Investigating Facilitator-driven, Multi-level Implementation Strategies in Federally Qualified Health Centers to Improve Provider Recommendation and HPV Vaccination Rates Among Latino/a Adolescents

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-17
SponsorThe University of Texas Health Science Center, Houston

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates

    Other intervention

    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.

Treatment groups

225 Participants
are divided into 3 treatment groups
Group A: Step 1 (3 clinics)-15 months control then 30 months interventionExperimental treatment 1 intervention
Group B: Step 2 (3 clinics)-21 months control then 24 months interventionExperimental treatment 1 intervention
Group C: Step 3 (3 clinics)-27 months control then 18 months interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)
2

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

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

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