Clinical trial NCT03186430: PreTeenVax Evaluation
Official title: A Practice-Provider-Parent-Adolescent Intervention to Increase HPV Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papilloma Virus
Keywords: Vaccine
Vaccination
Behavioral Research
Adolescent
Health Promotion
Public Health
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2017-06-14
Enrollment: 168
Sex: ALL
Minimum age (years): 11
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study uses a cluster-randomized design where six health provider practices are randomized to the intervention or control arm where all participants in the respective practices will receive the behavioral intervention or the standard information.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary research aim of this project is to test the effectiveness of a comprehensive, evidence-based vaccine promotion toolkit implemented in the pediatric healthcare setting on increasing the likelihood that adolescents in Georgia will initiate and complete the Human Papillomavirus (HPV) vaccine series. Secondary research aims include assessing the impact of the comprehensive toolkit on 1) patient and parent knowledge and attitudes regarding HPV vaccine, and 2) provider recommendation of HPV vaccine for males and females in the recommended age range (11-12 years). The intervention toolkit will include evidence-based components aimed at the practice-level, provider-level and parent-level that will be tested through a cluster-randomized trial design. The primary hypothesis is that implementation of the comprehensive vaccine promotion toolkit in the pediatric health care setting will increase the likelihood that an adolescent receives initiates HPV vaccination.

At the initial visit, parents of adolescent patients at participating pediatric practices will complete a brief questionnaire assessing their knowledge, attitudes, and beliefs about adolescent health, including protection against infectious diseases during adolescence. The parents will be contacted again three months later to complete a short follow-up interview on the general health of their adolescent child, immunization status, and attitudes regarding vaccination.

Detailed description: Since the introduction of HPV vaccine, there have been a number of studies examining attitudes and barriers related to HPV vaccine uptake among adolescent and young adult women, parents, and healthcare providers. Through these surveys, a number of distinct themes regarding reasons for not taking the HPV vaccine have emerged, including lack of provider recommendation, lack of awareness about the vaccine and the need for vaccination, concerns about vaccine effectiveness, concerns about vaccine safety, the potential of a vaccine against a sexually transmitted infection to increase promiscuity, cost of the vaccine doses, and the lack of routine adolescent well-care visits. However, many of these studies have used endpoints related to HPV vaccine knowledge or intention to vaccinate rather than actual vaccination uptake. Interventions that use endpoints related to vaccination uptake rather than knowledge or intention to vaccinate, as well as those that address multiple levels of the healthcare decision making process, will be crucial in addressing routine immunization coverage among adolescents. At the end of the evaluation of this intervention package, the researchers of this study hope to have identified a comprehensive and easily scalable "shelf-ready" toolkit aimed at increasing uptake of vaccines that are indicated during adolescence. If successful, this package could easily be implemented on a national level.

In the evaluation study, the researchers will use a cluster-randomized trial design to test whether exposure to the intervention package increases the likelihood of vaccine receipt by an adolescent in a practice randomized to receive the intervention package compared to an adolescent in a practice randomized to the control (standard of care) arm. Participating pediatric practices will be pair-matched based on overall adolescent patient load and historical HPV vaccine uptake and pairs will be randomized to one of two study arms:

1. Intervention arm: The pediatric practices randomized to this arm will receive the comprehensive adolescent vaccine promotion package. Practice physicians and staff will be familiarized with each component, and practices will be instructed to implement each vaccine-promotion component to the best of their ability.
2. Control arm: The pediatric practices randomized to the control arm will not receive the comprehensive vaccine promotion package and will instead be instructed to continue offering their standard adolescent vaccination promotion practices to adolescent patients.

Parents of eligible adolescents at participating practices will be given the opportunity to take part in this study. At the initial visit, parents of adolescent patients will complete a brief questionnaire assessing their knowledge, attitudes, and beliefs about adolescent health, including protection against infectious diseases during adolescence. The parents will be contacted again three months later to complete a short follow-up interview on the general health of their adolescent child, immunization status, and attitudes regarding vaccination.

Eligibility criteria: Parents are enrolled into the study based on their children meeting age and prior vaccination requirements.

Inclusion Criteria:

* Adolescent males and females aged 11-12 years and their parents
* No previous receipt of any HPV vaccine dose by the adolescent

Exclusion Criteria:

* Not English speaking (adolescents and parents)

Primary outcomes:
measure: Initiation of HPV vaccine by adolescents
timeFrame: Month 3 Follow-Up
Secondary outcomes:
measure: Vaccine Confidence Scale score
timeFrame: Month 3 Follow-Up
measure: Provider perception of the intervention
timeFrame: At the end of the study (about 2 years)
Other outcomes:
Locations:
city: Canton
country: United States
facility: DV Pediatrics
state: Georgia
city: Duluth
country: United States
facility: Crescent Pediatrics
state: Georgia
city: Lawrenceville
country: United States
facility: Lawrenceville Pediatrics - Lawrenceville Office
state: Georgia
city: Lithia Springs
country: United States
facility: West Atlanta Pediatrics
state: Georgia
city: Loganville
country: United States
facility: Lawrenceville Pediatrics - Loganville Office
state: Georgia
city: Stone Mountain
country: United States
facility: Northlake Pediatric Associates
state: Georgia
Study officials:
affiliation: Emory University
name: Robert Bednarczyk, PhD
role: PRINCIPAL_INVESTIGATOR
References: