Educational Intervention for HPV Vaccination
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Roswell Park Cancer Institute
Disqualifiers: Cognitive impairment, Prisoners, others
No Placebo Group
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?
This study evaluates the implementation of evidence based strategies to optimize HPV vaccination in rural primary care settings. Some of the largest disparities in human papillomavirus vaccination (HPVV) rates exist in rural communities, which represent missed opportunities for cancer prevention. Primary care provider visits in these communities serve as a crucial opportunity to communicate the importance of timely vaccination that is essential to effective cancer prevention. This study implements and tests a practice-level intervention (PC TEACH) using practice facilitation of evidence-based strategies to expand reach to rural community-based primary care settings to optimize delivery and increase HPVV rates. PC TEACH program may help rural communities overcome access and awareness factors that keep them from receiving HPVV.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment PC TEACH, Gardasil, Cervarix, Gardasil 9 for HPV vaccination?
Is the HPV vaccine safe for humans?
How does the educational intervention for HPV vaccination differ from other treatments for HPV prevention?
The educational intervention for HPV vaccination is unique because it focuses on increasing awareness and understanding of HPV vaccines like Cervarix and Gardasil, rather than being a vaccine itself. This approach aims to improve vaccination rates by addressing knowledge gaps and misconceptions, which is different from the direct prevention method of administering the vaccines.1112131415
Eligibility Criteria
This trial is for primary care settings in rural areas that are looking to improve their rates of HPV vaccination. The focus is on implementing a program called PC TEACH, which aims to educate and facilitate better vaccination practices.Inclusion Criteria
PARTICIPANTS: English speaking
PRACTICES: Are located in the 20-county target region
PARENT/GUARDIAN SURVEY: Presenting to the participating clinic for an outpatient well child visit or regular checkup
See 9 more
Exclusion Criteria
Prisoners
Unwilling or unable to follow protocol requirements
Adults unable to complete study measures in English
See 2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Implementation
Primary practice providers sites receive PC TEACH intervention over 3.5 hours for 12 months
12 months
Follow-up
Primary care provider sites are monitored for effectiveness of the intervention
3-6 months
Long-term Evaluation
Evaluate the impact of the PC TEACH intervention on HPV vaccination rates over a long-term period
Up to 5 years
Treatment Details
Interventions
- PC TEACH (Cancer Vaccine)
Trial OverviewThe study tests the effectiveness of an educational intervention known as PC TEACH designed to optimize HPV vaccine delivery in rural primary care. It evaluates how well this strategy works in increasing vaccination rates against human papillomavirus.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Health services research (PC TEACH)Experimental Treatment1 Intervention
Primary practice providers sites receive PC TEACH over 3.5 hours for 12 months
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Roswell Park Cancer InstituteBuffalo, NY
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Who Is Running the Clinical Trial?
Roswell Park Cancer InstituteLead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)Collaborator
National Cancer Institute (NCI)Collaborator
References
Evidence-Based Practice Model to Increase Human Papillomavirus Vaccine Uptake: A Stepwise Approach. [2022]To increase uptake of human papillomavirus (HPV) vaccination by implementing a stepwise evidence-based practice model to offer HPV education along with a strong provider recommendation to parents of youth and adolescents.
HPV vaccine communication training in healthcare systems: Evaluating a train-the-trainer model. [2021]Large healthcare systems provide an opportunity to disseminate evidence-based interventions to primary care. We evaluated the impact of a train-the-trainer model in two large systems to disseminate the Announcement Approach Training, which teaches providers to communicate about HPV vaccination more effectively.
Coaching and Communication Training for HPV Vaccination: A Cluster Randomized Trial. [2023]US health departments routinely conduct in-person quality improvement (QI) coaching to strengthen primary care clinics' vaccine delivery systems, but this intervention achieves only small, inconsistent improvements in human papillomavirus (HPV) vaccination. Thus, we sought to evaluate the effectiveness of combining QI coaching with remote provider communication training to improve impact.
The implementation and acceptability of an HPV vaccination decision support system directed at both clinicians and families. [2021]We developed an electronic medical record (EMR)-based HPV vaccine decision support intervention targeting clinicians, (immunization alerts, education, and feedback) and families (phone reminders and referral to an educational website). Through telephone surveys completed by 162 parents of adolescent girls, we assessed the acceptability of the family-focused intervention and its effect on information-seeking behavior, communication, and HPV vaccine decision-making. The intervention was acceptable to parents and 46% remembered receiving the reminder call. Parents reported that the call prompted them to seek out information regarding the HPV vaccine, discuss the vaccine with friends and family, and reach a decision. Parents whose adolescent girls attended practices receiving the clinician-focused intervention were more likely to report that their clinician discussed the HPV vaccine at preventive visits. The results of this study demonstrate the acceptability and potential impact on clinical care of a comprehensive decision support system directed at both clinicians and families.
A quality improvement initiative to increase HPV vaccine rates using an educational and reminder strategy with parents of preteen girls. [2015]A quality improvement project was undertaken to determine if an evidence-based educational brochure and reminder system can increase human papillomavirus (HPV) vaccine uptake and dose completion rates.
OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. [2022]Three licensed human papillomavirus (HPV) vaccines (Cervarix, Gardasil, and Gardasil 9) have been effectively used to prevent infection with oncogenic HPV types; however, many adverse events (AEs) have also been reported following their vaccinations. We assessed AE profiles after receiving the HPV vaccines based on the reported data from Vaccine Adverse Event Reporting System (VAERS).
Postlicensure safety evaluation of human papilloma virus vaccines. [2015]A summary of postlicensure safety information of HPV vaccines from three sources: VigiBase, the global database of WHO's Programme for International Drug Monitoring, the VAERS report on Gardasil and the RIVM report on Cervarix.
[Human papillomavirus vaccine register]. [2013]We carried out an active surveillance of common adverse events occurring among women (9 to 26 years old) receiving human papillomavirus vaccine (Gardasil® and Cervarix®) in 9 Italian Regions.
Real-Life Safety Profile of the 9-Valent HPV Vaccine Based on Data from the Puglia Region of Southern Italy. [2022]Human Papillomavirus (HPV) is responsible for epithelial lesions and cancers in both males and females. The latest licensed HPV vaccine is Gardasil-9®, a 9-valent HPV vaccine which is effective not only against the high-risk HPV types, but also against the ones responsible for non-cancerous lesions. This report describes adverse events following Gardasil-9® administration reported in Puglia, southern Italy, from January 2018 to November 2021. This is a retrospective observational study. Data about the adverse events following immunization (AEFIs) with Gardasil-9® were collected from the Italian Drug Authority database. AEFIs were classified as serious or non-serious accordingly to World Health Organization guidelines, and serious ones underwent causality assessment. During the study period, 266,647 doses of 9vHPVv were administered in Puglia and 22 AEFIs were reported, with a reporting rate (RR) of 8.25 per 100,000 doses. The most reported symptoms were neurological ones (7/22). A total of 5 (22.7%) AEFIs were classified as serious, and 2 of these led to the patient's hospitalization. In one case, permanent impairment occurred. Following causality assessment, only 2 out of 5 serious AEFIs were deemed to be consistently associated with the vaccination (RR: 0.750 per 100,000 doses). The data gathered in our study are similar to the pre-licensure evidence as far as the nature of the AEFIs is concerned. The reporting rate, though, is far lower than the ones described in clinical trials, likely due to the different approach to data collection: in our study, data were gathered via passive surveillance, while pre-marketing studies generally employ active calls for this purpose. Gardasil-9®'s safety profile appears to be favorable, with a low rate of serious adverse events and a risk/benefits ratio pending for the latter.
Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience. [2021]To summarise post-licensure safety surveillance over more than 4 years of routine use of the human papillomavirus-16/18-AS04-adjuvanted vaccine (HPV-16/18 vaccine: Cervarix®, GlaxoSmithKline, Belgium).
Human papillomavirus vaccines. [2015]To review the pharmacology, efficacy, safety, tolerability, and pharmacoeconomics of Cervarix and Gardasil, 2 human papillomavirus (HPV) vaccines.
[Did the recommendation of the French public health council modify the antipapillomavirus vaccines' prescription level?]. [2022]In France, two vaccines are approved for prevention of papillomavirus infection: Cervarix(®) and Gardasil(®). The 17th of December 2010 the French High Committee of Public Hearth changed its recommendation about Cervarix(®) and decided that no scientific element justified a preference using Gardasil(®). This notification was published the 25th of January 2011. Our study aimed to determine whether this decision changed medical prescriptions.
Currently approved prophylactic HPV vaccines. [2022]Cervarix and Gardasil are two prophylactic HPV vaccines designed primarily for cervical cancer prevention. Cervarix is effective against HPV-16, -18, -31, -33 and -45, the five most common cancer-causing types, including most causes of adenocarcinoma for which we cannot screen adequately. Gardasil is effective against HPV-16, 18 and 31, three common squamous cell cancer-causing types. In addition, Gardasil is effective against HPV-6 and -11, causes of genital warts and respiratory papillomatosis. The most important determinant of vaccine impact to reduce cervical cancer is its duration of efficacy. To date, Cervarix's efficacy is proven for 6.4 years and Gardasil's for 5 years.
An update of prophylactic human papillomavirus L1 virus-like particle vaccine clinical trial results. [2022]This review focuses on recent publications of clinical trials of two prophylactic human papillomavirus (HPV) vaccines: Gardasil (Merck & Co., Inc., Whitehouse Station, NJ USA), a quadrivalent vaccine containing L1 virus-like particles (VLPs) of types -6, 11, 16, and 18, and Cervarix (GlaxoSmithKline Biologicals, Rixensart, Belgium), a bivalent vaccine containing VLPs of types -16 and 18. In efficacy trials involving young women, both vaccines produced outstanding efficacy against primary and secondary endpoints associated with the vaccine type HPVs and were highly and consistently immunogenic. Both had excellent safety records and, as expected, the most frequent vaccine-related adverse were mild to moderate injection site sequelae. No evidence of waning protection was observed after four years for endpoints examined ranging from incident infection to cervical intraepithelial neoplasia grade 3 associated with the vaccine type HPVs. Gardasil was also highly efficacious at preventing vaginal/vulvar lesions and genital warts. However, neither vaccine demonstrated therapeutic efficacy against prevalent infections or lesions, regardless of the associated HPV type. Cervarix has shown limited cross-protection against infection with specific closely related types while preliminary results of limited cross-protection have been presented for Gardasil. As expected, more limited efficacy was noted for both vaccines when women with prevalent infection were included or endpoints associated with any HPV type were evaluated. Immunological bridging trials involving adolescent girls and boys were also recently published. For both vaccines, serum VLP antibody levels in girls were non-inferior to those generated in young women and antibody response to Gardasil was also non-inferior in boys. The results of these studies have led to the approval of Gardasil and Cervarix by national regulatory agencies in a number of countries.
[Nine-valent HPV vaccine - new generation of HPV vaccine]. [2018]To evaluate current knowledge about new generation of HPV vaccine - nine-valent vaccine Gardasil9.