High and Low Resource Interventions to Promote HPV Vaccines
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|ClinicalTrials.gov Identifier: NCT03824093|
Recruitment Status : Completed
First Posted : January 31, 2019
Last Update Posted : January 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Human Papilloma Virus Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination Meningitis, Meningococcal Communication Satisfaction||Behavioral: AFIX Only Behavioral: AFIX+ Provider Communication Training||Not Applicable|
Significance: Human Papillomavirus (HPV) is the most common sexually transmitted infection in the United States with an estimated 14 million new infections each year. While most HPV infections resolve without any symptoms or signs of infection, some HPV infections can lead to genital warts and cancer. Every year, more than 30,000 people are affected by an HPV-related cancer, including cervical, oropharyngeal, vaginal and anal cancers. Because most adults will become infected with HPV at some point in their lives, the CDC recommends routine vaccination for girls aged 11-26 and boys aged 11-21. While vaccines to prevent HPV infection have been widely available for more than a decade nearly 38% of eligible girls and 50% of eligible boys have not initiated the HPV vaccine series and more than 70% of boys and 50% of girls have not completed the full vaccine series. Rates of HPV vaccination are significantly lower than rates for other adolescent recommended vaccines including, tetanus, diptheria, and acellular pertussis (Tdap), and meningococcal conjugate (MenACWY), which range from 81 to 86 percent. There are many factors that contribute to less than optimal HPV vaccination rates but chief among them is lack of a strong provider recommendation to initiate and complete the HPV vaccine series.
Innovation: This study will be the first randomized controlled trial comparing the effectiveness of an AFIX intervention vs. an AFIX intervention combined with a provider "nudge" that includes a brief communication skills training and commitment messaging displays to increase HPV vaccination rates in pediatric outpatient settings.
Approach: 200 eligible parents (or caregivers) of adolescents between the ages of 11 and 18 will be enrolled and exposed to one of the interventions based on their clinic location. Parents will be recruited from the Children's Mercy Hospital Primary Care Clinic (CMH PCC) and Cradle Thru College Care Pediatrics in Kansas City, MO, Preferred Pediatrics in Lee's Summit, MO, and Cass County Pediatrics in Belton,MO. Practices will be randomized to receive either an in-person AFIX assessment or an in-person AFIX assessment combined with a brief, provider communication training and adolescent vaccine commitment poster displays. The primary outcome of this study is HPV vaccination rates. A secondary outcome is parent ratings of satisfaction with their child's visit with the health care provider. Data will be collected via a tablet computer administered RedCap survey in the exam room immediately following the child's visit.
Public Health Impact: This study could have a significant public health impact and contribute to meeting the Healthy People 2020 goals to reduce vaccine preventable infections by increasing vaccination rates in the pediatric population.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||225 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||Practices will be randomly assigned to the AFIX only or AFIX+ communication training study arms. Both groups will receive identical AFIX consultations, but only practices assigned to the AFIX+ communication training arm will receive brief, provider communication training and commitment poster displays. Once practices have been randomized, parents of adolescent patients will be exposed to one of the interventions based on their practice location. Participants will not be informed of their practice's study arm.|
|Primary Purpose:||Health Services Research|
|Official Title:||High and Low Resource Interventions to Promote HPV Vaccines|
|Actual Study Start Date :||July 1, 2018|
|Actual Primary Completion Date :||May 6, 2020|
|Actual Study Completion Date :||May 6, 2020|
Active Comparator: AFIX Only
Practices enrolled in the AFIX only arm will receive an in-person AFIX consultation that includes assessment of current HPV vaccination rates and feedback on strategies to increase vaccination rates.
Behavioral: AFIX Only
The intervention will include an in-person AFIX assessment of the practice's adolescent vaccination rates.
Active Comparator: AFIX+ Provider Communication Training
Practices enrolled in the AFIX+ Provider Training arm will receive an in-person AFIX consultation along with a brief communication training for providers and poster and brochure displays in clinic waiting and exam rooms.
Behavioral: AFIX+ Provider Communication Training
The intervention will include an in-person AFIX assessment of the practice's adolescent vaccination rates along with communication training for providers and poster and brochure displays.
- HPV vaccination rates [ Time Frame: 18 months ]Practice and provider level HPV vaccination rates will be collected from patient de-identified claims data.
- Parent Satisfaction [ Time Frame: 18 months ]Parent satisfaction with visit will be collected using validated measures on tablet computers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824093
|United States, Missouri|
|Children's Mercy Hospital Kansas City|
|Kansas City, Missouri, United States, 64108|