Sexual Behavior
Conditions
Keywords
Adolescent sexual minority males (ASMM), gay, bisexual, and other men who have sex with me (GBMSM), Online sexual health media literacy intervention, HIV prevention, Healthy sexual behaviors
Brief summary
Adolescent sexual minority males (ASMM) continue to account for a disproportionate number of HIV infections in the United States. Racial and ethnic minority populations are particularly affected. Increased HIV rates reflect sexual risk behaviors during early sexual experiences. Research suggests that initial sexual risk-taking occurs during adolescence among sexual minority males. Therefore, it is important for HIV prevention interventions to target adolescent sexual minority males. Targeting sexual minority males during adolescence will help them learn and establish healthy sexual behaviors early in their psychosexual development, which will have both immediate and long-term health benefits.To promote adolescent sexual minority males' critical examination of online media and decrease their sexual risk-taking, this study proposes an exploratory clinical trial to pilot test an online sexual health media literacy intervention that was developed during formative research for feasibility and acceptability. Overall, the proposed research has the potential to reach a wide audience of sexual minority males early in their sexual development, ultimately decreasing their sexual risk-taking and reducing the number of new HIV infections in this population.
Interventions
BEHAVIORALYoung 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.
BEHAVIORALAvailable 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.
Sponsors
National Institute of Mental Health (NIMH)
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
14 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Self-identify as sexual minority * Have intentionally accessed SEOM * Have a valid personal email address * Be a US resident * Be new to the study
Exclusion criteria
* Are unwilling or unable to provide informed assent * Are unable to understand and read English * Do not have the appropriate device and necessary software to experience all the intervention content
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count and Percentage of Participants Who Are Retained Through All Assessments | approximately 4.5 months | The percentage of participants who completed all assessments divided by the number of enrolled participants |
| Study Feasibility Based on the Overall Recruitment Rate | approximately 4.5 months | 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). |
| Study Feasibility Based on Banner ad Click Through Rate for All Participants Combined | approximately 4.5 months | 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. |
| Feasibility of the Media Literacy Intervention Based on Time Spent on the Intervention | 90 minutes | The time spent on each piece of intervention content will be determined from their online use. |
| Number and Percentage of Participants Who Complete All the Intervention Content | 90 minutes | The online intervention will track what intervention content is viewed and the rate of participants who complete of all content will be calculated. |
| Mean Participant Satisfaction of the Intervention Content Areas Based on a 5 Star Rating System | 90 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Sexual Partners | Baseline, 3 months | Participants will be asked information about the number of sex partners in the prior 3 months. |
| Number of Condomless Sex Acts With Male Partners | Baseline, 3 months | Participants will be asked information about the number of condomless sex acts with male partners in the prior 3 months. |
| Change in 6-item Condom Use and Attitudes Scale | Baseline, 3 weeks, 3 months | Self-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. |
| Change in 8-item Sexually Explicit Online Media (SEOM) Literacy Scale | Baseline, 3 weeks, 3 months | 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. |
| Change in 4-item SEOM Knowledge Scale | Baseline, 3 weeks, 3 months | 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. |
| Knowledge of HIV and STI Transmission and Prevention | Baseline, 3 weeks, 3 months | A 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 77 |
| 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. | 77 |
| Total | 154 |
Baseline characteristics
| Characteristic | Control Group | Total | Young Men & Media Program Group |
|---|---|---|---|
| Age, Categorical <=18 years | 77 Participants | 154 Participants | 77 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black/African American | 8 Participants | 17 Participants | 9 Participants |
| Race/Ethnicity, Customized Latino | 20 Participants | 40 Participants | 20 Participants |
| Race/Ethnicity, Customized Mixed Race/Other | 9 Participants | 16 Participants | 7 Participants |
| Race/Ethnicity, Customized Not provided | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 39 Participants | 80 Participants | 41 Participants |
| Region of Enrollment United States | 77 participants | 154 participants | 77 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 77 Participants | 154 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 77 |
| other Total, other adverse events | 0 / 77 | 0 / 77 |
| serious Total, serious adverse events | 0 / 77 | 0 / 77 |
Outcome results
Primary
Count and Percentage of Participants Who Are Retained Through All Assessments
The percentage of participants who completed all assessments divided by the number of enrolled participants
Time frame: approximately 4.5 months
Population: All participants were combined to obtain the overall retention percent and number for the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | Count and Percentage of Participants Who Are Retained Through All Assessments | 126 Participants |
Primary
Feasibility of the Media Literacy Intervention Based on Time Spent on the Intervention
The time spent on each piece of intervention content will be determined from their online use.
Time frame: 90 minutes
Population: 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.
Primary
Mean Participant Satisfaction of the Intervention Content Areas Based on a 5 Star Rating System
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.
Time frame: 90 minutes
Population: Only collected for intervention (Young Men \& Media Program) group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Eligible Participants | 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
Number and Percentage of Participants Who Complete All the Intervention Content
The online intervention will track what intervention content is viewed and the rate of participants who complete of all content will be calculated.
Time frame: 90 minutes
Population: Outcome measure is only applicable to the Young Men \& Media Program group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | Number and Percentage of Participants Who Complete All the Intervention Content | 38 Participants |
| Control Group | Number and Percentage of Participants Who Complete All the Intervention Content | 0 Participants |
Primary
Study Feasibility Based on Banner ad Click Through Rate for All Participants Combined
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.
Time frame: approximately 4.5 months
Population: The number of clicks on the banner ads could not be obtained from the system and therefore could not be reported.
Primary
Study Feasibility Based on the Overall Recruitment Rate
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).
Time frame: approximately 4.5 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Eligible Participants | Study Feasibility Based on the Overall Recruitment Rate | 36.5 overall recruitment rate |
Secondary
Change in 4-item SEOM Knowledge Scale
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.
Time frame: Baseline, 3 weeks, 3 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Eligible Participants | Change in 4-item SEOM Knowledge Scale | baseline | 2.35 units on a scale | Standard Deviation 0.13 |
| All Eligible Participants | Change in 4-item SEOM Knowledge Scale | 3 weeks | 2.97 units on a scale | Standard Deviation 0.1 |
| All Eligible Participants | Change in 4-item SEOM Knowledge Scale | 3 months | 2.64 units on a scale | Standard Deviation 0.14 |
| Control Group | Change in 4-item SEOM Knowledge Scale | baseline | 2.36 units on a scale | Standard Deviation 0.11 |
| Control Group | Change in 4-item SEOM Knowledge Scale | 3 weeks | 2.35 units on a scale | Standard Deviation 0.12 |
| Control Group | Change in 4-item SEOM Knowledge Scale | 3 months | 2.61 units on a scale | Standard Deviation 0.13 |
Secondary
Change in 6-item Condom Use and Attitudes Scale
Self-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.
Time frame: Baseline, 3 weeks, 3 months
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| All Eligible Participants | Change in 6-item Condom Use and Attitudes Scale | 3 months | 4.6 score on a scale | Standard Deviation 1.5 |
| All Eligible Participants | Change in 6-item Condom Use and Attitudes Scale | Baseline | 4.5 score on a scale | Standard Deviation 1.3 |
| All Eligible Participants | Change in 6-item Condom Use and Attitudes Scale | 3 weeks | 4.9 score on a scale | Standard Deviation 1.2 |
| Control Group | Change in 6-item Condom Use and Attitudes Scale | Baseline | 4.2 score on a scale | Standard Deviation 1.6 |
| Control Group | Change in 6-item Condom Use and Attitudes Scale | 3 weeks | 4.5 score on a scale | Standard Deviation 1.5 |
| Control Group | Change in 6-item Condom Use and Attitudes Scale | 3 months | 4.9 score on a scale | Standard Deviation 1.2 |
Secondary
Change in 8-item Sexually Explicit Online Media (SEOM) Literacy Scale
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.
Time frame: Baseline, 3 weeks, 3 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Eligible Participants | Change in 8-item Sexually Explicit Online Media (SEOM) Literacy Scale | baseline | 17.43 units on a scale | Standard Deviation 0.42 |
| All Eligible Participants | Change in 8-item Sexually Explicit Online Media (SEOM) Literacy Scale | 3 weeks | 16.01 units on a scale | Standard Deviation 0.38 |
| All Eligible Participants | Change in 8-item Sexually Explicit Online Media (SEOM) Literacy Scale | 3 months | 16.7 units on a scale | Standard Deviation 0.4 |
| Control Group | Change in 8-item Sexually Explicit Online Media (SEOM) Literacy Scale | baseline | 17.43 units on a scale | Standard Deviation 0.42 |
| Control Group | Change in 8-item Sexually Explicit Online Media (SEOM) Literacy Scale | 3 weeks | 16.6 units on a scale | Standard Deviation 0.46 |
| Control Group | Change in 8-item Sexually Explicit Online Media (SEOM) Literacy Scale | 3 months | 17.3 units on a scale | Standard Deviation 0.41 |
Secondary
Knowledge of HIV and STI Transmission and Prevention
A 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.
Time frame: Baseline, 3 weeks, 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Eligible Participants | Knowledge of HIV and STI Transmission and Prevention | 3 Weeks | 27.2 Score on a scale | Standard Deviation 7 |
| All Eligible Participants | Knowledge of HIV and STI Transmission and Prevention | Baseline | 22.3 Score on a scale | Standard Deviation 7.9 |
| All Eligible Participants | Knowledge of HIV and STI Transmission and Prevention | 3 Months | 26 Score on a scale | Standard Deviation 7.7 |
| Control Group | Knowledge of HIV and STI Transmission and Prevention | Baseline | 22.4 Score on a scale | Standard Deviation 7.9 |
| Control Group | Knowledge of HIV and STI Transmission and Prevention | 3 Weeks | 24.3 Score on a scale | Standard Deviation 8.4 |
| Control Group | Knowledge of HIV and STI Transmission and Prevention | 3 Months | 25.5 Score on a scale | Standard Deviation 8.5 |
Secondary
Number of Condomless Sex Acts With Male Partners
Participants will be asked information about the number of condomless sex acts with male partners in the prior 3 months.
Time frame: Baseline, 3 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Eligible Participants | Number of Condomless Sex Acts With Male Partners | Baseline | 0.39 number of condomless sex acts | Standard Deviation 0.15 |
| All Eligible Participants | Number of Condomless Sex Acts With Male Partners | 3 months | 0.05 number of condomless sex acts | Standard Deviation 0.04 |
| Control Group | Number of Condomless Sex Acts With Male Partners | Baseline | 0.27 number of condomless sex acts | Standard Deviation 0.09 |
| Control Group | Number of Condomless Sex Acts With Male Partners | 3 months | 0.10 number of condomless sex acts | Standard Deviation 0.07 |
Secondary
Number of Sexual Partners
Participants will be asked information about the number of sex partners in the prior 3 months.
Time frame: Baseline, 3 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Eligible Participants | Number of Sexual Partners | Baseline | 0.49 number of partners | Standard Deviation 0.07 |
| All Eligible Participants | Number of Sexual Partners | 3 months | 0.26 number of partners | Standard Deviation 0.07 |
| Control Group | Number of Sexual Partners | Baseline | 0.40 number of partners | Standard Deviation 0.07 |
| Control Group | Number of Sexual Partners | 3 months | 0.23 number of partners | Standard Deviation 0.06 |