Human Papillomavirus-Related CarcinomaNCT01769560
MeFirst: A Tailored Intervention to HPV Vaccine Decision Making
A study testing MeFirst Tailored Intervention in people with Human Papillomavirus-Related Carcinoma, run by University of Michigan at 1 site in United States.
Trial summary
This study will test whether a tailored, online educational intervention increases HPV vaccine uptake and intent among female college students. Read more about this study
- Who is it for?
- Ages 18 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus-Related Carcinoma
- What is being tested?
- MeFirst Tailored Intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 661 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Apr 2014
- 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 18 to 26 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- enrolled at the University of Michigan
Who cannot join
- receipt of any doses of HPV vaccine
Trial locations and contacts
1 site in 1 country.
About this study
This study will test whether a tailored, online educational intervention increases HPV vaccine uptake and intent among female college students.
Read the detailed description
MeFirst is the first web-based, online, educational tool designed to promote Human Papillomavirus (HPV) vaccine awareness and understanding in an effort to improve HPV vaccine intent and uptake among female university students. HPV is the most common sexually transmitted infection and causes genital warts and cancer. The HPV vaccine has been recommended for girls ages 11-26 since 2006, yet vaccination rates remain low. Tailored online interventions may be more effective tools to promote behavior change among college students than traditional static interventions. The proposed study is a randomized controlled trial testing the efficacy of the MeFirst tool vs. standard static educational material on increasing HPV vaccination intent and uptake among female university students aged 18-26.
- Conditions
- Human Papillomavirus-Related Carcinoma
- Being tested
- MeFirst Tailored Intervention
- Keywords
- tailored intervention, college aged students, HPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeFirst Tailored InterventionBehavioural
Participants will be lead through MeFirst, an interactive web-based tool that is tailored to their responses during the survey. This tool provides information regarding HPV Vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Centers for Disease Control and Prevention (CDC) Fact Sheet | No intervention | Participants will receive the CDC Fact sheet about HPV vaccination while they are taking the survey. |
| MeFirst Intervention | Experimental | Participants will receive a tailored website regarding their own individualized risk for HPV and information about HPV Vaccination while they are taking the survey as opposed to receiving the CDC fact sheet. This tailored website is generated based on answers provided by each subject in the baseline survey. Receives: Behavioral: MeFirst Tailored Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effect of the MeFirst tool, a tailored, online HPV vaccination decision-making guide, on HPV vaccination intention and/or uptake.
Intention will be assessed on a five-point scale immediately after and at 3 and 12 months. Uptake will be assessed by yes/no/don't know response to the statement, "I have received at least 1 dose of the HPV vaccine" at 3 and 12 months.
Measured: Immediately post intervention, 3 months and 12 months
Secondary outcomes (1)
Determine the effect of the MeFirst tool on HPV-related knowledge.
Comparing 5 or 10-point scales measuring participants' HPV-related knowledge (HPV, HPV vaccination, and cervical cancer) immediately post-intervention and at 3 months and 12 months.
Measured: Immediately post intervention, 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 661 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa K. Dalton, University of Michigan
- Investigators
- Vanessa K Dalton, MD, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769560
- Sponsor's protocol ID
- HUM00069032
- Status last verified
- Jul 2015
- First submitted
- 14 Jan 2013
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MeFirst: A Tailored Intervention to HPV Vaccine Decision Making
- ClinicalTrials.gov ID
- NCT01769560
- Acronym / sponsor ID
- HUM00069032
- Conditions
- Human Papillomavirus-Related Carcinoma
- Keywords
- tailored intervention, college aged students, HPV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 661 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 16 Jan 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.
This study will test whether a tailored, online educational intervention increases HPV vaccine uptake and intent among female college students.
Detailed description
MeFirst is the first web-based, online, educational tool designed to promote Human Papillomavirus (HPV) vaccine awareness and understanding in an effort to improve HPV vaccine intent and uptake among female university students. HPV is the most common sexually transmitted infection and causes genital warts and cancer. The HPV vaccine has been recommended for girls ages 11-26 since 2006, yet vaccination rates remain low. Tailored online interventions may be more effective tools to promote behavior change among college students than traditional static interventions. The proposed study is a randomized controlled trial testing the efficacy of the MeFirst tool vs. standard static educational material on increasing HPV vaccination intent and uptake among female university students aged 18-26.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Centers for Disease Control and Prevention (CDC) Fact Sheet | No intervention | –Participants will receive the CDC Fact sheet about HPV vaccination while they are taking the survey. |
| MeFirst Intervention | Experimental | Behavioral: MeFirst Tailored InterventionParticipants will receive a tailored website regarding their own individualized risk for HPV and information about HPV Vaccination while they are taking the survey as opposed to receiving the CDC fact sheet. This tailored website is generated based on answers provided by each subject in the baseline survey. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- enrolled at the University of Michigan
Key exclusion criteria (1 listed)
- receipt of any doses of 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 |
|---|---|---|
| MeFirst Tailored InterventionParticipants will be lead through MeFirst, an interactive web-based tool that is tailored to their responses during the survey. This tool provides information regarding HPV Vaccination. | Behavioural | MeFirst Intervention |
Primary outcome
Determine the effect of the MeFirst tool, a tailored, online HPV vaccination decision-making guide, on HPV vaccination intention and/or uptake.
Time frame: Immediately post intervention, 3 months and 12 months
Intention will be assessed on a five-point scale immediately after and at 3 and 12 months. Uptake will be assessed by yes/no/don't know response to the statement, "I have received at least 1 dose of the HPV vaccine" at 3 and 12 months.
1 secondary outcome
Determine the effect of the MeFirst tool on HPV-related knowledge.
Time frame: Immediately post intervention, 3 months and 12 months
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 22 Jul 2015.
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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.
Vanessa K Dalton, MD, MPH principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MeFirst Tailored Intervention in people with Human Papillomavirus-Related Carcinoma, run by University of Michigan 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 1 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: finished, as of the sponsor's last update on 22 Jul 2015. 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?
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?
Determine the effect of the MeFirst tool, a tailored, online HPV vaccination decision-making guide, on HPV vaccination intention and/or uptake. (time frame: Immediately post intervention, 3 months and 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 22 Jul 2015.