NCT00680147

Brief Summary

This will enroll 300 mothers of teenage girls and boys to identify barriers to HPV vaccination among low-income, African-American teens.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
614

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 15, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

May 21, 2015

Status Verified

May 1, 2015

Enrollment Period

3.6 years

First QC Date

May 15, 2008

Last Update Submit

May 19, 2015

Conditions

Keywords

HPVGardasilAfrican-Americanadolescenthealth behaviorsexually transmitted infectionsThis will enroll 300 mothers of teenage girls and boys to identify barriers to HPV vaccination among low-income, African-American teens.

Outcome Measures

Primary Outcomes (1)

  • completed vaccination with Gardasil

    6 months

Secondary Outcomes (1)

  • assessed cross-sectionally, at time of initial enrollment

    assessed at time of baseline assessment

Study Arms (1)

Brief HPV vaccine informational intervention

EXPERIMENTAL

Because we anticipated that knowledge and awareness of the HPV vaccine would be low in our study population, our CASI survey included a brief, informational overview of key facts concerning HPV vaccination prior to assessing vaccine acceptance, perceived barriers to vaccination, and intentions to vaccinate. The overview lasted approximately 3 minutes and consisted of a brief overview of key HPV vaccination facts that were presented visually (on the computer screen) and read aloud using a digital recording. HPV and vaccine knowledge, awareness, and attitudes items were administered prior to participants hearing the informational overview.

Behavioral: brief informational intervention to promote HPV vaccine acceptance

Interventions

Teen and parent participants will receive a brief informational intervention that provides basic facts about the HPV vaccine, including the health benefits and three-dose requirements, along with information regarding where to go to receive the vaccination. A coupon for a free HPV vaccination will provided to the parent for use by their teenage daughter.

Brief HPV vaccine informational intervention

Eligibility Criteria

Age11 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Females parent or guardian with an African-American daughter or son between the ages of 11 and 17
  • African-American adolescents between the ages of 11-17

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Health and Behavior, Syracuse University

Syracuse, New York, 13244, United States

Location

MeSH Terms

Conditions

Health BehaviorSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

BehaviorCommunicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 15, 2008

First Posted

May 19, 2008

Study Start

July 1, 2008

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

May 21, 2015

Record last verified: 2015-05

Locations