NCT07301905

Brief Summary

The goal of this clinical trial is to learn if culturally targeted messaging about the human papillomavirus (HPV) increases receptivity to the HPV vaccine among African American parents of vaccine-eligible daughters. The main question it aims to answer is:

  • Does culturally targeted messaging increase African American parents' intentions to vaccinate their daughter against HPV? Research will compare culturally targeted messaging to general, educational messaging and no messaging. Participants will:
  • View culturally targeted messages, education-only messages, or no messages about the HPV vaccine
  • Report their intentions to vaccinate their daughter against HPV
  • Report whether they have initiated HPV vaccination for their daughter six months later

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
265

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

March 13, 2026

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

September 8, 2025

Last Update Submit

March 11, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • HPV Vaccine Attitudes

    Subscale of Theory of Planned Behavior measuring attitudes toward the HPV vaccine on response scale ranging from 1 = Strongly disagree to 7 = Strongly agree, where higher average scores indicate more positive attitudes

    Immediately following and 6-months post-health messaging

  • HPV Vaccine Normative Beliefs

    Subscale of Theory of Planned Behavior measuring the extent to which participants believe other people are favorable toward the HPV vaccine on response scale ranging from 1 = Strongly disagree to 7 = Strongly agree, where higher average scores indicate stronger normative beliefs

    Immediately following and 6-months post-health messaging

  • HPV Vaccine Perceived Behavioral Control

    Subscale of Theory of Planned Behavior measuring beliefs about ability to vaccinate their child on response scale ranging from 1 = Strongly disagree to 7 = Strongly agree, where higher average scores indicate greater perceived behavioral control

    Immediately following and 6-months post-health messaging

  • HPV Vaccine Intentions

    Subscale of Theory of Planned Behavior measuring intentions to vaccinate their child on response scale ranging from 1 = Strongly disagree to 7 = Strongly agree, where higher average scores indicate greater intentions

    Immediately following and 6-months post-health messaging

  • Vaccination Initiation

    1 self-report item measuring whether parents' daughters have received at least one dose of the HPV vaccine since completion of the initial survey, with Yes/No response options

    6-months post-health messaging

  • Vaccination Discussion

    1 self-report item measuring whether parents have discussed the HPV vaccine with their daughters' healthcare provider since completion of the initial survey, with Yes/No response options

    6-months post-health messaging

Secondary Outcomes (1)

  • Anticipatory Racism

    Immediately following health messaging

Study Arms (5)

African American Culturally Targeted Messaging

EXPERIMENTAL

Culturally targeted messaging about the HPV vaccine for African American parents

Behavioral: Culturally Targeted HPV Vaccine Health Messaging

African American General, Education-Only Messaging

ACTIVE COMPARATOR

African American participants receive general, education-only messaging about the HPV vaccine.

Behavioral: General HPV Vaccine Health Messaging

African American No Message

NO INTERVENTION

African American participants receive no messaging about the HPV vaccine

White General, Education-Only Messaging

ACTIVE COMPARATOR

White participants receive general, education-only messaging about the HPV vaccine.

Behavioral: General HPV Vaccine Health Messaging

White No Message

NO INTERVENTION

White participants receive no messaging about the HPV vaccine

Interventions

General, education-only messaging about the HPV vaccine does not include culturally targeted messaging.

African American General, Education-Only MessagingWhite General, Education-Only Messaging

Educational messaging about the HPV vaccine includes culturally targeted messaging about the HPV vaccine.

African American Culturally Targeted Messaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Identify as Black/African American or White/Caucasian
  • Have at least one daughter who is between 8-17 years of age, who is not currently pregnant, and who has not received any doses of the HPV vaccine

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Flint Journal Building

Flint, Michigan, 48502, United States

RECRUITING

Central Study Contacts

Olivia Aspiras, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be unaware of their assignment to a general, education-only versus culturally targeted messaging condition.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This research will use a 2 (White, African American) x 3 (No message, Education-only message, Culturally targeted message) quasi-experimental design. All participants will be randomly assigned to a no-message control group or to receive educational materials about HPV vaccination. Half of African American parents who receive educational materials will also view culturally targeted messaging about the HPV vaccine.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 8, 2025

First Posted

December 24, 2025

Study Start

November 17, 2024

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

March 13, 2026

Record last verified: 2025-11

Locations