HPV Vaccine Confident Families

The objectives of the study are to pilot test a tailored intervention among Black families with adolescents. The hypotheses are that the study protocol will be feasible and messages tailored to parents' needs will increase vaccine confidence and intention to vaccinate.

Study Overview

• Status: Suspended
• Conditions: Human Papillomavirus Vaccines
• Intervention / Treatment: Behavioral: Tailored messages; Behavioral: Standard messages

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• parent or legal guardian of at least one child aged 9-13 years who has received 0 or 1 dose of HPV vaccine;
• identify as Black or African American adult;
• have access to personal mobile phone and agree to send/receive MMS messages;
• able to speak and understand English; and
• able to provide informed consent to participate

Exclusion Criteria:

• parent or legal guardian of child outside of participation age range or who has completed multiple doses of HPV vaccine;
• does not identify as Black or African American adult;
• does not have personal mobile phone;
• unable to speak and understand English;
• not willing to consent to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tailored Messaging; Tailored messages based on parents' HPV vaccine hesitancy and perceived barriers to vaccination.	Behavioral: Tailored messages; Messages will be individually tailored to parents' responses to a baseline survey (child gender, vaccination status) and real-time responses to interactive prompts about vaccine hesitancy determinants with links to additional information (e.g., CDC, NJ Department of Health) and community resources to overcome barriers.
Active Comparator: Standard Messaging; Standard (untailored) messages about HPV vaccination reminder/recall.	Behavioral: Standard messages; Generic reminder/recall HPV vaccination messages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - Recruitment	ratio of parents recruited to potential parents approached to participate in study	After enrollment completion, 6 months
Feasibility - Retention	ratio of parents completing post-intervention surveys to the number enrolled	Post intervention completion, 1 year
Feasibility - Intervention Delivery	ratio of parents receiving HPV message to the number enrolled	Two weeks after intervention begins
Feasibility - Intervention response	assessment of how often participants completed hesitancy questions across the intervention period	Two weeks after intervention completion
Feasibility - Intervention utility	Perceived ease of use, likeability, helpfulness, impact - Mobile App Rating Scale (1-inadequate, 2-poor, 3-acceptable, 4-good, and 5-excellent)	Two weeks after intervention completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccine Intention	Parent reported intention to vaccinate adolescent in next 6 months	Immediately post-intervention (6 months)
Vaccine Confidence	Parent-reported response to scale assessing benefits of vaccination, harms of vaccination, and trust in health care providers (1 - strongly disagree to 5 - strongly agree)	Immediately post-intervention (6 months)

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Racquel Kohler, PhD, Rutgers

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: August 12, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Pro2022001385; K22CA258675 (U.S. NIH Grant/Contract); 132211 (Other Identifier: Rutgers, Cancer Institute of New Jersey)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No