NCT02808832

Brief Summary

The purpose of this study is to develop, deliver and evaluate a provider intervention for mothers and their children to encourage receipt of the human papillomavirus (HPV) vaccine in the children and appropriate cervical cancer screening in the mothers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
806

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

5.5 years

First QC Date

June 16, 2016

Last Update Submit

September 12, 2016

Conditions

Human PapillomavirusUterine Cervical Neoplasms

Keywords

Human papillomavirus (HPV) vaccineCervical cancer screeningProvider intervention

Outcome Measures

Primary Outcomes (1)

  • Number of children participants who completed the 3-dose HPV vaccine series

    Although completion of the 3-dose HPV vaccine series is recommended within 6 months, the investigators measured completion within 12 months.

    12 months

Secondary Outcomes (1)

  • Number of mother participants who received appropriate cervical cancer screening

    12 months

Study Arms (2)

Educational materials

EXPERIMENTAL

5-minute video and information sheet with a list of suggested questions to ask the provider

Behavioral: Educational materials

Usual care

NO INTERVENTION

Usual care

Interventions

Educational materialsBEHAVIORAL

5-minute video and information sheet with a list of suggested questions to ask the provider

Educational materials

Eligibility Criteria

Age9 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being seen as a pediatric patient at a study clinic on the day of enrollment
  • Self-identified African American or Hispanic
  • Aged 9-18 years (mother accompanying child to clinic visit had no age limit)
  • Had received no doses of HPV vaccine or received one shot and was overdue for the second dose (three or more months after the first dose was given) prior to the clinic visit

You may not qualify if:

  • Already having received two or more doses of HPV vaccine
  • Mother or female guardian (referred to as "mother" henceforth) not accompanying the child
  • Plans to move away from the clinic catchment area within the next 12 months
  • Not completing the baseline assessment prior to entering the exam room
  • Mother not providing or unable to give consent
  • Child not giving assent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

Related Publications (1)

  • Sanderson M, Canedo JR, Khabele D, Fadden MK, Harris C, Beard K, Burress M, Pinkerton H, Jackson C, Mayo-Gamble T, Hargreaves MK, Hull PC. Pragmatic trial of an intervention to increase human papillomavirus vaccination in safety-net clinics. BMC Public Health. 2017 Feb 2;17(1):158. doi: 10.1186/s12889-017-4094-1.

    PMID: 28153042DERIVED

MeSH Terms

Conditions

Uterine Cervical NeoplasmsPapillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maureen Sanderson, PhD

    Meharry Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 22, 2016

Study Start

September 1, 2010

Primary Completion

March 1, 2016

Study Completion

August 1, 2016

Last Updated

September 14, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)