HPV Vaccine Confident Families

Human Papillomavirus Vaccines Clinical Trial

Official title:

HPV Vaccine Confident Families

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06002282
• Other study ID #: Pro2022001385
• Secondary ID: K22CA25867513221
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: October 2025

Study information

• Verified date: June 2024
• Source: Rutgers, The State University of New Jersey
• Contact: Racquel E Kohler, PhD
• Phone: 732.258.6031
• Email: kelly.kohler[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: October 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Human Papillomavirus Vaccines

Intervention

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.
• Standard messages
Generic reminder/recall HPV vaccination messages.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - Recruitment	ratio of parents recruited to potential parents approached to participate in study	After enrollment completion, 6 months
Primary	Feasibility - Retention	ratio of parents completing post-intervention surveys to the number enrolled	Post intervention completion, 1 year
Primary	Feasibility - Intervention Delivery	ratio of parents receiving HPV message to the number enrolled	Two weeks after intervention begins
Primary	Feasibility - Intervention response	assessment of how often participants completed hesitancy questions across the intervention period	Two weeks after intervention completion
Primary	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	Vaccine Intention	Parent reported intention to vaccinate adolescent in next 6 months	Immediately post-intervention (6 months)
Secondary	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)