Human Papillomavirus VaccinesNCT06002282
HPV Vaccine Confident Families
A study testing Tailored messages and Standard messages in people with Human Papillomavirus Vaccines, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The objectives of the study are to pilot test a tailored intervention among Black families with adolescents. The hypotheses are that the study protocol will be feasible and messages tailored to parents' needs will increase vaccine confidence and intention to vaccinate. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Vaccines
- What is being tested?
- Tailored messages and Standard messages
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2025to Jul 2026
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- parent or legal guardian of at least one child aged 9-13 years who has received 0 or 1 dose of HPV vaccine;
- identify as Black or African American adult;
- have access to personal mobile phone and agree to send/receive MMS messages;
- able to speak and understand English; and
- able to provide informed consent to participate
Who cannot join
- parent or legal guardian of child outside of participation age range or who has completed multiple doses of HPV vaccine;
- does not identify as Black or African American adult;
- does not have personal mobile phone;
- unable to speak and understand English;
- not willing to consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of the study are to pilot test a tailored intervention among Black families with adolescents. The hypotheses are that the study protocol will be feasible and messages tailored to parents' needs will increase vaccine confidence and intention to vaccinate.
- Conditions
- Human Papillomavirus Vaccines
- Being tested
- Tailored messages, Standard messages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored messagesBehavioural
Messages will be individually tailored to parents' responses to a baseline survey (child gender, vaccination status) and real-time responses to interactive prompts about vaccine hesitancy determinants with links to additional information (e.g., CDC, NJ Department of Health) and community resources to overcome barriers.
Standard messagesBehavioural
Generic reminder/recall HPV vaccination messages.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Messaging | Experimental | Tailored messages based on parents' HPV vaccine hesitancy and perceived barriers to vaccination. Receives: Behavioral: Tailored messages |
| Standard Messaging | Active comparator | Standard (untailored) messages about HPV vaccination reminder/recall. Receives: Behavioral: Standard messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Recruitment
ratio of parents recruited to potential parents approached to participate in study
Measured: After enrollment completion, 6 months
Feasibility - Retention
ratio of parents completing post-intervention surveys to the number enrolled
Measured: Post intervention completion, 1 year
Feasibility - Intervention Delivery
ratio of parents receiving HPV message to the number enrolled
Measured: Two weeks after intervention begins
Feasibility - Intervention response
assessment of how often participants completed hesitancy questions across the intervention period
Measured: Two weeks after intervention completion
Feasibility - Intervention utility
Perceived ease of use, likeability, helpfulness, impact - Mobile App Rating Scale (1-inadequate, 2-poor, 3-acceptable, 4-good, and 5-excellent)
Measured: Two weeks after intervention completion
Secondary outcomes (2)
Vaccine Intention
Parent reported intention to vaccinate adolescent in next 6 months
Measured: Immediately post-intervention (6 months)
Vaccine Confidence
Parent-reported response to scale assessing benefits of vaccination, harms of vaccination, and trust in health care providers (1 - strongly disagree to 5 - strongly agree)
Measured: Immediately post-intervention (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study startOct 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Why it stopped: NIH grant termination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus VaccinesStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Racquel Kohler, PhD, MSPH, Rutgers, The State University of New Jersey
- Investigators
- Racquel Kohler, PhD, Principal investigator, Rutgers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002282
- Sponsor's protocol ID
- Pro2022001385
- Other IDs
- K22CA258675, 132211
- Status last verified
- Aug 2025
- First submitted
- 31 Jul 2023
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Vaccine Confident Families
- ClinicalTrials.gov ID
- NCT06002282
- Acronym / sponsor ID
- Pro2022001385
- Conditions
- Human Papillomavirus Vaccines
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: NIH grant termination
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 21 Aug 2023 (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 objectives of the study are to pilot test a tailored intervention among Black families with adolescents. The hypotheses are that the study protocol will be feasible and messages tailored to parents' needs will increase vaccine confidence and intention to vaccinate.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored Messaging | Experimental | Behavioral: Tailored messagesTailored messages based on parents' HPV vaccine hesitancy and perceived barriers to vaccination. |
| Standard Messaging | Active comparator | Behavioral: Standard messagesStandard (untailored) messages about HPV vaccination reminder/recall. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- parent or legal guardian of at least one child aged 9-13 years who has received 0 or 1 dose of HPV vaccine;
- identify as Black or African American adult;
- have access to personal mobile phone and agree to send/receive MMS messages;
- able to speak and understand English; and
- able to provide informed consent to participate
Key exclusion criteria (5 listed)
- parent or legal guardian of child outside of participation age range or who has completed multiple doses of HPV vaccine;
- does not identify as Black or African American adult;
- does not have personal mobile phone;
- unable to speak and understand English;
- not willing to consent to participate
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 |
|---|---|---|
| Tailored messagesMessages will be individually tailored to parents' responses to a baseline survey (child gender, vaccination status) and real-time responses to interactive prompts about vaccine hesitancy determinants with links to additional information (e.g., CDC, NJ Department of Health) and community resources to overcome barriers. | Behavioural | Tailored Messaging |
| Standard messagesGeneric reminder/recall HPV vaccination messages. | Behavioural | Standard Messaging |
Primary outcome
Feasibility - Recruitment
Time frame: After enrollment completion, 6 months
ratio of parents recruited to potential parents approached to participate in study
Feasibility - Retention
Time frame: Post intervention completion, 1 year
ratio of parents completing post-intervention surveys to the number enrolled
Feasibility - Intervention Delivery
Time frame: Two weeks after intervention begins
ratio of parents receiving HPV message to the number enrolled
Feasibility - Intervention response
Time frame: Two weeks after intervention completion
assessment of how often participants completed hesitancy questions across the intervention period
Feasibility - Intervention utility
Time frame: Two weeks after intervention completion
Perceived ease of use, likeability, helpfulness, impact - Mobile App Rating Scale (1-inadequate, 2-poor, 3-acceptable, 4-good, and 5-excellent)
2 secondary outcomes
Vaccine Intention
Time frame: Immediately post-intervention (6 months)
Vaccine Confidence
Time frame: Immediately post-intervention (6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Human Papillomavirus Vaccines
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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.
Racquel Kohler, PhD principal investigator
Rutgers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored messages and Standard messages in people with Human Papillomavirus Vaccines, run by Rutgers, The State University of New Jersey 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 5 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: paused, as of the sponsor's last update on 11 Aug 2025. 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?
Results are not available in the source record.
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?
Feasibility - Recruitment (time frame: After enrollment completion, 6 months). The study lists 5 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 11 Aug 2025.