mVIP (Use of mHealth Technology for Supporting Symptom Management in Underserved Persons Living With HIV): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for mVIP (Use of mHealth Technology for Supporting Symptom Management in Underserved Persons Living With HIV) (NCT02897141), a randomized na study. The primary outcome is Change in Symptom Status From Baseline to Week 12.

2. Clinical Question

3. Trial Design

The registry record describes a randomized, double-masked, parallel-group study. Enrollment is listed as 80. The study is marked completed, with a start date of 2016-12-12 and a primary completion date of 2017-06-08. Its phase is listed as NA. Columbia University is named as the sponsor.

Participants were assigned to the mVIP group or the Attention Control Group. The intervention was a Health Management App that delivered symptom strategies based on symptoms participants reported. The control group used an app without symptom strategies, pre-loaded on their smartphones. The record does not explain how randomization was generated or concealed, who was masked, or whether masking was maintained throughout follow-up.

The primary outcome is described at baseline and 12 weeks. The record also lists secondary outcomes concerning quality of life measured with RAND-36, PROMIS-29, engagement with a healthcare provider, medication adherence, and usability measured with Health-ITUES. Their numerical results and analysis details are not reported in the registry record in the registry record for this account.

Although the primary outcome is described as a comparison of change between groups, the registry record indicates that the primary result has several categories or time points and is not reduced to one comparison. Thus, there is no single primary estimate to interpret alongside an uncertainty interval or significance test. The record also does not report protocol details such as planned follow-up procedures, sample-size justification, or a statistical analysis plan.

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

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 Change in Symptom Status From Baseline to Week 12, measured over Baseline and 12 weeks.

The primary endpoint is change in symptom status from baseline to week 12. The measure is based on the Revised Sign and Symptom Check-List for HIV (SSC-HIVrev). Participants reporting any of the 13 symptoms in the past 7 days were asked how much each symptom bothered them: a little bit, somewhat, quite a bit, or very much.

The registry description says symptom instances that did not bother a participant were coded as 0, while instances that bothered the participant by any amount were recoded as 1. It defines the primary comparison as the difference between groups in the change from baseline to follow-up, or a difference of differences. The stated range is -1 to 1. Lower numbers indicate that symptoms bothered a person less; higher numbers indicate that they bothered a person more. For the between-group difference, the record defines a more negative score, closer to -1, as a better outcome.

This type of outcome is intended to capture change in reported symptom burden, rather than a laboratory measure. The registry record does not provide the actual group means, standard errors, or a single primary comparison estimate. Consequently, the direction and precision of the observed primary result cannot be assessed from the reported information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies the primary measure as a continuous outcome summarized by a mean, with standard error listed as the dispersion measure. It describes a difference of differences: the change in symptom status between baseline and follow-up is compared between the intervention and control groups. The intended follow-up is at 12 weeks. Yet the primary result is explicitly not reduced to one comparison because it has several categories or time points. The record therefore does not provide a single estimate that can be interpreted as the trial’s overall primary contrast.

What does a difference of differences represent?

In general, a difference of differences contrasts change over time in one group with change over time in another. It is not simply a comparison of the groups at follow-up, nor is it only a comparison of their baseline values. It describes whether the amount of change differs between groups. In this trial, the outcome description assigns a specific direction: a more negative between-group score, closer to -1, represents a better outcome. That definition explains the scale, but without the reported estimate it does not reveal which direction the observed result took.

The score is based on whether reported symptoms bothered participants. The record says a symptom that did not bother the participant was coded as 0, while a symptom that bothered them any amount was recoded as 1. The report describes asking how much symptoms bothered participants, but does not explain in the available record how those responses were combined into the summary score, how multiple symptoms contributed to it, or how missing symptom responses were handled. These details matter for understanding the exact construction and interpretation of a mean score.

What does a standard error tell readers?

In general, a standard error describes the statistical uncertainty around an estimated quantity, such as a mean. It is not the same as the spread of individual participant scores. A smaller standard error generally indicates a more precise estimate, while a larger one indicates greater uncertainty. The registry lists standard error as the outcome’s dispersion measure, but does not report the actual standard errors or a confidence interval for a single primary comparison. Accordingly, the precision of the estimated group changes cannot be assessed from this record.

In general, confidence intervals can help readers assess both precision and the range of effects compatible with the data under the analysis assumptions. A point estimate without an uncertainty interval can give an incomplete account of the evidence; in this case, neither a single point estimate nor an interval is reported. A p-value, if reported, would address compatibility with a specified null hypothesis under a statistical model, not the size or practical importance of an effect. No single primary p-value is available to interpret.

Why can multiple outcome categories matter?

When an outcome is reported across several categories or time points, there may be more than one estimate and more than one statistical test. In general, evaluating multiple tests can increase the chance of finding an apparently notable result by chance, so a prespecified analysis approach can matter. The registry record does not report a statistical plan explaining how the categories or time points were to be combined, prioritized, or interpreted. It also does not state whether any adjustment for multiple comparisons was planned or used.

Over-dispersion is a general concern when observed variability exceeds what a chosen statistical model expects. Its importance depends on the outcome type and model. The primary measure is described as a continuous mean outcome, but the record does not identify the analysis model or report diagnostics. It is therefore not possible to determine whether over-dispersion was relevant or how variability was handled. General methodological considerations should not be mistaken for procedures documented for this trial.

How should the planning framework be understood?

The record describes a sample-size planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect, and that non-time-to-event calculations are expressed as participants per arm for 80% power or other listed planning targets. These are planning assumptions, not observed trial outcomes or observed power. The registry entries do not include a numerical observed effect, a specific fraction, or a planning result to interpret. The registry record does not report the trial’s own sample-size justification.

In general, a sample-size calculation estimates the number of participants needed under stated assumptions to detect a specified effect with a chosen error rate and power. Changing the assumed effect changes the resulting planning requirement. Such calculations depend on assumptions about the outcome, variability, allocation, and analysis. They do not establish that a trial had a particular probability of detecting its actual effect after data collection. In this case, the stated planning framework cannot fill the gap left by the absence of a single reported primary estimate and its uncertainty.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists several secondary outcomes in addition to the primary symptom-status outcome. It also indicates that the primary outcome has several categories or time points and was not reduced to one comparison. These features raise general questions about how outcomes and tests were prioritized, but the available record does not describe a multiplicity strategy, such as a hierarchy of tests or an adjustment for multiple comparisons. Whether any such procedure was specified or used is not reported in the registry record.

The record does not report a statistical analysis plan, the analysis population, or details about exclusions after randomization. It does not state whether analyses followed assigned groups, whether participants were analyzed only when outcome data were available, or how protocol deviations were treated. These omissions limit assessment of how the randomized comparison was carried through to analysis.

Missing data methods are also not reported in the registry record. There is no information about the amount or pattern of missing primary outcome data, reasons for missingness, imputation, or sensitivity analyses. In general, missing outcomes can affect interpretation when the likelihood of being observed is related to participants’ outcomes or group assignment; methods and assumptions should therefore be made clear. That general concern does not establish that missing data occurred in this trial.

The registry lists baseline and 12 weeks as the primary outcome timeframe but does not describe the timing of all measurements, rules for selecting among repeated measurements, or the handling of incomplete follow-up. Without these details and the outcome estimates, readers cannot assess whether the reported analysis matches a prespecified plan or how robust it is to analytic choices.

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 record lists no serious adverse events, no other adverse events, and no deaths in the mVIP group or the Attention Control Group. For each group, the listed risk sets are 40 for serious events and 40 for other events. These are the safety counts recorded for the groups; they are not the primary symptom outcome.

A zero count means that the registry reports no events of that category for the listed group and risk set. It does not establish that no event could occur, and it does not describe the precision of an event-rate estimate. In general, rare events can be difficult to characterize in a study, and a count alone does not show the completeness of event ascertainment or the duration of monitoring.

The registry record does not report detailed definitions, collection procedures, severity grading beyond the serious/other categories, or the timing of safety surveillance. It also does not provide additional narrative descriptions of events. The zero counts should therefore be read as the recorded figures, not as a complete account of all possible safety considerations or as evidence about the primary endpoint.

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

The registry record describes a randomized comparison of a symptom-strategy app with an app without symptom strategies. Its primary question concerns whether symptom status changed differently between groups from baseline to 12 weeks. The scoring description gives readers a direction for interpreting a between-group difference: a more negative value, closer to -1, is defined as a better outcome.

However, the record does not report a single numerical primary comparison. It says the primary outcome has several categories or time points and is not reduced to one comparison. No primary estimate, confidence interval, or single primary p-value is reported in the registry record for this account. Therefore, the trial’s observed direction, magnitude, and precision cannot be determined from this information.

This absence should not be interpreted as a finding of no difference, nor does it show that the intervention improved symptom status. The registry record establishes what was studied and how the primary measure was described, but the available information does not support a numerical conclusion about the primary result. The listed secondary outcomes likewise cannot be used to infer a primary result because their estimates are not reported.

The safety record lists zero serious adverse events, zero other adverse events, and zero deaths in each group. Those recorded counts do not establish the effect on symptoms or answer the primary comparison. More generally, an outcome estimate is most informative when accompanied by an uncertainty measure and enough analysis detail to understand how it was derived. Those elements are not reported for a single primary comparison in the registry record.

13. Why This Trial Matters Statistically

This trial is statistically informative as an example of why an outcome definition and an outcome result are different things. The registry record gives a detailed description of symptom scoring, its intended comparison across groups and time, and the direction assigned to a more negative score. Those details clarify what a reported estimate would mean. But the record does not provide a single reduced estimate for the primary comparison, so the clinical question cannot be answered numerically from the information available.

The design is randomized and parallel-group, with an app-based intervention compared with an attention control app. The comparison is relevant to statistical interpretation because the primary outcome is framed as a difference in change, not merely as an endpoint score in one group. To evaluate that contrast, readers would need the group-level results and an uncertainty measure, along with enough information about the analysis to understand how the estimates were produced.

The registry also illustrates the importance of documenting multiplicity, missing-data handling, and analysis populations when outcomes include multiple categories or time points. These are general methodological concerns; the record does not say how they were addressed. The listing of secondary outcomes broadens the scope of the study, but without their numerical results it does not establish whether findings were consistent across measures.

Finally, the planning framework is distinct from evidence about observed effects. Planning assumptions can describe how sample-size illustrations are generated, but they cannot stand in for a reported trial result. The main statistical lesson is that transparent outcome definitions, estimates, uncertainty, and analysis details are all needed for a complete interpretation.

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 principal limitation for interpreting this trial from the registry record is that the primary outcome is not reduced to one comparison and no numerical primary estimate is reported. The record identifies the measurement scale, scoring direction, and assessment timeframe, but does not provide group means, standard errors, a confidence interval, or a single primary test result. Therefore, neither the observed direction nor the precision of the primary result can be assessed.

The outcome description does not fully explain how symptom responses were combined to create the summary score. It also does not describe missing response handling, the analysis model, or which analysis population was used. These are important details for interpreting a mean-based change comparison, but they are not reported in the registry record.

The record lists secondary outcomes but does not provide their numerical results in the registry entries. It also does not report how multiple categories, time points, or outcomes were prioritized, whether any multiplicity adjustment was used, or whether the analysis followed a prespecified plan. The status of missing outcome data and any sensitivity analyses is not reported.

Design details are limited as well: randomization is recorded, but the method of sequence generation and concealment is not reported. The record identifies the study as double-masked without specifying who was masked or how masking was maintained. It does not report the trial’s own sample-size justification. These limitations describe gaps in the available registry information and do not establish that any particular procedure was absent from study conduct.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: mVIP (Use of mHealth Technology for Supporting Symptom Management in Underserved Persons Living With HIV) — NCT02897141.
• Registry record last updated 2019-03-26; status last verified 2019-03.
• Results first posted 2018-10-10.
• 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 NCT02897141, titled mVIP (Use of mHealth Technology for Supporting Symptom Management in Underserved Persons Living With HIV). Columbia University is listed as sponsor. The study is marked completed, with enrollment of 80, a start date of 2016-12-12, and a primary completion date of 2017-06-08. It is described as randomized, double-masked, and parallel-group; phase is listed as NA.

The mVIP group received a Health Management App with symptom strategies based on symptoms reported by participants. The Attention Control Group used an app without symptom strategies. The primary outcome concerns change in symptom status from baseline to 12 weeks, based on the SSC-HIVrev. The registry record does not report a single reduced primary comparison or its numerical result. Listed secondary outcomes include quality of life, provider engagement, medication adherence, and app usability. The safety record lists zero serious adverse events, zero other adverse events, and zero deaths in each group.