist only) | 7.4 years STANDARD_DEVIATION 7 | 13.31 years STANDARD_DEVIATION 8.36 | 19.22 years STANDARD_DEVIATION 17.13 | — |
| Years working in pharmacy (other personnel) | — | 11.88 years STANDARD_DEVIATION 6.83 | 11.88 years STANDARD_DEVIATION 6.83 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Acceptability of Providing HPV Vaccination to Children and of the Proposed Communication Strategy to Support HPV Vaccination
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.
Time frame: Up to 6 months after baseline survey and communication training
Population: This outcome measure was only assessed for Aim 2 participants. Only Aim 2 participants who completed all required Aim 2 protocol activities were assessed for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROMOTE Intervention (Aim 2) | Acceptability of Providing HPV Vaccination to Children and of the Proposed Communication Strategy to Support HPV Vaccination | 4.1 units on a scale | Standard Deviation 0.664 |
Primary
Adoption of HPV Vaccination
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.
Time frame: Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention)
Population: vaccine administration data for pharmacists who were participating in the study, pre and post-intervention. This outcome measure was only assessed for Aim 2 participants. Only Aim 2 participants who completed all required Aim 2 protocol activities were assessed for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PROMOTE Intervention (Aim 2) | Adoption of HPV Vaccination | pre-intervention | 2 sum of vaccine doses administered |
| PROMOTE Intervention (Aim 2) | Adoption of HPV Vaccination | post-intervention | 20 sum of vaccine doses administered |
Primary
Adoption of Other Adolescent Vaccines
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.
Time frame: Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention)
Population: vaccines administered by pharmacists participating in the study, pre- and post-intervention. This outcome measure was only assessed for Aim 2 participants. Only Aim 2 participants who completed all required Aim 2 protocol activities were assessed for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PROMOTE Intervention (Aim 2) | Adoption of Other Adolescent Vaccines | post-intervention | 145 sum of vaccine doses administered |
| PROMOTE Intervention (Aim 2) | Adoption of Other Adolescent Vaccines | pre-intervention | 75 sum of vaccine doses administered |
Primary
Appropriateness of Providing HPV Vaccination to Children and of the Proposed Communication Strategy to Support HPV Vaccination
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.
Time frame: Up to 6 months after baseline survey and communication training
Population: This outcome measure was only assessed for Aim 2 participants. Only Aim 2 participants who completed all required Aim 2 protocol activities were assessed for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROMOTE Intervention (Aim 2) | Appropriateness of Providing HPV Vaccination to Children and of the Proposed Communication Strategy to Support HPV Vaccination | 4.0 units on a scale | Standard Deviation 0.502 |
Primary
Feasibility of Providing HPV Vaccination to Children and of the Proposed Communication Strategy to Support HPV Vaccination
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.
Time frame: Up to 6 months after baseline survey and communication training
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROMOTE Intervention (Aim 2) | Feasibility of Providing HPV Vaccination to Children and of the Proposed Communication Strategy to Support HPV Vaccination | 4.1 units on a scale | Standard Deviation 0.529 |
Primary
Self-efficacy of Providing HPV Vaccination
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.
Time frame: Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention)
Population: This outcome measure was only assessed for Aim 2 participants. Only Aim 2 participants who completed all required Aim 2 protocol activities were assessed for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PROMOTE Intervention (Aim 2) | Self-efficacy of Providing HPV Vaccination | vaccine administration tasks (pre) | 4.2 units on a scale | Standard Deviation 0.893 |
| PROMOTE Intervention (Aim 2) | Self-efficacy of Providing HPV Vaccination | vaccine administration tasks (post) | 4.3 units on a scale | Standard Deviation 0.798 |
| PROMOTE Intervention (Aim 2) | Self-efficacy of Providing HPV Vaccination | personal interactions (pre) | 2.8 units on a scale | Standard Deviation 0.83 |
| PROMOTE Intervention (Aim 2) | Self-efficacy of Providing HPV Vaccination | personal interactions (post) | 3.4 units on a scale | Standard Deviation 0.919 |
| PROMOTE Intervention (Aim 2) | Self-efficacy of Providing HPV Vaccination | goal setting (pre) | 2.7 units on a scale | Standard Deviation 0.983 |
| PROMOTE Intervention (Aim 2) | Self-efficacy of Providing HPV Vaccination | goal setting (post) | 3.5 units on a scale | Standard Deviation 1.107 |
| PROMOTE Intervention (Aim 2) | Self-efficacy of Providing HPV Vaccination | HPV vaccine hesitancy (pre) | 2.6 units on a scale | Standard Deviation 0.941 |
| PROMOTE Intervention (Aim 2) | Self-efficacy of Providing HPV Vaccination | HPV vaccine hesitancy (post) | 3.3 units on a scale | Standard Deviation 1.045 |