Human Papillomavirus InfectionNCT06598475
Investigating Facilitator-driven, Multi-level Implementation Strategies in Federally Qualified Health Centers to Improve Provider Recommendation and HPV Vaccination Rates Among Latino/a Adolescents
A study testing Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates in people with Human Papillomavirus Infection, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to determine the provider- and practice-level characteristics that influence the impact of implementation strategies guided by practice facilitation in each clinical practice, to test whether the facilitator-driven provider- and practice-level implementation strategies increase provider… Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2025to 1 Aug 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- FQHC's with less than 60% HPV vaccine initiation rate for 11-12 year old adolescents overall at their practice sites
- FQHC's that have family medicine and/or pediatric practices
- a total adolescent patient population at least 50% Latino
- be willing for Health Care Provider (HCP) and staff members to receive education, training, and support; complete standardized measurement, and agree to randomization.
- Providers, aged 18 and over, employed at each FQHC (4 staff per practice)
- Staff, aged 18 and over, employed at each FQHC (5 staff per practice)
- Implementation team members (i.e., administrative designee, health care providers, immunization navigators, and other staff), aged 18 and over, employed at each FQHC (4 members per practice)
- Parents (aged 18 and over) of patients ages 11-17 seeking care at each FQHC (25 per practice).
Who cannot join
- -FQHCs that participated in the pilot study were excluded.
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
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Daisy Y Morales-Campos, PhD, 210-276-9042, Daisy.Y.MoralesCampos@uth.tmc.edu
About this study
The purpose of this study is to determine the provider- and practice-level characteristics that influence the impact of implementation strategies guided by practice facilitation in each clinical practice, to test whether the facilitator-driven provider- and practice-level implementation strategies increase provider recommendations and Human Papilloma Virus (HPV) vaccination rates and to evaluate implementation and future sustainability of the facilitator-driven implementation strategies across nine clinical practice sites
- Conditions
- Human Papillomavirus Infection
- Being tested
- Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates
- Keywords
- HPV vaccination
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination ratesOther
The practice facilitator (UTHealth research staff) will implement the following 4 strategies with providers and immunization navigators at each practice:
- Facilitator-driven provider education: The practice facilitator will conduct one provider education module (5 total modules) over three months with health care providers using a booklet and resource binder.
- Facilitator-driven clinical practice plan: The practice facilitator will assist the implementation team in creating their clinical practice in two additional modules and encourage providers to identify strategies to increase HPV vaccination.
- Training and education for staff (Immunization Navigators): The facilitator will train immunization navigators to implement the plan, and practice immunization navigators will implement the plan.
- Technical assistance plus assessment and feedback: During implementation of the plan, the facilitator will provide technical assistance, ongoing assessment and feedback, and booster trainings.
| Study group | Role | What they receive |
|---|---|---|
| Step 1 (3 clinics)-15 months control then 30 months intervention | Experimental | Not described Receives: Other: Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates |
| Step 2 (3 clinics)-21 months control then 24 months intervention | Experimental | Not described Receives: Other: Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates |
| Step 3 (3 clinics)-27 months control then 18 months intervention | Experimental | Not described Receives: Other: Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of vaccine-eligible males and females at each clinic who received the first valid dose of the HPV vaccine series before their 13th birthday.
Measured: From baseline to end of study ( about 60 months from baseline)
Percentage of vaccine-eligible males and females at each clinic who received the second valid dose of the HPV vaccine series 6-12 months after their first dose and before their 13th birthday.
Measured: From baseline to end of study ( about 60 months from baseline)
Secondary outcomes (6)
Percentage of vaccine-eligible males and females at each clinic who received the first valid dose of the HPV vaccine series before their 18th birthday.
Measured: From baseline to end of study ( about 60 months from baseline)
Percentage of vaccine-eligible 13-14 y/o males and females at each clinic who received the second valid dose of the HPV vaccine series 6-12 months after first dose and before their 15th birthday
Measured: From baseline to end of study ( about 60 months from baseline)
Percentage of vaccine-eligible 15-17 y/o males and females at each clinic who received the second valid dose of the HPV vaccine series 2 months after first dose and before their 18th birthday
Measured: From baseline to end of study ( about 60 months from baseline)
Percentage of vaccine-eligible 15-17 y/o males and females at each clinic who received the third valid dose of the HPV vaccine series 4 months after second dose and before their 18th birthday.
Measured: From baseline to end of study ( about 60 months from baseline)
Percentage of non-well visits in which HPV vaccine was not administered, among all visits for active vaccine-eligible patients ages 11-17 by clinic
Measured: From baseline to end of study ( about 60 months from baseline)
Percentage of males and females at each clinic who received Tdap and MenACWY at age 11 as a requirement to attend 7th grade in Texas.
Measured: From baseline to end of study ( about 60 months from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start13 Mar 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Aug 2028 (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 The University of Texas Health Science Center, HoustonThe 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
- Crossover
- Model description
- This is a stepwise cluster randomized control design study. There will be 3 clusters (FQHC's) having 3 practices each
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Daisy Y. Morales Campos, The University of Texas Health Science Center, Houston
- Investigators
- Daisy Y Morales Campos, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598475
- Sponsor's protocol ID
- HSC-SPH-24-0335
- Status last verified
- Apr 2026
- First submitted
- 13 Sep 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morales-Campos DY, Adsul P, Liang Y, Donovan E, Moczygemba LR, Kahn JA. Trusted health system implementation strategies to increase vaccination (TRUE SYNERGI): a stepped-wedge cluster randomized trial to reduce HPV-related cancers. BMC Public Health. 2025 Apr 9;25(1):1331. doi: 10.1186/s12889-025-22273-7.
PubMed 40205591
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Facilitator-driven, Multi-level Implementation Strategies in Federally Qualified Health Centers to Improve Provider Recommendation and HPV Vaccination Rates Among Latino/a Adolescents
- ClinicalTrials.gov ID
- NCT06598475
- Acronym / sponsor ID
- HSC-SPH-24-0335
- Conditions
- Human Papillomavirus Infection
- Keywords
- HPV vaccination
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 19 Sep 2024 (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 purpose of this study is to determine the provider- and practice-level characteristics that influence the impact of implementation strategies guided by practice facilitation in each clinical practice, to test whether the facilitator-driven provider- and practice-level implementation strategies increase provider recommendations and Human Papilloma Virus (HPV) vaccination rates and to evaluate implementation and future sustainability of the facilitator-driven implementation strategies across nine clinical practice sites
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a stepwise cluster randomized control design study. There will be 3 clusters (FQHC's) having 3 practices each
| Arm | Type | Receives |
|---|---|---|
| Step 1 (3 clinics)-15 months control then 30 months intervention | Experimental | Other: Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates |
| Step 2 (3 clinics)-21 months control then 24 months intervention | Experimental | Other: Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates |
| Step 3 (3 clinics)-27 months control then 18 months intervention | Experimental | Other: Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- FQHC's with less than 60% HPV vaccine initiation rate for 11-12 year old adolescents overall at their practice sites
- FQHC's that have family medicine and/or pediatric practices
- a total adolescent patient population at least 50% Latino
- be willing for Health Care Provider (HCP) and staff members to receive education, training, and support; complete standardized measurement, and agree to randomization.
- Providers, aged 18 and over, employed at each FQHC (4 staff per practice)
Key exclusion criteria (1 listed)
- -FQHCs that participated in the pilot study were excluded.
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 |
|---|---|---|
| Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination ratesThe practice facilitator (UTHealth research staff) will implement the following 4 strategies with providers and immunization navigators at each practice: * Facilitator-driven provider education: The practice facilitator will conduct one provider education module (5 total modules) over three months with health care providers using a booklet and resource binder. * Facilitator-driven clinical practice plan: The practice facilitator will assist the implementation team in creating their clinical practice in two additional modules and encourage providers to identify strategies to increase HPV vaccination. * Training and education for staff (Immunization Navigators): The facilitator will train immunization navigators to implement the plan, and practice immunization navigators will implement the plan. * Technical assistance plus assessment and feedback: During implementation of the plan, the facilitator will provide technical assistance, ongoing assessment and feedback, and booster trainings. | Other | Step 1 (3 clinics)-15 months control then 30 months intervention, Step 2 (3 clinics)-21 months control then 24 months intervention, Step 3 (3 clinics)-27 months control then 18 months intervention |
Primary outcome
Percentage of vaccine-eligible males and females at each clinic who received the first valid dose of the HPV vaccine series before their 13th birthday.
Time frame: From baseline to end of study ( about 60 months from baseline)
Percentage of vaccine-eligible males and females at each clinic who received the second valid dose of the HPV vaccine series 6-12 months after their first dose and before their 13th birthday.
Time frame: From baseline to end of study ( about 60 months from baseline)
6 secondary outcomes
Percentage of vaccine-eligible males and females at each clinic who received the first valid dose of the HPV vaccine series before their 18th birthday.
Time frame: From baseline to end of study ( about 60 months from baseline)
Percentage of vaccine-eligible 13-14 y/o males and females at each clinic who received the second valid dose of the HPV vaccine series 6-12 months after first dose and before their 15th birthday
Time frame: From baseline to end of study ( about 60 months from baseline)
Percentage of vaccine-eligible 15-17 y/o males and females at each clinic who received the second valid dose of the HPV vaccine series 2 months after first dose and before their 18th birthday
Time frame: From baseline to end of study ( about 60 months from baseline)
Percentage of vaccine-eligible 15-17 y/o males and females at each clinic who received the third valid dose of the HPV vaccine series 4 months after second dose and before their 18th birthday.
Time frame: From baseline to end of study ( about 60 months from baseline)
Percentage of non-well visits in which HPV vaccine was not administered, among all visits for active vaccine-eligible patients ages 11-17 by clinic
Time frame: From baseline to end of study ( about 60 months from baseline)
Percentage of males and females at each clinic who received Tdap and MenACWY at age 11 as a requirement to attend 7th grade in Texas.
Time frame: From baseline to end of study ( about 60 months from baseline)
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 4 May 2026.
- Derived from this study: PubMed 40205591Morales-Campos DY, Adsul P, Liang Y, Donovan E, Moczygemba LR, Kahn JA. Trusted health system implementation strategies to increase vaccination (TRUE SYNERGI): a stepped-wedge cluster randomized trial to reduce HPV-related cancers. BMC Public Health. 2025 Apr 9;25(1):1331. doi: 10.1186/s12889-025-22273-7.
- Individual participant dataSharing planned: No
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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.
Daisy Y Morales Campos, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates in people with Human Papillomavirus Infection, run by The University of Texas Health Science Center, Houston 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 8 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 4 May 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 Daisy Y Morales-Campos, PhD ((210) 276 9042, Daisy.Y.MoralesCampos@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of vaccine-eligible males and females at each clinic who received the first valid dose of the HPV vaccine series before their 13th birthday. (time frame: From baseline to end of study ( about 60 months from baseline)). 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 NCT06598475, 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 4 May 2026.