HPV Vaccine Confident Families

NCT06002282 | Suspended

• 3 other identifiers: Pro2022001385K22CA258675132211
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Papillomavirus Vaccines

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Vaccine Intention

  Immediately post-intervention (6 months)

• Vaccine Confidence

  Immediately post-intervention (6 months)

Study Arms (2)

Tailored Messaging

EXPERIMENTAL

Tailored messages based on parents' HPV vaccine hesitancy and perceived barriers to vaccination.

Behavioral: Tailored messages

Standard Messaging

ACTIVE COMPARATOR

Standard (untailored) messages about HPV vaccination reminder/recall.

Behavioral: Standard messages

Interventions

Tailored messages BEHAVIORAL

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.

Tailored Messaging

Standard messages BEHAVIORAL

Generic reminder/recall HPV vaccination messages.

Standard Messaging

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Rutgers

New Brunswick, New Jersey, 08901, United States

Location

Study Officials

• Racquel Kohler, PhD

  Rutgers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 21, 2023
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)