SHARE Project Define: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for SHARE Project Define (NCT06125509), a registered phase not stated study. The primary outcome is Alcohol Use.

2. Clinical Question

3. Trial Design

Project DEFINE is a completed study sponsored by Florida State University. The registry record lists enrollment of 105 and identifies HIV as the condition. The listed study dates are 2022-08-01 for the start and 2025-08-05 for primary completion. Its stated overall goal was to define modifiable intervention targets that are developmentally- and culturally-relevant in pathways between cumulative stress and self-management outcomes—alcohol use and HIV—among young people living with HIV.

The record describes a cohort, not a randomized comparison. It does not state how allocation was handled, and it warns that the arms are not a like-for-like control comparison. The intervention, if any, is not described as a delivered treatment. Accordingly, the record does not support treating any arm contrast as a randomized estimate of a treatment effect.

The primary outcome is continuous: the mean number of hazardous drinking days during the prior two weeks, measured at baseline and 9-month follow-up. The record specifies standard deviation as the dispersion measure. Although enrollment is listed as 105, only 41 participants at the 9-month follow-up completed the TLFB measure. The status of other participants’ follow-up measurements is not reported in the registry record.

The record lists two outcome measures and two analyses, but the details of the additional measure and the analyses are not reported in the registry record. It does not state the sample-size justification, analysis population definitions, adjustment variables, or a statistical analysis plan. The study’s completed status does not, by itself, supply those missing details or reveal the numerical outcome findings.

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.

Before assignment: When participants consented to enroll in the Define study, they were consenting to participate in both the Model Phase and Adapt Phase (qualitative focus groups). Participants were selected for the Adapt Phase based on completion of all Model Phase activities. However, there was a lack of participant interest in the Adapt Phase activities resulting in a small number of participants. Additionally, there were recording errors and the audio recordings were not able to be transcribed for analysis.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Only 41 participants at the 9-month follow-up completed the TLFB measure.

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 Alcohol Use, measured over 2 weeks, at baseline and 9 month follow up.

The primary endpoint is hazardous drinking, recorded as the number of hazardous drinking days over the prior two weeks. It is measured with the Timeline Followback (TLFB) at baseline and 9-month follow-up. The endpoint is continuous, and the registry identifies the mean as the summary parameter and standard deviation as the measure of dispersion.

The registry defines hazardous drinking according to NIAAA criteria: >7 drinks/week or >3 drinks/occasion for women, and >14 drinks/week or >4 drinks/occasion for men. The reported endpoint is the number of days meeting the hazardous-drinking definition during the recall period, rather than the number of drinks or a yes/no status. This makes the measure a way to describe the frequency of hazardous drinking over a specified period.

In general, a repeated measure can describe how an outcome changes over time, but the registry record does not report the baseline or follow-up mean, the amount of change, or uncertainty around that change. Only 41 participants completed the TLFB measure at the 9-month follow-up. The completeness and handling of other follow-up measurements are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the primary outcome as a continuous measure and identifies the mean and standard deviation as its summary statistics. In general, the mean represents the average outcome in an analyzed group. The standard deviation describes how dispersed individual observations are around that average. They answer different questions: the mean concerns the group’s typical level, while the standard deviation concerns variation among observations. The record does not include numerical values for either statistic.

What does a continuous outcome mean?

In general, a continuous outcome can take a range of values rather than belonging only to a set of categories. Here, the outcome is the number of hazardous drinking days during a two-week recall period. It is therefore a count-like measure summarized as a mean in the registry. The clinical interpretation remains tied to the endpoint definition and recall period; it is not a direct measure of drinks consumed or a diagnosis.

A mean can be useful for comparing group averages or describing average change over time, but it does not show the full distribution. Participants can have different outcome values while contributing to the same mean. A standard deviation adds information about spread, but neither statistic alone describes every feature of the data. The registry does not report the endpoint distribution, the means, or the standard deviations, so those features cannot be evaluated for this study.

How should repeated measurements be understood?

The endpoint is measured at baseline and 9-month follow-up. In general, repeated measurements allow researchers to describe outcomes at more than one time point and to estimate change when the relevant data and analysis are available. A change estimate would need to be accompanied by its uncertainty and interpreted in light of who contributed data at each time point. The registry record does not report a change estimate or its uncertainty.

In general, a within-participant comparison uses measurements from the same people over time, whereas a comparison of group averages may involve different sets of participants at each time. These approaches have different interpretations and assumptions. The statistical method used for the posted analyses is not reported in the registry record, so it is not possible to say which approach was used or how repeated observations were handled.

What does a confidence interval contribute?

In general, a confidence interval expresses uncertainty around an estimate under the assumptions of the statistical method. A narrow interval indicates greater precision than a wide interval, but precision is not the same as clinical importance. Intervals also do not remove concerns about design, missing observations, or measurement. No confidence interval for the primary endpoint is reported in the registry record, so the precision of any outcome estimate is not available.

A p-value, in general, describes how compatible the observed data are with a specified null model under the assumptions of an analysis. It does not measure the size of an effect or the probability that a hypothesis is true. The record does not report a p-value for the primary endpoint, and the analytic model and null hypothesis are not stated. A significance claim therefore cannot be assessed from the registry record.

Why does the study design affect interpretation?

The registry describes a cohort, says allocation is not stated, and cautions that the arms are not a like-for-like control comparison. In general, random allocation can help balance known and unknown factors between groups, while observational or nonrandomized comparisons can be influenced by differences between groups. The record does not establish that a randomized treatment comparison was conducted. Thus, any arm contrast should not automatically be interpreted as a causal treatment effect.

Even a baseline-to-follow-up change in a cohort is descriptive unless the design and analysis support a stronger causal interpretation. Other influences over time may contribute to change. In general, statistical adjustment can address measured differences under specific assumptions, but it cannot guarantee that all sources of bias have been removed. The adjustment variables and analysis strategy are not reported in the registry record.

What is the relevance of the follow-up completion detail?

The record says that only 41 participants completed the TLFB measure at the 9-month follow-up. In general, incomplete outcome data can affect both the precision and representativeness of an estimate. If follow-up completion is related to outcome values or participant characteristics, the analyzed group may differ from those without observed follow-up data. This is a general concern, not a claim about why completion was limited in this study. Reasons for incomplete measurement and the statistical handling of missing data are not reported in the registry record.

In general, missing-data methods rely on assumptions about the relationship between observed and unobserved information. Different assumptions can lead to different estimates. The record does not identify a missing-data method or explain whether analyses used all available observations, a defined subset, or another approach. No additional assumption should be attributed to the investigators based on the endpoint description alone.

What can planning calculations establish?

In general, sample-size planning illustrations use assumptions about a target effect, variability, significance level, allocation, and statistical model. Such calculations are prospective planning tools; they are not observed power and do not show whether a study found an effect. The registry record describes planning assumptions based on a fraction of an observed effect, with two-sided significance level 0.05, equal allocation, and a normal approximation. It does not report the resulting planning figures in the registry record for this analysis, and they should not be treated as trial results or as the study’s original design justification. The study’s own sample-size justification is not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures and two analyses, but it does not report their detailed definitions, analytic roles, or results. It does not identify which outcomes were designated primary or secondary beyond the listed primary endpoint, nor does it describe a hierarchy among outcomes or analyses. The strategy for handling multiplicity is not reported in the registry record.

In general, testing multiple outcomes or hypotheses can increase the chance of a false-positive finding if each is assessed independently without an appropriate plan. Statistical approaches can address multiplicity, but their relevance depends on which questions were prespecified and how the tests relate to one another. No correction method or other multiplicity strategy is reported, so it is not possible to assess how the analyses account for multiple questions.

Follow-up measurement is a further interpretive issue: the record states that only 41 participants completed the TLFB measure at the 9-month follow-up. Reasons for incomplete measurement, the number with baseline data, the analysis population, and the method used to handle missing outcomes are not reported in the registry record. In general, complete-case analyses and methods that use incomplete records can rely on different assumptions; the record does not identify which, if any, was used.

The record also does not describe whether analyses were prespecified, whether any interim analyses occurred, or which adjustment variables were included. Those details are not reported in the registry record. Without them, the statistical results and their sensitivity to missingness or multiple testing cannot be evaluated. These omissions do not establish that a particular procedure was or was not used; they limit what can be concluded from the registry entry.

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 registry lists a cohort of young people with HIV with 105 at risk for serious adverse events, 0 affected, and 0 deaths. These are the recorded serious-event counts for the cohort. The registry also lists 105 at risk and 0 affected in its other adverse-event fields. The record does not list serious adverse-event terms.

In general, an at-risk count describes the group for which events are being reported, while an affected count records participants with a reported event. A zero affected count means no events are listed in that registry field; it does not establish that every possible event was assessed in the same way or that no symptoms or non-serious events occurred. The record does not provide further details about safety monitoring or event definitions.

These figures should not be added across the serious and other fields, because the registry does not explain whether their at-risk counts represent separate groups or overlapping reporting categories. They also do not provide a comparison between randomized arms: the study is not described as randomized, and allocation is not stated. The counts are a descriptive registry report, not an estimate of comparative safety.

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

The registry record establishes the study’s stated purpose, population, primary endpoint, measurement schedule, and follow-up completion detail. It describes Project DEFINE as a completed cohort study aiming to identify modifiable, developmentally- and culturally-relevant intervention targets in pathways linking cumulative stress and trauma with alcohol use and HIV self-management among young people living with HIV.

The primary endpoint is the number of hazardous drinking days over the prior two weeks, measured at baseline and 9-month follow-up. The record identifies mean and standard deviation as the summary statistics, but does not report their values. It also does not report an estimate of change, a confidence interval, or a p-value. Consequently, the direction, magnitude, and precision of the primary outcome findings cannot be determined from the registry record.

The record states that only 41 participants completed the follow-up TLFB measure. It does not explain why follow-up measurement was incomplete or how missing observations were handled. This limits assessment of how representative the available follow-up outcome is and how sensitive any analysis may be to missing information.

The record does not describe a randomized comparison; allocation is not stated, and the arms are not characterized as a like-for-like control comparison. Therefore, the record does not support interpreting a contrast as a randomized treatment effect. More broadly, the study aim is not itself evidence that a particular pathway was identified or that an intervention target was validated. Results for the additional outcomes and analyses are not reported in the registry record.

In general, statistical results need to be read alongside study design, measurement, uncertainty, and missing-data handling. The registry entry supports describing these features and the stated aim, but it does not provide enough numerical outcome information to judge the size or certainty of a finding, or to make a causal claim.

13. Why This Trial Matters Statistically

Project DEFINE addresses a research question involving cumulative stress and trauma, alcohol use, and HIV self-management among young people living with HIV. The registry describes the intended contribution as defining modifiable targets that are developmentally- and culturally-relevant. This makes the distinction between a study aim and a demonstrated statistical result especially important: the aim frames what the research seeks to investigate, while the registry record does not report estimates showing which pathways or targets were identified.

The primary endpoint is defined in a specific way: hazardous drinking days over the prior two weeks, measured with the TLFB at baseline and 9-month follow-up. Clear measurement definitions help readers understand what a result would represent. The record also identifies the mean and standard deviation as relevant summaries. Yet those numerical results are not reported, so readers cannot evaluate the observed level, variability, or change in the endpoint.

The follow-up completion detail is also statistically important. Only 41 participants completed the TLFB at 9-month follow-up, and the record does not explain the status of other measurements or the handling of missing data. This highlights why reporting denominators, analysis populations, and missing-data methods is important for understanding which observations support an estimate.

Finally, the registry describes a cohort and does not establish a randomized comparison. That context matters when interpreting differences over time or between arms. The study’s conceptual focus may motivate later intervention research, but the record does not report evidence that would establish a causal effect or an intervention’s impact. Clear estimates, uncertainty measures, and design details are needed to make those distinctions.

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.

The central limitation for interpreting the primary endpoint is that numerical outcome results are not reported in the registry record. The mean number of hazardous drinking days, standard deviation, estimate of change, confidence interval, and p-value are absent. Consequently, the magnitude and precision of the endpoint findings cannot be assessed.

The record states that only 41 participants at the 9-month follow-up completed the TLFB measure. It does not report why other follow-up measurements are unavailable, the number with baseline TLFB data, or how missing outcomes were handled. This prevents assessment of whether follow-up completers may differ from participants without a completed measure, and how that could affect interpretation.

The study is not described as randomized; allocation is not stated, and the record cautions that arms are not a like-for-like control comparison. The record does not describe a specific intervention delivered, a comparator protocol, or adjustment methods. These limits mean that an arm contrast or change over time should not be read as a randomized causal treatment estimate.

Further details are also absent: the statistical analysis plan, sample-size justification, analysis population definitions, adjustment variables, multiplicity approach, interim analyses, and detailed results for the additional outcome measures and analyses are not reported in the registry record. The adverse-event entry provides counts but no further event descriptions or monitoring details. These omissions constrain interpretation of both efficacy-related outcomes and safety reporting without establishing what procedures were used beyond what the record states.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: SHARE Project Define — NCT06125509.
• Registry record last updated 2026-08-31; status last verified 2026-08.
• Results first posted 2026-07-28.
• 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

Project DEFINE is a completed Florida State University cohort study concerning young people living with HIV. The registry lists enrollment of 105, a start date of 2022-08-01, and primary completion on 2025-08-05. Its stated goal was to define modifiable, developmentally- and culturally-relevant intervention targets connecting cumulative stress and trauma with alcohol use and HIV self-management.

The primary endpoint is the mean number of hazardous drinking days during the prior two weeks, measured by TLFB at baseline and 9-month follow-up, with standard deviation as the dispersion measure. Only 41 participants completed the follow-up TLFB. Numerical endpoint results and details of the statistical analyses are not reported in the registry record. The record describes no randomized comparison and states that allocation is not stated. It lists 0 serious adverse events affected and 0 deaths in the cohort.