HPV Vaccine Confident Families

NCT ID: NCT06002282

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-07-31

Brief Summary

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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

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Conditions

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Human Papillomavirus Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Tailored Messaging

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

Group Type EXPERIMENTAL

Tailored messages

Intervention Type 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.

Standard Messaging

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

Group Type ACTIVE_COMPARATOR

Standard messages

Intervention Type BEHAVIORAL

Generic reminder/recall HPV vaccination messages.

Interventions

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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.

Intervention Type BEHAVIORAL

Standard messages

Generic reminder/recall HPV vaccination messages.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Racquel Kohler, PhD, MSPH

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Racquel Kohler, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers

Locations

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Rutgers

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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K22CA258675

Identifier Type: NIH

Identifier Source: secondary_id

View Link

132211

Identifier Type: OTHER

Identifier Source: secondary_id

Pro2022001385

Identifier Type: -

Identifier Source: org_study_id

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