Human Papilloma VirusEarly Phase 1NCT03953911
Increasing HPV Vaccination Rates Via Educational Interventions in Schools Located Within Cedars-Sinai Catchment Areas
A Early Phase 1 study testing Mobile Clinic and Educational Sessions for Parents in people with Human Papilloma Virus and HPV Vaccination, run by Cedars-Sinai Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus, HPV Vaccination, Health Education
- What is being tested?
- Mobile Clinic and Educational Sessions for Parents
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 28 May 2019to 30 Jun 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age 11-13
- student of a participating middle school assigned to Arm 2 or Arm 3
Who cannot join
- already received the HPV vaccine
Trial locations and contacts
No sites are listed yet.
About this study
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).
Read the 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).
- Conditions
- Human Papilloma Virus, HPV Vaccination, Health Education
- Being tested
- Mobile Clinic, Educational Sessions for Parents
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile ClinicBiological
This intervention involves the availability of a free mobile clinic operated by Cedar-Sinai Medical Center providing free HPV vaccinations at school campuses.
Educational Sessions for ParentsBehavioural
This intervention involves providing free weekly educational sessions for parents of students at the participant schools pertaining to the HPV Vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Control: Mobile Clinic Only | Active comparator | 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. Receives: Biological: Mobile Clinic |
| Mobile Clinic plus Educational Sessions | Experimental | 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. Receives: Biological: Mobile Clinic; Behavioral: Educational Sessions for Parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start28 May 2019 (estimated)
- Primary completion27 May 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Adriana Vidal, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953911
- Sponsor's protocol ID
- Pro54249
- Status last verified
- May 2019
- First submitted
- 3 Apr 2019
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing HPV Vaccination Rates Via Educational Interventions in Schools Located Within Cedars-Sinai Catchment Areas
- ClinicalTrials.gov ID
- NCT03953911
- Acronym / sponsor ID
- Pro54249
- Conditions
- Human Papilloma Virus, HPV Vaccination, Health Education
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 28 May 2019 (estimated)
- Primary completion
- 27 May 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 17 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Control: Mobile Clinic Only | Active comparator | Biological: Mobile ClinicThe 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 | Experimental | Biological: Mobile Clinic, Behavioral: Educational Sessions for ParentsThe 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. |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age 11-13
- student of a participating middle school assigned to Arm 2 or Arm 3
Key exclusion criteria (1 listed)
- already received the HPV vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile ClinicThis intervention involves the availability of a free mobile clinic operated by Cedar-Sinai Medical Center providing free HPV vaccinations at school campuses. | Biological | Control: Mobile Clinic Only, Mobile Clinic plus Educational Sessions |
| Educational Sessions for ParentsThis intervention involves providing free weekly educational sessions for parents of students at the participant schools pertaining to the HPV Vaccination. | Behavioural | Mobile Clinic plus Educational Sessions |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Mobile Clinic and Educational Sessions for Parents in people with Human Papilloma Virus and HPV Vaccination, run by Cedars-Sinai Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlene Chang, MA, MPH (6266899335, charlenechang@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV vaccination rates (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2019.