Young Men and Media Study

Sexual Behavior Clinical Trial

Official title:

Influences on Risk Behaviors Among Young Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04109443
• Other study ID #: H-39323
• Secondary ID: K23MH109346
• Status: Completed
• Phase: N/A
• Start date: March 27, 2020
• Est. completion date: August 17, 2020

Study information

• Verified date: August 2021
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: August 17, 2020
• Est. primary completion date: August 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Sexual Behavior

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Boston University School of Public Health	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Number of Sexual Partners	Participants will be asked information about the number of sex partners in the prior 3 months.	Baseline, 3 months
Secondary	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.	Baseline, 3 months
Secondary	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.	Baseline, 3 weeks, 3 months
Secondary	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.	Baseline, 3 weeks, 3 months
Secondary	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.	Baseline, 3 weeks, 3 months
Secondary	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.	Baseline, 3 weeks, 3 months