HPV Vaccine Confident Families

Not Applicable

Not yet recruiting

• Conditions: Human Papillomavirus Vaccines
• Interventions: Behavioral: Tailored messages; Behavioral: Standard messages

• Registration Number: NCT06002282
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-08-12
• Study First Posted: 2023-08-21
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13
• Study Start: 2024-09
• Primary Completion: 2025-08
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tailored Messaging	Tailored messages	Tailored messages based on parents' HPV vaccine hesitancy and perceived barriers to vaccination.
Standard Messaging	Standard messages	Standard (untailored) messages about HPV vaccination reminder/recall.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Vaccine Intention	Immediately post-intervention (6 months)	Parent reported intention to vaccinate adolescent in next 6 months
Vaccine Confidence	Immediately post-intervention (6 months)	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)