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Human Papilloma Virus (HPV) VaccineHPV MISTICSNCT05677360

HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)

A study testing HPV MISTICS -Provider Level, HPV MISTICS - Parent Level and HPV MISTICS- HPV Vaccine Champion Level in people with Human Papilloma Virus (HPV) Vaccine, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This intervention study will use parent-, provider-, and health center-level strategies to promote HPV vaccination among 11-17 year olds receiving care in 8 community health centers in Florida, will explore factors related to the intervention effect, and will explore implementation outcomes of the intervention. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Human Papilloma Virus (HPV) Vaccine
What is being tested?
HPV MISTICS -Provider Level, HPV MISTICS - Parent Level and HPV MISTICS- HPV Vaccine Champion Level
Could I receive a placebo?
No, everyone receives an active treatment
How many people
564 participants
Where
1 siteUnited States
Study dates
9 Jan 2023to Dec 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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • For Staff:
  • 18 years of age or older
  • Working within the participating Federally Qualified Health Center system
  • Able to read, write and speak English
  • For Providers:
  • 18 years of age or older
Show all 13Show fewer
  • Working within the participating Federally Qualified Health Center system
  • Interacting with parents of adolescents ages 11-17
  • Able to read, write and speak English
  • For parents:
  • Parent of 11-17 year old child that has received care within the prior two months at one of the participating Federally Qualified Health Centers
  • Whose child has not initiated or completed the HPV vaccine series at the time of their last visit
  • Able to read, write and speak English or Spanish, or Haitian Creole

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

This intervention study will use parent-, provider-, and health center-level strategies to promote HPV vaccination among 11-17 year olds receiving care in 8 community health centers in Florida, will explore factors related to the intervention effect, and will explore implementation outcomes of the intervention.

Read the detailed description

The goals of this multi-level intervention study are to: 1) test whether HPV MISTICS intervention increases human papillomavirus (HPV) vaccine initiation and completion rates among 11-17-year-old adolescents in 8 Health Choice Network-affiliated community health centers in Florida. 2) Explore other factors related to the intervention effect. 3) Explore implementation outcomes (i.e., reach, adoption, implementation, maintenance, and sustainability) and identify implementation barriers and facilitators with a focus on equity. The study will use parent-, provider-, and health center-level strategies to promote HPV vaccination.

Being tested
HPV MISTICS -Provider Level, HPV MISTICS - Parent Level, HPV MISTICS- HPV Vaccine Champion Level
Keywords
Human Papillomavirus, Vaccination, Multi-level intervention, Community Health Centers, Behavioral
Medical subject headings
Papillomavirus Infections, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HPV MISTICS -Provider LevelBehavioural

    The HPV MISTICS (Multilevel Intervention Strategies Targeting Immunization in Community Settings) provider-level intervention for all clinical staff (e.g., physicians, nurses, medical assistants) includes a 1-hour online training session on the Announcement Approach (i.e., presumptive recommendation) to recommend adolescent vaccinations.

  • HPV MISTICS - Parent LevelBehavioural

    The HPV MISTICS (Multilevel Intervention Strategies Targeting Immunization in Community Settings) parent-level intervention includes a low literacy pre-visit HPV vaccine notification post card in the parent's preferred language.

  • HPV MISTICS- HPV Vaccine Champion LevelBehavioural

    The HPV MISTICS (Multilevel Intervention Strategies Targeting Immunization in Community Settings) system-level intervention involves training an HPV Vaccine Champion at each FQHC on the provider and parent EBIs to monitor and share clinic HPV initiation and completion rates with providers, and to implement reminder/recall systems for subsequent vaccine doses

Study groups in NCT05677360
Study groupRoleWhat they receive
Wave 1: Initial Community Health CentersExperimentalInitial group of community health centers to receive intervention
Receives: Behavioral: HPV MISTICS -Provider Level; Behavioral: HPV MISTICS - Parent Level; Behavioral: HPV MISTICS- HPV Vaccine Champion Level
Wave 2: Second Community Health CentersExperimentalSecond group of community health centers to receive intervention
Receives: Behavioral: HPV MISTICS -Provider Level; Behavioral: HPV MISTICS - Parent Level; Behavioral: HPV MISTICS- HPV Vaccine Champion Level

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectiveness: HPV Vaccine series initiation rates

    HPV vaccine series initiation (1st dose) rates among adolescents ages 11-17 will be determined on a monthly basis as well as annually. Providers' vaccination rate data for their patient panel (using Florida SHOTS - a free, statewide centralized online immunization information system) will be compared to the National Immunization Survey-Teen (NIS-TEEN) data for the state of Florida.

    Measured: at 5 years

  2. Effectiveness: HPV Vaccine series completion rates

    HPV vaccine series completion (2nd and 3rd dose) rates among adolescents ages 11-17 will be determined on a monthly basis as well as annually. Providers' vaccination rate data for their patient panel (using Florida SHOTS - a free, statewide centralized online immunization information system) will be compared to the National Immunization Survey-Teen (NIS-TEEN) data for the state of Florida.

    Measured: at 5 years

Secondary outcomes (7)

  1. Implementation outcome: Reach

    The intervention's implementation will be evaluated for reach - proportion of eligible patients that receive the intervention.

    Measured: at 5 years

  2. Implementation outcome: Reach demographics

    The intervention's implementation will be evaluated for reach - demographics of patients reached.

    Measured: at 5 years

  3. Proportion of Healthcare providers who participate in the intervention

    The proportion of health care providers who participate in the intervention, measured by contact log data.

    Measured: at 5 years

  4. Proportion of Healthcare Providers, Rural vs Urban

    The proportion of health care providers in rural vs urban Federally Qualified Health Centers in network that participate.

    Measured: at 5 years

  5. Proportion of Health Care providers who complete training

    The proportion of participating health care providers and staff who complete training per site will be measured using the training attendance log

    Measured: at 5 years

  6. Intervention Sustainability: Health care Providers

    Long term intervention effects and use over time will be determined semi-structured interviews of providers

    Measured: at 5 years

  7. Intervention Sustainability: Healthcare staff

    Long term intervention effects and use over time will be determined semi-structured interviews of health care staff.

    Measured: at 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2023
  2. Study start9 Jan 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Why it stopped: Lack or Limited Slot Availability

Resources

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
Sequential
Model description
Hybrid Type 1 implementation design which will allow the team to examine both effectiveness of HPV MISTICS and implementation outcomes in a single study. Implementation outcomes will be evaluated using the RE-AIM Qualitative Evaluation for Systematic Translation (RE-AIM QuEST) framework, a mixed-methods framework to identify implementation barriers and facilitators while assessing implementation outcomes (e.g., reach, adoption, implementation, maintenance/sustainability) with a focus on evaluating equity across these outcomes.
Masking
None (open label)
Enrolment
564 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05677360
Sponsor's protocol ID
MCC-21902
Acronym
HPV MISTICS
Status last verified
Dec 2025
First submitted
22 Dec 2022
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Christy SM, Patel L, Arevalo M, Fuzzell L, Whitmer A, Turner K, Gore LR, Chung-Bridges K, Parras D, Endemano EY, Brownstein NC, Vadaparampil ST. HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS): Study protocol for a hybrid 1 stepped-wedge cluster randomized trial. Contemp Clin Trials. 2024 Jul;142:107576. doi: 10.1016/j.cct.2024.107576. Epub 2024 May 17.

    PubMed 38763306

Questions about this trial

What is this clinical trial studying?

A study testing HPV MISTICS -Provider Level, HPV MISTICS - Parent Level and HPV MISTICS- HPV Vaccine Champion Level in people with Human Papilloma Virus (HPV) Vaccine, run by H. Lee Moffitt Cancer Center and Research Institute 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 13 inclusion and 0 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 10 Dec 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?

Effectiveness: HPV Vaccine series initiation rates (time frame: at 5 years). 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 NCT05677360, 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 10 Dec 2025.

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