Young Men and Media Study

August 17, 2021 updated by: Boston University

Influences on Risk Behaviors Among Young Men

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Active Comparator: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months
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.
Baseline, 3 months
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.
Baseline, 3 weeks, 3 months
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.
Baseline, 3 weeks, 3 months
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.
Baseline, 3 weeks, 3 months
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.
Baseline, 3 weeks, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Kimberly M Nelson, PhD, Boston University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2020

Primary Completion (Actual)

August 17, 2020

Study Completion (Actual)

August 17, 2020

Study Registration Dates

First Submitted

September 26, 2019

First Submitted That Met QC Criteria

September 27, 2019

First Posted (Actual)

September 30, 2019

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-39323
  • K23MH109346 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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