Young Men and Media Study

Study Overview
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Brief Summary
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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.

Official Title
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Influences on Risk Behaviors Among Young Men

Conditions
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Sexual Behavior

Intervention / Treatment
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* Behavioral: Young Men & Media Program
* Behavioral: Available websites on safe sex and preventing STIs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Young Men & Media Program group<br>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. | Behavioral: Young Men & Media Program<br>* 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.<br>|
| Active Comparator: Control group<br>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. | Behavioral: Available websites on safe sex and preventing STIs<br>* Available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | approximately 4.5 months | 
| 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. | approximately 4.5 months | 
| 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. | 90 minutes | 
| 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. | 90 minutes | 
| 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. | 90 minutes | 
| 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 | approximately 4.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Sexual Partners | Participants will be asked information about the number of sex partners in the prior 3 months. | Baseline, 3 months | 
| 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. | Baseline, 3 months | 
| 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. | Baseline, 3 weeks, 3 months | 
| 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. | Baseline, 3 weeks, 3 months | 
| 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. | Baseline, 3 weeks, 3 months | 
| 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. | Baseline, 3 weeks, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy sexual behaviors, Adolescent sexual minority males (ASMM), gay, bisexual, and other men who have sex with me (GBMSM), Online sexual health media literacy intervention, HIV prevention