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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-08529 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 10600 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Communication Intervention | Other | Undergo communication strategy intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Parth Shah | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | PROMOTE Key Informant Interviews: Parents/Guardians (Aim 1) | 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. |
| FG001 | PROMOTE Key Informant Interviews: Pharmacy Staff (Aim 1) | 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 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. |
| FG002 | PROMOTE Intervention (Aim 2) | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PROMOTE Key Informant Interviews (Aim 1) |
| |||||||||||||
| PROMOTE Intervention (Aim 2) |
|
Participants in the two Aim 1 arms are English-speaking pharmacy staff and parents or guardians of children aged 9-17. Participants in the Aim 2 arm are English-speaking pharmacy staff at enrolled sites participating in a remote, 1-part communication strategy intervention. There is no participant overlap between the groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Up to 6 months after baseline survey and communication training |
|
Adverse events were not collected/assessed.
Adverse events were not collected/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PROMOTE 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Parth Shah | Fred Hutchinson Cancer Center | 2066676120 | pshah@fredhutch.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 5, 2022 | Aug 22, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 5, 2022 | Jan 18, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| ID | Term |
|---|---|
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Communication Skills Training | Other | Undergo communication training sessions |
|
| Healthcare Activity | Behavioral | Participate in interview |
|
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| Healthcare Activity | Behavioral | Undergo environmental scan |
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| Survey Administration | Other | Complete survey |
|
| 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. | 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. | 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. | Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention) |
| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Role | Count of Participants | Participants |
|
| Years in practice (pharmacist only) | This measure was only assessed for participants identifying as pharmacists. | Mean | Standard Deviation | years |
|
| Years working in pharmacy (other personnel) | This measure of was only assessed for Aim 2 participants. | Mean | Standard Deviation | years |
|
| OG000 | PROMOTE Intervention (Aim 2) | 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. |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Up to 6 months after baseline survey and communication training |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Up to 6 months after baseline survey and communication training |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention) |
|
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|
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| 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. | 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. | Posted | Number | sum of vaccine doses administered | Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention) |
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| 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. | 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. | Posted | Number | sum of vaccine doses administered | Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention) |
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|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| personal interactions (post) |
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| goal setting (pre) |
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| goal setting (post) |
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| HPV vaccine hesitancy (pre) |
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| HPV vaccine hesitancy (post) |
|