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

H. Lee Moffitt Cancer Center and Research Institute

Status: Suspended

Conditions: Human Papilloma Virus (HPV) Vaccine

Treatments: Behavioral: HPV MISTICS- HPV Vaccine Champion Level; Behavioral: HPV MISTICS - Parent Level; Behavioral: HPV MISTICS -Provider Level

Study type: Interventional

Funder types: Other

Identifiers

NCT05677360

MCC-21902

Details and patient eligibility

About

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.

Full 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.

Enrollment: 564 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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564 participants in 2 patient groups

Wave 1: Initial Community Health Centers

Experimental group

Description:

Initial group of community health centers to receive intervention

Treatment:

Behavioral: HPV MISTICS -Provider Level

Behavioral: HPV MISTICS - Parent Level

Behavioral: HPV MISTICS- HPV Vaccine Champion Level

Wave 2: Second Community Health Centers

Experimental group

Description:

Second group of community health centers to receive intervention

Treatment:

Behavioral: HPV MISTICS -Provider Level

Behavioral: HPV MISTICS - Parent Level

Behavioral: HPV MISTICS- HPV Vaccine Champion Level