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| ID | Type | Description | Link |
|---|---|---|---|
| Merck - Emory UPN 08042902 | Other Identifier | Other |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 - Girls OnGuard/HPV awareness | Experimental | 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. |
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| 2 - General health promotion | No Intervention | Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Girls OnGuard | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| GARDASIL Vaccination Uptake and Compliance With Second and Third Doses | Number of participants who received at least 1 dose, 2 doses, 3 doses | measured at 7 months post-randomization |
| Total Doses Received of HPV Vaccine | As an additional primary outcome, we assessed the total number of vaccine doses received | measured at 7-months post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| STD Incidence | Number of participants who tested positive for any STD 7 months post randomization, information was gathered via medical chart abstraction | 7 months post randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralph J. DiClemente, PhD | Emory University Rollins School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fulton County Department of Health and Wellness | Atlanta | Georgia | 30303 | United States | ||
| DeKalb County Health Department |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | GARDASIL Vaccination Uptake and Compliance With Second and Third Doses | Number of participants who received at least 1 dose, 2 doses, 3 doses | Posted | Number | participants | measured at 7 months post-randomization |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Limited sample size; Brevity of the computer-administered intervention; Substantial variability between and within clinics with respect to patient-provider interactions; Lack of a follow-up assessment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ralph DiClemente, Principal Investigator | Emory University Rollins School of Public Health | 404-727-0237 | rdiclem@emory.edu |
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| Decatur |
| Georgia |
| 30034 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. |
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| Secondary | STD Incidence | Number of participants who tested positive for any STD 7 months post randomization, information was gathered via medical chart abstraction | Posted | Number | participants | 7 months post randomization |
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| Primary | Total Doses Received of HPV Vaccine | As an additional primary outcome, we assessed the total number of vaccine doses received | Posted | Number | Doses | measured at 7-months post randomization |
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|
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| 0 |
| 108 |
| 0 |
| 108 |
| EG001 | 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. | 0 | 108 | 0 | 108 |
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