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HPV Vaccine Confident Families

HPV Vaccine Confident Families

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06002282
Enrollment
70
Registered
2023-08-21
Start date
2025-10-31
Completion date
2026-07-31
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papillomavirus Vaccines

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.

Interventions

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.

BEHAVIORALStandard messages

Generic reminder/recall HPV vaccination messages.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility - RetentionPost intervention completion, 1 yearratio of parents completing post-intervention surveys to the number enrolled
Feasibility - Intervention responseTwo weeks after intervention completionassessment of how often participants completed hesitancy questions across the intervention period
Feasibility - Intervention utilityTwo weeks after intervention completionPerceived ease of use, likeability, helpfulness, impact - Mobile App Rating Scale (1-inadequate, 2-poor, 3-acceptable, 4-good, and 5-excellent)
Feasibility - RecruitmentAfter enrollment completion, 6 monthsratio of parents recruited to potential parents approached to participate in study
Feasibility - Intervention DeliveryTwo weeks after intervention beginsratio of parents receiving HPV message to the number enrolled

Secondary

MeasureTime frameDescription
Vaccine ConfidenceImmediately 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)
Vaccine IntentionImmediately post-intervention (6 months)Parent reported intention to vaccinate adolescent in next 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026