Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms (NCT03182738), a randomized na study. The primary outcome is Symptom Burden Score.

2. Clinical Question

3. Trial Design

VIP-HANA was a randomized, double-masked, parallel-group behavioral study sponsored by Columbia University. The registry record lists enrollment of 100 and a completed status. The study began on 2016-11-16, and primary completion was recorded as 2019-04-03. Its phase is listed as NA.

The two arms differed in the app content described in the record. The intervention arm used a VIP app delivering HIV-related symptom strategies; the control arm used a VIP app without those strategies. Randomization is reported, but details such as the sequence-generation method, allocation concealment, and how masking was maintained are not reported in the registry record. The record labels the study double-masked without specifying which roles were masked.

The primary endpoint was the Symptom Burden Score, with assessments planned at baseline, 3 months and 6 months. The registry describes the outcome analysis in three periods corresponding to those visits: period 1 = 1-6 weeks (baseline), period 2 = 6-18 weeks (3 months), and period 3 = >18 weeks (6 months). It also notes that not all participants completed the scale and that their observations did not all align with the three designated periods.

The registry lists a secondary outcome, the PROMIS-29 score, along with 6 outcome measures and 70 analyses. Those counts indicate that multiple outcomes or analyses are recorded, but do not identify which analyses were prespecified or how they were handled statistically. The protocol, sample-size justification, and detailed statistical analysis plan are not reported in the registry record. The available endpoint description does not supply a single arm comparison across the listed assessment periods.

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:

Analysis population for the primary outcome, as defined in the registry: The statistical analysis defined the time points into 3 periods to correlate with the baseline, 3-month, and 6-month visits. Not all participants completed the symptom burden scale and therefore did not align within the 3 designated periods.

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 Symptom Burden Score, measured over Baseline, 3 months and 6 months; period 1 = 1-6 weeks (baseline), period 2 = 6-18 weeks (3 months), period 3 = >18 weeks (6 months).

The primary endpoint, the Symptom Burden Score, is a measure of how much common HIV-related symptoms are experienced and how bothersome they are. The registry describes it as an expanded version of the 20-item HIV symptom index, covering 28 of the most common symptoms in persons living with HIV. Each symptom is scored from 0 to 4: 0 means it was not experienced, while higher values indicate increasing bother, with 4 meaning it bothers the participant a lot. A higher score therefore represents greater symptom burden and a worse outcome on this measure.

The endpoint is relevant to the trial’s stated purpose because the intervention was intended to deliver symptom-management strategies and the investigators hypothesized improvement in symptom frequency and intensity. A patient-reported measure can capture participants’ experience of symptoms and their impact, which may not be represented by clinical measures alone. That general rationale does not establish that the score changed in this study.

The registry identifies the score as a continuous measure analyzed as a mean with standard deviation and lists assessments at baseline, 3 months and 6 months. The statistical analysis grouped time points into three periods, but the record notes that some participants did not complete the scale or did not fit those designated periods. Arm-level means, standard deviations, and a between-arm estimate for the primary endpoint are not reported in the registry record. Without those results, the size and precision of any difference cannot be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, double-masked, parallel-group study. In general, random assignment is intended to make the comparison between groups less vulnerable to systematic differences in participant characteristics. Masking is intended to limit the influence of knowing an assignment on behavior, care, or outcome assessment. These are general purposes of the design labels; the registry record does not describe the allocation procedure or specify who was masked and how masking was maintained.

What does the primary outcome measure?

The Symptom Burden Score is a continuous score based on reported experience of common symptoms. The registry says that the score covers 28 symptoms and that each symptom uses a 0-to-4 scale, where higher scores indicate more burden. Continuous outcomes are often described using a mean and a measure of variability. Here, the specified summary is the mean with standard deviation. A mean gives an average score, while a standard deviation describes how much individual scores vary around that average. The registry record does not report those primary outcome summaries by arm.

How should the assessment periods be understood?

The record lists baseline, 3-month and 6-month assessments and describes periods aligned to those visits: 1-6 weeks for baseline, 6-18 weeks for 3 months, and >18 weeks for 6 months. The record also states that not all participants completed the scale and that observations did not all align with the three designated periods. This means the period labels should not be read as proof that every participant contributed an observation at every visit or period. How observations were assigned when timing did not align, and how incomplete data were handled, are not reported in the registry record.

What would an arm contrast tell a reader?

In general, a between-arm estimate would quantify how the average outcome differed between the app with symptom strategies and the app without them. A confidence interval would describe the range of values compatible with the data under the analysis assumptions and would convey precision. A p-value, if reported, would address the compatibility of the data with a specified null hypothesis under a statistical model; it would not by itself measure clinical importance. None of these primary-outcome comparison results is reported in the registry record, so no such interpretation can be made for this trial from the listed details.

What does variability mean for a continuous score?

General statistical interpretation distinguishes variability among participants from uncertainty about an estimated group mean or contrast. The standard deviation describes the former. A confidence interval for a mean or contrast describes the latter, incorporating sample information and assumptions about the analysis. A score may vary substantially among participants even when its mean is estimated precisely, or the mean may be uncertain when the data are sparse or incomplete. The registry record identifies standard deviation as the dispersion measure but does not report primary endpoint standard deviations or confidence intervals.

Why can incomplete data affect the comparison?

When participants do not complete an outcome measure, the analyzed observations may differ from the set of participants initially assigned to the groups. If missingness is related to symptoms, app use, or other factors, an analysis of observed scores alone may not represent all assigned participants. This is a general concern, not a conclusion that bias occurred in this trial. The registry specifically notes incomplete scale completion and period misalignment but does not report missing-data counts, reasons for missingness, or the method used to address it.

What statistical plan is documented?

The record reports 6 outcome measures and 70 analyses, and lists the primary outcome as a mean with standard deviation. It does not provide the detailed statistical plan, the prespecified primary comparison, model specification, covariate adjustment, or a multiplicity procedure. It also does not report whether interim analyses were planned or conducted. Those features are not reported in the registry record and should not be inferred from the outcome description or analysis count.

A sample-size calculation is useful for planning a future study, but it is not an observed result or a measure of the strength of evidence from a completed trial. The planning assumptions listed in the registry describe a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects expressed as fractions of an observed effect. No sample-size illustration values or primary effect estimate are included in the registry record for this analysis. Such planning assumptions cannot replace an observed between-arm estimate or establish observed power.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 6 outcome measures and 70 analyses. These figures indicate that the record contains multiple outcomes and analyses, but they do not reveal how many were prespecified, which comparisons were considered primary, or whether any statistical adjustment was made for multiple testing. A multiplicity procedure is not reported in the registry record. Without that information, the chance of false-positive findings across a family of tests cannot be evaluated from the analysis count alone.

The primary endpoint is assessed at baseline, 3 months and 6 months, with three analysis periods described. The record does not reduce these time points to one comparison, and it does not report a selected primary time point or a prespecified summary across time. This leaves the intended primary contrast unclear. The fact that the registry describes a hypothesis about symptom improvement does not identify which time-specific or combined analysis was intended to determine that question.

Missingness is explicitly noted: not all participants completed the Symptom Burden Score, and observations did not all align with the designated periods. The number of missing observations, the reasons for missingness, and their distribution across arms and periods are not reported in the registry record. The analysis population, including whether results were based on all randomized participants or only participants with observed scores, is also not reported. No imputation method, sensitivity analysis, or other missing-data approach is reported.

These omissions limit assessment of both bias and precision. They do not show that the analysis was inappropriate; they mean the registry record does not provide the information needed to evaluate those aspects of the analysis.

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 1% reporting threshold.

The safety listing records serious adverse events for the intervention and control arms. In each arm, 50 participants are listed as at risk, zero are listed as affected by a serious adverse event, and deaths are recorded as zero. These are the serious-event counts recorded in the registry, not evidence that every possible event was assessed or that no event went unreported.

A zero count should be read in relation to the population and observation captured by the safety record. It does not establish that the underlying risk is zero, and it does not show that the arms are equivalent in safety. The record does not give further detail about the observation period for these counts, the method of event collection, or the criteria used to classify events. The top serious-event terms list is empty, so no specific serious-event category is identified there.

The listing also records zero in the other-event affected field for each arm, but the registry entries do not describe the event definitions or reporting procedures behind that field. It should not be used to conclude that no non-serious symptoms or other unwanted experiences occurred. These safety counts are separate from the primary Symptom Burden Score, whose arm-level results are not reported. Safety counts alone cannot answer the trial’s primary symptom-burden question.

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

The registry record establishes what the study was designed to compare: an app delivering HIV-related symptom strategies against an app without those strategies, with symptom burden assessed over time. It describes the score’s meaning and its direction, the randomized and double-masked parallel design, the recorded enrollment, and the listed serious-event counts. These registry entries help readers understand the research question and the intended outcome.

The record does not report the primary endpoint scores by arm or a statistical contrast between the arms. It therefore does not show whether average symptom burden differed, in which direction a difference may have gone, how large it may have been, or how precisely it was estimated. No conclusion about statistical significance or clinical importance can be drawn from the listed details. The study hypothesis is not evidence that the hypothesis was confirmed.

Even if an estimated difference were available, its interpretation would depend on the size and precision of that estimate, the score’s clinical meaning, the completeness and timing of outcome collection, and the analysis choices. The registry entries do not provide the information needed to assess these elements. The noted incomplete scale completion and period misalignment make the missing-data and analysis-population details especially relevant, but those details are not reported.

The zero serious adverse event and death counts in the safety listing are descriptive observations. They do not demonstrate the absence of all harms or establish comparative safety. Nor do they answer whether the intervention changed symptom burden.

Accordingly, the most defensible conclusion is limited: the registry record describes a trial intended to test whether HIV-related symptom strategies delivered through an app could improve symptom status, but the posted primary endpoint results needed to evaluate that question are not reported in the registry record. This is a limitation of the available record, not proof that the trial did or did not observe an effect.

13. Why This Trial Matters Statistically

This trial is statistically interesting because its question concerns a patient-reported symptom measure collected at multiple periods. Such outcomes can capture experiences that matter to participants, but they also require clear definitions of the measurement, timing, and analysis. The registry gives useful detail about the Symptom Burden Score, including its symptom coverage, scoring direction, and intended assessment schedule.

The repeated assessment structure makes the choice of comparison important. A result at baseline, 3 months, or 6 months could address a different aspect of the trajectory than a single summary across time. The registry describes three periods but does not report which contrast was designated as the primary one. With 70 analyses listed, clarification of prespecification and multiplicity handling would also help readers distinguish confirmatory analyses from other analyses.

Completeness and timing of outcome data are central to interpreting a longitudinal symptom measure. The registry notes that not all participants completed the scale and that observations did not all align with the designated periods. Transparent reporting of missingness, analysis populations, and methods for handling incomplete observations would help readers judge how well the analyzed data represent the randomized groups.

The study’s randomized, double-masked, parallel design provides a framework for comparing the two app approaches, while the active app comparator focuses the contrast on the symptom-strategy content described in the record. But design features alone cannot establish an effect. The absence of reported primary endpoint results means readers cannot assess the estimate, its uncertainty, or its relevance. Statistically, the record is most useful as a description of the question and measurement, while leaving the outcome comparison unresolved.

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 key trial-specific limitation of the registry record is that the primary Symptom Burden Score results are not reported by arm. No between-arm estimate, confidence interval, or p-value is listed. Consequently, the central comparison cannot be quantified or evaluated for precision. The record’s stated hypothesis cannot substitute for those results.

The endpoint is described at baseline, 3 months and 6 months, but the registry does not identify a single primary time-point contrast or a combined longitudinal estimand. It defines three periods and notes that some completed observations did not align with those periods. The rules used to assign observations to periods are not reported. The record also does not report how many scores were missing, why they were missing, or whether missingness differed between arms.

Details that would support evaluation of the analysis are not reported in the registry record. These include the full statistical plan, the analysis population, any model or covariate adjustments, handling of incomplete observations, and methods for addressing multiple outcomes or analyses. The record lists 6 outcome measures and 70 analyses, but those counts alone do not explain which analyses were planned in advance or how findings were selected for emphasis.

The trial is labeled double-masked, but the record does not specify who was masked or how masking was maintained. It also does not provide details about app engagement, adherence, or implementation that could help explain exposure to the intervention content. These are limits of the information available in the registry record and should not be taken as evidence that those procedures or data were absent from the study itself.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms — NCT03182738.
• Registry record last updated 2019-12-13; status last verified 2019-11.
• Results first posted 2019-12-13.
• 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

VIP-HANA was a completed randomized, double-masked, parallel-group behavioral study sponsored by Columbia University. The registry lists enrollment of 100, a start date of 2016-11-16, and primary completion on 2019-04-03. The intervention was a VIP app delivering HIV-related symptom strategies; the control was a VIP app without those strategies.

The primary endpoint was the Symptom Burden Score, assessed at baseline, 3 months and 6 months. Higher scores indicate greater symptom burden. The registry notes incomplete scale completion and observations that did not all align with the designated periods. Although it lists 6 outcome measures and 70 analyses, it does not report the arm-level primary results, a between-arm estimate, or its precision. The safety listing records zero serious adverse events and zero deaths in each arm, with 50 at risk in each. Detailed analysis, missing-data, and multiplicity methods are not reported in the registry record.