Young Men and Media Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Young Men and Media Study (NCT04109443), a randomized na study. The primary outcome is Feasibility of the Media Literacy Intervention Based on Time Spent on the Intervention.

2. Clinical Question

The study’s rationale centers on sexual risk behaviors during early sexual experiences and the potential value of addressing sexual health media literacy during adolescence. The registry summary notes that adolescent sexual minority males account for a disproportionate number of HIV infections in the United States and that racial and ethnic minority populations are particularly affected. These statements describe the investigators’ rationale; they are not findings from this trial.

The proposed comparison is between access to the program and access to existing sexual health websites. The clinical question is therefore about the feasibility of delivering and assessing an online media literacy intervention, rather than whether the program reduced HIV infections. The listed secondary outcomes include sexual partners, condomless sex acts with male partners, condom-use attitudes, media literacy, media-related knowledge, and knowledge of HIV and STI transmission and prevention. Numerical results for these outcomes are not reported in the registry record.

3. Trial Design

This completed study is registered as an exploratory clinical trial of the Young Men and Media Program. The registry describes its design as randomized, with no masking and a parallel-group model. Enrollment was 154. The sponsor is Boston University. The registry lists a start date of 2020-03-27 and a primary completion date of 2020-08-17.

Participants were assigned to the Young Men & Media Program group or the control group. The intervention group had access to online sexual health media literacy materials. The control group had access to available websites, such as those from the CDC, with information about sexual health and preventing sexually transmitted infections, including HIV. Both arm descriptions refer to 3 assessments, including baseline and post-intervention assessment; the intervention description specifies a 3 month follow-up.

Randomization is intended to make the groups comparable on average at the start of a trial, although the registry record does not report the randomization procedure, allocation concealment, or any stratification factors. With no masking, participants and study staff could know which access condition was assigned. The registry record does not report whether outcome assessors were masked separately.

The record describes the study as a pilot test of feasibility and acceptability, but detailed feasibility criteria, acceptability measures, and thresholds for success are not reported in the registry record. The primary outcome concerns time spent on intervention content, while the listed secondary outcomes span sexual behavior, attitudes, media literacy, and knowledge. The registry lists 12 outcome measures. It does not report a statistical analysis plan, a sample-size justification, or interim analyses.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Analysis population for the primary outcome, as defined in the registry: 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.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Feasibility of the Media Literacy Intervention Based on Time Spent on the Intervention, measured over 90 minutes.

The primary endpoint concerns feasibility of the media literacy intervention, measured by time spent on each piece of intervention content. The registry says time was to be determined from participants’ online use, with a timeframe of 90 minutes. This type of measure can describe whether and how participants engage with online material, an aspect of feasibility that matters when assessing an intervention delivered through a digital platform.

The record also explains a key measurement problem: for some content, such as viewing images, investigators could not reliably determine how long participants stayed on a page because participants could leave that page in different ways. As a result, this outcome could not be measured reliably for that content, and the data are not presented. The record does not provide a numerical estimate of time spent, a summary across content, or a comparison between groups.

Time spent is an engagement measure, not a direct measure of sexual behavior, knowledge, HIV transmission, or health benefit. More time on a piece of content would not by itself establish that participants understood or acted on its information. The registry record does not report a decision threshold for what amount of time would count as feasible. Because the primary outcome data are not presented, the posted record cannot quantify intervention engagement using this endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does randomization contribute?

In general, randomization assigns participants to study groups using a chance-based process. It is intended to reduce systematic differences between groups at baseline, including differences that investigators may not have measured. If outcomes are collected and analyzed appropriately, the randomized comparison can support a causal interpretation more strongly than a comparison based only on observed characteristics. Randomization does not guarantee identical groups, ensure that participants follow their assigned access condition, or resolve problems in outcome measurement.

The registry identifies this study as randomized and parallel, but it does not report the specific sequence-generation process or how allocation was concealed before assignment. The adverse-event figures list 77 participants at risk in each group. Those safety denominators are consistent with equal group counts in the posted safety data, but they do not describe the randomization procedure itself.

What does an open-label design mean?

No masking is reported. In general, an open-label study is one in which participants and study staff know the assigned intervention. Knowledge of assignment can influence engagement, reporting, or other behavior, especially when outcomes involve self-report or time spent interacting with content. This is a potential source of measurement or performance bias, not proof that bias occurred. The registry record does not report a separate masked outcome assessment process.

How should the primary measure be understood?

The primary outcome was time spent on intervention content based on online use. Duration measures from digital systems can be affected by how a page is opened, left, or revisited. The registry specifically says the investigators could not reliably capture time for some content, such as viewing images, because participants could leave a page in various ways. This is a measurement limitation: if recorded time does not reliably represent actual engagement, a statistical comparison of recorded durations may be misleading. The record says the data are not presented, so no duration estimate or comparison is available.

In general, time spent can indicate exposure to content, but it does not directly measure comprehension or behavior change. A feasibility endpoint may be useful for assessing delivery and engagement, while separate outcomes are needed to assess knowledge, attitudes, or behavior. The registry lists such secondary outcomes, but numerical analyses are not reported.

What can an estimate and confidence interval tell readers?

In general, an estimate summarizes the observed outcome or group contrast, while a confidence interval communicates uncertainty around that estimate under the chosen model. A narrow interval indicates greater precision than a wide interval, but neither an estimate nor its interval alone establishes that an intervention is beneficial. Interpretation depends on the outcome, study design, assumptions, and what differences would be meaningful. The registry record does not report estimates or confidence intervals for the outcomes, so precision cannot be assessed.

For outcomes measured as counts, the distribution can be highly variable, and some count outcomes may have more variability than a simple model assumes. In general, over-dispersion means the observed variability exceeds the model’s expected variability; failing to account for it can make uncertainty appear too small. The registry record does not state which models, distributional assumptions, or variance adjustments were used for the listed count outcomes.

How should planning illustrations be read?

In general, sample-size calculations describe how many participants a study might need under specified assumptions about the target effect, variability, significance level, allocation, and analysis. The planning illustrations for this study use a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect set as a stated fraction of the observed effect. For non-time-to-event outcomes, the illustrations are expressed as participants per arm; time-to-event calculations would instead concern total events.

Such calculations are planning illustrations, not evidence that the trial had a particular probability of finding a result. They are not observed power. Their interpretation depends on the assumptions and effect estimate used. The registry record does not report the study’s own sample-size justification, and the posted outcome record does not provide a primary-outcome estimate with which to assess a planning illustration. A planning calculation cannot substitute for observed results or show that a result was statistically significant.

What is not specified?

The registry record does not report the detailed statistical analysis methods, the handling of repeated assessments, covariate adjustment, missing-data methods, or a prespecified analysis population. It also does not describe interim analyses. These are relevant details for evaluating how estimates were produced and how uncertainty should be interpreted. In their absence, no particular method should be assumed.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 12 outcome measures and includes outcomes related to sexual behavior, attitudes, sexually explicit online media literacy and knowledge, and HIV and STI knowledge. When a study assesses multiple outcomes, multiple time points, or multiple comparisons, the chance of at least one apparently notable result can increase if each is tested separately. In general, a prespecified outcome hierarchy or a statistical adjustment can help address that issue. The registry record does not report a multiplicity strategy or explain how the listed outcomes were prioritized for analysis.

The record indicates that the primary outcome involved several categories or time points and was not reduced to one comparison. It also states that the primary endpoint data are not presented because time spent could not be measured reliably for some intervention content. Without a defined reported comparison, there is no primary estimate to interpret alongside secondary findings. The record lists 0 analyses, so it contains no numerical outcome analysis from which to assess multiplicity in practice.

Missing-data methods and analysis populations are not reported in the registry record. The endpoint’s measurement problem should not automatically be described as ordinary missing data: the registry says some time measurements could not be obtained reliably and that data are not presented. It does not report how many observations were affected, whether other content had usable measurements, or whether any imputation or exclusion approach was used.

Random assignment alone does not establish whether results were analyzed according to original assignment, restricted to participants with available data, or handled in another way. The registry record does not specify an intention-to-treat population, a per-protocol population, or rules for retaining participants in the analysis. Therefore, the analysis population and the implications of any missing observations cannot be determined from the posted record.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The serious adverse event figures list 77 participants at risk in the Young Men & Media Program group and 77 in the control group. The record reports 0 serious adverse events, 0 other adverse events, and 0 deaths for each group. No serious adverse event terms are listed.

These figures should be read as the event counts recorded in the registry, not as a statistical comparison of safety between groups. A count of 0 does not demonstrate that the underlying risk is absent, nor does it establish that risks are equal. The record does not provide confidence intervals or other uncertainty estimates for these counts.

The registry record does not report definitions for serious or other adverse events, details of how events were elicited, or the period over which safety was monitored. Without that context, readers cannot determine how completely events were captured or how the counts relate to exposure time. The figures describe what was posted; they do not support broader conclusions about safety beyond those reported observations.

12. What the Result Does, and Does Not, Mean

The record establishes that investigators conducted a completed randomized, parallel-group pilot of an online sexual health media literacy program, with access to sexual health websites as the control condition. It identifies the intended primary feasibility measure as time spent on intervention content and explains why data for that endpoint were not presented: time could not be measured reliably for some content.

The record does not establish whether the program changed sexual behavior, attitudes, knowledge, or media literacy. Although those outcomes are listed, numerical analyses are not reported. No effect estimate, confidence interval, or p-value is available for interpreting group differences. The absence of an analysis in the registry should not be mistaken for evidence of no effect; it means the posted record cannot quantify an effect.

The record also does not show whether the intervention was feasible according to a prespecified threshold. Time spent may describe exposure to online material, but it is not itself proof of comprehension, acceptability, or behavioral change. The registry characterizes the study as a pilot intended to test feasibility and acceptability, yet detailed criteria and numerical findings for those aims are not reported.

The safety entries show 0 reported serious adverse events, 0 other adverse events, and 0 deaths in each group, with 77 participants at risk per group. These counts are limited to the posted record and do not establish that there was no safety risk. Further details about event monitoring and observation are not reported.

Overall, the registry supports a description of the trial’s design and measurement challenge, but not a conclusion about intervention effectiveness or the magnitude of any outcome difference. Those conclusions would require reported outcome data and analyses.

13. Why This Trial Matters Statistically

This trial is statistically notable for the gap between an intended digital engagement measure and the ability to measure it reliably. A digital intervention can generate detailed records of online use, but recorded activity is only useful when it validly represents the behavior of interest. The registry’s account of difficulty measuring time on some pages illustrates how interface behavior can complicate a seemingly direct duration measure.

The issue matters because measurement quality precedes statistical interpretation. A precise estimate based on an unreliable measure would not necessarily be informative. When some content cannot be timed reliably, investigators may need to define which engagement behaviors can be captured, how they will be aggregated, and whether the measure reflects exposure in a meaningful way. The registry record does not report whether alternative engagement measures were analyzed.

The study also places feasibility alongside outcomes that are farther from intervention exposure, including sexual behavior, attitudes, media literacy, and knowledge. Those domains represent different kinds of constructs and may require distinct measurement and analysis approaches. The record lists these outcomes but does not report numerical analyses, so it cannot show how they relate to engagement or to one another.

Finally, the absence of reported outcome analyses limits what can be learned about precision and multiplicity. A randomized design is valuable, but the design alone does not produce an interpretable treatment-effect estimate. Reporting outcome definitions, analysis populations, missing-data handling, and uncertainty would be needed to evaluate the results statistically. In this record, the clearest statistical information concerns the study structure and the limitation affecting its primary endpoint.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

A central limitation is that the primary feasibility data are not presented. The registry says that time spent could not be measured reliably for some content, including image viewing, because participants could leave a page in different ways. The record does not say how much content was affected, whether other content yielded usable measurements, or whether an alternative measure was used.

Outcome results are also not available in the registry record. Although 12 outcome measures are listed, the record reports 0 analyses. This prevents assessment of the magnitude and precision of differences in sexual behavior, attitudes, media literacy, or knowledge. It also prevents evaluation of whether outcomes were analyzed according to a prespecified plan.

Additional methodological details are not reported in the registry record, including eligibility criteria, participant characteristics, the randomization procedure, allocation concealment, analysis populations, missing-data methods, outcome-model specifications, and any multiplicity strategy. The absence of these details limits evaluation of comparability, potential bias, and the robustness of any results.

The study was described as an exploratory pilot, so its stated purpose differs from a definitive assessment of clinical outcomes. The registry record does not report feasibility thresholds, acceptability criteria, or the investigators’ sample-size justification. The safety figures are limited to counts and do not include event definitions or monitoring details. These limitations constrain interpretation of both feasibility and safety from the posted record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Young Men and Media Study — NCT04109443.
• Registry record last updated 2021-09-14; status last verified 2021-08.
• Results first posted 2021-09-14.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The registry record describes the completed Young Men and Media Study, a randomized, unmasked, parallel-group pilot sponsored by Boston University. Enrollment was 154. Participants were assigned to the Young Men & Media Program or access to available sexual health websites. The primary outcome concerned time spent on intervention content, with a timeframe of 90 minutes.

The primary endpoint data are not presented because time spent could not be measured reliably for some content. The registry lists 12 outcome measures and 0 analyses. Safety figures list 77 participants at risk in each group and report 0 serious adverse events, 0 other adverse events, and 0 deaths in each group. The record does not report numerical efficacy results, a detailed statistical plan, or methods for missing data and analysis populations.