Trial Outcomes & Findings for Young Men and Media Study (NCT NCT04109443)
NCT ID: NCT04109443
Last Updated: 2021-09-14
Results Overview
The overall recruitment rate will be calculated by dividing the total number of participants enrolled (n=154) by the total number of eligible potential participants from the initial online screener (n=422).
COMPLETED
NA
154 participants
approximately 4.5 months
2021-09-14
Participant Flow
Recruitment occurred online at the study website. Based on responses to the online screener survey, 422 potential participants were identified and 225 of them agreed to complete the baseline screening. 183 actually completed the baseline screening and of those 29 were determined ineligible leaving a final sample of 154 who were consented/enrolled in the study.
Participant milestones
| Measure |
Young Men & Media Program Group
Participants randomized to the Young Men and Media Program group will have access to the online sexual health media literacy materials. They will also complete three assessments at baseline, post-intervention, and a 3 month follow-up.
Young Men \& Media Program: The online sexual health media literacy website includes content about (1) male anatomy; (2) HIV/STI prevention; (3) overall sexual health; and (4) sexually explicit online media (SEOM) literacy.
|
Control Group
Participants randomized to the control group will have access to available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections including HIV. They will complete three assessments at baseline, post-intervention, and a 3 month follow-up.
Available websites on safe sex and preventing STIs: Available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV.
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
77
|
|
Overall Study
COMPLETED
|
67
|
65
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Young Men and Media Study
Baseline characteristics by cohort
| Measure |
Young Men & Media Program Group
n=77 Participants
Participants randomized to the Young Men and Media Program group will have access to the online sexual health media literacy materials. They will also complete three assessments at baseline, post-intervention, and a 3 month follow-up.
Young Men \& Media Program: The online sexual health media literacy website includes content about (1) male anatomy; (2) HIV/STI prevention; (3) overall sexual health; and (4) sexually explicit online media (SEOM) literacy.
|
Control Group
n=77 Participants
Participants randomized to the control group will have access to available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections including HIV. They will complete three assessments at baseline, post-intervention, and a 3 month follow-up.
Available websites on safe sex and preventing STIs: Available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV.
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
77 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
154 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
154 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
41 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Latino
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Mixed Race/Other
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not provided
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
77 participants
n=99 Participants
|
77 participants
n=107 Participants
|
154 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: approximately 4.5 monthsPopulation: Based on responses to the online screener survey, 422 potential participants were identified and 225 of them agreed to complete the baseline screening. 183 actually completed the baseline screening and of those 29 were determined ineligible leaving a final sample of 154 who were consented/enrolled in the study.
The overall recruitment rate will be calculated by dividing the total number of participants enrolled (n=154) by the total number of eligible potential participants from the initial online screener (n=422).
Outcome measures
| Measure |
All Eligible Participants
n=422 percent recruited
Based on responses to the online screener survey, 422 potential participants were identified.
|
Control Group
Participants randomized to the control group will have access to available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections including HIV. They will complete three assessments at baseline, post-intervention, and a 3 month follow-up.
Available websites on safe sex and preventing STIs: Available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV.
|
|---|---|---|
|
Study Feasibility Based on the Overall Recruitment Rate
|
36.5 overall recruitment rate
|
—
|
PRIMARY outcome
Timeframe: approximately 4.5 monthsPopulation: The number of clicks on the banner ads could not be obtained from the system and therefore could not be reported.
The banner click through rate will be calculated as the proportion of banner ads that participants click each week and then averaged for an overall rate at the end of study completion.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 90 minutesPopulation: For some intervention content, like viewing images, the investigators were not able to capture reliably how long participants stayed on a page due to the various ways that they could leave that page. Therefore, this outcome could not be measured reliably and the data are not presented.
The time spent on each piece of intervention content will be determined from their online use.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 90 minutesPopulation: Outcome measure is only applicable to the Young Men \& Media Program group.
The online intervention will track what intervention content is viewed and the rate of participants who complete of all content will be calculated.
Outcome measures
| Measure |
All Eligible Participants
n=77 Participants
Based on responses to the online screener survey, 422 potential participants were identified.
|
Control Group
Participants randomized to the control group will have access to available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections including HIV. They will complete three assessments at baseline, post-intervention, and a 3 month follow-up.
Available websites on safe sex and preventing STIs: Available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV.
|
|---|---|---|
|
Number and Percentage of Participants Who Complete All the Intervention Content
|
38 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 90 minutesPopulation: Only collected for intervention (Young Men \& Media Program) group.
Participants will be asked to rate each of the 9 content area using a 5-star rating system where 1 star is the lowest and 5 stars is the highest rating. A mean of all ratings will be calculated. The closer the mean is to 5.0, the higher the satisfaction with the content areas. Participants will also be given the option of providing written feedback on each piece of content as well.
Outcome measures
| Measure |
All Eligible Participants
n=77 Participants
Based on responses to the online screener survey, 422 potential participants were identified.
|
Control Group
Participants randomized to the control group will have access to available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections including HIV. They will complete three assessments at baseline, post-intervention, and a 3 month follow-up.
Available websites on safe sex and preventing STIs: Available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV.
|
|---|---|---|
|
Mean Participant Satisfaction of the Intervention Content Areas Based on a 5 Star Rating System
|
4.3 units on a scale
Standard Error 0.8
|
—
|
PRIMARY outcome
Timeframe: approximately 4.5 monthsPopulation: All participants were combined to obtain the overall retention percent and number for the study.
The percentage of participants who completed all assessments divided by the number of enrolled participants
Outcome measures
| Measure |
All Eligible Participants
n=154 Participants
Based on responses to the online screener survey, 422 potential participants were identified.
|
Control Group
Participants randomized to the control group will have access to available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections including HIV. They will complete three assessments at baseline, post-intervention, and a 3 month follow-up.
Available websites on safe sex and preventing STIs: Available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV.
|
|---|---|---|
|
Count and Percentage of Participants Who Are Retained Through All Assessments
|
126 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Data collection for this project concurred with the initial months of the COVID-19 pandemic in the United States. Although sexual behavior data were collected, our data indicates that at baseline the COVID-19 pandemic had already substantially reduced participants sexual contacts because most participants were no longer seeking out or interacting with sexual partners in-person. Thus, the validity and meaningfulness of these data are unclear.
Participants will be asked information about the number of sex partners in the prior 3 months.
Outcome measures
| Measure |
All Eligible Participants
n=77 Participants
Based on responses to the online screener survey, 422 potential participants were identified.
|
Control Group
n=77 Participants
Participants randomized to the control group will have access to available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections including HIV. They will complete three assessments at baseline, post-intervention, and a 3 month follow-up.
Available websites on safe sex and preventing STIs: Available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV.
|
|---|---|---|
|
Number of Sexual Partners
3 months
|
0.26 number of partners
Standard Deviation 0.07
|
0.23 number of partners
Standard Deviation 0.06
|
|
Number of Sexual Partners
Baseline
|
0.49 number of partners
Standard Deviation 0.07
|
0.40 number of partners
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Data collection for this project concurred with the initial months of the COVID-19 pandemic in the United States. Although sexual behavior data were collected, our data indicates that at baseline the COVID-19 pandemic had already substantially reduced participants sexual contacts because most participants were no longer seeking out or interacting with sexual partners in-person. Thus, the validity and meaningfulness of these data are unclear.
Participants will be asked information about the number of condomless sex acts with male partners in the prior 3 months.
Outcome measures
| Measure |
All Eligible Participants
n=77 Participants
Based on responses to the online screener survey, 422 potential participants were identified.
|
Control Group
n=7 Participants
Participants randomized to the control group will have access to available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections including HIV. They will complete three assessments at baseline, post-intervention, and a 3 month follow-up.
Available websites on safe sex and preventing STIs: Available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV.
|
|---|---|---|
|
Number of Condomless Sex Acts With Male Partners
Baseline
|
0.39 number of condomless sex acts
Standard Deviation 0.15
|
0.27 number of condomless sex acts
Standard Deviation 0.09
|
|
Number of Condomless Sex Acts With Male Partners
3 months
|
0.05 number of condomless sex acts
Standard Deviation 0.04
|
0.10 number of condomless sex acts
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Baseline, 3 weeks, 3 monthsSelf-reported agreement with statements about condom use. Each item is scored 0-4 (0=strongly disagree; 4=strongly agree), yielding a total score of 0-24 with higher scores indicating more agreement that condom use interferes with sexual intimacy.
Outcome measures
| Measure |
All Eligible Participants
n=77 Participants
Based on responses to the online screener survey, 422 potential participants were identified.
|
Control Group
n=77 Participants
Participants randomized to the control group will have access to available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections including HIV. They will complete three assessments at baseline, post-intervention, and a 3 month follow-up.
Available websites on safe sex and preventing STIs: Available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV.
|
|---|---|---|
|
Change in 6-item Condom Use and Attitudes Scale
Baseline
|
4.5 score on a scale
Standard Deviation 1.3
|
4.2 score on a scale
Standard Deviation 1.6
|
|
Change in 6-item Condom Use and Attitudes Scale
3 weeks
|
4.9 score on a scale
Standard Deviation 1.2
|
4.5 score on a scale
Standard Deviation 1.5
|
|
Change in 6-item Condom Use and Attitudes Scale
3 months
|
4.6 score on a scale
Standard Deviation 1.5
|
4.9 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline, 3 weeks, 3 monthsPopulation: This scale was developed for this study and shows only acceptable internal reliability (Chronbach's alpha = 0.71, 0.75, 0.69). Results should be interpreted with caution as they may be unreliable.
Self-reported agreement with statements about SEOM. Each item is scored 0-4 (0=strongly disagree; 4=strongly agree), yielding a total score of 0-32 with higher scores indicating more agreement with less SEOM literacy.
Outcome measures
| Measure |
All Eligible Participants
n=77 Participants
Based on responses to the online screener survey, 422 potential participants were identified.
|
Control Group
n=77 Participants
Participants randomized to the control group will have access to available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections including HIV. They will complete three assessments at baseline, post-intervention, and a 3 month follow-up.
Available websites on safe sex and preventing STIs: Available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV.
|
|---|---|---|
|
Change in 8-item Sexually Explicit Online Media (SEOM) Literacy Scale
baseline
|
17.43 units on a scale
Standard Deviation 0.42
|
17.43 units on a scale
Standard Deviation 0.42
|
|
Change in 8-item Sexually Explicit Online Media (SEOM) Literacy Scale
3 weeks
|
16.01 units on a scale
Standard Deviation 0.38
|
16.6 units on a scale
Standard Deviation 0.46
|
|
Change in 8-item Sexually Explicit Online Media (SEOM) Literacy Scale
3 months
|
16.7 units on a scale
Standard Deviation 0.40
|
17.3 units on a scale
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: Baseline, 3 weeks, 3 monthsPopulation: This scale was developed for this study and shows unacceptable internal reliability (Chronbach's alpha = 0.41, 0.38, 0.49). Results should be interpreted with caution as they are likely unreliable.
Self-reported assessment of True/False statements about SEOM. Each item will be scored as 0-1 (0=incorrect, 1=correct), yielding a total score of 0-4 with higher scores indicating higher levels of knowledge.
Outcome measures
| Measure |
All Eligible Participants
n=77 Participants
Based on responses to the online screener survey, 422 potential participants were identified.
|
Control Group
n=77 Participants
Participants randomized to the control group will have access to available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections including HIV. They will complete three assessments at baseline, post-intervention, and a 3 month follow-up.
Available websites on safe sex and preventing STIs: Available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV.
|
|---|---|---|
|
Change in 4-item SEOM Knowledge Scale
3 months
|
2.64 units on a scale
Standard Deviation 0.14
|
2.61 units on a scale
Standard Deviation 0.13
|
|
Change in 4-item SEOM Knowledge Scale
baseline
|
2.35 units on a scale
Standard Deviation 0.13
|
2.36 units on a scale
Standard Deviation 0.11
|
|
Change in 4-item SEOM Knowledge Scale
3 weeks
|
2.97 units on a scale
Standard Deviation 0.10
|
2.35 units on a scale
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Baseline, 3 weeks, 3 monthsA 52-item sexual health knowledge scale will be used to assess HIV/STI knowledge. The scale presents self-reported assessment of True/False statements about HIV and STI transmission and prevention. Each item will be scored as 0-1 (0=incorrect; 1=correct), yielding a total score of 0-52 with higher scores indicating higher levels of HIV/STI knowledge.
Outcome measures
| Measure |
All Eligible Participants
n=77 Participants
Based on responses to the online screener survey, 422 potential participants were identified.
|
Control Group
n=77 Participants
Participants randomized to the control group will have access to available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections including HIV. They will complete three assessments at baseline, post-intervention, and a 3 month follow-up.
Available websites on safe sex and preventing STIs: Available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV.
|
|---|---|---|
|
Knowledge of HIV and STI Transmission and Prevention
Baseline
|
22.3 Score on a scale
Standard Deviation 7.9
|
22.4 Score on a scale
Standard Deviation 7.9
|
|
Knowledge of HIV and STI Transmission and Prevention
3 Weeks
|
27.2 Score on a scale
Standard Deviation 7.0
|
24.3 Score on a scale
Standard Deviation 8.4
|
|
Knowledge of HIV and STI Transmission and Prevention
3 Months
|
26 Score on a scale
Standard Deviation 7.7
|
25.5 Score on a scale
Standard Deviation 8.5
|
Adverse Events
Young Men & Media Program Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kimberly M Nelson, PhD
Boston University School of Public Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place