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Clinical Trials/NCT02067507
NCT02067507CompletedNot Applicable

Increasing Human Papillomavirus Vaccine Uptake in Low-Income, Ethnic Minority Adolescents in Los Angeles County

University of California, Los Angeles2 sites in 1 country53,414 target enrollmentStarted: June 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
53,414
Locations
2
Primary Endpoint
HPV Vaccine Uptake

Study Overview

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. The intervention group will have a higher rate of HPV vaccine initiation at follow-up compared to the control group.

Secondary hypothesis: 2. The intervention group will have higher vaccine completion rates (3 doses) at follow-up compared to the control group.

Detailed Description

The primary aim of the project is to increase HPV vaccine receipt rates among low-income, ethnic minority adolescents (girls and boys ages 9-17 years) in LA 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. The intervention group will have a higher rate of HPV vaccine initiation at follow-up compared to the control group.

Secondary hypothesis: 2. The intervention group will have higher vaccine completion rates (3 doses) at follow-up compared to the control group.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
9 Years to 70 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Recruitment Venue 1 (LACDPH) Criteria:
  • •Inclusion Criteria:
  • •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

Exclusion Criteria

  • •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:
  • •Inclusion Criteria:
  • •Adolescent male or female (9-17 years)
  • •Has received at least one service at the FQHC in the past 2 years
  • •Exclusion Criteria:
  • •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:
  • •Inclusion 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
  • •Exclusion Criteria:
  • •Younger than 12 or older than 13 years of age
  • •Has not received any services at the FQHC in the past 2 years
  • •Has completed the 3-dose HPV vaccine

Arms & Interventions

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

Intervention: Tailored education and referral (Behavioral)

Staff training and patient reminders

Experimental

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

Intervention: Staff training and patient reminders (Behavioral)

Clinic-level reminder systems

Experimental

Clinic-level reminders administered at Northeast Valley Health Corporation Site

Intervention: Clinic-level reminder systems (Behavioral)

Outcomes

Primary Outcomes

HPV Vaccine Uptake

Time Frame: 3 months, 6 months

The receipt of one or more doses of the HPV vaccine

Secondary Outcomes

  • HPV Vaccine Series Completion(9 months, 12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Roshan Bastani

Professor of Health Policy and Management

University of California, Los Angeles

Study Sites (2)

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