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

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.

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