Experiential HIV Testing Increasing Testing Related Knowledge and Practice, and Reduce Stigma Toward HIV of Nurses.: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Experiential HIV Testing Increasing Testing Related Knowledge and Practice, and Reduce Stigma Toward HIV of Nurses. (NCT05615935), a randomized na study. The primary outcome is HIV Testing Related Knowledge and Practice.

2. Clinical Question

The trial asks whether adding an experiential component to learning material is associated with a different score on the HIV Testing-Related Knowledge and Practice Scale. The registry describes the post-test as week 4. Its summary gives the control group’s post-test timing as one month after pre-test and the experimental group’s timing as one month after the intervention was completed.

The scale is described as a self-developed measure containing twenty-eight true-false and multiple-choice questions. A correct answer earns one point, with total scores ranging from 0 to 28; higher scores represent more knowledge and practice related to HIV testing. The registry also describes a stigma scale and an interview of the experimental group, but it does not identify those as the primary endpoint in the record details available for this analysis.

This is a question about a measured score in a specific group of nurses and setting. The registry record does not report the group-level score results or an estimated comparison between groups. Therefore, it does not establish the size, direction or precision of any difference in the primary outcome.

3. Trial Design

The registry classifies this as a randomized, single-masked, parallel-group trial. Participants were assigned to an experimental group or a control group. The masking field says “single,” but the registry record does not report who was masked or how masking was maintained. The study is listed as completed, and its phase is recorded as NA.

The experimental group received learning material about HIV testing and experiential HIV testing. The experiential component is described as HIV testing and counselling, education and discussion; post-test interviews were also described for that group. The control group received the learning material alone before its post-test. The registry says that experiential HIV testing would be offered to the control group after the post-test. This sequence matters when interpreting the comparison: the primary post-test contrast is described as occurring before that later offer to the control group.

The registry summary describes pre-testing with a demographic data sheet, the HIV testing-related knowledge and practice scale, and the Health Care Provider HIV/AIDS Stigma Scale. The post-test was described as occurring one month later in the control group and one month after completion of the intervention in the experimental group. The registry’s primary outcome timeframe is given as pre-test (baseline) and post-test (week 4).

Enrollment is recorded as 74. The summary describes a plan to recruit about 60 to 70 emergency department nurses from a medical center in Taipei, Taiwan. The registry record does not report the number randomized to each arm, the number completing each assessment, or reasons for any non-completion. It also does not report the identity of the institution or further details about recruitment procedures.

The study start is recorded as 2022-11-09, and primary completion as 2023-02-01. These dates describe the registered study timeline; they do not provide information about the timing or completeness of outcome reporting. Although the record describes random assignment, it does not report the sequence-generation method, concealment procedures, or whether assignment was stratified.

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

Reasons for not completing this period:

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 HIV Testing Related Knowledge and Practice, measured over pre-test(Baseline) and post-test (week 4).

The primary endpoint is HIV Testing Related Knowledge and Practice, measured with the HIV Testing-Related Knowledge and Practice Scale. The registry describes a self-developed questionnaire with twenty-eight true-false and multiple-choice questions. Each correct answer earns one point, for a total score from 0 to 28. A higher score is defined as a more positive outcome, indicating greater knowledge and practice related to HIV testing.

This endpoint is used to represent the learning and practice-related outcome that the intervention is intended to address. A score gives a quantitative summary of answers across the questionnaire rather than a description of a single response. The registry specifies the mean and standard deviation as the outcome summary and gives the measurement occasions as baseline and post-test at week 4.

In general, a mean describes the average score in a group, while a standard deviation describes how dispersed individual scores are around that average. Both can help characterize score distributions, but neither alone establishes whether groups differ. Interpretation of a randomized comparison also depends on the estimated between-group contrast, its uncertainty, and the analysis used.

The registry record does not report the scale’s group means, standard deviations, or a between-group estimate at either measurement occasion. It also does not report validation evidence, reliability estimates, or a prespecified clinically meaningful score difference. As a result, the endpoint’s definition and direction can be described, but the observed outcome and its precision cannot be evaluated from the registry results available in this record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous: each participant’s score can take values on a numeric scale, and the registry identifies the mean as its summary measure. Continuous outcomes are often described with a mean and standard deviation. The mean gives the group’s average score, and the standard deviation describes how much scores vary around that average. These are descriptive summaries; by themselves, they do not estimate the uncertainty in a treatment comparison.

What would a group comparison represent?

In general, a between-group estimate compares outcomes under the randomized assignments. For a post-test score, an analysis could compare group averages at that assessment; another analysis could compare change from baseline or account for both assessments together. These approaches can answer related but not identical questions. Which approach was planned for this trial is not reported in the registry record, so none can be attributed to the investigators.

A confidence interval is a range that reflects uncertainty in an estimate under a specified statistical model and its assumptions. It helps readers judge both the possible size of an effect and the precision with which it was estimated. A p-value, when reported, describes how compatible the observed data are with a specified null hypothesis under the analysis assumptions; it is not a measure of effect size or of the probability that the null hypothesis is true. The registry record does not report a primary outcome estimate, confidence interval or p-value.

Why the analysis details matter

The trial has baseline and post-test measurements, and the registry notes several categories or time points. Repeated measurements from one participant are related rather than independent observations. In general, an analysis that accounts for that relationship can differ from one that treats measurements as unrelated. The registry does not identify the model used, the exact comparison, any covariates, or the handling of repeated observations. These details are not reported in the registry record.

Randomization supports a comparison by assigning participants to groups, but the analysis population also matters. An analysis of participants according to their assigned groups can preserve the randomized comparison, while analyses that exclude participants or reclassify them may answer a different question and can be more vulnerable to bias. The registry record does not report the analysis population or explain how participants with incomplete follow-up were handled.

Missing data require particular attention when a baseline and post-test outcome are planned. In general, missingness can reduce the information available and may bias estimates if the likelihood of missing a score is related to participant characteristics or outcomes. Methods can make assumptions about the missingness process, but those assumptions should be stated and examined where possible. The registry does not report missing-data counts, reasons for missingness, or the method used to address it.

Multiple outcomes and time points

When a study evaluates multiple outcomes, time points or categories, the number of statistical comparisons can affect how results are interpreted. In general, multiplicity refers to the increased chance of at least one apparently notable finding when many hypotheses are tested. Researchers may prespecify a primary comparison, use an adjustment, or treat additional analyses as exploratory. The record reports two outcome measures and three analyses and notes that the primary outcome has several categories or time points. It does not report a multiplicity strategy, the individual analyses, or which result was designated as the main contrast.

As a result, a reader cannot determine from the registry record whether a particular analysis was prespecified, whether it was adjusted for other comparisons, or whether the reported analysis set was selected after seeing the data. Those details should not be inferred from the randomized design or from the outcome description.

Planning illustrations are not observed power

In general, a sample-size planning illustration describes how many participants per arm might be needed under stated assumptions about a target effect, significance level, allocation and statistical approximation. Such an illustration is conditional on those assumptions. It does not show the probability that the completed trial detected its actual effect, and it is not a substitute for the observed effect estimate and its confidence interval. The registry’s planning assumptions refer to a two-sided significance level of 0.05, equal allocation, a normal approximation, and a target effect expressed as a fraction of the observed effect. The registry record does not report the trial’s own sample-size justification.

The phrase “observed effect” in a planning calculation would depend on an effect estimate, but the primary outcome estimate is not reported in the registry record. Any planning values should therefore be understood only as conditional illustrations, not as trial findings or observed power. The registry also does not report a detailed statistical analysis plan, so the planned treatment of the several categories or time points cannot be reconstructed from the design description.

10. Multiplicity, Missing Data and Analysis Populations

The registry identifies two outcome measures and three analyses. It also states that the primary outcome has several categories or time points and was not reduced to one comparison. The specific analyses, the exact number of comparisons, and the designation of any single primary contrast are not reported in the registry record. The record also does not describe a multiplicity adjustment or explain whether any secondary analyses were intended to be exploratory.

In general, examining multiple outcomes or time points creates multiple opportunities to observe a result that appears notable by chance. A prespecified analysis plan can clarify which comparison is primary and whether other tests will be adjusted or treated as secondary. Without those details, the registry information is insufficient to determine how any individual result should be interpreted in relation to the complete set of analyses. No outcome-level estimates or p-values are reported to assess.

The registry describes a baseline assessment and a post-test, but does not report how many participants completed each assessment or how many scores were missing. Reasons for missing data, rules for excluding records, and methods for handling incomplete measurements are not reported in the registry record. It is also not stated whether all randomized participants were included in the analysis, whether participants were analyzed according to assigned group, or whether a different analysis population was used.

These omissions matter because missingness and analysis-population decisions can affect the estimated comparison. In general, complete-case analyses use only participants with the required measurements, while other methods may incorporate incomplete records under stated assumptions. Neither approach can be attributed to this trial based on the registry record.

The record gives an enrollment total of 74, but does not report the number assigned to each group or the flow from enrollment through follow-up and analysis. It also does not report a prespecified statistical analysis plan or its timing. Thus, neither the multiplicity approach nor the handling of missing data and analysis populations can be evaluated.

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 zero serious adverse events, zero other adverse events and zero deaths in each group. It lists 72 participants at risk for serious adverse events and 72 at risk for other adverse events in each group. These are the adverse-event counts recorded in the registry; they do not describe the primary knowledge-and-practice outcome.

A zero count means that no events of the listed type were recorded in the registry entry for the stated group. It does not, by itself, establish that no event occurred outside the scope of monitoring or reporting. To interpret safety counts fully, readers would need the event definitions, surveillance procedures, observation period, and information about how completely participants were followed. Those details are not reported in the registry record.

The listed at-risk counts are not the same as the total enrollment of 74, and the registry does not explain this difference or provide participant-flow details. The number randomized to each group and the number with complete safety follow-up are not reported in the registry record. The registry also lists no serious-event terms. The zero counts should therefore be read as registry-reported counts, not as proof that the intervention or study procedures have no risks.

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

The record describes a randomized trial comparing experiential HIV testing plus learning material with learning material alone among emergency department nurses. It identifies the primary outcome instrument, its score range and the direction in which higher scores are interpreted. It also describes baseline and week-4 assessment and gives a total enrollment of 74.

Those design details do not reveal what happened to the measured scores. The registry record does not report group means, standard deviations, change scores, a between-group effect estimate, confidence intervals or p-values for the primary endpoint. Without those results, neither the magnitude nor direction of an outcome difference can be stated. The registry also does not report the detailed analysis plan needed to understand how its several categories or time points were handled.

In general, a randomized design is intended to support comparisons between assigned groups, but causal interpretation also depends on implementation, follow-up, analysis and outcome reporting. Information about allocation procedures, participant flow, missing measurements and analysis populations is not reported in the registry record. These omissions prevent a full assessment of whether the comparison preserves the advantages intended by randomization.

The scale’s stated score range and higher-is-better direction define how scores would be read if results were available. They do not establish that a change in score occurred or that any difference would be meaningful in practice. The registry does not report a threshold for a clinically meaningful difference or evidence about the scale’s measurement properties.

The safety entries report zero serious adverse events, zero other adverse events and zero deaths in each group, with 72 listed at risk in each. These entries do not replace detailed safety methods or participant follow-up information, neither of which is reported in the registry record.

Accordingly, the registry supports a description of the question and design, but not a conclusion about the primary outcome effect. It cannot establish that the intervention improved knowledge or practice, that it had no effect, or that the estimate was precise. Those conclusions require outcome results and supporting analysis details that are not reported in the registry record.

13. Why This Trial Matters Statistically

This trial is statistically interesting because it combines random assignment with a continuous score measured at baseline and post-test. That structure raises familiar questions about defining the contrast, accounting for repeated measurements, reporting uncertainty and handling incomplete follow-up. The registry describes the trial design and scale, but does not provide enough analysis detail or outcome results to answer those questions for this study.

The score has a clear stated range, from 0 to 28, and the registry specifies that higher values indicate a more positive knowledge-and-practice outcome. A scale-based endpoint can summarize responses across multiple questions. For meaningful interpretation, however, readers also need the group distributions or summary statistics, the estimated comparison and its precision. Those primary results are not reported in the registry record.

The registry notes multiple categories or time points and records two outcomes and three analyses. This makes prespecification and multiplicity relevant: the interpretation of a selected comparison depends on how it was chosen relative to the other analyses. The record does not describe that selection or any adjustment strategy. The study therefore illustrates why a clear statistical plan and complete reporting are important alongside randomization.

Likewise, a completed study and a recorded enrollment total do not tell readers how many participants contributed primary outcome data. Arm-specific allocation, follow-up and missing-data information are not reported. Without those details, it is difficult to assess the information available for the primary comparison or the potential influence of incomplete observations.

The registry’s planning assumptions also illustrate a general distinction between sample-size planning and evidence from the completed study. Planning calculations depend on assumptions and do not replace an observed estimate with an uncertainty interval. The record does not report the trial’s own sample-size justification or the primary effect estimate needed to judge a planning illustration against the study’s results.

The central statistical lesson is that trial design identifies how a question was intended to be investigated, while results and transparent methods are needed to support an answer. Here, the question and measurement are described, but the primary outcome comparison and key analysis details are not reported in the registry record.

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 main limitation for interpreting this trial from the registry record is the absence of primary outcome results. Although the scale, score range, direction and measurement occasions are described, group-level scores and a between-group estimate are not reported. The size, direction and precision of any difference therefore cannot be assessed.

The registry notes that the primary outcome has several categories or time points and was not reduced to one comparison. The record does not identify the individual comparisons or explain their relationship to a prespecified primary analysis. It also does not describe the statistical model, covariate adjustment, treatment of repeated measures, or multiplicity strategy. These details are needed to understand how the outcome was analyzed and how any result would relate to the full set of analyses.

Participant-flow information is limited. Enrollment is recorded as 74, but arm-specific numbers, completion counts and reasons for non-completion are not reported in the registry record. The safety entry lists 72 participants at risk in each group, but the record does not explain how those counts relate to enrollment or provide further follow-up details. Missing primary outcome data and their handling are not reported.

The masking designation is single, but the identity of the masked parties and the masking procedures are not described. The allocation method and concealment procedures are also not reported. These gaps limit assessment of how assignment and measurement were implemented.

The primary scale is described as self-developed, but validation, reliability and interpretation thresholds are not reported. The registry does not provide a clinically meaningful difference threshold. The trial’s sample-size justification is also not reported, and no primary effect estimate is available to contextualize a planning illustration.

Finally, the registry’s brief summary describes nurses from a medical center in Taipei, Taiwan, but does not provide further setting details. The information available does not support conclusions about the generalizability of results beyond the population and setting described, particularly because the outcome results themselves are not reported.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Experiential HIV Testing Increasing Testing Related Knowledge and Practice, and Reduce Stigma Toward HIV of Nurses. — NCT05615935.
• Registry record last updated 2025-10-01; status last verified 2025-09.
• Results first posted 2024-08-02.
• 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

NCT05615935 is listed as a completed, randomized, single-masked, parallel-group study with 74 enrolled participants. The registry describes emergency department nurses and a comparison of learning material plus experiential HIV testing against learning material alone. The experimental component includes HIV testing and counselling, education and discussion. The control group is described as receiving the experiential component after its post-test.

The primary outcome is HIV Testing Related Knowledge and Practice, assessed using a self-developed twenty-eight-question scale scored from 0 to 28, with higher scores indicating a more positive outcome. The registry gives baseline and week-4 assessment time points. Study start is recorded as 2022-11-09 and primary completion as 2023-02-01.

The registry record does not report primary outcome estimates, uncertainty intervals, p-values, the detailed statistical analysis plan, or participant flow and missing-data handling. It records zero serious adverse events, zero other adverse events and zero deaths in each group, with 72 participants at risk listed in each group. The record describes the trial question and design, but does not provide the outcome results needed to assess the primary comparison.