HPV Vaccine Confident Families

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

Official Title
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HPV Vaccine Confident Families

Conditions
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Human Papillomavirus Vaccines

Intervention / Treatment
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* Behavioral: Tailored text messages
* Behavioral: Standard text messages


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored Messaging<br>Tailored text messages based on parents' HPV vaccine hesitancy and perceived barriers to vaccination. | Behavioral: Tailored text messages<br>* Text 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.<br>|
| Active Comparator: Standard Messaging<br>Standard (untailored) text messages about HPV vaccination reminder/recall. | Behavioral: Standard text messages<br>* Generic reminder/recall HPV vaccination text messages.<br>|

What is the study measuring?
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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 of texts- Mobile App Rating Scale | 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 | Immediately post-intervention (6 months) |