Sexual BehaviorNCT04109443

Young Men and Media Study

A study testing Young Men & Media Program and Available websites on safe sex and preventing STIs in people with Sexual Behavior, run by Boston University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 14 to 17 years, men onlyHealthy volunteers can take part
Conditions the study is for: Sexual Behavior
What is being tested?: Young Men & Media Program and Available websites on safe sex and preventing STIs
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 154 participants
Where: 1 siteUnited States
Study dates: 27 Mar 2020to 17 Aug 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 to 17 years
Men only
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Boston University School of Public Health
Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: 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.

Conditions: Sexual Behavior
Being tested: Young Men & Media Program, Available websites on safe sex and preventing STIs
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
Medical subject headings: Sexual Behavior, Homosexuality, Bisexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04109443
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Available websites on safe sex and preventing STIs

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: approximately 4.5 months

Secondary outcomes (6)

Number of Sexual Partners
Participants will be asked information about the number of sex partners in the prior 3 months.
Measured: Baseline, 3 months
Number of Condomless Sex Acts With Male Partners
Participants will be asked information about the number of condomless sex acts with male partners in the prior 3 months.
Measured: Baseline, 3 months
Change in 6-item Condom Use and Attitudes Scale
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.
Measured: Baseline, 3 weeks, 3 months
Change in 8-item Sexually Explicit Online Media (SEOM) Literacy Scale
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.
Measured: Baseline, 3 weeks, 3 months
Change in 4-item SEOM Knowledge Scale
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.
Measured: Baseline, 3 weeks, 3 months
Knowledge of HIV and STI Transmission and Prevention
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.
Measured: Baseline, 3 weeks, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 202017 Aug 2020

First posted30 Sep 2019
Study start27 Mar 2020
Primary completion17 Aug 2020
Study completion17 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sexual BehaviorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04109443
Sponsor's protocol ID: H-39323
Other IDs: K23MH109346
Status last verified: Aug 2021
First submitted: 26 Sep 2019
Last updated: 14 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influences on Risk Behaviors Among Young Men
ClinicalTrials.gov ID: NCT04109443
Acronym / sponsor ID: H-39323
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 154 participants (actual)
Lead sponsor: Boston UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 27 Mar 2020 (actual)
Primary completion: 17 Aug 2020 (actual)
Study completion: 17 Aug 2020 (actual)
First posted: 30 Sep 2019 (actual)
Results: Posted 14 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Young Men & Media Program group	Experimental	Behavioral: Young Men & Media ProgramParticipants 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.
Control group	Active comparator	Behavioral: Available websites on safe sex and preventing STIsParticipants 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.

Who may qualify

Ages: 14 to 17 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Young Men & Media ProgramThe 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.	Behavioural	Young Men & Media Program group
Available websites on safe sex and preventing STIsAvailable websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV.	Behavioural	Control group

Primary outcome

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).
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.
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.
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.
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.
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

6 secondary outcomes

Number of Sexual Partners
Time frame: Baseline, 3 months
Number of Condomless Sex Acts With Male Partners
Time frame: Baseline, 3 months
Change in 6-item Condom Use and Attitudes Scale
Time frame: Baseline, 3 weeks, 3 months
Change in 8-item Sexually Explicit Online Media (SEOM) Literacy Scale
Time frame: Baseline, 3 weeks, 3 months
Change in 4-item SEOM Knowledge Scale
Time frame: Baseline, 3 weeks, 3 months
Knowledge of HIV and STI Transmission and Prevention
Time frame: Baseline, 3 weeks, 3 months

Results and safety

Results posted to the registry on 14 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Young Men & Media Program Group	77	67
Control Group	77	65

Primary outcome: Study Feasibility Based on the Overall Recruitment Rate

Time frame: approximately 4.5 months. Number. Unit: overall recruitment rate

Measure	All Eligible Participants n = 154
Value	36.5

Population analysed: Based on responses to the online screener survey, 422 potential participants were identified and 225 of them agreed to complete the baseline screening. 183 actually completed the baseline screening and of those 29 were determined ineligible leaving a final sample of 154 who were consented/enrolled in the study.

Primary outcome: Study Feasibility Based on Banner ad Click Through Rate for All Participants Combined

Time frame: approximately 4.5 months

Population analysed: The number of clicks on the banner ads could not be obtained from the system and therefore could not be reported.

Primary outcome: Feasibility of the Media Literacy Intervention Based on Time Spent on the Intervention

Time frame: 90 minutes

Population analysed: For some intervention content, like viewing images, the investigators were not able to capture reliably how long participants stayed on a page due to the various ways that they could leave that page. Therefore, this outcome could not be measured reliably and the data are not presented.

Primary outcome: Number and Percentage of Participants Who Complete All the Intervention Content

Time frame: 90 minutes. Count of participants. Unit: Participants

Measure	Young Men & Media Program Group n = 77	Control Group n = 0
Value	38	0

Population analysed: Outcome measure is only applicable to the Young Men \& Media Program group.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: approximately 4.5 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Young Men & Media Program Group	0 of 77 (0%)	0 of 77 (0%)	0 of 77
Control Group	0 of 77 (0%)	0 of 77 (0%)	0 of 77

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kimberly M Nelson, PhD principal investigator

Boston University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Young Men & Media Program and Available websites on safe sex and preventing STIs in people with Sexual Behavior, run by Boston University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study Feasibility Based on the Overall Recruitment Rate (time frame: approximately 4.5 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04109443.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.