Human Papillomavirus InfectionPROMOTENCT04660331
Communication Strategy to PROMOTE HPV Vaccination in Pharmacies: PROMOTE Study
A study testing Communication Intervention, Communication Skills Training and Healthcare Activity in people with Human Papillomavirus Infection, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Communication Intervention, Communication Skills Training and Healthcare Activity
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: PROMOTE Pilot Study: Pharmacy Multimodal Communication Strategy to Promote HPV Vaccination
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.
Read the 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).
- Conditions
- Human Papillomavirus Infection
- Being tested
- Communication Intervention, Communication Skills Training, Healthcare Activity, Survey Administration
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication InterventionOther
Undergo communication strategy intervention
Communication Skills TrainingOther
Undergo communication training sessions
Healthcare ActivityBehavioural
Also called Health Care Activity, Healthcare
Participate in interview
Healthcare ActivityBehavioural
Also called Health Care Activity, Healthcare
Undergo environmental scan
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| Aim I (interview) | Experimental | Participants participate in a semi-structured interview in-person or via phone over 90 minutes about barriers/facilitators of HPV vaccination in pharmacies. Receives: Behavioral: Healthcare Activity |
| Aim 2 (survey, training, communication intervention, and environmental scan) | Experimental | 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. Receives: Other: Communication Intervention; Other: Communication Skills Training; Behavioral: Healthcare Activity; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months after baseline survey and communication training
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.
Measured: Up to 6 months after baseline survey and communication training
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.
Measured: Up to 6 months after baseline survey and communication training
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.
Measured: Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention)
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.
Measured: Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention)
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.
Measured: Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Feb 2021
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Parth Shah, Fred Hutchinson Cancer Center
- Investigators
- Parth Shah, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660331
- Sponsor's protocol ID
- RG1007825
- Other IDs
- NCI-2020-08529, 10600, P30CA015704
- Acronym
- PROMOTE
- Status last verified
- Oct 2024
- First submitted
- 16 Nov 2020
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROMOTE Pilot Study: Pharmacy Multimodal Communication Strategy to Promote HPV Vaccination
- ClinicalTrials.gov ID
- NCT04660331
- Acronym / sponsor ID
- PROMOTE / RG1007825
- Conditions
- Human Papillomavirus Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Posted 9 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim I (interview) | Experimental | Behavioral: Healthcare ActivityParticipants participate in a semi-structured interview in-person or via phone over 90 minutes about barriers/facilitators of HPV vaccination in pharmacies. |
| Aim 2 (survey, training, communication intervention, and environmental scan) | Experimental | Other: Communication Intervention, Other: Communication Skills Training, Behavioral: Healthcare Activity, Other: Survey AdministrationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication InterventionUndergo communication strategy intervention | Other | Aim 2 (survey, training, communication intervention, and environmental scan) |
| Communication Skills TrainingUndergo communication training sessions | Other | Aim 2 (survey, training, communication intervention, and environmental scan) |
| Healthcare ActivityAlso: Health Care Activity, HealthcareParticipate in interview | Behavioural | Aim I (interview) |
| Healthcare ActivityAlso: Health Care Activity, HealthcareUndergo environmental scan | Behavioural | Aim 2 (survey, training, communication intervention, and environmental scan) |
| Survey AdministrationComplete survey | Other | Aim 2 (survey, training, communication intervention, and environmental scan) |
Primary outcome
Acceptability of Providing HPV Vaccination to Children and of the Proposed Communication Strategy to Support HPV Vaccination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parth Shah principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication Intervention, Communication Skills Training and Healthcare Activity in people with Human Papillomavirus Infection, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Providing HPV Vaccination to Children and of the Proposed Communication Strategy to Support HPV Vaccination (time frame: Up to 6 months after baseline survey and communication training). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.