--- 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 nct_id: NCT06598475 overall_status: RECRUITING phase: NA sponsor: The University of Texas Health Science Center, Houston study_type: INTERVENTIONAL primary_condition: Human Papillomavirus Infection countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06598475.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06598475" ct_last_update_post_date: 2026-05-04 last_seen_at: "2026-05-12T07:14:38.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Investigating Facilitator-driven, Multi-level Implementation Strategies in Federally Qualified Health Centers to Improve Provider Recommendation and HPV Vaccination Rates Among Latino/a Adolescents **NCT ID:** [NCT06598475](https://clinicaltrials.gov/study/NCT06598475) ## Key Facts - **Status:** RECRUITING - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 225 - **Lead Sponsor:** The University of Texas Health Science Center, Houston - **Collaborators:** National Cancer Institute (NCI) - **Conditions:** Human Papillomavirus Infection - **Start Date:** 2025-03-13 - **Completion Date:** 2028-08-01 - **CT.gov Last Update:** 2026-05-04 ## Brief 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 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 ## Eligibility - **Minimum age:** 11 Years - **Maximum age:** 17 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * 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). Exclusion Criteria: -FQHCs that participated in the pilot study were excluded. ``` ## Arms - **Step 1 (3 clinics)-15 months control then 30 months intervention** (EXPERIMENTAL) - **Step 2 (3 clinics)-21 months control then 24 months intervention** (EXPERIMENTAL) - **Step 3 (3 clinics)-27 months control then 18 months intervention** (EXPERIMENTAL) ## Interventions - **Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates** (OTHER) — 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. ## Primary Outcomes - **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))_ ## 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))_ ## Locations (1) - The University of Texas Health Science Center at Houston, Houston, Texas, United States — _RECRUITING_ ## Recent Field Changes (last 30 days) - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.the university of texas health science center at houston|houston|texas|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT06598475.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT06598475* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*