HPV VaccinesCHATNCT01276184
Effectiveness of SMS (Short Message Service) Text Messaging in Increasing Adherence to Gardasil
A study testing SMS Text Message in people with HPV Vaccines, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
Human papillomavirus (HPV) is the most common sexually transmitted disease among adolescent females in the United States. Our primary objective is to determine if Short Message Service (SMS) text message reminders increase adherence to the recommended 3 dose schedule for Gardasil compared to usual care in an… Read more about this study
- Who is it for?
- Ages 12 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Vaccines
- What is being tested?
- SMS Text Message
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to 15 Jun 2016
- 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 12 to 26 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Have a mobile phone with text message capability
- Patient of University of Maryland Medical Center outpatient gynecology clinics
- Able to speak and read English
- Capable of understanding, consenting, and complying with the entire study protocol
Who cannot join
- Pregnant
- Previously completed the Gardasil vaccine
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Redwood Clinic
Baltimore, Maryland, 21201
Western-Penn Center
Baltimore, Maryland, 21201
About this study
Official title: A Randomized, Controlled Trial to Compare the Effectiveness of SMS Text Message Reminders Compared to Usual Care to Increase Adherence to the Gardasil Vaccine Dosing Schedule (GCC 1063GCC).
Human papillomavirus (HPV) is the most common sexually transmitted disease among adolescent females in the United States. Our primary objective is to determine if Short Message Service (SMS) text message reminders increase adherence to the recommended 3 dose schedule for Gardasil compared to usual care in an outpatient clinic setting. Secondary objectives of this study are: 1) to demonstrate the feasibility of using SMS text message reminders to increase adherence with Gardasil vaccination; and 2) to assess satisfaction and acceptability of text message reminders compared to telephone reminders among women who receive the text message arm of the intervention. The investigators hypothesize that receiving SMS text message reminders will increase adherence to the recommended 3 dose schedule for Gardasil compared to usual care.
Read the detailed description
Technological innovations such as Short Message Service (SMS) text messages reminders are one strategy that may be used to increase adherence to the Gardasil dosing schedule. Although the literature in this area is in its infancy, several studies have demonstrated that SMS text reminders are an effective strategy for reducing nonattendance with medical appointments. Further, SMS text message reminders have been shown to be popular with patients and more cost-effective than paper or telephone-based reminder strategies. The investigators believe SMS text message reminders can be used as a feasible and cost-effective strategy to increase adherence to the Gardasil vaccine schedule, thus reducing risk of cervical cancer.
Women who are enrolled will be randomly assigned to one of 2 study groups (Usual Care v. SMS Text Message group). For women in the SMS Text Message group, text message reminders will be sent once per day for each of the seven days prior to the scheduled date for each of their follow up vaccinations. Participants follow the usual practices for scheduling their follow up visit(s) for vaccination at the clinic. Participants in both the Usual Care group and the SMS Text Message group will receive the standard reminder from the clinic for their scheduled appointment(s) (phone call, letter, etc, as appropriate). At enrollment, the participant will answer questions regarding social and demographic history, cell phone use patterns, attitudes and acceptance of HPV vaccine, gynecologic and sexual history.
All participants will be sent a packet of self-report measures to complete regarding attitudes toward HPV vaccination at the completion of the study. Participants in the SMS Text Message group will also receive rating scales to assess acceptability of text message reminders and preference for text message reminders over telephone reminders.
- Conditions
- HPV Vaccines
- Being tested
- SMS Text Message
- Keywords
- HPV Vaccine, HPV vaccination, SMS, Text Message, Gardasil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS Text MessageBehavioural
Also called Usual care, Text message
Women in the SMS Text Message group that reschedule a vaccination visit will receive text message reminders one per day for each of the seven days prior to the rescheduled visit (or as many days as possible depending on when the rescheduled visit will take place - for example, if they call in and reschedule the visit to take place in 4 days, they will receive text messages for the 3 days prior to the rescheduled visit). Participants in both the Usual Care group and the SMS Text Message group will receive the standard reminder from the clinic for their re-scheduled appointment(s).
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants follow the usual practices for scheduling their follow up visit(s) for vaccination at the clinic. Participants will receive the standard reminder from the clinic for their scheduled appointment(s) (phone call, letter, etc, as appropriate). |
| SMS Text Message | Experimental | Participants in both the Usual Care group and the SMS Text Message group will receive the standard reminder from the clinic for their scheduled appointment(s) (phone call, letter, etc, as appropriate). Women in the SMS Text Message group that reschedule a vaccination visit will receive text message reminders one per day for each of the seven days prior to the rescheduled visit. Receives: Behavioral: SMS Text Message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Adhered to Vaccine Schedule
Our primary objective is to determine if Short Message Service (SMS) text message reminders increase number of participants that adhered to the recommended 3 dose schedule for Gardasil compared to usual care in an outpatient clinic setting.
Measured: at the end of the study (30 days after the third vaccination or 360 days after the first vaccination, whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startJan 2011
- Primary completion15 Jun 2016
- Study completion15 Jun 2016
Why it stopped: Unable to recruit sufficient sample for study completion.
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.
- Other trials for HPV VaccinesStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, J. Kathleen Tracy, University of Maryland, Baltimore
- Investigators
- Kathleen Tracy, Ph.D., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276184
- Sponsor's protocol ID
- HP-00047046
- Other IDs
- GCC 1063GCC, Merck-37944
- Acronym
- CHAT
- Status last verified
- Jul 2021
- First submitted
- 11 Jan 2011
- Last updated
- 14 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial to Compare the Effectiveness of SMS Text Message Reminders Compared to Usual Care to Increase Adherence to the Gardasil Vaccine Dosing Schedule (GCC 1063GCC).
- ClinicalTrials.gov ID
- NCT01276184
- Acronym / sponsor ID
- CHAT / HP-00047046
- Conditions
- HPV Vaccines
- Keywords
- HPV Vaccine, HPV vaccination, SMS, Text Message, Gardasil
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit sufficient sample for study completion.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2011
- Primary completion
- 15 Jun 2016 (actual)
- Study completion
- 15 Jun 2016 (actual)
- First posted
- 13 Jan 2011 (estimated)
- Results
- Posted 14 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Human papillomavirus (HPV) is the most common sexually transmitted disease among adolescent females in the United States. Our primary objective is to determine if Short Message Service (SMS) text message reminders increase adherence to the recommended 3 dose schedule for Gardasil compared to usual care in an outpatient clinic setting. Secondary objectives of this study are: 1) to demonstrate the feasibility of using SMS text message reminders to increase adherence with Gardasil vaccination; and 2) to assess satisfaction and acceptability of text message reminders compared to telephone reminders among women who receive the text message arm of the intervention. The investigators hypothesize that receiving SMS text message reminders will increase adherence to the recommended 3 dose schedule for Gardasil compared to usual care.
Detailed description
Technological innovations such as Short Message Service (SMS) text messages reminders are one strategy that may be used to increase adherence to the Gardasil dosing schedule. Although the literature in this area is in its infancy, several studies have demonstrated that SMS text reminders are an effective strategy for reducing nonattendance with medical appointments. Further, SMS text message reminders have been shown to be popular with patients and more cost-effective than paper or telephone-based reminder strategies. The investigators believe SMS text message reminders can be used as a feasible and cost-effective strategy to increase adherence to the Gardasil vaccine schedule, thus reducing risk of cervical cancer.
Women who are enrolled will be randomly assigned to one of 2 study groups (Usual Care v. SMS Text Message group). For women in the SMS Text Message group, text message reminders will be sent once per day for each of the seven days prior to the scheduled date for each of their follow up vaccinations. Participants follow the usual practices for scheduling their follow up visit(s) for vaccination at the clinic. Participants in both the Usual Care group and the SMS Text Message group will receive the standard reminder from the clinic for their scheduled appointment(s) (phone call, letter, etc, as appropriate). At enrollment, the participant will answer questions regarding social and demographic history, cell phone use patterns, attitudes and acceptance of HPV vaccine, gynecologic and sexual history.
All participants will be sent a packet of self-report measures to complete regarding attitudes toward HPV vaccination at the completion of the study. Participants in the SMS Text Message group will also receive rating scales to assess acceptability of text message reminders and preference for text message reminders over telephone reminders.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants follow the usual practices for scheduling their follow up visit(s) for vaccination at the clinic. Participants will receive the standard reminder from the clinic for their scheduled appointment(s) (phone call, letter, etc, as appropriate). |
| SMS Text Message | Experimental | Behavioral: SMS Text MessageParticipants in both the Usual Care group and the SMS Text Message group will receive the standard reminder from the clinic for their scheduled appointment(s) (phone call, letter, etc, as appropriate). Women in the SMS Text Message group that reschedule a vaccination visit will receive text message reminders one per day for each of the seven days prior to the rescheduled visit. |
Who may qualify
- Ages
- 12 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Have a mobile phone with text message capability
- Patient of University of Maryland Medical Center outpatient gynecology clinics
- Able to speak and read English
- Capable of understanding, consenting, and complying with the entire study protocol
Key exclusion criteria (2 listed)
- Pregnant
- Previously completed the Gardasil 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 |
|---|---|---|
| SMS Text MessageAlso: Usual care, Text messageWomen in the SMS Text Message group that reschedule a vaccination visit will receive text message reminders one per day for each of the seven days prior to the rescheduled visit (or as many days as possible depending on when the rescheduled visit will take place - for example, if they call in and reschedule the visit to take place in 4 days, they will receive text messages for the 3 days prior to the rescheduled visit). Participants in both the Usual Care group and the SMS Text Message group will receive the standard reminder from the clinic for their re-scheduled appointment(s). | Behavioural | SMS Text Message |
Primary outcome
Number of Participants That Adhered to Vaccine Schedule
Time frame: at the end of the study (30 days after the third vaccination or 360 days after the first vaccination, whichever comes first)
Our primary objective is to determine if Short Message Service (SMS) text message reminders increase number of participants that adhered to the recommended 3 dose schedule for Gardasil compared to usual care in an outpatient clinic setting.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for HPV Vaccines
Active, not recruiting
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Human Papilloma Virus (HPV) Vaccine
Active, not recruitingPhase 4
A Trial to Establish Non-inferiority of Immunogenicity of a Single-dose of CERVAVAC® Quadrivalent HPV Vaccine Compared to the Gardasil® Quadrivalent Vaccine Among Girls and Boys Aged 9 to 14 Years and in Girls/Women Aged 15 to 20 Years in Zambia
Vaccine Effectiveness, HPV Vaccination
Not yet recruiting
Maximizing HPV Vaccination: Real-time Reminders, Guidance, and Recommendations - Part 4: Feasibility Trial
Human Papillomavirus (HPV) Vaccines
RecruitingPhase 4
Adding Male Single Dose HPV Vaccination to Female HPV Vaccination in Tanzania
HPV Infection, Vaccine Preventable Disease
Recruiting
HPV Ends Here: Increasing Uptake of the HPV Vaccine
HPV Vaccine
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.
Kathleen Tracy, Ph.D. principal investigator
University of Maryland, Baltimore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS Text Message in people with HPV Vaccines, run by University of Maryland, Baltimore 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 2 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: stopped early, as of the sponsor's last update on 14 Jul 2021. 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?
Yes. Results are posted in the registry (first posted 14 Jul 2021). 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 That Adhered to Vaccine Schedule (time frame: at the end of the study (30 days after the third vaccination or 360 days after the first vaccination, whichever comes first)). 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 14 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.