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出境医 / 临床实验 / Increasing HPV Vaccination Rates Via Educational Interventions in Schools Located Within Cedars-Sinai Catchment Areas

Increasing HPV Vaccination Rates Via Educational Interventions in Schools Located Within Cedars-Sinai Catchment Areas

Study Description
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).

Condition or disease Intervention/treatment Phase
Human Papilloma Virus HPV Vaccination Health Education Biological: Mobile Clinic Behavioral: Educational Sessions for Parents Early Phase 1

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Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In this parallel study, three middle schools located in Los Angeles County will be assigned to 2 intervention arms: control (mobile clinic-only every 6-months); intervention (mobile clinic every 6-months or every month PLUS weekly educational sessions for parents).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Increasing HPV Vaccination Rates Via Educational Interventions in Schools Located Within Cedars-Sinai Catchment Areas
Estimated Study Start Date : May 28, 2019
Estimated Primary Completion Date : May 27, 2020
Estimated Study Completion Date : June 30, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Control: Mobile Clinic Only
The 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.
Biological: Mobile Clinic
This intervention involves the availability of a free mobile clinic operated by Cedar-Sinai Medical Center providing free HPV vaccinations at school campuses.

Experimental: Mobile Clinic plus Educational Sessions
The 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.
Biological: Mobile Clinic
This intervention involves the availability of a free mobile clinic operated by Cedar-Sinai Medical Center providing free HPV vaccinations at school campuses.

Behavioral: Educational Sessions for Parents
This intervention involves providing free weekly educational sessions for parents of students at the participant schools pertaining to the HPV Vaccination.

Outcome Measures
Primary Outcome Measures :
  1. HPV vaccination rates [ Time Frame: 12 months ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   11 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 11-13
  • student of a participating middle school assigned to Arm 2 or Arm 3

Exclusion Criteria:

  • already received the HPV vaccine
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Charlene Chang, MA, MPH 6266899335 charlenechang@mednet.ucla.edu
Contact: Adriana C Vidal, PhD 310-423-4972 Adriana.Vidal@cshs.org

Sponsors and Collaborators
Cedars-Sinai Medical Center
University of California, Los Angeles
Tracking Information
First Submitted Date  ICMJE April 3, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date May 17, 2019
Estimated Study Start Date  ICMJE May 28, 2019
Estimated Primary Completion Date May 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
HPV vaccination rates [ Time Frame: 12 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Increasing HPV Vaccination Rates Via Educational Interventions in Schools Located Within Cedars-Sinai Catchment Areas
Official Title  ICMJE Increasing HPV Vaccination Rates Via Educational Interventions in Schools Located Within Cedars-Sinai Catchment Areas
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).
Detailed Description

Rationale and Significance

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. The vaccine is covered under Vaccine for Children Program so the underinsured and uninsured have access. 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 remain an important access to educational formats. Barriers associated with the HPV vaccine uptake is the initial stigmatizing information created by anti-vaccine groups, providers not recommending the vaccine and not understanding the cancer prevention strategies (i.e. getting vaccination prior to exposure).

Barriers to HPV vaccination

Although the US has invested in a large national effort toward improvement of HPV vaccination rates, little progress has been achieved since 2006. While financial access should not be a barrier to vaccination for most children, some insurance plans do not cover vaccines. Several factors appear to influence vaccination rates: a) limited understanding of HPV and HPV-related diseases by parents and patients; b) parental safety concerns about the vaccine; c) provider discomfort talking about sexual behavior; d) providers lack of time for discussions about the vaccine; e) parental perception that there is no clear recommendation from a health care provider; f) parental belief that son or daughter is too young for the vaccine because they are not sexually active; and g) provider concern that there is lack of adequate reimbursement. In LA County, lack of knowledge that a cancer vaccine exists, lack of transportation, and fear of immigration status disclosure are further barriers to vaccination.

We hypothesize HPV vaccine uptake will be improved through the receipt of educational sessions to the parents of middle school children about the importance of the anti-cancer vaccine, the HPV vaccine.

Such sessions will increase knowledge about HPV vaccine availability, as well as improve the perceptions around HPV vaccination. Vaccination rates are lower in the Service Planning areas (SPA) 4 and 6 compared to SAP 5 (West LA).

Primary Objectives

To evaluate the ability of educational sessions about the HPV vaccine to increase HPV vaccine uptake, by comparing HPV vaccination rates before and after the intervention.

Endpoints

The primary outcome will be HPV vaccination rates. Vaccination rates will be compared between before (baseline) and after the intervention at the end of the observation period (12 months). We expect to find higher HPV vaccine rates after the intervention.

Study Design

We will recruit 3 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). These MOUs were obtained through the Cedars-Sinai Coach-for Kids Program Director, Michele Rigsby-Pauley, a co-investigator in this study. We will first conduct focus group interviews with parents to learn about parents' concerns about the HPV vaccine and to identify important messages for parents. These would also include strategies for dissemination of information (PTA meetings, text messages to parents, online education). HPV vaccination rates will be compared before and after the intervention at the end of the observation period (12 months).

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
In this parallel study, three middle schools located in Los Angeles County will be assigned to 2 intervention arms: control (mobile clinic-only every 6-months); intervention (mobile clinic every 6-months or every month PLUS weekly educational sessions for parents).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
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.
Primary Purpose: Prevention
Condition  ICMJE
  • Human Papilloma Virus
  • HPV Vaccination
  • Health Education
Intervention  ICMJE
  • Biological: Mobile Clinic
    This intervention involves the availability of a free mobile clinic operated by Cedar-Sinai Medical Center providing free HPV vaccinations at school campuses.
  • Behavioral: Educational Sessions for Parents
    This intervention involves providing free weekly educational sessions for parents of students at the participant schools pertaining to the HPV Vaccination.
Study Arms  ICMJE
  • Active Comparator: Control: Mobile Clinic Only
    The 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.
    Intervention: Biological: Mobile Clinic
  • Experimental: Mobile Clinic plus Educational Sessions
    The 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:
    • Biological: Mobile Clinic
    • Behavioral: Educational Sessions for Parents
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 15, 2019)
3
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date May 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age 11-13
  • student of a participating middle school assigned to Arm 2 or Arm 3

Exclusion Criteria:

  • already received the HPV vaccine
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03953911
Other Study ID Numbers  ICMJE Pro54249
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Adriana Vidal, Cedars-Sinai Medical Center
Study Sponsor  ICMJE Cedars-Sinai Medical Center
Collaborators  ICMJE University of California, Los Angeles
Investigators  ICMJE Not Provided
PRS Account Cedars-Sinai Medical Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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