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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
154

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 17, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 17, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings