Text and Talk: A Multi-level Intervention to Increase Provider HPV Vaccine Recommendation Effectiveness

NCT05006833 | Active Not Recruiting

• 2 other identifiers: IRB202001633 -NR37CA234030
• Study Type: interventional
• Target: 21,110
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the effectiveness of two interventions (parent-targeted text messages and a brief clinician-targeted training) at increasing HPV vaccination among 11- to 12-year-olds living in Florida.

Conditions

HPV

Outcome Measures

Primary Outcomes (2)

• Initiation of the HPV Vaccine

  Binary measure at the participant level of receipt of one or more does of the HPV vaccine

  24 months

• Up to date for the HPV Vaccine

  Binary measure at the participant level of receipt of two or more doses of the HPV vaccine

  24 months

Secondary Outcomes (1)

• Frequency of Provider recommendations

  12 months

Other Outcomes (1)

• Visited the clinic

  24 months

Study Arms (9)

Bundled clinician training and bundled text messages

EXPERIMENTAL

Clinicians will receive bundled approach training and parents will receive bundled text messages.

Behavioral: Brief Provider Training - Bundled Approach; Behavioral: Parent Interactive Text Message - Bundled Approach

Bundled clinician training and benefits text messages

EXPERIMENTAL

Clinicians will receive bundled approach training and parents will receive benefits text messages.

Behavioral: Brief Provider Training - Bundled Approach; Behavioral: Parent Interactive Text Message - Benefits Approach

Bundled clinician training and no text messages

EXPERIMENTAL

Clinicians will receive bundled approach training and parents will not receive any intervention text messages.

Behavioral: Brief Provider Training - Bundled Approach

Benefits clinician training and bundled text messages

EXPERIMENTAL

Clinicians will receive benefits approach training and parents will receive bundled text messages.

Behavioral: Brief Provider Training - Benefits Approach; Behavioral: Parent Interactive Text Message - Bundled Approach

Benefits clinician training and benefits text messages

EXPERIMENTAL

Clinicians will receive benefits approach training and parents will receive benefits text messages.

Behavioral: Brief Provider Training - Benefits Approach; Behavioral: Parent Interactive Text Message - Benefits Approach

Benefits clinician training and no text messages

EXPERIMENTAL

Clinicians will receive benefits approach training and parents will not receive any intervention text messages.

Behavioral: Brief Provider Training - Benefits Approach

Deferred-clinician training and bundled text messages

EXPERIMENTAL

Clinicians will receive training after the study and parents will receive bundled text messages.

Behavioral: Parent Interactive Text Message - Bundled Approach

Deferred-clinician training and benefits text messages

EXPERIMENTAL

Clinicians will receive training after the study and parents will receive benefits text messages.

Behavioral: Parent Interactive Text Message - Benefits Approach

Deferred-clinician training and no text messages

NO INTERVENTION

Clinicians will receive training after the study and parents will not receive intervention text messages.

Interventions

Brief Provider Training - Bundled Approach BEHAVIORAL

At each clinic randomized to bundled training, providers will be invited to participate in one, in-clinic, group-based training. Each training will last one-hour and providers will receive continuing medical education (CME) credit for participating. Trainings will focus on introducing the HPV vaccine in a bundle of the other two adolescent vaccines (Tdap and MenACWY).

Bundled clinician training and benefits text messages; Bundled clinician training and bundled text messages; Bundled clinician training and no text messages

Brief Provider Training - Benefits Approach BEHAVIORAL

At each clinic randomized to benefits training, providers will be invited to participate in one, in-clinic, group-based training . Each training will last one-hour and providers will receive continuing medical education (CME) credit for participating. Trainings will focus on providers presenting the HPV vaccine as safe, best if received at 11- to 12-years of age, and prevents cancer.

Benefits clinician training and benefits text messages; Benefits clinician training and bundled text messages; Benefits clinician training and no text messages

Parent Interactive Text Message - Bundled Approach BEHAVIORAL

Text messages sent to parents will focus on receiving all three adolescent vaccines.

Benefits clinician training and bundled text messages; Bundled clinician training and bundled text messages; Deferred-clinician training and bundled text messages

Parent Interactive Text Message - Benefits Approach BEHAVIORAL

Text message will state that the HPV vaccine prevents cancer, is safe and effective, and is recommended for 11- to 12-year-olds.

Benefits clinician training and benefits text messages; Bundled clinician training and benefits text messages; Deferred-clinician training and benefits text messages

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adolescents
• Age 10- to 12-years-old
• Visited participating clinic in past two years
• No records of the adolescent vaccines Parents
• Parent of adolescent meeting the above criteria
• Parent of 10- to 12-year-old Providers
• Provide 11 to 12-year-old patients primary care
• Practice at a participating clinic

You may not qualify if:

• Adolescents
• Out of the age range for participation
• Previously opted-out of text messages
• No cell phone numbers on file at clinic
• Parents/Providers
• Unwilling to consent to participation

Sponsors & Collaborators

• University of Florida: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Study Officials

• Stephanie Staras, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 16, 2021
• Study Start: November 18, 2021
• Primary Completion: February 25, 2025
• Study Completion: March 30, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Once findings from the main study have been released.
• Access Criteria: Investigators will complete a data-sharing agreement and be charged a nonrefundable fee to cover administrative handling chargers and user support.

Locations

US (1)