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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH109346 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Sexual Partners | 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 | Participants will be asked information about the number of condomless sex acts with male partners in the prior 3 months. |
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Inclusion Criteria:
Exclusion Criteria:
cisgender
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly M Nelson, PhD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University School of Public Health | Boston | Massachusetts | 02118 | United States |
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Recruitment occurred online at the study website. 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Number | overall recruitment rate | approximately 4.5 months | percent recruited | percent recruited |
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approximately 4.5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberly M Nelson, PhD | Boston University School of Public Health | 617-358-1482 | knel@bu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2019 | Jun 4, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 28, 2019 | Jul 15, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D006716 | Homosexuality |
| D001727 | Bisexuality |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019529 | Sexuality |
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| 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. |
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The percentage of participants who completed all assessments divided by the number of enrolled participants |
| approximately 4.5 months |
| 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. | 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. | 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. | 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. | Baseline, 3 weeks, 3 months |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| percent recruited |
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| 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. | The number of clicks on the banner ads could not be obtained from the system and therefore could not be reported. | Posted | approximately 4.5 months | Clicks | Clicks |
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| 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. | 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. | Posted | 90 minutes |
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| 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. | Outcome measure is only applicable to the Young Men & Media Program group. | Posted | Count of Participants | Participants | 90 minutes |
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| 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. | Only collected for intervention (Young Men & Media Program) group. | Posted | Mean | Standard Error | units on a scale | 90 minutes |
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| 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 | All participants were combined to obtain the overall retention percent and number for the study. | Posted | Count of Participants | Participants | approximately 4.5 months |
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| Secondary | Number of Sexual Partners | Participants will be asked information about the number of sex partners in the prior 3 months. | Data collection for this project concurred with the initial months of the COVID-19 pandemic in the United States. Although sexual behavior data were collected, our data indicates that at baseline the COVID-19 pandemic had already substantially reduced participants sexual contacts because most participants were no longer seeking out or interacting with sexual partners in-person. Thus, the validity and meaningfulness of these data are unclear. | Posted | Mean | Standard Deviation | number of partners | Baseline, 3 months |
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| 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. | Data collection for this project concurred with the initial months of the COVID-19 pandemic in the United States. Although sexual behavior data were collected, our data indicates that at baseline the COVID-19 pandemic had already substantially reduced participants sexual contacts because most participants were no longer seeking out or interacting with sexual partners in-person. Thus, the validity and meaningfulness of these data are unclear. | Posted | Mean | Standard Deviation | number of condomless sex acts | Baseline, 3 months |
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|
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| 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. | Posted | Median | Standard Deviation | score on a scale | Baseline, 3 weeks, 3 months |
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| 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. | This scale was developed for this study and shows only acceptable internal reliability (Chronbach's alpha = 0.71, 0.75, 0.69). Results should be interpreted with caution as they may be unreliable. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 weeks, 3 months |
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| 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. | This scale was developed for this study and shows unacceptable internal reliability (Chronbach's alpha = 0.41, 0.38, 0.49). Results should be interpreted with caution as they are likely unreliable. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 weeks, 3 months |
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| 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 3 weeks, 3 months |
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| 0 |
| 77 |
| 0 |
| 77 |
| 0 |
| 77 |
| EG001 | 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. 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. | 0 | 77 | 0 | 77 | 0 | 77 |
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| 3 months |
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| 3 months |
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| 3 months |
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| 3 Months |
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