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| ID | Type | Description | Link |
|---|---|---|---|
| 39991 | Other Identifier | Merck Pharmaceuticals |
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The purposes of this study are to (1) identify predictors of Human papillomavirus (HPV) vaccine acceptability among college men based on the Health Belief Model through focus groups, (2) triangulate focus group results with a prior quantitative study in developing an intervention based on the Health Belief Model to enhance HPV vaccine acceptability, and (3) test the efficacy of the above intervention based on the Health Belief Model by comparing it to a knowledge-based intervention. Approximately five focus groups with ten participants in each group with college students in the ages 18-25 years will be conducted at a large Midwestern University for the qualitative piece. Data will be analyzed for categories and triangulated with previous study to develop a theory based intervention. For the quantitative piece a randomized controlled design with 45 participants in each arm (theory based intervention and knowledge based intervention) will be implemented.
Up to this date, there was a lack of qualitative research on vaccine acceptability among men and theory-based interventions that promote HPV vaccination among men. A few studies have been conducted with parents and physicians regarding HPV vaccination with girls, and a few regarding women's awareness and acceptability. Results indicated increasing awareness of HPV, informing costs and benefits associated with the vaccine, and perceived susceptibility. Based on this information, it is crucial to obtain a further understanding of knowledge, awareness, and predictors related to HPV and its vaccination in men. Information obtained can be utilized in developing an intervention to increase intentions of taking the HPV vaccine. Refining results will lead to a standardization of an intervention that can be implemented across college campuses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health belief model based education | Experimental | This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability. |
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| Knowledge-based education | Active Comparator | This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV vaccine acceptability | Behavioral | One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions the Number of Participants Who Have Taken the HPV Vaccine | Before, after and one to three month following the health belief model based educational intervention and knowledge-based educational intervention the participants will be asked if they have taken the first dose of HPV vaccine and changes noted. | Post intervention and up to 3 months after the interventions |
| Change From Baseline to Post Intervention to Follow-up up to 3 Months After the Interventions the Number of Participants Who Intend to Take HPV Vaccine Using HPV Intent Scale (Possible Range 0-4 Likert Units) | Before the interventions, post test after the interventions and follow-up 1 to 3 months after the interventions (health belief model based and knowledge based) participants will be asked about their intent to take the HPV vaccine on a scale of 0-4 Likert units and changes noted. Posttest was conducted immediately after the intervention. Minimum score = 0 indicating no intent to take vaccine; Maximum score = 4 indicating strong intent to take vaccine. Scale was a single item scale. | Post intervention and up to 3 months after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions in Score of Perceived Susceptibility for HPV | Before the interventions, after the interventions and up to 3 months following the interventions the health belief model construct of perceived susceptibility for HPV scores will be measured on a paper pencil self-report test and changes noted. Perceived susceptibility for HPV will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely and 12-very likely). The subscale has acceptable validity and reliability. Difference between posttest and pre-test was done. This value was then used to run the multiple regressions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manoj Sharma, Ph.D. | University of Cincinnati | Principal Investigator |
| Rebecca Lee, Ph.D. | University of Cincinnati | Study Director |
| Purvi Mehta, MS | University of Cincinnati | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manoj Sharma | Cincinnati | Ohio | 45221-0068 | United States |
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| Label | URL |
|---|---|
| Manufactures HPV vaccine | View source |
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Recruitment for Phase I of the study was conducted between Oct. 2011-Nov. 2011 at the University of Cincinnati. Snowball sampling was done (n=50).
Phase II occurred between March 2012-April 2012 at the University. A snowball sample was used. 90 participants were recruited. A post test was done immediately after the intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Health Belief Model Based Education | This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability. HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention. |
| FG001 | Knowledge-based Education | This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability. HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Health Belief Model Based Education | This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability. HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention. |
| 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, Categorical | Count of Participants |
| 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 | Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions the Number of Participants Who Have Taken the HPV Vaccine | Before, after and one to three month following the health belief model based educational intervention and knowledge-based educational intervention the participants will be asked if they have taken the first dose of HPV vaccine and changes noted. | A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90. | Posted | Number | participants | Post intervention and up to 3 months after the interventions |
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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 | Health Belief Model Based Education | This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability. HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention. |
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Overall limitation of the trial were due to attrition at the one month follow up.
This was due to the end of school year.This meant that students were busy preparing for finals, starting co-ops/internships, moving back home, or lack of interest.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Manoj Sharma, PI | University of Cincinnati | 513-556-3878 | manoj.sharma@uc.edu |
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| Post interventions and up to 3 months after the interventions |
| Change From Baseline to Post Test to Upto 3 Month Follow-up After the Interventions in Score for Perceived Severity for HPV | Before the interventions, after the interventions and up to 3 months following the interventions the health belief model construct of perceived severity for HPV scores will be measured on a paper pencil self-report test and changes noted. Perceived severity for HPV will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 to 12 (0- not likely and 12-very likely). The subscale has acceptable validity and reliability. Difference between posttest and pre-test was done. This value was then used to run the multiple regressions. | Post interventions and up to 3 months after the intervention |
| Change From Baseline to Post Test After the Interventions to up to 3 Month Follow-up in Score of Perceived Benefits of HPV Vaccine | Before the interventions, after the interventions and one month following the interventions the health belief model construct of Perceived benefits of HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Perceived benefits of HPV vaccine will be measured as a summative score on a four item Likert subscale with a range of 0 to 16 (0-not very likely and 16- very likely). The subscale has acceptable validity and reliability. Difference between posttest and pre-test was done. This value was then used to run the multiple regressions. | post intervention and up to 3 months after the interventions |
| Change From Baseline to Post Test After the Interventions to Follow-up (up to 3 Months) in the Score of Perceived Barriers to Receiving HPV Vaccine | Before the interventions, post test after the interventions following the interventions the health belief model construct of perceived barriers to receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Perceived barriers for receiving HPV vaccine will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely to 12- very likely). The subscale has acceptable validity and reliability. A difference between post-test and pre-test were taken to obtain the score. This score was then used in the regression. | post interventions and up to 3 months after the intervention |
| Change From Baseline to After the Interventions to Follow-up up to 3 Months After the Interventions in Score of Cues to Action to Receiving HPV Vaccine | Before the interventions, and after the interventions and up to 3 months after the interventions the health belief model construct of cues to action to receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Cues to action to receiving HPV vaccine will be measured as a summative score on a four item Likert subscale with a range of 0 to 16 (0- not at all likely to 16-very likely). The subscale has acceptable validity and reliability. Difference between post and pre-test were used to obtain a change score. This score was used for regressions. | Post interventions and up to three months after the intervention |
| Change From Baseline and After the Interventions to up to 3 Months Follow-up in Score of Self-efficacy for Receiving HPV Vaccine | Before the interventions and after the interventions the health belief model construct of self-efficacy for receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Self-efficacy for receiving HPV vaccine will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely to 12- very likely). The subscale has acceptable validity and reliability. The difference between post and pre-test was taken to determine a change score. This score was then used for regressions. | Post interventions and up to 3 months follow-up |
| BG001 |
| Knowledge-based Education |
This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability. HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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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 | Baseline Knowledge-based Education | This comparison arm will provide baseline data for number of people who have taken the HPV vaccine before an education based on knowledge regarding HPV vaccine acceptability. HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention. |
| OG002 | Post Test Health Belief Model Based Education | This experimental arm will provide post test data for number of people who have taken HPV vaccine after an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability. |
| OG003 | Post Test Knowledge-based Education | This comparison arm will provide post test data for number of people who have taken the HPV vaccine after an education based on knowledge regarding HPV vaccine acceptability. |
| OG004 | Follow-up Health Belief Model Based Education | This experimental arm will provide follow-up data for number of people who have taken HPV vaccine upto 3 months after an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability. |
| OG005 | Follow-up Knowledge-based Education | This comparison arm will provide follow-up data for number of people who have taken the HPV vaccine after an education based on knowledge regarding HPV vaccine acceptability. |
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| Primary | Change From Baseline to Post Intervention to Follow-up up to 3 Months After the Interventions the Number of Participants Who Intend to Take HPV Vaccine Using HPV Intent Scale (Possible Range 0-4 Likert Units) | Before the interventions, post test after the interventions and follow-up 1 to 3 months after the interventions (health belief model based and knowledge based) participants will be asked about their intent to take the HPV vaccine on a scale of 0-4 Likert units and changes noted. Posttest was conducted immediately after the intervention. Minimum score = 0 indicating no intent to take vaccine; Maximum score = 4 indicating strong intent to take vaccine. Scale was a single item scale. | A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90. | Posted | Mean | Standard Deviation | units on a scale | Post intervention and up to 3 months after the intervention |
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| Secondary | Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions in Score of Perceived Susceptibility for HPV | Before the interventions, after the interventions and up to 3 months following the interventions the health belief model construct of perceived susceptibility for HPV scores will be measured on a paper pencil self-report test and changes noted. Perceived susceptibility for HPV will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely and 12-very likely). The subscale has acceptable validity and reliability. Difference between posttest and pre-test was done. This value was then used to run the multiple regressions. | A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90. | Posted | Mean | Standard Deviation | units on a scale | Post interventions and up to 3 months after the interventions |
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| Secondary | Change From Baseline to Post Test to Upto 3 Month Follow-up After the Interventions in Score for Perceived Severity for HPV | Before the interventions, after the interventions and up to 3 months following the interventions the health belief model construct of perceived severity for HPV scores will be measured on a paper pencil self-report test and changes noted. Perceived severity for HPV will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 to 12 (0- not likely and 12-very likely). The subscale has acceptable validity and reliability. Difference between posttest and pre-test was done. This value was then used to run the multiple regressions. | A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90. | Posted | Mean | Standard Deviation | units on a scale | Post interventions and up to 3 months after the intervention |
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| Secondary | Change From Baseline to Post Test After the Interventions to up to 3 Month Follow-up in Score of Perceived Benefits of HPV Vaccine | Before the interventions, after the interventions and one month following the interventions the health belief model construct of Perceived benefits of HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Perceived benefits of HPV vaccine will be measured as a summative score on a four item Likert subscale with a range of 0 to 16 (0-not very likely and 16- very likely). The subscale has acceptable validity and reliability. Difference between posttest and pre-test was done. This value was then used to run the multiple regressions. | A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90. | Posted | Mean | Standard Deviation | units on a scale | post intervention and up to 3 months after the interventions |
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| Secondary | Change From Baseline to Post Test After the Interventions to Follow-up (up to 3 Months) in the Score of Perceived Barriers to Receiving HPV Vaccine | Before the interventions, post test after the interventions following the interventions the health belief model construct of perceived barriers to receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Perceived barriers for receiving HPV vaccine will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely to 12- very likely). The subscale has acceptable validity and reliability. A difference between post-test and pre-test were taken to obtain the score. This score was then used in the regression. | A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90. | Posted | Mean | Standard Deviation | units on a scale | post interventions and up to 3 months after the intervention |
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| Secondary | Change From Baseline to After the Interventions to Follow-up up to 3 Months After the Interventions in Score of Cues to Action to Receiving HPV Vaccine | Before the interventions, and after the interventions and up to 3 months after the interventions the health belief model construct of cues to action to receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Cues to action to receiving HPV vaccine will be measured as a summative score on a four item Likert subscale with a range of 0 to 16 (0- not at all likely to 16-very likely). The subscale has acceptable validity and reliability. Difference between post and pre-test were used to obtain a change score. This score was used for regressions. | A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90. | Posted | Mean | Standard Deviation | units on a scale | Post interventions and up to three months after the intervention |
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| Secondary | Change From Baseline and After the Interventions to up to 3 Months Follow-up in Score of Self-efficacy for Receiving HPV Vaccine | Before the interventions and after the interventions the health belief model construct of self-efficacy for receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Self-efficacy for receiving HPV vaccine will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely to 12- very likely). The subscale has acceptable validity and reliability. The difference between post and pre-test was taken to determine a change score. This score was then used for regressions. | A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90. | Posted | Mean | Standard Deviation | units on a scale | Post interventions and up to 3 months follow-up |
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| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Knowledge-based Education | This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability. HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention. | 0 | 45 | 0 | 45 |
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