Trial Outcomes & Findings for HPV Vaccine Intervention for Young Sexual Minority Men (NCT NCT04032106)
NCT ID: NCT04032106
Last Updated: 2025-03-14
Results Overview
Number and proportion of participants who initiate and complete the HPV vaccine series during the study period
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1227 participants
Primary outcome timeframe
Baseline up to 9 months
Results posted on
2025-03-14
Participant Flow
Participant milestones
| Measure |
Group A (Standard HPV Information)
Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website.
Best Practice: Receive standard information about HPV and HPV vaccine
Questionnaire Administration: Ancillary studies
|
Group B (Outsmart HPV, Unidirectional Vaccine Reminders)
Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond).
Informational Intervention: Receive Outsmart HPV intervention
Questionnaire Administration: Ancillary studies
Text Message-Based Intervention: Receive unidirectional text message vaccine reminders
|
Group C (Outsmart HPV, Interactive Vaccine Reminders)
Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond).
Informational Intervention: Receive Outsmart HPV intervention
Questionnaire Administration: Ancillary studies
Text Message-Based Intervention: Receive interactive text message vaccine reminders
|
|---|---|---|---|
|
Overall Study
STARTED
|
412
|
407
|
408
|
|
Overall Study
COMPLETED
|
295
|
271
|
276
|
|
Overall Study
NOT COMPLETED
|
117
|
136
|
132
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HPV Vaccine Intervention for Young Sexual Minority Men
Baseline characteristics by cohort
| Measure |
Group A (Standard HPV Information)
n=412 Participants
Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website.
Best Practice: Receive standard information about HPV and HPV vaccine
Questionnaire Administration: Ancillary studies
|
Group B (Outsmart HPV, Unidirectional Vaccine Reminders)
n=407 Participants
Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond).
Informational Intervention: Receive Outsmart HPV intervention
Questionnaire Administration: Ancillary studies
Text Message-Based Intervention: Receive unidirectional text message vaccine reminders
|
Group C (Outsmart HPV, Interactive Vaccine Reminders)
n=408 Participants
Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond).
Informational Intervention: Receive Outsmart HPV intervention
Questionnaire Administration: Ancillary studies
Text Message-Based Intervention: Receive interactive text message vaccine reminders
|
Total
n=1227 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Ages 18-21
|
142 Participants
n=99 Participants
|
152 Participants
n=107 Participants
|
143 Participants
n=206 Participants
|
437 Participants
n=7 Participants
|
|
Age, Customized
Ages 22-25
|
270 Participants
n=99 Participants
|
255 Participants
n=107 Participants
|
265 Participants
n=206 Participants
|
790 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
412 Participants
n=99 Participants
|
407 Participants
n=107 Participants
|
408 Participants
n=206 Participants
|
1227 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
188 Participants
n=99 Participants
|
198 Participants
n=107 Participants
|
193 Participants
n=206 Participants
|
579 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
37 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
129 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Other
|
57 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
167 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
130 Participants
n=99 Participants
|
112 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
352 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
412 Participants
n=99 Participants
|
407 Participants
n=107 Participants
|
408 Participants
n=206 Participants
|
1227 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 9 monthsNumber and proportion of participants who initiate and complete the HPV vaccine series during the study period
Outcome measures
| Measure |
Group A (Standard HPV Information)
n=412 Participants
Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website.
Best Practice: Receive standard information about HPV and HPV vaccine
Questionnaire Administration: Ancillary studies
|
Group B (Outsmart HPV, Unidirectional Vaccine Reminders)
n=407 Participants
Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond).
Informational Intervention: Receive Outsmart HPV intervention
Questionnaire Administration: Ancillary studies
Text Message-Based Intervention: Receive unidirectional text message vaccine reminders
|
Group C (Outsmart HPV, Interactive Vaccine Reminders)
n=408 Participants
Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond).
Informational Intervention: Receive Outsmart HPV intervention
Questionnaire Administration: Ancillary studies
Text Message-Based Intervention: Receive interactive text message vaccine reminders
|
|---|---|---|---|
|
Human Papillomavirus (HPV) Vaccine Initiation and Completion
HPV Vaccine Series Initiation · Yes
|
114 Participants
|
139 Participants
|
147 Participants
|
|
Human Papillomavirus (HPV) Vaccine Initiation and Completion
HPV Vaccine Series Initiation · No
|
298 Participants
|
268 Participants
|
261 Participants
|
|
Human Papillomavirus (HPV) Vaccine Initiation and Completion
HPV Vaccine Series Completion · Yes
|
14 Participants
|
30 Participants
|
47 Participants
|
|
Human Papillomavirus (HPV) Vaccine Initiation and Completion
HPV Vaccine Series Completion · No
|
398 Participants
|
377 Participants
|
361 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 9 monthsPopulation: Participants who completed the end-of-study survey at 9 months
Changes in theoretical constructs from baseline to follow-up as assessed by study surveys. Survey items developed by the study team were used to assess changes in perceived severity of HPV-related disease (possible range of -3 to 3), response efficacy of HPV vaccine (possible range of -4 to 4), and worry about getting HPV-related disease (possible range of -3 to 3). The reported numbers represent the mean change for each construct that occurred from baseline to follow-up. For each construct, a score of 0 represents no change between survey timepoints. Change scores greater than 0 indicate an increase in that construct between survey timepoints, with more positive values indicating a greater amount of change. Change scores less than 0 indicate an decrease in that construct between survey timepoints, with more negative values indicating a greater amount of change.
Outcome measures
| Measure |
Group A (Standard HPV Information)
n=295 Participants
Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website.
Best Practice: Receive standard information about HPV and HPV vaccine
Questionnaire Administration: Ancillary studies
|
Group B (Outsmart HPV, Unidirectional Vaccine Reminders)
n=271 Participants
Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond).
Informational Intervention: Receive Outsmart HPV intervention
Questionnaire Administration: Ancillary studies
Text Message-Based Intervention: Receive unidirectional text message vaccine reminders
|
Group C (Outsmart HPV, Interactive Vaccine Reminders)
n=276 Participants
Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond).
Informational Intervention: Receive Outsmart HPV intervention
Questionnaire Administration: Ancillary studies
Text Message-Based Intervention: Receive interactive text message vaccine reminders
|
|---|---|---|---|
|
Changes in Theoretical Constructs
Perceived severity of HPV-related disease
|
-0.04 Scores on a scale
Standard Deviation 0.74
|
0.01 Scores on a scale
Standard Deviation 0.79
|
-0.09 Scores on a scale
Standard Deviation 0.75
|
|
Changes in Theoretical Constructs
Response efficacy of HPV vaccine
|
0.41 Scores on a scale
Standard Deviation 0.84
|
0.58 Scores on a scale
Standard Deviation 0.88
|
0.50 Scores on a scale
Standard Deviation 0.85
|
|
Changes in Theoretical Constructs
Worry about getting HPV-related disease
|
0.63 Scores on a scale
Standard Deviation 0.98
|
0.56 Scores on a scale
Standard Deviation 1.05
|
0.57 Scores on a scale
Standard Deviation 0.98
|
PRIMARY outcome
Timeframe: Baseline up to 9 monthsCounts of human papillomavirus (HPV) vaccine initiation by demographic and health-related characteristics as assessed by study surveys
Outcome measures
| Measure |
Group A (Standard HPV Information)
n=412 Participants
Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website.
Best Practice: Receive standard information about HPV and HPV vaccine
Questionnaire Administration: Ancillary studies
|
Group B (Outsmart HPV, Unidirectional Vaccine Reminders)
n=407 Participants
Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond).
Informational Intervention: Receive Outsmart HPV intervention
Questionnaire Administration: Ancillary studies
Text Message-Based Intervention: Receive unidirectional text message vaccine reminders
|
Group C (Outsmart HPV, Interactive Vaccine Reminders)
n=408 Participants
Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond).
Informational Intervention: Receive Outsmart HPV intervention
Questionnaire Administration: Ancillary studies
Text Message-Based Intervention: Receive interactive text message vaccine reminders
|
|---|---|---|---|
|
Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics
No preventive health visit within the last year
|
58 Participants
|
74 Participants
|
81 Participants
|
|
Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics
Ages 18-21
|
41 Participants
|
53 Participants
|
46 Participants
|
|
Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics
Ages 22-25
|
73 Participants
|
86 Participants
|
101 Participants
|
|
Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics
High school education or less
|
33 Participants
|
44 Participants
|
39 Participants
|
|
Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics
Some college education or more
|
81 Participants
|
95 Participants
|
108 Participants
|
|
Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics
Preventive health visit within the last year
|
56 Participants
|
65 Participants
|
66 Participants
|
Adverse Events
Group A (Standard HPV Information)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B (Outsmart HPV, Unidirectional Vaccine Reminders)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group C (Outsmart HPV, Interactive Vaccine Reminders)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place