Increasing HPV Vaccination Rates Via Educational Interventions in Schools Located Within Cedars-Sinai Catchment Areas
1 other identifier
interventional
3
0 countries
N/A
Brief Summary
Infections with human papillomavirus (HPV) can cause cancer of the cervix, vagina, anus, throat, mouth, and penis. Prevention of these HPV-related cancers could be achieved by immunization with the nonavalent (HPV6,11,16,18,31,33,45,52,58) vaccine currently commercially available. However, in the U.S. approximately only 30% of females and 20% of males in the recommended age group receive the complete, three-dose HPV vaccine. Furthermore, data from the Los Angeles county suggest that HPV vaccination rates among these groups are lower than the national average. Significant barriers clearly remain including knowledge of the vaccine, transportation, number of doses and concern of side effects. Several programs worldwide have shown that schools remain an important venue for education as well as vaccination. In the US, vaccination within schools remains difficult because of many barriers including lack of nursing, insurance reimbursement, and liability. However, the school remains an important access to educational formats. The objective of this study is to evaluate the effectiveness of educational sessions on the HPV vaccine among parents with children of vaccination age as a strategy to increase HPV vaccine uptake, by comparing HPV vaccination rates before and after the intervention. It is hypothesized HPV vaccine uptake will improve through the receipt of educational sessions to the parents of middle school children about the importance of the anti-cancer vaccine, the HPV vaccine. Three schools within Cedars-Sinai catchment area with whom Cedars-Sinai already has a Memorandum of Understanding in place: Berendo, Drew, and Carver Middle Schools in Los Angeles (SPA 4, SPA 6) will be recruited to the study. HPV vaccination rates will be compared before and after the intervention at the end of the observation period (12 months).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started May 2019
Shorter than P25 for early_phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2019
CompletedFirst Posted
Study publicly available on registry
May 17, 2019
CompletedStudy Start
First participant enrolled
May 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedMay 17, 2019
May 1, 2019
1 year
April 3, 2019
May 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
HPV vaccination rates
The primary outcome will be HPV-vaccination rates. Vaccination rates will be compared between baseline and intervention (12 months) between the intervention and control arms. We will conduct at least 50 educational sessions. Briefly, using a two-sided Z-test with unpooled variances with 5% significance.
12 months
Study Arms (2)
Control: Mobile Clinic Only
ACTIVE COMPARATORThe middle school assigned to the control arm will receive a visit by a mobile clinic every 6 months only. The school will follow normal protocol for HPV vaccination awareness. Parents will be made aware of the mobile clinic per normal school newsletters and mailers.
Mobile Clinic plus Educational Sessions
EXPERIMENTALThe middle school assigned to the Mobile Clinic every 6-mos or month plus Educational Sessions arm will receive visitation of a mobile clinic providing free HPV vaccination among other school-related vaccines once every 6-months or once a month. Parents will be made aware of the mobile clinic per normal school newsletters and mailers. In addition, parents will be provided with free weekly educational sessions about the HPV Vaccine as a cancer-prevention effort.
Interventions
This intervention involves the availability of a free mobile clinic operated by Cedar-Sinai Medical Center providing free HPV vaccinations at school campuses.
This intervention involves providing free weekly educational sessions for parents of students at the participant schools pertaining to the HPV Vaccination.
Eligibility Criteria
You may qualify if:
- age 11-13
- student of a participating middle school assigned to Arm 2 or Arm 3
You may not qualify if:
- already received the HPV vaccine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cedars-Sinai Medical Centerlead
- University of California, Los Angelescollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Participants at the Schools, providers of the mobile clinic and the outcomes assessor will be masked from the allocation of participants to the arms to ensure reduction in bias.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 3, 2019
First Posted
May 17, 2019
Study Start
May 28, 2019
Primary Completion
May 27, 2020
Study Completion
June 30, 2020
Last Updated
May 17, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share