Vaccination
Conditions
Keywords
GARDASIL, HPV, Vaccination
Brief summary
African American adolescent females seeking treatment for STIs are an underserved population at increased risk for HPV infection. While GARDASIL is an effective preventive vaccine, vaccination rates are low. Given the risk for HPV infection among this subgroup and the negative health effects associated with HPV, enhancing uptake of GARDASIL is necessary. The goal of this project is to promote GARDASIL vaccination through the development of a new multi-component, culturally-appropriate, interactive DVD. We propose to recruit 280 unmarried African American adolescent females, 13-18 years of age, from participating clinic sites in Atlanta, Georgia. While seeking clinical services, adolescents will be contacted and invited to participate in the proposed study. Eligible adolescents will be required to provide written assent/consent prior to participation. Adolescents who are eligible and willing to participate in the project will complete a short survey on a laptop computer. The survey is designed to assess adolescents' risk taking and preventive behaviors. After they complete the survey, adolescents will be assigned at random to one of two groups. In one group, adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses. In the second group, adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. All adolescents are eligible to receive the GARDASIL vaccine at participating study clinics as part of their routine standard of care. With the help of clinic staff, participant medical records will be reviewed over a 7 month period to assess vaccination rates. Vaccination rates from adolescents who received the interactive HPV/GARDASIL awareness DVD will be compared to the group of adolescents who received the healthy lifestyles DVD. It is hypothesized that study participants receiving the interactive DVD intervention that promotes HPV awareness will have higher vaccination rates over time.
Interventions
BEHAVIORALGirls OnGuard
Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination.
Sponsors
Merck Sharp & Dohme LLC
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* African American * Female * Age 13-18 years * Seeking reproductive/STI services at participating clinic * Ability to give written informed consent or assent
Exclusion criteria
* Pregnant * Married * Already received the HPV vaccine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GARDASIL Vaccination Uptake and Compliance With Second and Third Doses | measured at 7 months post-randomization | Number of participants who received at least 1 dose, 2 doses, 3 doses |
| Total Doses Received of HPV Vaccine | measured at 7-months post randomization | As an additional primary outcome, we assessed the total number of vaccine doses received |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| STD Incidence | 7 months post randomization | Number of participants who tested positive for any STD 7 months post randomization, information was gathered via medical chart abstraction |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1 - Girls OnGuard/HPV Awareness Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.
Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination. | 108 |
| 2 - General Health Promotion Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed. | 108 |
| Total | 216 |
Baseline characteristics
| Characteristic | 1 - Girls OnGuard/HPV Awareness | 2 - General Health Promotion | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 108 Participants | 108 Participants | 216 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 16.68 Years STANDARD_DEVIATION 1.44 | 16.26 Years STANDARD_DEVIATION 1.54 | 16.47 Years STANDARD_DEVIATION 1.5 |
| Region of Enrollment United States | 108 participants | 108 participants | 216 participants |
| Sex: Female, Male Female | 108 Participants | 108 Participants | 216 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 108 | 0 / 108 |
| serious Total, serious adverse events | 0 / 108 | 0 / 108 |
Outcome results
Primary
GARDASIL Vaccination Uptake and Compliance With Second and Third Doses
Number of participants who received at least 1 dose, 2 doses, 3 doses
Time frame: measured at 7 months post-randomization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1 - Girls OnGuard/HPV Awareness | GARDASIL Vaccination Uptake and Compliance With Second and Third Doses | Number of participants who received at least 1 dos | 12 participants |
| 1 - Girls OnGuard/HPV Awareness | GARDASIL Vaccination Uptake and Compliance With Second and Third Doses | Number of participants who received 2 doses | 8 participants |
| 1 - Girls OnGuard/HPV Awareness | GARDASIL Vaccination Uptake and Compliance With Second and Third Doses | Number of participants who received 3 doses | 6 participants |
| 2 - General Health Promotion | GARDASIL Vaccination Uptake and Compliance With Second and Third Doses | Number of participants who received at least 1 dos | 12 participants |
| 2 - General Health Promotion | GARDASIL Vaccination Uptake and Compliance With Second and Third Doses | Number of participants who received 2 doses | 3 participants |
| 2 - General Health Promotion | GARDASIL Vaccination Uptake and Compliance With Second and Third Doses | Number of participants who received 3 doses | 2 participants |
Comparison: This comparison is for participants in the Girls OnGuard/HPV Awareness condition compared to the General Health Promotion conditionp-value: >0.05Chi-squared
Primary
Total Doses Received of HPV Vaccine
As an additional primary outcome, we assessed the total number of vaccine doses received
Time frame: measured at 7-months post randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 - Girls OnGuard/HPV Awareness | Total Doses Received of HPV Vaccine | 26 Doses |
| 2 - General Health Promotion | Total Doses Received of HPV Vaccine | 17 Doses |
Comparison: This comparison is for total doses received (26 in Girls OnGuard/HPV Awareness condition compared to 17 in General Health Promotion condition)p-value: =0.12Chi-squared
Secondary
STD Incidence
Number of participants who tested positive for any STD 7 months post randomization, information was gathered via medical chart abstraction
Time frame: 7 months post randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 - Girls OnGuard/HPV Awareness | STD Incidence | 35 participants |
| 2 - General Health Promotion | STD Incidence | 32 participants |
p-value: =0.52Chi-squared