Human Papillomavirus Vaccines
Conditions
Keywords
Implementation Strategy, Quality Improvement
Brief summary
Washington University will evaluate the effectiveness of a multi-component implementation strategy to increase use of HPV vaccine in primary care practices.
Detailed description
The investigators at Washington University will complete a cluster-randomized trial to evaluate the effectiveness of a multi-component implementation strategy (the intervention) to increase use of the HPV vaccine according to CDC guidelines. The unit of randomization is a community-based, primary care pediatric practice. Twenty practices will be randomized into two groups, the intervention group (n=10) or a wait-list control group (n=10). The intervention will be implemented over 2-years and includes: 1) an educational video for providers; 2) audit and feedback of vaccine coverage; 3) a communication strategy; and 4) practice facilitation. The primary outcome of HPV vaccination by age 13 will be assessed at 24 months, and at 36 months to assess if change is sustained.
Interventions
Practice facilitation to support quality improvement methods to effect practice change to develop a sustainable HPV vaccine delivery system.
OTHEREducation
An educational video to increase the provider's knowledge about guideline recommendations and patient and practice benefits of vaccination by age 13.
OTHERAudit and Feedback
Audit and feedback of vaccine coverage to increase motivation to engage in practice change.
A communication strategy to improve the provider's communication skills and their self-efficacy to address parental hesitation.
Sponsors
National Cancer Institute (NCI)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Practices: * Community-based pediatric primary care practices with 2 or more providers. * Providers who deliver wellness care to preteens and adolescents. * Willingness to participate in the practice facilitator-guided QI process. Providers: * Providers who deliver wellness care to preteens and adolescents. * Willingness to complete study questionnaires. * Willingness to participate in the practice facilitator-guided QI process.
Exclusion criteria
* Practices and providers may be excluded at the discretion of the PI.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initiation of the HPV Vaccine 2-dose Series. | 24 months | The proportion of eligible preteens who initiate the HPV vaccine before their 13th birthday, at 24 months, post randomization |
| Completion of the HPV Vaccine 2-dose Series. | 24 months | The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 24 months, post randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustainability of the Intervention Benefit for Initiation of the HPV Vaccine. | 36 months | The proportion of eligible preteens who receive the 1st dose of HPV vaccine before their 13th birthday at 36 months, post randomization |
| Sustainability of the Intervention Benefit for Completion of the HPV Vaccine. | 36 months | The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 36 months, post randomization |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group (24 Months Post-randomization) Practices randomly assigned to this arm will receive the multi-component intervention. | 2,151 |
| Wait List Control Group (24 Months Post-randomization) Practices randomly assigned to this arm will be offered the intervention in the last two years of the study. | 1,615 |
| Intervention Group (36 Months Post-randomization) Practices randomly assigned to this arm will receive the multi-component intervention. | 2,211 |
| Wait List Control Group (36 Months Post-randomization) Practices randomly assigned to this arm will be offered the intervention in the last two years of the study. | 1,410 |
| Total | 7,387 |
Baseline characteristics
| Characteristic | Intervention Group (24 Months Post-randomization) | Wait List Control Group (24 Months Post-randomization) | Intervention Group (36 Months Post-randomization) | Wait List Control Group (36 Months Post-randomization) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 2151 Participants | 1615 Participants | 2211 Participants | 1410 Participants | 7387 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants | 63 Participants | 32 Participants | 23 Participants | 150 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1634 Participants | 1226 Participants | 1692 Participants | 1128 Participants | 5680 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 485 Participants | 326 Participants | 487 Participants | 259 Participants | 1557 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 60 Participants | 19 Participants | 40 Participants | 25 Participants | 144 Participants |
| Race (NIH/OMB) Black or African American | 92 Participants | 446 Participants | 120 Participants | 384 Participants | 1042 Participants |
| Race (NIH/OMB) More than one race | 30 Participants | 45 Participants | 15 Participants | 35 Participants | 125 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 3 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 454 Participants | 213 Participants | 471 Participants | 144 Participants | 1282 Participants |
| Race (NIH/OMB) White | 1514 Participants | 890 Participants | 1560 Participants | 819 Participants | 4783 Participants |
| Region of Enrollment United States | 2151 participants | 1615 participants | 2211 participants | 1410 participants | 7387 participants |
| Sex/Gender, Customized Female | 1037 Participants | 818 Participants | 1108 Participants | 701 Participants | 3664 Participants |
| Sex/Gender, Customized Male | 1113 Participants | 797 Participants | 1103 Participants | 704 Participants | 3717 Participants |
| Sex/Gender, Customized Unknown | 1 Participants | 0 Participants | 0 Participants | 5 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2,151 | 0 / 1,615 | 0 / 2,211 | 0 / 1,410 |
| other Total, other adverse events | 0 / 2,151 | 0 / 1,615 | 0 / 2,211 | 0 / 1,410 |
| serious Total, serious adverse events | 0 / 2,151 | 0 / 1,615 | 0 / 2,211 | 0 / 1,410 |
Outcome results
Primary
Completion of the HPV Vaccine 2-dose Series.
The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 24 months, post randomization.
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Completion of the HPV Vaccine 2-dose Series. | 1135 Participants |
| Wait List Control Group | Completion of the HPV Vaccine 2-dose Series. | 809 Participants |
Primary
Initiation of the HPV Vaccine 2-dose Series.
The proportion of eligible preteens who initiate the HPV vaccine before their 13th birthday, at 24 months, post randomization
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Initiation of the HPV Vaccine 2-dose Series. | 1723 Participants |
| Wait List Control Group | Initiation of the HPV Vaccine 2-dose Series. | 1219 Participants |
Secondary
Sustainability of the Intervention Benefit for Completion of the HPV Vaccine.
The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 36 months, post randomization
Time frame: 36 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Sustainability of the Intervention Benefit for Completion of the HPV Vaccine. | 1279 Participants |
| Wait List Control Group | Sustainability of the Intervention Benefit for Completion of the HPV Vaccine. | 703 Participants |
Secondary
Sustainability of the Intervention Benefit for Initiation of the HPV Vaccine.
The proportion of eligible preteens who receive the 1st dose of HPV vaccine before their 13th birthday at 36 months, post randomization
Time frame: 36 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Sustainability of the Intervention Benefit for Initiation of the HPV Vaccine. | 1812 Participants |
| Wait List Control Group | Sustainability of the Intervention Benefit for Initiation of the HPV Vaccine. | 1052 Participants |