Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV (NCT05314088), a randomized na study. The primary outcome is Experience Sampling Method (ESM) Resilience Resources-Hardiness.

2. Clinical Question

3. Trial Design

This was a randomized, double-masked, parallel behavioral trial sponsored by the University of Alabama at Birmingham. The registry lists the study phase as NA and the status as completed. The recorded start date is 2023-02-03 and the primary completion date is 2025-05-31. Enrollment was 82. The registry describes two groups: RISE+ Resilience Intervention and Stress Reduction Control.

Both groups were assigned to structured activities delivered over four two-hour weekly sessions in small groups. The RISE+ description mentions psychoeducational videos and individual written activities, with topics including coping strategies, cognitive appraisals, and the responsibility model. The control description mentions an attention-matched internet stress reduction paradigm, an internet navigation protocol, and placebo computer games. The registry’s arm descriptions are truncated, so their full content is not reported in the registry record.

Randomization is reported, but the method used to generate the allocation sequence, any allocation concealment procedures, and the ratio beyond the reported 41 participants per group are not described. The registry labels masking as double; who was masked and how masking was implemented are not reported in the registry record. The parallel model indicates that the groups were followed as separate arms rather than described as a crossover comparison. Further details about the timing and conduct of follow-up, beyond the listed outcome timeframes, are not reported in the registry record.

The registry reports that 82 participants completed baseline and were randomized, while 67 completed the 1 month assessment. The primary outcome description also gives texting completion counts by group and assessment. Those counts indicate that the available texting observations do not include every randomized participant at every assessment. The registry record does not report why participants did not complete assessments, or whether those with missing observations differed from those with observed data.

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: One hundred and six participants were screened as eligible, meaning they met all eligibility criteria and were scheduled for a baseline visit. Of these, 82 completed baseline and were randomized (i.e., they were enrolled). No significant events occurred after enrollment but prior to assignment to a group/randomization.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Although 82 (41 per group) completed baseline and were randomized, only 67 (35 control/32 intervention) completed the 1 month assessment. Only 36 control completed baseline texting, and 34 completed 1 month texting. While 41 in the RISE group completed baseline texting, only 31 completed 1 month texting. Furthermore, for resilience resources, participants had to have at least one text messaging instance with a stressor, which explains the analyzed sample sizes.

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 Experience Sampling Method (ESM) Resilience Resources-Hardiness, measured over immediately following the 4 week intervention.

The primary outcome is Experience Sampling Method (ESM) Resilience Resources-Hardiness, expressed in units on a scale and summarized as a mean with standard error. Participants received text messages twice daily. They were asked whether they had experienced a stressor and, if so, to rate their use of seven resilience resources on a 5 pt Likert scale. The listed resources are hardiness, optimism, self-efficacy, locus of control, positive reframing, proactive coping, and social support. Scores are described as average scores for each resource; higher scores indicate greater levels of the resource, and the scale ranges from 1-5.

The outcome description specifies daily texting at baseline for 10 days and after the intervention for 10 days. The primary outcome timeframe is immediately following the 4 week intervention. Repeated, brief reports are intended to capture participants’ accounts of resource use in relation to stressors in daily life, rather than relying only on a single general retrospective assessment. That is a general rationale for experience-sampling measures, not a reported finding from this trial.

The outcome title singles out hardiness, while the description discusses seven resilience resources. The registry record does not explain whether hardiness alone is the primary endpoint for the reported comparison, how repeated reports were combined for analysis, or how a group-level change was defined. Most importantly, no primary outcome estimates or group comparison are reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a randomized, double-masked, parallel study and describes a continuous primary measure summarized as a mean with standard error. It does not report the statistical model or test used for the primary comparison. The following concepts are general explanations of the methods that might be relevant to a continuous repeated measure; they are not claims about analyses conducted in this trial.

What does a mean describe?

General: A mean is a measure of the central level of observed scores. For a scale where higher values represent greater levels of a resource, a group mean would describe the average reported level among the observations included in that calculation. A mean by itself does not show how scores are distributed, whether individuals changed, or whether groups differ beyond sampling variation. The registry identifies a mean as the summary parameter, but does not report group means for the primary outcome.

What does the standard error describe?

General: A standard error describes the uncertainty in an estimated quantity, such as a sample mean, under a statistical model. It is not the same as the spread of individual participant scores. A confidence interval combines an estimate with its uncertainty to give a range of values compatible with the data and the chosen method. No standard errors or confidence intervals for the primary comparison are reported in the registry record, so precision cannot be assessed from the posted results.

Why does the analysis need to respect repeated observations?

General: Repeated reports from the same participant are usually related to one another. Treating every report as if it came from a different, unrelated person can understate uncertainty. Statistical approaches for repeated observations account for the dependence among reports while estimating patterns across people and time. The registry describes twice-daily messages and assessments at baseline and after the intervention, but does not report how repeated reports were combined, what model was used, or whether the primary analysis used participant-level summaries or individual messages.

What would a group comparison need to specify?

General: A clear group comparison states the outcome being compared, the time point or change being estimated, the groups included, and the statistical method used to quantify uncertainty. If baseline and follow-up measurements are both available, an analysis might compare follow-up scores while accounting for baseline, or compare changes over time. These are examples of possible approaches, not descriptions of this trial’s analysis. The registry does not specify which contrast was intended or report a model, covariates, or effect estimate.

How should a confidence interval be read?

General: A confidence interval expresses the statistical uncertainty around an estimate according to a specified method. A narrower interval indicates greater precision than a wider interval, while the values inside the interval indicate which effect sizes remain compatible with the analysis. A confidence interval should be interpreted alongside the estimate and the outcome’s meaning. Since no primary estimate or interval is posted, the magnitude and precision of the comparison are unknown.

What does a p-value answer?

General: A p-value evaluates how compatible the observed data are with a specified null hypothesis, under the assumptions of the test. It does not measure the size or practical importance of an effect, and it is not the probability that the null hypothesis is true. A p-value must be linked to a stated test and outcome. The registry reports zero analyses and gives no primary-outcome p-value, so there is no posted significance test to interpret.

Why might over-dispersion matter?

General: Over-dispersion occurs when observed variability is greater than a statistical model assumes. If a model understates variability, uncertainty estimates can be too small and tests can appear more decisive than warranted. Models for repeated or clustered data may need to account for extra variation as well as dependence among observations. The registry does not report an analysis model or a check for over-dispersion; it is therefore not possible to say whether this issue applied or how it was addressed.

What is the status of the planning illustrations?

The stated sample-size assumptions describe a planning illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation. The illustration is explicitly not the trial’s own design calculation. Such planning values describe the number of participants per arm for a chosen power under the stated assumptions; they are not observed power and do not establish what the trial was capable of detecting. The registry does not report the trial’s own sample-size justification or the underlying primary effect estimate needed to interpret the illustration as a study-specific design rationale.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists seven outcome measures and names several secondary measures, while the primary outcome description covers resilience resources and identifies hardiness in its title. Multiple outcomes and repeated assessments can create a multiplicity issue: when many hypotheses are tested, the chance of at least one apparently unusual result can increase. General approaches include defining a primary hypothesis in advance, controlling error rates across tests, or treating secondary analyses as exploratory. The registry does not report a multiplicity strategy, a hierarchy of hypotheses, or adjustments to significance levels.

The posted registry information reports zero analyses and does not reduce the primary outcome’s several categories or time points to one comparison. As a result, there is no test-level information with which to assess how multiplicity was handled. The record does not report whether the seven registered measures correspond to separate analyses, how outcomes were prioritized, or whether any analyses were prespecified in a protocol or statistical analysis plan.

Missing-data methods are also not reported in the registry record. The record states that 82 participants completed baseline and were randomized, and that 67 completed the 1 month assessment. It gives separate texting completion counts by group, but does not explain why observations were unavailable, whether participants withdrew, or how missing values were addressed. It does not report whether all randomized participants were included in the analysis, whether an intention-to-treat population was used, or whether a per-protocol analysis was conducted.

General: Missing observations can affect both the amount of information available and the validity of a comparison, depending on why they are missing and how the analysis handles them. Completion counts alone do not establish that missingness is harmless or biased. Without the planned analysis population, missing-data assumptions, and methods, the sensitivity of any result to incomplete follow-up cannot be judged.

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’s adverse-event record lists the RISE+ group and Stress Reduction Control group separately. For each group, 41 participants are listed as at risk for serious adverse events and 41 for other adverse events. The recorded counts are zero serious adverse events, zero other adverse events, and zero deaths in each group. No top serious-event terms are listed.

These entries should be read as registry-reported counts, not as proof that no health events occurred. The record does not report additional detail about event definitions, how events were collected, the observation period for the adverse-event summaries, or whether events were assessed for relation to the intervention. The absence of listed serious-event terms means that none are listed in this record; it does not explain how the categories were defined or captured.

Zero recorded events also do not provide a precise estimate of the underlying event risk. General: When event counts are sparse, uncertainty about the rate can remain substantial even when no events are recorded. The registry’s safety entries are distinct from the primary resilience outcome and do not provide information about the effect of RISE+ on hardiness. They should be considered within the limits of the event reporting available in the registry record.

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

The trial record identifies a randomized comparison of RISE+ with a Stress Reduction Control among people aging with HIV. It describes an experience-sampling measure of resilience resources, including hardiness, collected through text messages at baseline and after the intervention. It also documents that not all randomized participants completed the 1 month assessment or every texting assessment. These details help define the intended research question and the available follow-up, but they are not outcome findings.

The record does not report a group-specific primary outcome mean, an estimated difference, a confidence interval, or a p-value. The registry labels the primary outcome as having several categories or time points and lists zero analyses. Therefore, the posted information does not establish whether resilience resource scores differed between the intervention and control groups, how large any difference was, or how precisely it was estimated. A completed trial status is not a substitute for a reported result.

The same caution applies to the secondary outcomes named in the registry, including physical health-related quality of life, depressive symptoms, medication adherence, treatment adherence self-efficacy, and viral load. Their inclusion as registered outcomes does not reveal the observed data or the results of comparisons. Those results are not reported in the registry record.

The trial’s design may be informative for studying a structured resilience intervention and daily reports of responses to stressors. However, the record does not provide enough statistical information to assess the intervention’s effect, the analysis assumptions, or the robustness of any findings. No clinical recommendation follows from the registry information alone. The defensible conclusion is limited: the registry describes a randomized trial and its intended outcomes, while the primary and secondary statistical results needed to interpret comparative effects are not reported.

13. Why This Trial Matters Statistically

This trial raises statistical questions that are important when behavioral interventions are evaluated with repeated, participant-reported measures. The primary outcome uses text messages to collect reports about stressors and resilience resources in daily life. Such a measure can capture context-specific experiences, but it also creates analytic decisions about how reports are summarized, how within-person dependence is handled, and how time points are compared. The registry describes the collection approach but does not report those analysis choices.

The participant counts also make follow-up and missingness relevant to interpretation. The registry reports 82 participants randomized after completing baseline, 67 completing the 1 month assessment, and different completion counts for baseline and follow-up texting by group. Those counts show why an analysis needs to state which participants and observations contributed to each estimate. Without the analysis population and missing-data methods, readers cannot judge how incomplete follow-up may affect a group comparison.

The record names several secondary outcomes in addition to the primary resilience measure and counts seven outcome measures overall. A prespecified hierarchy and multiplicity strategy can help distinguish a primary confirmatory question from secondary or exploratory questions. Such details are not reported in the registry record. The lack of posted analyses means the concern is not whether a reported p-value survives adjustment, but that there is no reported statistical result to evaluate.

Finally, the record distinguishes the registered intervention and control activities, but its arm descriptions are incomplete. Complete descriptions of intervention delivery, masking, and analysis would support evaluation of reproducibility and potential sources of bias. The main statistical importance of this record is therefore the gap between a clearly identified randomized study and the absence of posted comparative results needed to assess its primary question.

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 statistical interpretation is that the registry does not report a numerical result for the primary outcome. It gives no group means, effect estimate, measure of uncertainty, or test result. It also records zero analyses and indicates that the primary outcome has several categories or time points rather than one reported comparison. The direction, magnitude, and precision of the primary contrast cannot be assessed.

Assessment completion was incomplete. The registry reports 82 participants completing baseline and being randomized, 67 completing the 1 month assessment, and separate texting counts that vary between groups and time points. The reasons for missing assessments and the methods used to handle missing data are not reported in the registry record. Without those details, the potential effect of incomplete follow-up on any estimate cannot be evaluated.

The registry does not describe the statistical model, analysis population, handling of repeated reports, adjustment for baseline values, or approach to multiple outcomes and time points. It also does not report a sample-size justification for the trial itself. The listed planning assumptions are described as an illustration based on an observed effect, not as the trial’s own design calculation; no posted primary estimate is available to assess the illustration’s relationship to trial findings.

Some design and intervention details are also incomplete. The arm descriptions are truncated, and the record does not explain who was masked, how masking was implemented, or how randomization was conducted. These omissions limit assessment of reproducibility and potential sources of bias. Results for the secondary outcomes are not reported in the registry information. The safety record supplies event counts, but further detail about event definitions, collection, and observation is not reported.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV — NCT05314088.
• Registry record last updated 2026-09-04; status last verified 2026-07.
• Results first posted 2026-09-04.
• 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

NCT05314088 is a completed, randomized, double-masked, parallel behavioral trial sponsored by the University of Alabama at Birmingham. The registry reports enrollment of 82 and compares RISE+ Resilience Intervention with Stress Reduction Control among people aging with HIV. The primary outcome is ESM Resilience Resources-Hardiness, assessed by text messaging at baseline and after the intervention. The recorded primary completion date is 2025-05-31.

The registry reports that 82 participants completed baseline and were randomized, while 67 completed the 1 month assessment. Texting completion counts are also reported separately by group. However, the registry reports zero analyses and does not provide a numerical primary outcome comparison, statistical uncertainty, or results for the named secondary outcomes. The record therefore describes the study and its assessment procedures but does not permit a quantitative interpretation of comparative effects.