H. Lee Moffitt Cancer Center and Research Institute
Who can join
18 and older, any sex, with HPV Vaccine or HPV. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Part 1: HPV Vaccine Knowledge (Aim 1)Primary· Day 1
A scale consisting of 19 items (Score range 0-18) assessing general HPV knowledge and 9 items (Score range 0-9) assessing HPV vaccination-specific knowledge (modified from scales by Perez et al 2016 and Waller et al 2013, respectively), using a response scale consisting of True, False, and I don't know; higher scores mean higher knowledge.
HPV Knowledge (Scale Score range 0-18)
Group
Value
95% CI
Aim 1 Only: Online Survey Group
10.10
± 4.87
HPV Vaccination Knowledge Scale (Score range 0-9)
Group
Value
95% CI
Aim 1 Only: Online Survey Group
3.19
± 2.56
Part 1: HPV Vaccine Awareness (Aim 1)Primary· Day 1
A scale consisting of 2 items from the Health Information National Trends Survey (HINTS) 2018, with response options Yes or No; Positive responses mean higher awareness
Ever Heard of HPV?
Group
Value
95% CI
Aim 1 Only: Online Survey Group
21
Aim 1 Only: Online Survey Group
81
Ever Heard of HPV Vaccine?
Group
Value
95% CI
Aim 1 Only: Online Survey Group
45
Aim 1 Only: Online Survey Group
57
Part 1: HPV Vaccine Attitude (Aim 1)Primary· Day 1
A scale consisting of 8 items modified from the Carolina HPV Immunization Attitudes and Beliefs Scale (CHIAS); with a 5-point response scale ranging from strongly disagree to strongly agree; higher scores mean stronger attitudes. The possible scale score range = 8-40.
Group
Value
95% CI
Aim 1 Only: Online Survey Group
27.38
± 4.36
Part 1: HPV Vaccine Health Beliefs 1 (Aim 1)Primary· Day 1
Participants will complete scales; a. Perceived Risk 5 point scale from no chance to Certain I will get; higher scores mean higher perceived risk; b. Descriptive norms scale from 0% to 100%, higher score mean greater descriptive norms; c. Perceived norms 8 point scale ranging from strongly disagree to strongly agree, not applicable, higher scores mean stronger perceived norms; d. Perceived Barriers 3-point scale ranging from Not concerned at all to Very concerned, higher scores mean higher perceived barriers; e. Self-efficacy scale ranging from Strongly agree to Strongly Disagree; lower scores
Perceived Risk. 5 point scale with of Possible scale range 5-40
Group
Value
95% CI
Aim 1 Only: Online Survey Group
22.81
± 10.93
What percentage of peers do you think have received the HPV vaccine? Possible scale Range 0-100
Group
Value
95% CI
Aim 1 Only: Online Survey Group
20.01
± 22.78
What percentage of male peers do you think have received HPV vaccine? Possible scale Range 0-100
Group
Value
95% CI
Aim 1 Only: Online Survey Group
16.26
± 20.03
What percentage of gay/bisexual males do you think have received HPV vaccine? Possible Range 1-100
Group
Value
95% CI
Aim 1 Only: Online Survey Group
16.67
± 19.95
What percentage of female peers have received the HPV vaccine? Possible Scale Range 0-100
Group
Value
95% CI
Aim 1 Only: Online Survey Group
24.71
± 26.62
What percentage of gay/bisexual females received the HPV vaccine? Possible Scale Range 0-100
Group
Value
95% CI
Aim 1 Only: Online Survey Group
20.25
± 23.02
Perceived Norms. 8 items. Possible Score range 8-40
Group
Value
95% CI
Aim 1 Only: Online Survey Group
26.55
± 8.65
Perceived Barriers. 3 items. Possible score range 3-15.
Group
Value
95% CI
Aim 1 Only: Online Survey Group
7.19
± 3.01
Part 1: HPV Vaccine Health Beliefs 2 (Aim 1)Primary· Day 1
Count of participants who responded what they thought their perceived risk is contracting HPV. Questions range from Much below average, below average, average risk, above average risk, much above average risk, and I don't know.
Group
Value
95% CI
Aim 1 Only: Online Survey Group
27
Aim 1 Only: Online Survey Group
14
Aim 1 Only: Online Survey Group
29
Aim 1 Only: Online Survey Group
6
Part 1: HPV Vaccine Health Beliefs 3 (Aim 1)Primary· Day 1
Count of participants who responded within each category asking intention to get HPV vaccine among those unvaccinated, using a 7-point scale ranging from Very unlikely to Very likely, higher scores mean stronger intentions.
Intention to get information about the HPV vaccine
Group
Value
95% CI
Aim 1 Only: Online Survey Group
15
Aim 1 Only: Online Survey Group
2
Aim 1 Only: Online Survey Group
5
Aim 1 Only: Online Survey Group
13
Intention to obtain more than 1 shot in the next 12 months,
Group
Value
95% CI
Aim 1 Only: Online Survey Group
14
Aim 1 Only: Online Survey Group
5
Aim 1 Only: Online Survey Group
5
Aim 1 Only: Online Survey Group
27
Intention to get more than one dose in the future
Group
Value
95% CI
Aim 1 Only: Online Survey Group
12
Aim 1 Only: Online Survey Group
9
Aim 1 Only: Online Survey Group
4
Aim 1 Only: Online Survey Group
20
Part 1: HPV Vaccine Behaviors 1 (Aim 1)Primary· Day 1
Count of participants who responded within each category that assesses past receipt of the HPV vaccine (modified from Brewer et al., 2009 and Brewer et al., 2017). Responses were: Yes, No, I don't know.
Group
Value
95% CI
Aim 1 Only: Online Survey Group
0
Aim 1 Only: Online Survey Group
17
Aim 1 Only: Online Survey Group
6
Part 1: HPV Vaccine Behaviors 2 (Aim 1)Primary· Day 1
Count of participants that self reported number of shots received among vaccinated individuals. Items range from 1 shot to I don't know.
Group
Value
95% CI
Aim 1 Only: Online Survey Group
2
Aim 1 Only: Online Survey Group
1
Aim 1 Only: Online Survey Group
1
Aim 1 Only: Online Survey Group
1
Part 1: HPV Vaccine Educational Preferences 1 (Aim 1)Primary· Day 1
A scale developed by Christy (unpublished) assessing HPV vaccine education preferences. The survey question, "Who would you like to receive information from?". Options were Physician, Other healthcare provider (Nurse, Medical Assistant), Female peer, Male peer, Parent of teen, Parent of young adult, Someone who has survived an HPV-related Cancer Other. Participants marked all that applied.
Physicians
Group
Value
95% CI
Aim 1 Only: Online Survey Group
96
Other Healthcare Providers
Group
Value
95% CI
Aim 1 Only: Online Survey Group
59
Female Peer
Group
Value
95% CI
Aim 1 Only: Online Survey Group
8
Male Peer
Group
Value
95% CI
Aim 1 Only: Online Survey Group
19
Parent of Teen
Group
Value
95% CI
Aim 1 Only: Online Survey Group
3
Parent of Young Adult
Group
Value
95% CI
Aim 1 Only: Online Survey Group
4
HPV Cancer Survivor
Group
Value
95% CI
Aim 1 Only: Online Survey Group
40
Other
Group
Value
95% CI
Aim 1 Only: Online Survey Group
2
Part 1: HPV Vaccine Educational Preferences 2 (Aim 1)Primary· Day 1
Items developed by Christy (unpublished) assessing HPV vaccine education preferences. The survey question, "Best method for delivering education?". 1 being the best method and 8 being the worst method.
In Person
Group
Value
95% CI
Aim 1 Only: Online Survey Group
55
Aim 1 Only: Online Survey Group
6
Aim 1 Only: Online Survey Group
3
Aim 1 Only: Online Survey Group
7
Website
Group
Value
95% CI
Aim 1 Only: Online Survey Group
13
Aim 1 Only: Online Survey Group
26
Aim 1 Only: Online Survey Group
18
Aim 1 Only: Online Survey Group
14
Smart Phone App
Group
Value
95% CI
Aim 1 Only: Online Survey Group
1
Aim 1 Only: Online Survey Group
11
Aim 1 Only: Online Survey Group
17
Aim 1 Only: Online Survey Group
8
Online Webinar
Group
Value
95% CI
Aim 1 Only: Online Survey Group
2
Aim 1 Only: Online Survey Group
15
Aim 1 Only: Online Survey Group
14
Aim 1 Only: Online Survey Group
25
Text Message
Group
Value
95% CI
Aim 1 Only: Online Survey Group
6
Aim 1 Only: Online Survey Group
10
Aim 1 Only: Online Survey Group
13
Aim 1 Only: Online Survey Group
12
Printed Booklet
Group
Value
95% CI
Aim 1 Only: Online Survey Group
2
Aim 1 Only: Online Survey Group
13
Aim 1 Only: Online Survey Group
7
Aim 1 Only: Online Survey Group
9
Social Media Platform
Group
Value
95% CI
Aim 1 Only: Online Survey Group
13
Aim 1 Only: Online Survey Group
10
Aim 1 Only: Online Survey Group
16
Aim 1 Only: Online Survey Group
16
Healthcare System Portal
Group
Value
95% CI
Aim 1 Only: Online Survey Group
10
Aim 1 Only: Online Survey Group
11
Aim 1 Only: Online Survey Group
14
Aim 1 Only: Online Survey Group
11
Part 1: HPV Vaccine Educational Preferences 3 (Aim 1)Primary· Day 1
An item developed by Christy (unpublished) assessing HPV vaccine education preferences. The survey question, "What age would it be most helpful to for a person to receive educational information?"
Ages 9-10
Group
Value
95% CI
Aim 1 Only: Online Survey Group
89
Aim 1 Only: Online Survey Group
13
Ages 11-14
Group
Value
95% CI
Aim 1 Only: Online Survey Group
74
Aim 1 Only: Online Survey Group
28
Ages 15-17
Group
Value
95% CI
Aim 1 Only: Online Survey Group
49
Aim 1 Only: Online Survey Group
53
Ages 18-22
Group
Value
95% CI
Aim 1 Only: Online Survey Group
50
Aim 1 Only: Online Survey Group
52
Ages 23-30
Group
Value
95% CI
Aim 1 Only: Online Survey Group
70
Aim 1 Only: Online Survey Group
32
Ages 30-45
Group
Value
95% CI
Aim 1 Only: Online Survey Group
84
Aim 1 Only: Online Survey Group
18
I Do Not Think So
Group
Value
95% CI
Aim 1 Only: Online Survey Group
102
Aim 1 Only: Online Survey Group
0
Part 2: Facilitators and Barriers to Intervention Implementation (Aim 2)Primary· Day 1
Number of participants who consented and participated in individual interviews.
Group
Value
95% CI
Aim 2 Only: Interview Group
20
Sponsor's own description
The purpose of the study is to assess Human Papillomavirus (HPV) and HPV vaccination knowledge, awareness, attitudes, health beliefs, and behaviors as well as educational preferences for learning more about HPV and HPV vaccination and to receive feedback on and adapt HPV educational materials for Young Latino Men who have Sex with Men (YLMSM).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute
Last refreshed: 4 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04974619.