Trial Outcomes & Findings for Girls OnGuard: HPV Vaccination Uptake Among African American Adolescent Females (NCT NCT00813319)
NCT ID: NCT00813319
Last Updated: 2014-08-12
Results Overview
Number of participants who received at least 1 dose, 2 doses, 3 doses
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
216 participants
Primary outcome timeframe
measured at 7 months post-randomization
Results posted on
2014-08-12
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
108
|
|
Overall Study
COMPLETED
|
108
|
108
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Girls OnGuard: HPV Vaccination Uptake Among African American Adolescent Females
Baseline characteristics by cohort
| Measure |
1 - Girls OnGuard/HPV Awareness
n=108 Participants
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.
|
2 - General Health Promotion
n=108 Participants
Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.68 Years
STANDARD_DEVIATION 1.44 • n=93 Participants
|
16.26 Years
STANDARD_DEVIATION 1.54 • n=4 Participants
|
16.47 Years
STANDARD_DEVIATION 1.50 • n=27 Participants
|
|
Age, Categorical
<=18 years
|
108 Participants
n=93 Participants
|
108 Participants
n=4 Participants
|
216 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=93 Participants
|
108 Participants
n=4 Participants
|
216 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
108 participants
n=93 Participants
|
108 participants
n=4 Participants
|
216 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: measured at 7 months post-randomizationNumber of participants who received at least 1 dose, 2 doses, 3 doses
Outcome measures
| Measure |
1 - Girls OnGuard/HPV Awareness
n=100 Participants
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.
|
2 - General Health Promotion
n=104 Participants
Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
|
|---|---|---|
|
GARDASIL Vaccination Uptake and Compliance With Second and Third Doses
Number of participants who received at least 1 dos
|
12 participants
|
12 participants
|
|
GARDASIL Vaccination Uptake and Compliance With Second and Third Doses
Number of participants who received 2 doses
|
8 participants
|
3 participants
|
|
GARDASIL Vaccination Uptake and Compliance With Second and Third Doses
Number of participants who received 3 doses
|
6 participants
|
2 participants
|
PRIMARY outcome
Timeframe: measured at 7-months post randomizationAs an additional primary outcome, we assessed the total number of vaccine doses received
Outcome measures
| Measure |
1 - Girls OnGuard/HPV Awareness
n=100 Participants
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.
|
2 - General Health Promotion
n=104 Participants
Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
|
|---|---|---|
|
Total Doses Received of HPV Vaccine
|
26 Doses
|
17 Doses
|
SECONDARY outcome
Timeframe: 7 months post randomizationNumber of participants who tested positive for any STD 7 months post randomization, information was gathered via medical chart abstraction
Outcome measures
| Measure |
1 - Girls OnGuard/HPV Awareness
n=100 Participants
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.
|
2 - General Health Promotion
n=104 Participants
Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
|
|---|---|---|
|
STD Incidence
|
35 participants
|
32 participants
|
Adverse Events
1 - Girls OnGuard/HPV Awareness
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 - General Health Promotion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ralph DiClemente, Principal Investigator
Emory University Rollins School of Public Health
Phone: 404-727-0237
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place