Human Papillomavirus InfectionNCT05057312
Promoting HPV Vaccination Among Young Adults in Texas
A study testing Enhancing Accessibility to Health Care, Informational Intervention and Interview in people with Human Papillomavirus Infection, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies how to improve the human papillomavirus (HPV) vaccination rate in young adults in Texas. This trial aims to learn more about how researchers and health care providers can increase HPV vaccination among college students. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Enhancing Accessibility to Health Care, Informational Intervention and Interview
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2021to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Being pregnant
- Having a life-threatening allergy to any component of the HPV vaccine
Trial locations and contacts
1 site in 1 country.
About this study
This clinical trial studies how to improve the human papillomavirus (HPV) vaccination rate in young adults in Texas. This trial aims to learn more about how researchers and health care providers can increase HPV vaccination among college students.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Human Papillomavirus Infection
- Being tested
- Enhancing Accessibility to Health Care, Informational Intervention, Interview, Questionnaire Administration
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhancing Accessibility to Health CareOther
Receive enhanced access to vaccination
Informational InterventionOther
Receive standard CDC information
Informational InterventionOther
Receive video narratives
Informational InterventionOther
Receive written narratives
InterviewOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (standard CDC information) | Active comparator | Participants receive standard CDC information about HPV vaccination. Receives: Other: Informational Intervention; Other: Interview; Other: Questionnaire Administration |
| Group II (video narratives) | Experimental | Participants receive video narratives about HPV vaccination. Receives: Other: Informational Intervention; Other: Interview; Other: Questionnaire Administration |
| Group III (written narratives) | Experimental | Participants receive written narratives about HPV vaccination. Receives: Other: Informational Intervention; Other: Interview; Other: Questionnaire Administration |
| Group IV (enhanced access to vaccine, CDC information) | Experimental | Participants receive enhanced access to vaccination and standard CDC information about HPV vaccination. Receives: Other: Enhancing Accessibility to Health Care; Other: Informational Intervention; Other: Interview; Other: Questionnaire Administration |
| Group V (enhanced access to vaccine, video narratives) | Experimental | Participants receive enhanced access to vaccination and video narratives about HPV vaccination. Receives: Other: Enhancing Accessibility to Health Care; Other: Informational Intervention; Other: Interview; Other: Questionnaire Administration |
| Group VI (enhanced access to vaccine, written narratives) | Experimental | Participants receive enhanced access to vaccination and written narratives about HPV vaccination. Receives: Other: Enhancing Accessibility to Health Care; Other: Informational Intervention; Other: Interview; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of human papillomavirus (HPV) vaccination initiation
Measured: At 3 months
Rate of HPV vaccination completion
Measured: At 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start26 Jul 2021
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Qian Lu, MD,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057312
- Sponsor's protocol ID
- 2020-1142
- Other IDs
- R01CA248216, NCI-2021-09416, 2020-1142
- Status last verified
- Jul 2026
- First submitted
- 25 Aug 2021
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lu Q, Dawkins-Moultin L, Cho D, Tan NQP, Hopfer S, Li Y, Ramondetta L, Xu Y, Lun D, Chen M. A multilevel intervention to promote HPV vaccination among young adults in Texas: protocol for a randomized controlled trial. BMC Public Health. 2024 Jun 5;24(1):1506. doi: 10.1186/s12889-024-18828-9.
PubMed 38840086
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting HPV Vaccination Among Young Adults in Texas
- ClinicalTrials.gov ID
- NCT05057312
- Acronym / sponsor ID
- 2020-1142
- Conditions
- Human Papillomavirus Infection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 27 Sep 2021 (actual)
- 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 clinical trial studies how to improve the human papillomavirus (HPV) vaccination rate in young adults in Texas. This trial aims to learn more about how researchers and health care providers can increase HPV vaccination among college students.
Detailed description
PRIMARY OBJECTIVES:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group I (standard CDC information) | Active comparator | Other: Informational Intervention, Other: Interview, Other: Questionnaire AdministrationParticipants receive standard CDC information about HPV vaccination. |
| Group II (video narratives) | Experimental | Other: Informational Intervention, Other: Interview, Other: Questionnaire AdministrationParticipants receive video narratives about HPV vaccination. |
| Group III (written narratives) | Experimental | Other: Informational Intervention, Other: Interview, Other: Questionnaire AdministrationParticipants receive written narratives about HPV vaccination. |
| Group IV (enhanced access to vaccine, CDC information) | Experimental | Other: Enhancing Accessibility to Health Care, Other: Informational Intervention, Other: Interview, Other: Questionnaire AdministrationParticipants receive enhanced access to vaccination and standard CDC information about HPV vaccination. |
| Group V (enhanced access to vaccine, video narratives) | Experimental | Other: Enhancing Accessibility to Health Care, Other: Informational Intervention, Other: Interview, Other: Questionnaire AdministrationParticipants receive enhanced access to vaccination and video narratives about HPV vaccination. |
| Group VI (enhanced access to vaccine, written narratives) | Experimental | Other: Enhancing Accessibility to Health Care, Other: Informational Intervention, Other: Interview, Other: Questionnaire AdministrationParticipants receive enhanced access to vaccination and written narratives about HPV vaccination. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Being pregnant
- Having a life-threatening allergy to any component of 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 |
|---|---|---|
| Enhancing Accessibility to Health CareReceive enhanced access to vaccination | Other | Group IV (enhanced access to vaccine, CDC information), Group V (enhanced access to vaccine, video narratives), Group VI (enhanced access to vaccine, written narratives) |
| Informational InterventionReceive standard CDC information | Other | Group I (standard CDC information), Group IV (enhanced access to vaccine, CDC information) |
| Informational InterventionReceive video narratives | Other | Group II (video narratives), Group V (enhanced access to vaccine, video narratives) |
| Informational InterventionReceive written narratives | Other | Group III (written narratives), Group VI (enhanced access to vaccine, written narratives) |
| InterviewAncillary studies | Other | Group I (standard CDC information), Group II (video narratives), Group III (written narratives), Group IV (enhanced access to vaccine, CDC information), Group V (enhanced access to vaccine, video narratives), Group VI (enhanced access to vaccine, written narratives) |
| Questionnaire AdministrationAncillary studies | Other | Group I (standard CDC information), Group II (video narratives), Group III (written narratives), Group IV (enhanced access to vaccine, CDC information), Group V (enhanced access to vaccine, video narratives), Group VI (enhanced access to vaccine, written narratives) |
Primary outcome
Rate of human papillomavirus (HPV) vaccination initiation
Time frame: At 3 months
Rate of HPV vaccination completion
Time frame: At 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Derived from this study: PubMed 38840086Lu Q, Dawkins-Moultin L, Cho D, Tan NQP, Hopfer S, Li Y, Ramondetta L, Xu Y, Lun D, Chen M. A multilevel intervention to promote HPV vaccination among young adults in Texas: protocol for a randomized controlled trial. BMC Public Health. 2024 Jun 5;24(1):1506. doi: 10.1186/s12889-024-18828-9.
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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.
Qian Lu, MD,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhancing Accessibility to Health Care, Informational Intervention and Interview in people with Human Papillomavirus Infection, run by M.D. Anderson Cancer Center 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 5 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: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of human papillomavirus (HPV) vaccination initiation (time frame: At 3 months). 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?
On the ClinicalTrials.gov record for NCT05057312, 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 20 Jul 2026.