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Completed

NCT Number: NCT04109443

Young Men and Media Study

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.

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Key information

Conditions

Sexual Behavior Behavior Bisexuality Homosexuality Sexuality

Age range

14 year–17 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Boston University School of Public Health

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Young Men & Media Program

Behavioral

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.

Available websites on safe sex and preventing STIs

Behavioral

Available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV.

Primary outcomes

  1. Study Feasibility Based on the Overall Recruitment Rate

    Time frame: 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).

  2. Study Feasibility Based on Banner ad Click Through Rate for All Participants Combined

    Time frame: 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.

  3. Feasibility of the Media Literacy Intervention Based on Time Spent on the Intervention

    Time frame: 90 minutes

    The time spent on each piece of intervention content will be determined from their online use.

  4. Number and Percentage of Participants Who Complete All the Intervention Content

    Time frame: 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.

  5. Mean Participant Satisfaction of the Intervention Content Areas Based on a 5 Star Rating System

    Time frame: 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.

  6. Count and Percentage of Participants Who Are Retained Through All Assessments

    Time frame: approximately 4.5 months

    The percentage of participants who completed all assessments divided by the number of enrolled participants

Secondary outcomes

  1. Number of Sexual Partners

    Time frame: Baseline, 3 months

    Participants will be asked information about the number of sex partners in the prior 3 months.

  2. Number of Condomless Sex Acts With Male Partners

    Time frame: Baseline, 3 months

    Participants will be asked information about the number of condomless sex acts with male partners in the prior 3 months.

  3. Change in 6-item Condom Use and Attitudes Scale

    Time frame: 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.

  4. Change in 8-item Sexually Explicit Online Media (SEOM) Literacy Scale

    Time frame: 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.

  5. Change in 4-item SEOM Knowledge Scale

    Time frame: 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.

  6. Knowledge of HIV and STI Transmission and Prevention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Influences on Risk Behaviors Among Young Men

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 30, 2019
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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