Young Men and Media Study

NCT04109443 | Completed Results

• 2 other identifiers: H-39323K23MH109346
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Number of Sexual Partners

  Baseline, 3 months

• Number of Condomless Sex Acts With Male Partners

  Baseline, 3 months

• Change in 6-item Condom Use and Attitudes Scale

  Baseline, 3 weeks, 3 months

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

  Baseline, 3 weeks, 3 months

• Change in 4-item SEOM Knowledge Scale

  Baseline, 3 weeks, 3 months

Study Arms (2)

Young Men & Media Program group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

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.

Young Men & Media Program group

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.

Control group

Eligibility Criteria

• Age: 14 Years - 17 Years
• Gender Eligibility Details: cisgender
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Self-identify as sexual minority
• Have intentionally accessed SEOM
• Have a valid personal email address
• Be a US resident
• Be new to the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Boston University School of Public Health

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Sexual Behavior; Homosexuality; Bisexuality

Condition Hierarchy (Ancestors)

Behavior; Sexuality

Limitations and Caveats

Data collection for this project concurred with the initial months of the COVID-19 pandemic in the United States. As such, it is possible that some of the outcomes changed independent of the intervention. Additionally, the SEOM measures (outcomes 10 and 11) were developed for this study and appear to have some potential issues with internal reliability. As such, they should be interpreted with caution.

Results Point of Contact

• Title: Kimberly M Nelson, PhD
• Organization: Boston University School of Public Health

knel@bu.edu

617-358-1482

Study Officials

• Kimberly M Nelson, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Study Start: March 27, 2020
• Primary Completion: August 17, 2020
• Study Completion: August 17, 2020
• Last Updated: September 14, 2021
• Results First Posted: September 14, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)