Increasing Human Papillomavirus Vaccine Uptake in Low-Income, Ethnic Minority Adolescents in Los Angeles County
Condition: Human Papilloma Virus Infection
MeSH terms: Papillomavirus Infections; Papilloma
Study type: Interventional

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.

      Recruitment Venue 1: Los Angeles County Department of Public Health. At the LACDPH, the
      multi-component intervention will be directed at caregivers of age-eligible adolescents
      (11-17 years) and include brief individually-tailored telephone education, referral to a
      clinic offering low cost/free vaccine, and a mailed brochure. The control group will receive
      usual care and a standard Centers for Disease Control and Prevention (CDC) HPV vaccine fact
      sheet.

      Additional secondary hypotheses for this recruitment venue include:

        1. The intervention group will have higher knowledge of HPV and the HPV vaccine than the
           control group.

        2. The intervention will have a greater effect on the more acculturated than less
           acculturated participants (moderator effect).

        3. The intervention will exert its effect on vaccine receipt by increasing knowledge and
           reducing barriers (mediator effects).

      This recruitment venue will utilize a two-arm time-randomized (on-off) controlled design to
      assess the effect of a multi-component intervention targeting mothers and fathers, to
      increase HPV vaccine uptake among their adolescents (ages 11-17). Hotline users will be
      randomized into the intervention or control condition on an alternating (on/off) weekly
      schedule. Eligible participants will complete a baseline telephone interview. Immediately
      following the baseline interview, participants calling during intervention weeks will receive
      the individually-tailored multi-component intervention, including tailored education and
      clinic referral. A tailored print intervention will also be mailed to intervention
      participants. All participants will be re-contacted at 3 months and 9 months for telephone
      follow-up interviews. Control group participants will receive the intervention after the
      9-month follow-up. Prior to study protocol implementation, about 25-50 individuals will be
      recruited to pre-test the baseline survey in different languages (English, Spanish, Chinese,
      Armenian) to ensure the baseline questionnaires are similar in content across languages and
      the questions are clear.

      The study site will enroll men and women of diverse racial-ethnic backgrounds from the Office
      of Women's Health (OWH) women's health telephone hotline database. The database includes
      contact information about adult women LA County residents who telephoned a 1-800 hotline to
      receive information and referrals about women's health issues, including cervical cancer and
      cervical cancer screening. Male callers also use the hotline. The OWH has promoted the
      hotline through partnerships with over 300 community-based organizations. Recruitment of
      callers from the database will consist of operators calling women to invite them to be
      screened for study eligibility. Recruitment of new hotline callers will take place during
      their first contact with the hotline. Upon receiving an incoming call, operators will first
      respond to the caller's request using routine hotline protocols which include screening for
      income eligibility (<200% of poverty) for county services. Following this, operators invite
      the caller to be screened for study eligibility. Eligible participants will be asked to
      complete the baseline interview.

      Callers will be randomized to the intervention or control condition on alternating weeks
      (on-off or time randomized design). This randomization scheme was selected in close
      consultation with OWH to ensure the integrity of the randomization process and minimize
      disruption of routine hotline operation. The telephone intervention will be delivered
      immediately following the baseline telephone interview to participants calling during
      intervention weeks. The intervention is based on the Health Behavior Framework and pilot
      study findings and incorporates individual-level tailoring. The three segments of the
      telephone intervention include: 1) basic information about the HPV vaccine; 2)
      individually-tailored information to address each participant's primary concerns regarding
      the vaccine; 3) individually-tailored referral to a local clinic where free/low cost vaccine
      is available.

      Baseline interviews (10-15 mins) will be conducted immediately following the eligibility
      screener and the verbal informed consent, via a Computer Assisted Telephone Interviewing
      System. All eligible subjects who complete the baseline interview will receive brief (<10
      mins) 3 and 9-month follow-up telephone interviews.

      Following the 3-month interviews, half of intervention participants will receive a "booster"
      intervention wherein we will repeat the clinic referral procedure/language given during the
      intervention at baseline. Intervention participants will be randomized to the "booster" or no
      "booster" condition based on the order in which they completed the baseline survey.

      Recruitment Venue 2: AltaMed Health Services Corporation. At AltaMed Health Services
      Corporation, the largest federally qualified health center in the nation, we will implement a
      multi-level intervention that includes patient (i.e., caregiver) and provider reminders,
      physician, nurse, and other staff training regarding the HPV vaccine and processes and
      procedures for its delivery. We will utilize a quasi-experimental study design to assess the
      effect of this multi-level intervention to increase HPV vaccine initiation and completion
      among adolescents (ages 9-17). Eight clinic sites that serve the majority of AltaMed's
      adolescent population will be matched based on the size of the adolescent population served
      and baseline HPV vaccination rates. We will randomly assign matched paired clinics to either
      the intervention (n=4) or usual care group (n=4).

      Clinics assigned to the usual care condition will only receive: (1) the standing order for
      the HPV vaccine, which authorizes non-physician providers to assess adolescents' immunization
      eligibility and administer the HPV vaccine without a physician examination or order and (2) a
      required web-based training module for medical assistants and nurses containing basic
      information on HPV, the HPV vaccine, and standing order implementation.

      In addition to usual care activities, intervention clinics will receive the following: (1)
      health care provider training on the importance of HPV vaccination and a strong provider
      recommendation, 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 and provider reminders to promote
      completion of the three-dose vaccine series; and (4) organizational strategies to improve
      processes for vaccine delivery, in addition to usual care activities.

      The intervention will be developed in close collaboration with administrative leadership and
      providers, who will provide input at each stage of the design, implementation, and evaluation
      process. A physician vaccine champion from the organization will assist with the development
      of and lead a one-hour, in-person provider presentation and discussion. For the staff
      training presentation, nurse managers will be convened regularly to discuss processes for HPV
      and general standing order implementation, strategies to optimize clinical workflow and
      increase follow-up, and development of back office staff training. Using a train-the-trainer
      approach, the nurse mangers will lead the approximate one-hour presentation and discussion at
      their respective clinics. They will also monitor process implementation through direct staff
      observation and quality reports and retrain staff as needed.

      In addition to provider and staff trainings, organizational strategies at intervention sites
      will include implementation of standard practices for HPV vaccine delivery that complement
      existing clinical workflow. At intake, back office staff will check vaccination history at
      each visit, implement needed standing orders, inform caregivers of vaccines due, and notify
      the provider of vaccines ordered. During the provider encounter, providers will confirm
      recommended vaccinations and recommend the HPV vaccine as part of other routine vaccines. At
      check-out, back office staff will administer vaccines, schedule a visit for the second dose,
      and provide caregivers both a standard appointment card and an intervention site reminder
      magnet. A clinic provider vaccine champion will be identified to monitor implementation,
      adapt processes, and serve as a resource at intervention sites.

      To estimate intervention effects, we will use data extracted from AltaMed's electronic
      medical record system to measure HPV vaccine initiation and completion rates among
      adolescents ages 9-17 at baseline and at regular intervals post intervention implementation.
      Patient, provider and clinic factors associated with vaccine receipt will also be examined.

      Recruitment Venue 3: Northeast Valley Health Corporation. At Northeast Valley Health
      Corporation, another large federally qualified health center, we will implement and evaluate
      the effects of three different clinic-level reminder systems (mailed letter, automated/robo
      telephone call, text message) on HPV vaccine initiation and completion among adolescents
      (ages 12-13).

      We will utilize a quasi-experimental study design. This FQHC comprises 8 sites that provide
      primary care for medically underserved adults and adolescents in LA County. We will select 6
      clinics matched on baseline vaccine receipt rates and other clinic characteristics and
      randomly assign matched paired clinics to usual care or one of the three reminder system
      interventions: mailed letter, automated/robo telephone call, or text message. Eligible
      caregivers of adolescent boys and girls ages 12-13 who have received no doses or only one
      dose of the HPV vaccine will be identified through Northeast Valley's electronic medical
      record and population health management systems.

      After identification of eligible patients (i.e. caregivers), the centralized call center will
      generate a standard letter and the automated/robocalls. A third-party vendor will send the
      text messages. The reminder content will be adapted from existing clinical message scripts
      and include a short message, which will be consistent across all modalities, on the
      importance of HPV vaccination and how to make an appointment. Reminder messages will be
      delivered in the patients' preferred language (either English or Spanish). The same reminder
      type (either letter, call, or text message) will be used on up to two occasions: once at
      baseline and a second time approximately one month after baseline for those who have not yet
      received the targeted vaccine dose. To monitor receipt of reminders, number of unaccepted
      telephone calls, returned letters, and stopped text messages will be monitored. Clinics
      assigned to the usual care condition will receive standard of care, which does not include
      any systematic reminders.

      Similar to the AltaMed FQHC site, to estimate intervention effects, we will use data
      extracted from electronic medical records to measure HPV vaccine initiation and completion
      rates at baseline and at regular intervals post intervention implementation.
    

Intervention name(s): Tailored education and referral; Staff training and patient reminders; Clinic-level reminder systems
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): LACDPH Site: 5-minute tailored educational messages and clinic referral for vaccine plus tailored small media; 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; Northeast Valley Health Corporation Site: Three different clinic-level reminder systems, including a mailed letter, automated/robo telephone call, or text message reminder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Human Papillomavirus; Immunization; Oncogenic viruses; Cervical Cancer; Health Disparities