Patient ComplianceNCT01908517
Human Papilloma Viruses (HPV) Vaccine Adherence Community Clinic Study
A study testing HPV Vaccine Electronic Reminders in people with Patient Compliance, run by East Carolina University at 2 sites in United States.
Trial summary
There has been very limited research that has looked at electronic reminders (text messages) and its effectiveness in adherence to vaccination among low-income minority populations. Read more about this study
- Who is it for?
- Ages 9 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Compliance
- What is being tested?
- HPV Vaccine Electronic Reminders
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 522 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2013to May 2016
- Phase
- Interventional
- 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 9 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent/Caretaker has Medicaid or is Uninsured
- Parent/Caretaker has a child between 11- 18 y/o
- Parent/Caretaker should be able to read English or Spanish
- Parent/Caretaker should have a phone and/or email address to provide for the study
Who cannot join
- Parents who have children younger than 11 or older than 18 years of age
- Parents who are not currently uninsured or enrolled in Medicaid/Medicare.
- Parent/Caretaker's child who received the 1st dose of HPV vaccine before enrolling in study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
East Carolina University's General Pediatric Outpatient Clinic
Greenville, North Carolina, 27858
Kate B. Reynolds Medical Center
Snow Hill, North Carolina, 28580
About this study
Official title: A Randomized Longitudinal Intervention Study to Assess Whether Electronic Messaging Can Increase Human Papilloma Viruses (HPV) Vaccine Utilization and Adherence Among Adolescents in Eastern North Carolina.
There has been very limited research that has looked at electronic reminders (text messages) and its effectiveness in adherence to vaccination among low-income minority populations. Results have shown that text messages, among low-income parents and adolescents who were identified as having a cellphone, is an effective strategy to increase the likelihood of adolescent vaccination adherence. Hard copy and electronic messaging reminders have also been proven to be effective when coupled with other prevention strategies for immunizations for influenza and pneumococcal pneumonia and screening for colon, breast, and cervical cancer in adults. Additionally, Merck and Co. recommend electronic reminders in their patient compliance program as a key strategy for adherence. To our knowledge, this community-based pilot intervention study will be the first to assess electronic reminders and HPV vaccine initiation and adherence among rural uninsured and Medicaid populations. The investigators hypothesize that adolescent whose parents who receive the intervention will be more likely to initiate HPV vaccination and be compliant at 3 months and at 7 months as compared to the control group.
- Conditions
- Patient Compliance
- Being tested
- HPV Vaccine Electronic Reminders
- Keywords
- HPV Vaccine Adherence, Electronic Reminders
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV Vaccine Electronic RemindersBehavioural
The intervention group will receive 4 education messages, 2 reminder/education messages, as well as 1 baseline and 1 final assessment survey. Control group participants will receive 2 contacts throughout the study, 1 at baseline and 1 at their final assessment survey. Up to two reminder contacts will be used if surveys are not completed for both intervention and control group participants. Preference for receipt of reminders will be obtained from the information study card parents complete at study enrollment. Enrollment card content, educational messages and patient- reminders will all be developed with community input.
| Study group | Role | What they receive |
|---|---|---|
| HPV Vaccine Electronic Reminders | Experimental | Parents in the intervention group will receive 1 electronic message per month in addition to the baseline and final assessments which equates to 8 contacts over a 7 month period. Specifically, intervention group participants will receive 4 education messages, 2 reminder/education messages, as well as 1 baseline and 1 final assessment survey. Receives: Behavioral: HPV Vaccine Electronic Reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine Adherence, as measure by receiving the 3 recommended doses withing a 6 month time period.
Vaccine adherence will be measured using the CDC's guidelines which state that the second dose be given one to two months after the first, and the third dose be given six months after the first dose.
Measured: 7 months after initial HPV Vaccince shot
Secondary outcomes (1)
HPV Knowledge, as measured by a 20% increase in knowledge about HPV and HPV vaccine among the intervention group.
Parents in the intervention group will receive 4 tailored education messages and 2 tailored reminder/education messages within the 6 month window period for the recommended HPV vaccine adherence guidelines. In order to assess a 20% increase in knowledge about HPV and the HPV vaccine, parents will take a baseline assessment survey and then a final assessment survey at the 7-month point once the vaccine series is completed.
Measured: 7 months after the first initial HPV vaccine shot
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient ComplianceStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 522 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Essie Torres, East Carolina University
- Investigators
- Essie Torres, PhD, MPH, Principal investigator, East Carolina UniversityAlice Richman, PhD, MPH, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908517
- Sponsor's protocol ID
- Merck-50915
- Status last verified
- May 2016
- First submitted
- 15 Jul 2013
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Richman AR, Torres E, Wu Q, Carlston L, O'Rorke S, Moreno C, Olsson J. Text and Email Messaging for Increasing Human Papillomavirus Vaccine Completion among Uninsured or Medicaid-insured Adolescents in Rural Eastern North Carolina. J Health Care Poor Underserved. 2019;30(4):1499-1517. doi: 10.1353/hpu.2019.0090.
PubMed 31680111
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Longitudinal Intervention Study to Assess Whether Electronic Messaging Can Increase Human Papilloma Viruses (HPV) Vaccine Utilization and Adherence Among Adolescents in Eastern North Carolina.
- ClinicalTrials.gov ID
- NCT01908517
- Acronym / sponsor ID
- Merck-50915
- Conditions
- Patient Compliance
- Keywords
- HPV Vaccine Adherence, Electronic Reminders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 522 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 Jul 2013 (estimated)
- 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.
There has been very limited research that has looked at electronic reminders (text messages) and its effectiveness in adherence to vaccination among low-income minority populations. Results have shown that text messages, among low-income parents and adolescents who were identified as having a cellphone, is an effective strategy to increase the likelihood of adolescent vaccination adherence. Hard copy and electronic messaging reminders have also been proven to be effective when coupled with other prevention strategies for immunizations for influenza and pneumococcal pneumonia and screening for colon, breast, and cervical cancer in adults. Additionally, Merck and Co. recommend electronic reminders in their patient compliance program as a key strategy for adherence. To our knowledge, this community-based pilot intervention study will be the first to assess electronic reminders and HPV vaccine initiation and adherence among rural uninsured and Medicaid populations. The investigators hypothesize that adolescent whose parents who receive the intervention will be more likely to initiate HPV vaccination and be compliant at 3 months and at 7 months as compared to the control group.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV Vaccine Electronic Reminders | Experimental | Behavioral: HPV Vaccine Electronic RemindersParents in the intervention group will receive 1 electronic message per month in addition to the baseline and final assessments which equates to 8 contacts over a 7 month period. Specifically, intervention group participants will receive 4 education messages, 2 reminder/education messages, as well as 1 baseline and 1 final assessment survey. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Parent/Caretaker has Medicaid or is Uninsured
- Parent/Caretaker has a child between 11- 18 y/o
- Parent/Caretaker should be able to read English or Spanish
- Parent/Caretaker should have a phone and/or email address to provide for the study
Key exclusion criteria (3 listed)
- Parents who have children younger than 11 or older than 18 years of age
- Parents who are not currently uninsured or enrolled in Medicaid/Medicare.
- Parent/Caretaker's child who received the 1st dose of HPV vaccine before enrolling in study
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 |
|---|---|---|
| HPV Vaccine Electronic RemindersThe intervention group will receive 4 education messages, 2 reminder/education messages, as well as 1 baseline and 1 final assessment survey. Control group participants will receive 2 contacts throughout the study, 1 at baseline and 1 at their final assessment survey. Up to two reminder contacts will be used if surveys are not completed for both intervention and control group participants. Preference for receipt of reminders will be obtained from the information study card parents complete at study enrollment. Enrollment card content, educational messages and patient- reminders will all be developed with community input. | Behavioural | HPV Vaccine Electronic Reminders |
Primary outcome
Vaccine Adherence, as measure by receiving the 3 recommended doses withing a 6 month time period.
Time frame: 7 months after initial HPV Vaccince shot
Vaccine adherence will be measured using the CDC's guidelines which state that the second dose be given one to two months after the first, and the third dose be given six months after the first dose.
1 secondary outcome
HPV Knowledge, as measured by a 20% increase in knowledge about HPV and HPV vaccine among the intervention group.
Time frame: 7 months after the first initial HPV vaccine shot
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
- Derived from this study: PubMed 31680111Richman AR, Torres E, Wu Q, Carlston L, O'Rorke S, Moreno C, Olsson J. Text and Email Messaging for Increasing Human Papillomavirus Vaccine Completion among Uninsured or Medicaid-insured Adolescents in Rural Eastern North Carolina. J Health Care Poor Underserved. 2019;30(4):1499-1517. doi: 10.1353/hpu.2019.0090.
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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.
Essie Torres, PhD, MPH principal investigator
East Carolina University
Alice Richman, PhD, MPH principal investigator
East Carolina University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV Vaccine Electronic Reminders in people with Patient Compliance, run by East Carolina University at 2 sites in United States.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine Adherence, as measure by receiving the 3 recommended doses withing a 6 month time period. (time frame: 7 months after initial HPV Vaccince shot). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01908517, which also lists 1 linked publication.
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 25 May 2016.