Clinical trial NCT04109443: Young Men and Media Study
Official title: Influences on Risk Behaviors Among Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Behavior
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
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-09-30
Enrollment: 154
Sex: MALE
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Study Feasibility Based on the Overall Recruitment Rate
timeFrame: approximately 4.5 months
measure: Study Feasibility Based on Banner ad Click Through Rate for All Participants Combined
timeFrame: approximately 4.5 months
measure: Feasibility of the Media Literacy Intervention Based on Time Spent on the Intervention
timeFrame: 90 minutes
measure: Number and Percentage of Participants Who Complete All the Intervention Content
timeFrame: 90 minutes
measure: Mean Participant Satisfaction of the Intervention Content Areas Based on a 5 Star Rating System
timeFrame: 90 minutes
measure: Count and Percentage of Participants Who Are Retained Through All Assessments
timeFrame: approximately 4.5 months
Secondary outcomes:
measure: Number of Sexual Partners
timeFrame: Baseline, 3 months
measure: Number of Condomless Sex Acts With Male Partners
timeFrame: Baseline, 3 months
measure: Change in 6-item Condom Use and Attitudes Scale
timeFrame: Baseline, 3 weeks, 3 months
measure: Change in 8-item Sexually Explicit Online Media (SEOM) Literacy Scale
timeFrame: Baseline, 3 weeks, 3 months
measure: Change in 4-item SEOM Knowledge Scale
timeFrame: Baseline, 3 weeks, 3 months
measure: Knowledge of HIV and STI Transmission and Prevention
timeFrame: Baseline, 3 weeks, 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University School of Public Health
state: Massachusetts
Study officials:
affiliation: Boston University
name: Kimberly M Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References: