Human PapillomavirusNCT02236273
Interactive, Health Literacy Promoting Text Messages and HPV Vaccine Completion In Minority Adolescents
A study testing Conventional text message reminder and Enhanced text message reminders in people with Human Papillomavirus, run by Columbia University at 1 site in United States.
Trial summary
Emerging communication technologies, such as text messaging offer low-cost, scalable opportunities to improve health literacy and promote healthy behaviors, such as vaccination. While the investigators reported the success of text message vaccine reminders, effects were limited by their untailored approach. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Human Papillomavirus
- What is being tested?
- Conventional text message reminder and Enhanced text message reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 956 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parenting adult of adolescent age 11-17 years
- Adolescent received 1st dose of HPV at a study site within the last 2 weeks.
- Eligible parent's cell phone has text message capability
Who cannot join
- Language other than English or Spanish only
- Parent already in the study
- Intends to move away from the New York City area in <12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Comparative Effectiveness of Interactive, Health Literacy Promoting Text Messages on HPV Vaccine Completion In Minority Adolescents
Emerging communication technologies, such as text messaging offer low-cost, scalable opportunities to improve health literacy and promote healthy behaviors, such as vaccination. While the investigators reported the success of text message vaccine reminders, effects were limited by their untailored approach. The trans-theoretical model of behavior change supports tailoring interventions to an individual's stage of decision-making. Human papillomavirus (HPV) is the most prevalent sexually transmitted virus in the U.S. and can lead to genital warts, and cervical, anal and penile cancer. The three-dose vaccine is 90-100% efficacious. Minorities are at greatest risk for such cancers but have low HPV vaccine completion rates. Limited health literacy regarding the vaccine can affect series completion. The investigators will compare the effects of enhancing text message vaccination reminders with interactive, vaccine health literacy-promoting information tailored to vaccine decision making-stage on HPV vaccine series completion. The effects of these messages represent a new paradigm in interactive health communications.
- Conditions
- Human Papillomavirus
- Being tested
- Conventional text message reminder, Enhanced text message reminders
- Keywords
- Human papillomavirus, vaccination, text message, reminder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional text message reminderBehavioural
Receipt of conventional text message notifying when due for next dose
Enhanced text message remindersBehavioural
Receipt of enhanced text messages notifying when due for next dose coupled with educational information
| Study group | Role | What they receive |
|---|---|---|
| Conventional Text Message | Experimental | Conventional text message reminder Receives: Behavioral: Conventional text message reminder |
| Enhanced reminders | Experimental | Enhanced text message reminders Receives: Behavioral: Enhanced text message reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Completed HPV Vaccine Series
receipt of 3 doses of HPV vaccine by 12 months after initiation
Measured: 12 months
Secondary outcomes (2)
Time Between 1st and 2nd Dose
Time elapsed in days between first and second dose- for those in need of three doses
Measured: 12 months
Time Between 1st and 3rd Dose
Time elapsed (in days) between 1st and 3rd dose for those in need of three doses
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 posted10 Sep 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human PapillomavirusStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 956 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Melissa Stockwell, Columbia University
- Investigators
- Melissa S Stockwell, MD MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236273
- Sponsor's protocol ID
- AAAM3960
- Status last verified
- Jul 2025
- First submitted
- 7 Sep 2014
- Last updated
- 29 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Undecided
Publications
Wynn CS, Catallozzi M, Kolff CA, Holleran S, Meyer D, Ramakrishnan R, Stockwell MS. Personalized Reminders for Immunization Using Short Messaging Systems to Improve Human Papillomavirus Vaccination Series Completion: Parallel-Group Randomized Trial. JMIR Mhealth Uhealth. 2021 Dec 27;9(12):e26356. doi: 10.2196/26356.
PubMed 34958306
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Interactive, Health Literacy Promoting Text Messages on HPV Vaccine Completion In Minority Adolescents
- ClinicalTrials.gov ID
- NCT02236273
- Acronym / sponsor ID
- AAAM3960
- Conditions
- Human Papillomavirus
- Keywords
- Human papillomavirus, vaccination, text message, reminder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 956 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Posted 29 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Emerging communication technologies, such as text messaging offer low-cost, scalable opportunities to improve health literacy and promote healthy behaviors, such as vaccination. While the investigators reported the success of text message vaccine reminders, effects were limited by their untailored approach. The trans-theoretical model of behavior change supports tailoring interventions to an individual's stage of decision-making. Human papillomavirus (HPV) is the most prevalent sexually transmitted virus in the U.S. and can lead to genital warts, and cervical, anal and penile cancer. The three-dose vaccine is 90-100% efficacious. Minorities are at greatest risk for such cancers but have low HPV vaccine completion rates. Limited health literacy regarding the vaccine can affect series completion. The investigators will compare the effects of enhancing text message vaccination reminders with interactive, vaccine health literacy-promoting information tailored to vaccine decision making-stage on HPV vaccine series completion. The effects of these messages represent a new paradigm in interactive health communications.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Text Message | Experimental | Behavioral: Conventional text message reminderConventional text message reminder |
| Enhanced reminders | Experimental | Behavioral: Enhanced text message remindersEnhanced text message reminders |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parenting adult of adolescent age 11-17 years
- Adolescent received 1st dose of HPV at a study site within the last 2 weeks.
- Eligible parent's cell phone has text message capability
Key exclusion criteria (3 listed)
- Language other than English or Spanish only
- Parent already in the study
- Intends to move away from the New York City area in <12 months
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 |
|---|---|---|
| Conventional text message reminderReceipt of conventional text message notifying when due for next dose | Behavioural | Conventional Text Message |
| Enhanced text message remindersReceipt of enhanced text messages notifying when due for next dose coupled with educational information | Behavioural | Enhanced reminders |
Primary outcome
Number of Participants Who Completed HPV Vaccine Series
Time frame: 12 months
receipt of 3 doses of HPV vaccine by 12 months after initiation
2 secondary outcomes
Time Between 1st and 2nd Dose
Time frame: 12 months
Time Between 1st and 3rd Dose
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34958306Wynn CS, Catallozzi M, Kolff CA, Holleran S, Meyer D, Ramakrishnan R, Stockwell MS. Personalized Reminders for Immunization Using Short Messaging Systems to Improve Human Papillomavirus Vaccination Series Completion: Parallel-Group Randomized Trial. JMIR Mhealth Uhealth. 2021 Dec 27;9(12):e26356. doi: 10.2196/26356.
- Individual participant dataSharing planned: Undecided
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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.
Melissa S Stockwell, MD MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional text message reminder and Enhanced text message reminders in people with Human Papillomavirus, run by Columbia University at 1 site 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 3 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 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 29 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Completed HPV Vaccine Series (time frame: 12 months). 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 NCT02236273, 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 29 Jul 2025.