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

NCT05006833 | Completed Results

• 2 other identifiers: IRB202001633 -NR37CA234030
• Study Type: interventional
• Target: 8,043
• 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. The percentage of participants is estimated with predicted probabilities to adjust for clustering at the clinic-level.

  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 (2)

• Frequency of Clinician Recommendation

  12 months

• Parent Text Message Acceptability

  Upon receipt of text message

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

Results Point of Contact

• Title: Stephanie A. S. Staras, PhD
• Organization: University of Florida

sstaras@ufl.edu

352.627.9467

Study Officials

• Stephanie Staras, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: February 16, 2026
• Last Updated: August 4, 2026
• Results First Posted: August 4, 2026

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)