VaccinationPhase 3Girls OnGuardNCT00813319
Girls OnGuard: HPV Vaccination Uptake Among African American Adolescent Females
A Phase 3 study testing Girls OnGuard in people with Vaccination, run by Emory University at 2 sites in United States.
Trial summary
African American adolescent females seeking treatment for STIs are an underserved population at increased risk for HPV infection. While GARDASIL is an effective preventive vaccine, vaccination rates are low. Read more about this study
- Who is it for?
- Ages 13 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaccination
- What is being tested?
- Girls OnGuard
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Mar 2014
- Phase
- Phase 3
- 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 13 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- African American
- Female
- Age 13-18 years
- Seeking reproductive/STI services at participating clinic
- Ability to give written informed consent or assent
Who cannot join
- Pregnant
- Married
- Already received the HPV vaccine
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fulton County Department of Health and Wellness
Atlanta, Georgia, 30303
DeKalb County Health Department
Decatur, Georgia, 30034
About this study
Official title: Overcoming Barriers to Vaccination With GARDASIL in Underserved Girls and Adolescents
African American adolescent females seeking treatment for STIs are an underserved population at increased risk for HPV infection. While GARDASIL is an effective preventive vaccine, vaccination rates are low. Given the risk for HPV infection among this subgroup and the negative health effects associated with HPV, enhancing uptake of GARDASIL is necessary. The goal of this project is to promote GARDASIL vaccination through the development of a new multi-component, culturally-appropriate, interactive DVD.
We propose to recruit 280 unmarried African American adolescent females, 13-18 years of age, from participating clinic sites in Atlanta, Georgia. While seeking clinical services, adolescents will be contacted and invited to participate in the proposed study. Eligible adolescents will be required to provide written assent/consent prior to participation. Adolescents who are eligible and willing to participate in the project will complete a short survey on a laptop computer. The survey is designed to assess adolescents' risk taking and preventive behaviors. After they complete the survey, adolescents will be assigned at random to one of two groups. In one group, adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses. In the second group, adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. All adolescents are eligible to receive the GARDASIL vaccine at participating study clinics as part of their routine standard of care.
With the help of clinic staff, participant medical records will be reviewed over a 7 month period to assess vaccination rates. Vaccination rates from adolescents who received the interactive HPV/GARDASIL awareness DVD will be compared to the group of adolescents who received the healthy lifestyles DVD. It is hypothesized that study participants receiving the interactive DVD intervention that promotes HPV awareness will have higher vaccination rates over time.
- Conditions
- Vaccination
- Being tested
- Girls OnGuard
- Keywords
- GARDASIL, HPV, Vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Girls OnGuardBehavioural
Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination.
| Study group | Role | What they receive |
|---|---|---|
| 1 - Girls OnGuard/HPV awareness | Experimental | Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses. Receives: Behavioral: Girls OnGuard |
| 2 - General health promotion | No intervention | Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
GARDASIL Vaccination Uptake and Compliance With Second and Third Doses
Number of participants who received at least 1 dose, 2 doses, 3 doses
Measured: measured at 7 months post-randomization
Total Doses Received of HPV Vaccine
As an additional primary outcome, we assessed the total number of vaccine doses received
Measured: measured at 7-months post randomization
Secondary outcomes (1)
STD Incidence
Number of participants who tested positive for any STD 7 months post randomization, information was gathered via medical chart abstraction
Measured: 7 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startOct 2009
- Primary completionNov 2012
- Study completionMar 2014
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 VaccinationStudies of the same condition, open and under way.
- More trials run by Emory 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Ralph J. DiClemente, Emory University
- Investigators
- Ralph J. DiClemente, PhD, Principal investigator, Emory University Rollins School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813319
- Sponsor's protocol ID
- IRB00015576
- Other IDs
- Merck - Emory UPN 08042902
- Acronym
- Girls OnGuard
- Status last verified
- Aug 2014
- First submitted
- 22 Dec 2008
- Last updated
- 12 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overcoming Barriers to Vaccination With GARDASIL in Underserved Girls and Adolescents
- ClinicalTrials.gov ID
- NCT00813319
- Acronym / sponsor ID
- Girls OnGuard / IRB00015576
- Conditions
- Vaccination
- Keywords
- GARDASIL, HPV, Vaccination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Oct 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 23 Dec 2008 (estimated)
- Results
- Posted 12 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
African American adolescent females seeking treatment for STIs are an underserved population at increased risk for HPV infection. While GARDASIL is an effective preventive vaccine, vaccination rates are low. Given the risk for HPV infection among this subgroup and the negative health effects associated with HPV, enhancing uptake of GARDASIL is necessary. The goal of this project is to promote GARDASIL vaccination through the development of a new multi-component, culturally-appropriate, interactive DVD.
We propose to recruit 280 unmarried African American adolescent females, 13-18 years of age, from participating clinic sites in Atlanta, Georgia. While seeking clinical services, adolescents will be contacted and invited to participate in the proposed study. Eligible adolescents will be required to provide written assent/consent prior to participation. Adolescents who are eligible and willing to participate in the project will complete a short survey on a laptop computer. The survey is designed to assess adolescents' risk taking and preventive behaviors. After they complete the survey, adolescents will be assigned at random to one of two groups. In one group, adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses. In the second group, adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. All adolescents are eligible to receive the GARDASIL vaccine at participating study clinics as part of their routine standard of care.
With the help of clinic staff, participant medical records will be reviewed over a 7 month period to assess vaccination rates. Vaccination rates from adolescents who received the interactive HPV/GARDASIL awareness DVD will be compared to the group of adolescents who received the healthy lifestyles DVD. It is hypothesized that study participants receiving the interactive DVD intervention that promotes HPV awareness will have higher vaccination rates over time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - Girls OnGuard/HPV awareness | Experimental | Behavioral: Girls OnGuardAdolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses. |
| 2 - General health promotion | No intervention | –Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- African American
- Female
- Age 13-18 years
- Seeking reproductive/STI services at participating clinic
- Ability to give written informed consent or assent
Key exclusion criteria (3 listed)
- Pregnant
- Married
- 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 |
|---|---|---|
| Girls OnGuardUsing the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination. | Behavioural | 1 - Girls OnGuard/HPV awareness |
Primary outcome
GARDASIL Vaccination Uptake and Compliance With Second and Third Doses
Time frame: measured at 7 months post-randomization
Number of participants who received at least 1 dose, 2 doses, 3 doses
Total Doses Received of HPV Vaccine
Time frame: measured at 7-months post randomization
As an additional primary outcome, we assessed the total number of vaccine doses received
1 secondary outcome
STD Incidence
Time frame: 7 months post randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ralph J. DiClemente, PhD principal investigator
Emory University Rollins School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Girls OnGuard in people with Vaccination, run by Emory 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 5 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 12 Aug 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2014). 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?
GARDASIL Vaccination Uptake and Compliance With Second and Third Doses (time frame: measured at 7 months post-randomization). The study lists 2 primary outcomes in all. 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 12 Aug 2014.