Mobilizing Social Network Resources for HIV Care Support: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Mobilizing Social Network Resources for HIV Care Support (NCT05123274), a randomized na study. The primary outcome is HIV Medical Appointments Kept.

2. Clinical Question

The comparison is framed around attendance at HIV medical appointments, rather than a direct measure of viral suppression, treatment status, or health outcomes. The outcome includes appointments whether scheduled or not, and participants reporting no appointments are counted as having 0 visits. This makes the measure an indicator of recent care engagement that includes people with no reported attendance.

The study was randomized, but the registry record does not report the method used to generate the allocation sequence or whether allocation was concealed. It also does not report a numerical estimate of the difference between the arms, a confidence interval, or a p-value for the primary outcome. The registry’s brief summary describes an investigation of preliminary evidence, but its primary-question text is incomplete. Accordingly, the record does not establish the size or precision of an arm difference in appointment attendance.

3. Trial Design

The registry describes a randomized, parallel-group behavioral study with no masking. Its official title identifies the intervention as being developed and tested for HIV-positive men who have sex with men in St. Petersburg, Russia. The listed condition is HIV infections. The sponsor is the Medical College of Wisconsin, and the phase is recorded as NA.

The comparison was between individual care counseling and individual care counseling plus social support mobilization. Participants were to complete baseline assessments before randomization. The counseling-only arm received an individual session focused on HIV medical care. The added social support mobilization program included five main sessions and two booster sessions. Its stated aims included promoting resilience and developing or mobilizing care-supportive social resources. The registry also describes assessments at baseline and at 6 and 12 months after the intervention, as well as in-depth follow-up interviews with a subset of 20 participants.

The registry lists enrollment of 94. The brief summary describes plans to recruit 100 participants; that planned recruitment figure is not the same as the enrollment figure recorded in the trial entry. The study status is completed. The listed start date is 2021-01-15, and the primary completion date is 2024-10-31.

Randomization supports a comparison of assigned groups, but it does not by itself establish that follow-up was complete or that outcome measurements were free from bias. Because masking is listed as none, participants and study personnel were not masked according to the registry entry. Whether outcome assessors were masked, how allocation was implemented, and how the analysis handled departures from assigned intervention are not reported in the registry record. Those details matter when judging the strength of causal interpretations.

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: The actual number of enrolled participants was 94, slightly fewer than the originally-proposed number of 100 due to a limited recruitment period that resulted from site relocation (see Limitations and Caveats). Of these 94, half of participants (47) were randomized into one of the two conditions. The other half of enrolled participants (47) were impossible to locate prior to randomization, primarily due to their social circumstances (homelessness and lack of communication means such as phones).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: There were 5 participants lost to follow-up. At the 6-month follow-up assessment 20 participants remained in the Individual Care Counseling Arm of the study, and 22 participants remained in the Social Support Mobilization Arm (see Participant Flow).

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 Medical Appointments Kept, measured over 6 months.

The primary endpoint is the self-reported number of HIV medical care appointments attended during the previous 6 months. Its unit is number of visits in past 6 months, and the registry describes it as a mean with standard error. The assessment counts appointments whether they were scheduled or not. A participant who did not schedule or attend any appointment is included as 0 appointments.

This measure is used as an indicator of engagement with HIV medical care. Counting zero visits as zero preserves information about participants who report no attendance, rather than restricting the outcome to people who had appointments. A mean can describe the average number of visits in an arm, while a comparison of arm means can estimate how average attendance differs between the assigned groups. The standard error describes the precision of an estimated mean; it is not a measure of the spread of individual participants’ visit counts.

The endpoint is based on self-report, and the registry record does not report a validation method or a numerical result. It measures appointment attendance over a recent period, not whether the appointments led to a change in treatment, viral suppression, or another health outcome. Those outcomes should not be inferred from attendance alone. Although assessments were planned at 6 and 12 months, the registry record does not provide numerical primary-outcome results at either assessment or a numerical comparison between arms.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The study is listed as randomized and parallel. In a randomized study, participants are assigned to intervention groups using a chance-based process. The purpose is to reduce systematic differences between groups at the point of assignment, so that an outcome contrast can be interpreted in relation to the assigned interventions. Randomization does not guarantee that every characteristic is balanced, and it does not prevent bias arising after assignment. The registry record does not report the sequence-generation method or allocation concealment, so those implementation details cannot be assessed.

What does a parallel-group comparison estimate?

In a parallel-group design, participants are assigned to an arm and the groups are compared over follow-up. Here, the arms were individual care counseling and individual care counseling plus social support mobilization. A comparison of their mean appointment counts would describe the average difference in reported visits over the specified period. The record does not report the numerical means or the estimated arm contrast, so the comparison cannot be quantified from the registry entry.

Because masking is listed as none, participants and study personnel were not masked according to the entry. For a self-reported outcome, awareness of assigned intervention could potentially influence reporting or recall; this is a general consideration, not evidence that such influence occurred in this study. Whether outcome assessors were masked is not reported. The endpoint’s self-reported nature also means that its interpretation depends on what participants recall and how they understand the appointment question.

What do the mean and standard error describe?

The endpoint is summarized as a mean with standard error. A mean is an average of the measured visit counts in an analysis group. A standard error describes the uncertainty in estimating that group mean from the observed participants. It is not the same as the standard deviation, which describes variation among individual observations. Standard errors can help convey the precision of means and contrasts, but they do not replace a clearly reported between-arm estimate and confidence interval. The registry record does not provide the numerical means or standard errors for this endpoint.

The outcome is a count of visits, but it is characterized in the record as a continuous measure. Counts can have distributions that are uneven or concentrated at zero. In general, a model for a count outcome may need to account for features such as skewness or over-dispersion, where variability exceeds what a simpler model assumes. This is a general methodological consideration only. The registry record does not report the model or test used for the primary outcome, so it is not possible to determine whether or how these properties were addressed.

How should confidence intervals and p-values be read?

In general, a confidence interval expresses the precision of an estimated effect under the assumptions of the statistical method. A p-value measures how incompatible the observed data are with a specified null model, subject to the analysis assumptions. Neither quantity gives the probability that an intervention works, and neither conveys the practical importance of an effect on its own. The registry record does not report a confidence interval or p-value for the primary endpoint, so neither statistical significance nor the range of plausible effect sizes can be assessed from the entry.

The record lists two outcome measures and two analyses. It does not report a statistical analysis plan, the model specification, covariate adjustment, a test-selection rationale, or whether analyses were prespecified. The primary outcome description also indicates that it has several categories or time points and is not reduced to one comparison. The approach to selecting or combining time points and the handling of multiplicity are not reported. Multiple comparisons can increase the chance of finding an apparently notable result by chance when results are considered together; whether and how this was addressed in the trial is unknown.

What do the planning illustrations mean?

The sample-size illustrations are described as planning calculations based on the observed effect, not as the trial’s own design calculations. Their stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. Such calculations illustrate the number of participants per arm that would be needed under the stated assumptions to detect a target effect at a specified power. They are not observed power, do not show the probability that the trial’s result is true, and do not replace the trial’s outcome estimate. The record does not report the trial’s own sample-size justification or planning assumptions.

In general, planning calculations based on an observed effect should be interpreted cautiously because an effect estimated in a study can be imprecise. A smaller assumed target effect generally requires a larger study to detect under otherwise unchanged assumptions. This general relationship does not establish what effect the intervention produced in this trial. Numerical planning estimates are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures and two analyses. It describes the primary outcome as having several categories or time points, without reducing it to one comparison. Assessments were planned at baseline and at 6 and 12 months after the intervention. The registry record does not report which outcome and time-point comparisons were designated for formal testing, whether any multiplicity adjustment was used, or how the results across outcomes and time points were interpreted together. Without that information and the numerical results, the risk of selectively emphasizing a result cannot be evaluated.

The record reports 5 participants lost to follow-up. At the 6-month assessment, 20 participants remained in the Individual Care Counseling Arm and 22 remained in the Social Support Mobilization Arm. These figures describe follow-up status at that assessment; they do not establish which participants contributed to a particular analysis. The record does not report the amount or pattern of missing outcome data by arm beyond these statements, the reasons for loss to follow-up, or the analysis methods used for missing values.

It is also not reported whether the primary analysis included all randomized participants according to assigned arm, used only participants with observed outcomes, or applied imputation or another missing-data method. These choices can affect the estimate and its uncertainty, particularly if missingness is related to care attendance or intervention experience. No assumptions about the missing outcomes can be checked without the analysis description. The registry record also does not report whether baseline outcome values or other participant characteristics were included in the model. Therefore, the analysis population, missing-data handling, and multiplicity strategy remain unclear.

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 figures list 24 participants at risk in the Individual Care Counseling group and 23 in the Social Support Mobilization group. The serious adverse event count is 0 affected in each group. The count for other adverse events is also 0 affected in each group, and deaths are recorded as 0 in each group. No serious adverse event terms are listed.

These are counts recorded in the registry, not evidence that no events of any kind occurred outside the captured reporting categories or observation period. The registry record does not provide a detailed description of event collection, the time window for safety reporting, or the relationship of any event to an intervention. The at-risk counts are not the same as the 6-month follow-up counts reported for the primary outcome; the record does not explain that difference. These safety entries should therefore be read as the specific reported counts, not as a complete measure of safety or as a comparison establishing that the arms had equivalent safety outcomes.

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

The record describes a randomized study of individual care counseling with or without added social support mobilization, and identifies self-reported HIV medical appointment attendance as the primary outcome. It also records enrollment of 94 and reports follow-up counts for the 6-month assessment. These details clarify the intervention comparison and the endpoint, but they do not establish the outcome result.

Most importantly, the registry record does not report numerical arm results for appointment attendance, a between-arm estimate, a confidence interval, or a p-value. It is therefore not possible to state from the record whether reported attendance was higher in either arm, how large any difference was, or how precise an estimate might be. The intervention’s stated aims and the study’s randomized design do not substitute for the missing results.

Even if an attendance difference were reported, its meaning would be limited to the measured outcome and follow-up period unless additional evidence connected it to other outcomes. Appointment counts do not directly measure viral suppression, treatment adherence, or health status. They are self-reported and cover the prior 6 months, so they also do not describe every aspect of care engagement. The registry does not report a validation method for the self-reported count.

The reported loss to follow-up and remaining participants at 6 months make the handling of missing outcomes important. Because the analysis population and missing-data methods are not reported, the completeness and robustness of an outcome comparison cannot be judged. The absence of reported numerical results should not be interpreted as evidence of no difference, just as the study’s objective should not be interpreted as evidence of benefit. The defensible conclusion is that the registry record describes the trial and its primary endpoint, but does not contain enough numerical outcome information to determine the observed effect.

13. Why This Trial Matters Statistically

This study raises a useful statistical question about an intervention aimed at care engagement: how should a trial measure and compare a behavior that may include participants reporting no visits? Defining appointment attendance to include zero visits makes the outcome relevant to the full range of reported engagement rather than only to people who had scheduled appointments. Interpreting the resulting mean still requires attention to the distribution of visit counts and to the way missing assessments are handled.

The randomized parallel design provides a structure for comparing assigned groups, while the unmasked design and self-reported outcome identify considerations for interpreting that comparison. Randomization can reduce systematic baseline differences on average, but it cannot resolve reporting differences, incomplete follow-up, or uncertainty about the analysis population. Those issues need to be addressed through transparent reporting of estimates, uncertainty, and analysis methods.

The registry record also illustrates why an endpoint description and a completed study status are not equivalent to a numerical result. The entry identifies the primary measure and reports some follow-up information, but does not report the arm estimates or their uncertainty. Without those results, readers cannot evaluate the magnitude or precision of the comparison. Clear reporting of outcome estimates, missing-data methods, and how multiple time points and outcomes were handled is necessary for statistical interpretation.

The sample-size illustrations are also distinct from the original trial design. They are planning calculations based on an observed effect under stated assumptions and should not be mistaken for observed power or for evidence that the study was adequately sized for every outcome. Their interpretation depends on the assumed target effect and statistical model, while the registry does not report the trial’s own sample-size justification. These distinctions matter when using a completed trial to inform future study planning.

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 registry record does not report numerical results for the primary endpoint. Without arm-specific means, a between-arm estimate, or measures of uncertainty, the effect and its precision cannot be evaluated. The analysis model, test, covariate adjustment, and whether analysis followed randomized assignment are also not reported.

The primary outcome is self-reported appointment attendance over the prior 6 months. The record does not describe validation of these reports or procedures for reducing recall or reporting error. Because the study is listed as unmasked, awareness of assignment is a consideration for a self-reported endpoint, although the record does not establish that it caused bias. Whether outcome assessors were masked is not reported.

Follow-up information is incomplete for evaluating missing-data effects. The record reports 5 participants lost to follow-up and gives the numbers remaining in each arm at the 6-month assessment, but does not describe reasons for loss, missingness patterns, or methods for handling missing outcomes. The analysis population is not stated. The record also does not explain the relationship between the safety at-risk counts and the follow-up counts for the primary endpoint.

There were planned assessments at 6 and 12 months, and the record lists two outcome measures and two analyses. It does not describe the prespecified testing strategy or any adjustment for multiple outcomes or time points. The registry’s primary outcome entry is not reduced to one comparison, limiting clarity about which comparison should be treated as definitive. These reporting gaps prevent a full appraisal of the result, even though the study status is completed.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Mobilizing Social Network Resources for HIV Care Support — NCT05123274.
• Registry record last updated 2026-08-20; status last verified 2026-04.
• Results first posted 2026-08-20.
• 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 identifies a completed randomized, parallel, unmasked behavioral study of individual care counseling alone versus counseling plus social support mobilization for HIV-positive men who have sex with men in St. Petersburg, Russia. The registry lists enrollment of 94; its brief summary describes plans to recruit 100. Assessments were planned at baseline and at 6 and 12 months after the intervention.

The primary outcome is the self-reported number of HIV medical appointments attended in the previous 6 months, including zero appointments. The record reports 5 participants lost to follow-up and gives 6-month follow-up counts of 20 in the counseling arm and 22 in the social support mobilization arm. It also records zero serious adverse events, zero other adverse events, and zero deaths in each group listed.

Numerical primary-outcome results, an arm comparison, and statistical uncertainty are not reported in the registry record. Details of the primary analysis, missing-data methods, and multiplicity handling are also not reported.