HPV VaccinationNCT07301905
Culturally Targeted Health Communication and Receptivity to the Human Papillomavirus Vaccine Among Parents in Flint, MI
A study testing General HPV Vaccine Health Messaging and Culturally Targeted HPV Vaccine Health Messaging in people with HPV Vaccination, run by Michigan State University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if culturally targeted messaging about the human papillomavirus (HPV) increases receptivity to the HPV vaccine among African American parents of vaccine-eligible daughters. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HPV Vaccination
- What is being tested?
- General HPV Vaccine Health Messaging and Culturally Targeted HPV Vaccine Health Messaging
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2024to Dec 2028
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Identify as Black/African American or White/Caucasian
- Have at least one daughter who is between 8-17 years of age, who is not currently pregnant, and who has not received any doses of the HPV vaccine
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Flint Journal Building
Flint, Michigan, 48502
Olivia, 3306126007, aspiraso@msu.edu
About this study
Official title: Culturally Targeted Messaging and Parental Receptivity to the Human Papillomavirus Vaccine
The goal of this clinical trial is to learn if culturally targeted messaging about the human papillomavirus (HPV) increases receptivity to the HPV vaccine among African American parents of vaccine-eligible daughters. The main question it aims to answer is:
- Does culturally targeted messaging increase African American parents' intentions to vaccinate their daughter against HPV?
Read more
Research will compare culturally targeted messaging to general, educational messaging and no messaging.
Participants will:
- View culturally targeted messages, education-only messages, or no messages about the HPV vaccine
- Report their intentions to vaccinate their daughter against HPV
- Report whether they have initiated HPV vaccination for their daughter six months later
Read the detailed description
Cervical cancer incidence and mortality are higher for African American women than for White women. The human papillomavirus (HPV) vaccine is the most effective strategy for reducing risk for cervical cancer. However, African American girls are less likely to have completed the HPV vaccine series than White girls. The present research will evaluate a culturally targeted approach to health messaging about the HPV vaccine for parents with vaccine-eligible daughters. The central hypothesis is that African American parents will have greater receptivity to the HPV vaccine after receiving culturally targeted messaging compared to parents who receive no messaging or education-only messaging about HPV vaccination. The primary aims are: 1) evaluate effects of HPV vaccine education on White and African American parents' receptivity to the HPV vaccine, and whether culturally targeted messaging enhances HPV vaccine receptivity among African American parents, 2) compare effects of education-only versus culturally targeted messaging on activation of racism-related thinking when considering child HPV vaccination, and 3) examine the effects of racism-related medical mistrust on the effectiveness of culturally targeted messaging. General and culturally targeted messaging about the HPV vaccine were developed in collaboration with community members and a local health educator. Participants will report their intentions to vaccinate their daughter against HPV immediately after viewing health messaging, as well as initiation of the HPV vaccine series for their daughter 6-months post-messaging.
- Conditions
- HPV Vaccination
- Being tested
- General HPV Vaccine Health Messaging, Culturally Targeted HPV Vaccine Health Messaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General HPV Vaccine Health MessagingBehavioural
General, education-only messaging about the HPV vaccine does not include culturally targeted messaging.
Culturally Targeted HPV Vaccine Health MessagingBehavioural
Educational messaging about the HPV vaccine includes culturally targeted messaging about the HPV vaccine.
| Study group | Role | What they receive |
|---|---|---|
| African American Culturally Targeted Messaging | Experimental | Culturally targeted messaging about the HPV vaccine for African American parents Receives: Behavioral: Culturally Targeted HPV Vaccine Health Messaging |
| African American General, Education-Only Messaging | Active comparator | African American participants receive general, education-only messaging about the HPV vaccine. Receives: Behavioral: General HPV Vaccine Health Messaging |
| African American No Message | No intervention | African American participants receive no messaging about the HPV vaccine |
| White General, Education-Only Messaging | Active comparator | White participants receive general, education-only messaging about the HPV vaccine. Receives: Behavioral: General HPV Vaccine Health Messaging |
| White No Message | No intervention | White participants receive no messaging about the HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV Vaccine Attitudes
Subscale of Theory of Planned Behavior measuring attitudes toward the HPV vaccine on response scale ranging from 1 = Strongly disagree to 7 = Strongly agree, where higher average scores indicate more positive attitudes
Measured: Immediately following and 6-months post-health messaging
HPV Vaccine Normative Beliefs
Subscale of Theory of Planned Behavior measuring the extent to which participants believe other people are favorable toward the HPV vaccine on response scale ranging from 1 = Strongly disagree to 7 = Strongly agree, where higher average scores indicate stronger normative beliefs
Measured: Immediately following and 6-months post-health messaging
HPV Vaccine Perceived Behavioral Control
Subscale of Theory of Planned Behavior measuring beliefs about ability to vaccinate their child on response scale ranging from 1 = Strongly disagree to 7 = Strongly agree, where higher average scores indicate greater perceived behavioral control
Measured: Immediately following and 6-months post-health messaging
HPV Vaccine Intentions
Subscale of Theory of Planned Behavior measuring intentions to vaccinate their child on response scale ranging from 1 = Strongly disagree to 7 = Strongly agree, where higher average scores indicate greater intentions
Measured: Immediately following and 6-months post-health messaging
Vaccination Initiation
1 self-report item measuring whether parents' daughters have received at least one dose of the HPV vaccine since completion of the initial survey, with Yes/No response options
Measured: 6-months post-health messaging
Vaccination Discussion
1 self-report item measuring whether parents have discussed the HPV vaccine with their daughters' healthcare provider since completion of the initial survey, with Yes/No response options
Measured: 6-months post-health messaging
Secondary outcomes (1)
Anticipatory Racism
3 items measuring the extent to which parents expect racism-related factors to interfere with getting the HPV vaccine for their daughter on a 7-point response scale on response scale ranging from 1 = Strongly disagree to 7 = Strongly agree, where higher average scores indicate greater expectations of racism
Measured: Immediately following health messaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start17 Nov 2024
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV VaccinationStudies of the same condition, open and under way.
- 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
- Model description
- This research will use a 2 (White, African American) x 3 (No message, Education-only message, Culturally targeted message) quasi-experimental design. All participants will be randomly assigned to a no-message control group or to receive educational materials about HPV vaccination. Half of African American parents who receive educational materials will also view culturally targeted messaging about the HPV vaccine.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Lucas, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301905
- Sponsor's protocol ID
- 00630245
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Targeted Messaging and Parental Receptivity to the Human Papillomavirus Vaccine
- ClinicalTrials.gov ID
- NCT07301905
- Acronym / sponsor ID
- 00630245
- Conditions
- HPV Vaccination
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- 17 Nov 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Dec 2025 (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.
The goal of this clinical trial is to learn if culturally targeted messaging about the human papillomavirus (HPV) increases receptivity to the HPV vaccine among African American parents of vaccine-eligible daughters. The main question it aims to answer is:
- Does culturally targeted messaging increase African American parents' intentions to vaccinate their daughter against HPV?
Research will compare culturally targeted messaging to general, educational messaging and no messaging.
Participants will:
- View culturally targeted messages, education-only messages, or no messages about the HPV vaccine
- Report their intentions to vaccinate their daughter against HPV
- Report whether they have initiated HPV vaccination for their daughter six months later
Detailed description
Cervical cancer incidence and mortality are higher for African American women than for White women. The human papillomavirus (HPV) vaccine is the most effective strategy for reducing risk for cervical cancer. However, African American girls are less likely to have completed the HPV vaccine series than White girls. The present research will evaluate a culturally targeted approach to health messaging about the HPV vaccine for parents with vaccine-eligible daughters. The central hypothesis is that African American parents will have greater receptivity to the HPV vaccine after receiving culturally targeted messaging compared to parents who receive no messaging or education-only messaging about HPV vaccination. The primary aims are: 1) evaluate effects of HPV vaccine education on White and African American parents' receptivity to the HPV vaccine, and whether culturally targeted messaging enhances HPV vaccine receptivity among African American parents, 2) compare effects of education-only versus culturally targeted messaging on activation of racism-related thinking when considering child HPV vaccination, and 3) examine the effects of racism-related medical mistrust on the effectiveness of culturally targeted messaging. General and culturally targeted messaging about the HPV vaccine were developed in collaboration with community members and a local health educator. Participants will report their intentions to vaccinate their daughter against HPV immediately after viewing health messaging, as well as initiation of the HPV vaccine series for their daughter 6-months post-messaging.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- This research will use a 2 (White, African American) x 3 (No message, Education-only message, Culturally targeted message) quasi-experimental design. All participants will be randomly assigned to a no-message control group or to receive educational materials about HPV vaccination. Half of African American parents who receive educational materials will also view culturally targeted messaging about the HPV vaccine.
| Arm | Type | Receives |
|---|---|---|
| African American Culturally Targeted Messaging | Experimental | Behavioral: Culturally Targeted HPV Vaccine Health MessagingCulturally targeted messaging about the HPV vaccine for African American parents |
| African American General, Education-Only Messaging | Active comparator | Behavioral: General HPV Vaccine Health MessagingAfrican American participants receive general, education-only messaging about the HPV vaccine. |
| African American No Message | No intervention | –African American participants receive no messaging about the HPV vaccine |
| White General, Education-Only Messaging | Active comparator | Behavioral: General HPV Vaccine Health MessagingWhite participants receive general, education-only messaging about the HPV vaccine. |
| White No Message | No intervention | –White participants receive no messaging about the HPV vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Identify as Black/African American or White/Caucasian
- Have at least one daughter who is between 8-17 years of age, who is not currently pregnant, and who has not received any doses of the HPV vaccine
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| General HPV Vaccine Health MessagingGeneral, education-only messaging about the HPV vaccine does not include culturally targeted messaging. | Behavioural | African American General, Education-Only Messaging, White General, Education-Only Messaging |
| Culturally Targeted HPV Vaccine Health MessagingEducational messaging about the HPV vaccine includes culturally targeted messaging about the HPV vaccine. | Behavioural | African American Culturally Targeted Messaging |
Primary outcome
HPV Vaccine Attitudes
Time frame: Immediately following and 6-months post-health messaging
Subscale of Theory of Planned Behavior measuring attitudes toward the HPV vaccine on response scale ranging from 1 = Strongly disagree to 7 = Strongly agree, where higher average scores indicate more positive attitudes
HPV Vaccine Normative Beliefs
Time frame: Immediately following and 6-months post-health messaging
Subscale of Theory of Planned Behavior measuring the extent to which participants believe other people are favorable toward the HPV vaccine on response scale ranging from 1 = Strongly disagree to 7 = Strongly agree, where higher average scores indicate stronger normative beliefs
HPV Vaccine Perceived Behavioral Control
Time frame: Immediately following and 6-months post-health messaging
Subscale of Theory of Planned Behavior measuring beliefs about ability to vaccinate their child on response scale ranging from 1 = Strongly disagree to 7 = Strongly agree, where higher average scores indicate greater perceived behavioral control
HPV Vaccine Intentions
Time frame: Immediately following and 6-months post-health messaging
Subscale of Theory of Planned Behavior measuring intentions to vaccinate their child on response scale ranging from 1 = Strongly disagree to 7 = Strongly agree, where higher average scores indicate greater intentions
Vaccination Initiation
Time frame: 6-months post-health messaging
1 self-report item measuring whether parents' daughters have received at least one dose of the HPV vaccine since completion of the initial survey, with Yes/No response options
Vaccination Discussion
Time frame: 6-months post-health messaging
1 self-report item measuring whether parents have discussed the HPV vaccine with their daughters' healthcare provider since completion of the initial survey, with Yes/No response options
1 secondary outcome
Anticipatory Racism
Time frame: Immediately following health messaging
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 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for HPV Vaccination
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An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen
HPV Infection
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Human Papillomavirus Infection
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HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Human Papilloma Virus (HPV) Vaccine
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PREVENT HPV -Related Cancers Trial
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General HPV Vaccine Health Messaging and Culturally Targeted HPV Vaccine Health Messaging in people with HPV Vaccination, run by Michigan State University 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 2 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: looking for participants now, as of the sponsor's last update on 29 Oct 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?
Contact Olivia Aspiras, PhD (810-600-9181, aspiraso@msu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV Vaccine Attitudes (time frame: Immediately following and 6-months post-health messaging). The study lists 6 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 29 Oct 2026.