- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05057312
Promoting HPV Vaccination Among Young Adults in Texas
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the impact of addressing individual and system levels of influence on HPV vaccination initiation and completion rates.
II. To gain insight into mechanisms of the intervention's efficacy, individual differences, and implementation of the intervention using mixed methods.
OUTLINE: Participants are randomized to 1 of 6 groups.
GROUP I: Participants receive standard Centers for Disease Control and Prevention (CDC) information about HPV vaccination.
GROUP II: Participants receive video narratives about HPV vaccination.
GROUP III: Participants receive written narratives about HPV vaccination.
GROUP IV: Participants receive enhanced access to vaccination and standard CDC information about HPV vaccination.
GROUP V: Participants receive enhanced access to vaccination and video narratives about HPV vaccination.
GROUP VI: Participants receive enhanced access to vaccination and written narratives about HPV vaccination.
After completion of study, participants are followed up at 3 and 9 months.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-26 years. This criterion is based on the CDC recommendation of vaccination up to 26 years of age and the fact that individuals 18 years and older can consent by themselves for on-site vaccination
- Ability to read and understand English
- Self-identification as not yet having received any HPV vaccine injections. Self-identification is justified because it is safe to be vaccinated again, which could happen if a previously vaccinated person forgets their vaccination. Furthermore, in a person previously vaccinated with an older version of the vaccine, which targeted fewer HPV types, receiving the newer version would be advantageous and not cause any harm. Alternatives to self-identification, such as obtaining medical records from doctors' offices, would be very challenging for young adults, especially for those who do not remember when and where they might have received vaccination
- Access to a smart phone, tablet or computer that is connected to the internet
- Current enrollment in one of the participating schools with an anticipated continuous enrollment of at least 9 months
Exclusion Criteria:
- Being pregnant
- Having a life-threatening allergy to any component of the HPV vaccine
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group I (standard CDC information)
Participants receive standard CDC information about HPV vaccination.
|
Ancillary studies
Ancillary studies
Receive standard CDC information
Receive video narratives
Receive written narratives
|
|
Experimental: Group II (video narratives)
Participants receive video narratives about HPV vaccination.
|
Ancillary studies
Ancillary studies
Receive standard CDC information
Receive video narratives
Receive written narratives
|
|
Experimental: Group III (written narratives)
Participants receive written narratives about HPV vaccination.
|
Ancillary studies
Ancillary studies
Receive standard CDC information
Receive video narratives
Receive written narratives
|
|
Experimental: Group IV (enhanced access to vaccine, CDC information)
Participants receive enhanced access to vaccination and standard CDC information about HPV vaccination.
|
Ancillary studies
Ancillary studies
Receive standard CDC information
Receive video narratives
Receive written narratives
Receive enhanced access to vaccination
|
|
Experimental: Group V (enhanced access to vaccine, video narratives)
Participants receive enhanced access to vaccination and video narratives about HPV vaccination.
|
Ancillary studies
Ancillary studies
Receive standard CDC information
Receive video narratives
Receive written narratives
Receive enhanced access to vaccination
|
|
Experimental: Group VI (enhanced access to vaccine, written narratives)
Participants receive enhanced access to vaccination and written narratives about HPV vaccination.
|
Ancillary studies
Ancillary studies
Receive standard CDC information
Receive video narratives
Receive written narratives
Receive enhanced access to vaccination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate of human papillomavirus (HPV) vaccination initiation
Time Frame: At 3 months
|
At 3 months
|
|
Rate of HPV vaccination completion
Time Frame: At 9 months
|
At 9 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Qian Lu, MD,PHD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Pathologic Processes
- Disease Attributes
- Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- DNA Virus Infections
- Tumor Virus Infections
- Pathological Conditions, Signs and Symptoms
- Papillomavirus Infections
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Interviews as Topic
Other Study ID Numbers
- 2020-1142 (Other Identifier: M D Anderson Cancer Center)
- NCI-2021-09416 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- R01CA248216 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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