NCT02067507

Brief Summary

The primary aim of the project is to increase human papillomavirus (HPV) vaccine receipt rates among low-income, ethnic minority adolescents (girls and boys 11-17 years of age) in Los Angeles County. We will accomplish this goal by implementing and rigorously evaluating interventions in multiple venues that serve our target population, including the Los Angeles County Department of Public Health (LACDPH) and two large Federally Qualified Health Centers (FQHCs). Our hypotheses are: Primary hypothesis:

  1. 1.The intervention group will have a higher rate of HPV vaccine initiation at follow-up compared to the control group.
  2. 2.The intervention group will have higher vaccine completion rates (3 doses) at follow-up compared to the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53,414

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

June 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

7.3 years

First QC Date

February 18, 2014

Last Update Submit

October 23, 2019

Conditions

Human Papilloma Virus Infection

Keywords

Human PapillomavirusImmunizationOncogenic virusesCervical CancerHealth Disparities

Outcome Measures

Primary Outcomes (1)

  • HPV Vaccine Uptake

    The receipt of one or more doses of the HPV vaccine

    3 months, 6 months

Secondary Outcomes (1)

  • HPV Vaccine Series Completion

    9 months, 12 months

Other Outcomes (1)

  • Knowledge and Attitudes Regarding HPV Vaccination

    9 months

Study Arms (4)

Control

NO INTERVENTION

LACDPH Site: CDC-developed small media in preferred language AltaMed Health Services Corporation Site: Usual care - Standing order for the HPV vaccine; required web-based training module for medical assistants and nurses containing basic information on HPV, the HPV vaccine, and standing order implementation Northeast Valley Health Corporation Site: Usual care

Tailored education and referral

EXPERIMENTAL

LACDPH Site: Tailored education and referral intervention administered at LACDPH Site

Behavioral: Tailored education and referral

Staff training and patient reminders

EXPERIMENTAL

Staff training and patient reminders administered at AltaMed Health Services Corporation Site

Behavioral: Staff training and patient reminders

Clinic-level reminder systems

EXPERIMENTAL

Clinic-level reminders administered at Northeast Valley Health Corporation Site

Behavioral: Clinic-level reminder systems

Interventions

Tailored education and referralBEHAVIORAL

LACDPH Site: 5-minute tailored educational messages and clinic referral for vaccine plus tailored small media

Tailored education and referral
Staff training and patient remindersBEHAVIORAL

AltaMed Health Services Corporation Site: (1) Health care provider training on the importance of HPV vaccination, strategies to appropriately frame the HPV vaccine conversation, and recommended processes and procedures for vaccine delivery; (2) Staff training on the importance of HPV vaccination, strategies to promote uptake of the vaccine, and recommended processes and procedures for vaccine delivery; (3) Patient reminders and provider cues for follow-up doses; and (4) Organizational strategies to improve processes for vaccine delivery, in addition to usual care activities

Staff training and patient reminders
Clinic-level reminder systemsBEHAVIORAL

Northeast Valley Health Corporation Site: Three different clinic-level reminder systems, including a mailed letter, automated/robo telephone call, or text message reminder

Clinic-level reminder systems

Eligibility Criteria

Age9 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult male or female
  • Current or previous user of the Los Angeles County Office of Women's Health Hotline
  • Speaks one of the hotline languages (English, Spanish, Korean, Mandarin, Cantonese, Armenian)
  • Is the medical decision-maker for a male or female adolescent aged 11-17 in his or her home
  • Adolescent has not started the HPV vaccine series
  • Current resident of Los Angeles County

You may not qualify if:

  • Younger than 18 or older than 70 years of age
  • Not conversant in one of the hotline languages (English, Spanish, Korean, Mandarin, Cantonese, Armenian)
  • Is not the medical decision-maker for an adolescent aged 11-17 in his or her home
  • Adolescent has initiated the HPV vaccine series
  • Not a current resident of Los Angeles County
  • Recruitment Venue 2 (AltaMed) Criteria:
  • Adolescent male or female (9-17 years)
  • Has received at least one service at the FQHC in the past 2 years
  • Younger than 9 or older than 17 years of age
  • Has not received any services at the FQHC in the past 2 years
  • Recruitment Venue 3 (NEVHC) Criteria:
  • Adolescent male or female (12-13 years)
  • Has received at least one service at the FQHC in the past 2 years
  • Has received no doses or 1 dose of the HPV vaccine
  • Younger than 12 or older than 13 years of age
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Los Angeles County Department of Public Health

Alhambra, California, 91803, United States

Location

Northeast Valley Health Corporation

San Fernando, California, 91340, United States

Location

MeSH Terms

Conditions

Papillomavirus InfectionsUterine Cervical Neoplasms

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Roshan Bastani, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

  • Beth Glenn, PhD

    University of California, Los Angeles

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Health Policy and Management

Study Record Dates

First Submitted

February 18, 2014

First Posted

February 20, 2014

Study Start

June 1, 2012

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

October 25, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)