This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for InTSHA: Interactive Transition Support for HIV-infected Adolescents Using Social Media (NCT03624413), a randomized na study. The primary outcome is Acceptability of Intervention Measure Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03624413 |
| Phase | NA |
| Condition | HIV-1-infection, Adolescent Behavior |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 80 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Emory University |
| Results posted | Yes |
2. Clinical Question
Population
Adolescents living with HIV in South Africa are the population described in the study summary. The arm descriptions refer to adolescent HIV-positive participants. The registry record does not report an age range, detailed eligibility criteria, or further characteristics of the participants.
Intervention
The intervention is a social media behavioral program intended to support transition care. The study summary says it is based on the Social-ecological Model of Adolescent and Young Adult Readiness to Transition (SMART). The registry record does not give further detail about the intervention’s content or delivery.
Comparator
The comparator is standard of care. Participants were randomized to receive either the social media intervention or standard of care. The registry record does not describe the components of standard care, so the specific difference between care in the two arms is not reported.
Primary question
The primary endpoint is the Acceptability of Intervention Measure score at Month 6. The measure is intended to capture participants’ acceptability ratings for the InTSHA intervention. The registry record does not report the resulting scores or a comparison between arms, so the primary question’s answer cannot be determined from the posted results.
3. Trial Design
InTSHA is a randomized, parallel-group study sponsored by Emory University. The record lists the allocation as randomized and the model as parallel. It describes two groups: adolescents receiving the social media intervention and adolescents receiving standard of care. Masking is listed as none, meaning the registry does not describe a masked design. The study phase is listed as NA.
The study’s stated goal was to develop and evaluate a social media behavioral intervention to improve transition care for adolescents living with HIV in South Africa. The intervention is described as based on the Social-ecological Model of Adolescent and Young Adult Readiness to Transition (SMART). The record does not report further details about how the program was delivered, the standard-care activities, or the practical procedures used to support transition care.
Enrollment is reported as 80. The registry lists a study start date of 2021-04-15, a primary completion date of 2022-08-04, and a status of completed. These design and registration details do not establish how many participants contributed data to a particular endpoint; endpoint-specific analysis counts are not reported in the registry record.
The primary outcome is acceptability at Month 6. Listed secondary outcomes concern social support, connection to clinic, retention in care, and HIV viral suppression. The record lists 8 outcome measures and 0 analyses. It does not report the statistical analysis plan, the allocation procedure in further detail, or whether interim analyses were planned or conducted.
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
| Stage | InTSHA Social Media Intervention | Standard of Care |
|---|---|---|
| STARTED | 40 | 40 |
| COMPLETED | 40 | 40 |
| NOT COMPLETED | 0 | 0 |
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.
| Characteristic | Unit | InTSHA Social Media Intervention | Standard of Care | Total |
|---|---|---|---|---|
| Participants analysed | 40 | 40 | 80 | |
| Age, Continuous | years | 16.9 (SD 1.2) | 17.0 (SD 1.3) | 16.9 (SD 1.3) |
| Sex: Female, Male: Female | Participants | 19 | 18 | 37 |
| Sex: Female, Male: Male | Participants | 21 | 22 | 43 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: South Africa | participants | 40 | 40 | 80 |
6. Primary Endpoint
The registry lists the primary outcome as Acceptability of Intervention Measure Score, measured over Month 6.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | score on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the Acceptability of Intervention Measure score at Month 6. According to the registry description, the measure uses 4 questions rated on a 5-point scale, with responses ranging from 1, completely disagree, to 5, completely agree. The total score is the average of the item scores and ranges from 1 to 5. Higher scores indicate greater acceptability of the InTSHA intervention.
This endpoint focuses on participants’ assessment of the intervention, rather than directly measuring retention in care, social support, or viral suppression. Acceptability can be useful when evaluating an intervention because it describes whether participants regard the program favorably. As a general statistical point, an acceptability measure answers a different question from an outcome that measures a health state or care process; it should be interpreted according to its stated construct.
The registry record specifies the endpoint, scale, and Month 6 timeframe, but does not report a score, a measure of variability, participant counts contributing to the result, or an arm comparison. Although the planned summary is identified as a median with an inter-quartile range, those endpoint results are not reported in the registry record. Consequently, the posted information does not establish the level of acceptability observed or how precisely it was estimated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study’s design and the type of primary outcome it intended to assess. It does not provide the primary endpoint’s numerical result. There is no posted median or inter-quartile range for the Month 6 Acceptability of Intervention Measure score, and no reported comparison of scores between the social media intervention and standard-of-care groups. The magnitude and precision of any difference therefore cannot be assessed from the registry record.
The record lists 80 participants enrolled and describes two randomized groups. Enrollment is not the same as the number with an observed Month 6 score. The numbers assessed at that time, the numbers included in an analysis, and the handling of any missing endpoint data are not reported in the registry record. Without those details, the extent to which the posted endpoint—if collected—represents the enrolled participants is unknown.
Eight outcome measures are listed, including the primary acceptability measure and secondary outcomes related to social support, connection to clinic, retention in care, and viral suppression. The record lists 0 analyses. It does not provide results for these outcomes, so their direction, size, and uncertainty cannot be described. Nor does the registry record report p-values, confidence intervals, or other inferential results for the primary or secondary outcomes.
The record’s absence of numerical results should not be interpreted as evidence that the groups had identical outcomes or that no changes occurred. It means that the posted information does not support a quantitative conclusion about the outcomes. In general, a confidence interval describes a range of values compatible with the data and an analysis model; no such interval is reported for the primary endpoint. A point estimate alone would also be insufficient to judge precision, and no point estimate is reported.
There are no reported primary endpoint results from which to assess an intervention effect, and there is no reported statistical analysis to take precedence over a recalculation. The registry record describes the study as completed, but completion status does not itself establish that results were posted. The appropriate reading is therefore limited: the planned question and outcome are identifiable, while the outcome evidence and its uncertainty are not reported in the registry record.
9. Statistical Methods Explained
The registry identifies a randomized, parallel-group design and a primary endpoint summarized as a median with an inter-quartile range. It does not report the analyses used to evaluate that endpoint. The explanations below describe general statistical concepts, not methods confirmed to have been used in this trial.
What does randomization contribute?
In general, randomization assigns participants to study groups using a chance-based procedure. Its purpose is to reduce systematic differences between groups at the point of allocation, although randomization does not guarantee that every characteristic will be balanced in a particular trial. It also does not remove the need to report who was analyzed, what outcomes were observed, or how missing data were handled. The registry identifies the study as randomized but does not report the detailed allocation procedure or an analysis plan.
A parallel-group design means that the study is described as comparing groups rather than assigning the same participant to receive each condition in sequence. Here, the two listed groups are the social media intervention and standard of care. The record lists masking as none. It does not report additional details about participant or assessor awareness, or how outcome assessment was conducted.
Why report a median and inter-quartile range?
In general, the median is the middle value when observations are ordered. The inter-quartile range describes the span from the lower quartile to the upper quartile, covering the central half of the observed values. These summaries can be informative when a distribution is skewed or when a small number of extreme values could make the mean less representative. The median and inter-quartile range describe the distribution of observed scores; by themselves, they do not test whether groups differ.
The score is formed by averaging the responses to 4 questions and has a stated range from 1 to 5. A score summary would need to be interpreted in light of that scale and the endpoint’s meaning: higher scores indicate greater acceptability. However, the registry record does not report the median, inter-quartile range, or the number of participants whose scores contributed to either summary. No numerical interpretation of the observed acceptability is possible without those results.
What would a group comparison add?
In general, a group comparison estimates how outcomes differ between the assigned groups and quantifies uncertainty in that estimate. The choice of method depends on features such as the outcome’s distribution, the study design, and the prespecified analysis plan. A confidence interval can express the precision of an estimate, while a p-value addresses compatibility between the data and a specified null model. Neither type of result is reported for this primary endpoint. The statistical plan, including any adjustment or covariate strategy, is not reported in the registry record; no method should be inferred from the design label alone.
How should planning illustrations be understood?
General sample-size planning asks how much information a study might need to detect an effect under stated assumptions. The registry describes a planning illustration based on a fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It also specifies that the illustration is not the trial’s own design calculation. A planning illustration is not an observed result, and it is not observed power. Because the primary endpoint’s observed effect is not reported, these assumptions do not supply evidence about the trial’s outcome or its precision. The registry does not report the study’s own sample-size justification.
The record’s planning description does not substitute for an analysis of the collected data. In general, a design calculation concerns assumptions made before or for planning a study; an analysis uses observed participant data. These answer different questions. The record does not report whether the stated illustration was used in study planning, and it explicitly distinguishes it from the trial’s own design.
What cannot be reconstructed?
The record lists 0 analyses and does not report outcome estimates, confidence intervals, p-values, analysis populations, or endpoint-specific participant counts. It also does not report an interim analysis plan or the approach to missing values. Recalculation from posted summary statistics is not possible when the relevant summaries are absent. In general, a recalculation from summary statistics would be an unadjusted calculation and would not replace a sponsor’s own analysis when a discrepancy exists; the registry contains no such reported comparison to evaluate.
These distinctions matter because a study’s design, its endpoint definition, and its results are separate kinds of information. Randomization describes allocation, the endpoint definition describes what was to be measured, and an analysis describes how observed data were used to answer the question. The registry supplies design and endpoint descriptions but does not report the outcome analysis needed to evaluate the primary question.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 8 outcome measures, including the primary acceptability endpoint and secondary outcomes concerning social support, connection to clinic, retention in care, and viral suppression. When a study assesses multiple outcomes, general statistical practice considers multiplicity: the more comparisons or hypotheses examined, the greater the chance that some results may appear noteworthy by chance alone. Methods for addressing multiplicity depend on the analysis plan and the questions of interest.
The registry record does not report a multiplicity adjustment, a hierarchy for testing outcomes, or a statistical analysis plan. It lists 0 analyses and reports no endpoint estimates or inferential results. It is therefore not possible to determine whether any multiplicity procedure was used, or how outcome-specific results were interpreted.
Missing-data methods also matter because participants may not contribute an observed value at every assessment. The record does not report the number assessed at Month 6, missingness by group, reasons for missing observations, or any method used to handle missing data. Enrollment of 80 does not establish the analysis count for the primary endpoint.
The analysis populations are not reported in the registry record. For example, the record does not say which participants were included in the primary outcome analysis or whether the analysis followed randomized assignment. These omissions prevent assessment of how much information supported the endpoint and whether exclusions or missing data could affect interpretation. They do not establish that data were missing or that a particular analysis population was used; those details are simply not reported.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| InTSHA Social Media Intervention | 0 | 40 | 0.0% |
| Standard of Care | 0 | 40 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| InTSHA Social Media Intervention | 0 of 40 |
| Standard of Care | 0 of 40 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| InTSHA Social Media Intervention | 0 of 40 |
| Standard of Care | 0 of 40 |
For both the InTSHA Social Media Intervention group and the Standard of Care group, the registry lists 40 participants at risk for serious adverse events and 0 affected. It also lists 40 participants at risk in each group for the other adverse-event category and 0 affected. Deaths are listed as 0 in both groups. The record does not list serious adverse-event terms.
These figures describe what is recorded in the registry for the stated groups and risk counts. They do not indicate that the study established the absence of all possible harms. In general, an event count of zero is a count within the recorded observation and reporting process; interpretation also depends on the period of observation, event definitions, completeness of follow-up, and how events were collected. Those details are not reported in the registry record.
The figures should not be read as a comparison proving that risks are the same between groups. The record supplies no statistical safety analysis, uncertainty interval, or further event detail. It also does not report how long participants were followed for adverse-event collection. The safest statistical description is that no affected participants and no deaths are listed in either group in the registry record, with the limitations of the recorded information kept in view.
12. What the Result Does, and Does Not, Mean
The record identifies a completed randomized study of a social media behavioral intervention intended to support transition care for adolescents living with HIV in South Africa. Its primary outcome is an acceptability score at Month 6, based on a questionnaire with a stated scoring range and interpretation. This describes the question the study set out to address, not the result of that assessment.
The registry does not report the primary score, its variability, a between-group estimate, or an inferential analysis. It therefore does not establish the observed acceptability of the intervention, the size or direction of a group difference, or the precision of any such difference. Secondary outcome results are likewise not reported. The absence of posted results cannot be treated as a null result or as proof that the intervention had no effect.
As a general point, an acceptability measure captures participants’ evaluations of an intervention and is distinct from outcomes such as retention in care or viral suppression. Evidence about one of these outcome types would not automatically answer questions about the others. The registry lists several such secondary outcomes, but does not report their values or analyses.
The adverse-event record lists zero affected participants in both groups for the serious and other categories and zero deaths. Those entries describe the registry’s recorded counts; without details about event collection and follow-up, they should not be stretched into a broad claim about safety.
Overall, the posted record supports a description of the design, target population, intervention, comparator, and intended primary endpoint. It does not support a quantitative conclusion about the trial’s primary or secondary outcomes. Readers should distinguish a completed study from a study with results reported in the registry: the former is recorded, while the outcome evidence needed to answer the clinical question is not reported.
13. Why This Trial Matters Statistically
This study raises a practical research question about support during transition care for adolescents living with HIV in South Africa. Its randomized, parallel-group design places a social media behavioral intervention alongside standard of care, while its stated primary endpoint focuses on whether participants find the intervention acceptable. The distinction between an intervention’s acceptability and other outcomes is statistically important: each outcome represents a different aspect of the study question and needs its own measurement and interpretation.
The registry also illustrates why outcome definitions alone are not enough for statistical interpretation. A scale, timeframe, and direction of scoring clarify what investigators intended to measure, but they do not reveal the observed values or their uncertainty. Without posted estimates and analysis details, readers cannot assess whether the measurement was complete, how variable scores were, or how the groups compared.
Listing several secondary outcomes makes transparent that the evaluation extends beyond acceptability to social support, clinic connection, retention, and viral suppression. At the same time, multiple outcomes create methodological questions about analysis plans, missing data, and how results are interpreted together. Those details are not reported in the registry record, so they cannot be evaluated for this study.
The study is recorded as completed and has enrollment of 80, yet the record lists 0 analyses and gives no outcome results. That contrast is a useful reminder that registration details can clarify a trial’s intended design while leaving its empirical findings unavailable. Clear outcome reporting, analysis methods, and participant counts are necessary for readers to assess evidence and its precision. Here, those elements are not reported for the primary outcome.
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 numerical results. The primary endpoint is described in detail, but its Month 6 median and inter-quartile range are not reported. No primary comparison, confidence interval, p-value, or endpoint-specific analysis count is reported. As a result, the central study question cannot be answered quantitatively from the posted information.
The record lists 80 enrolled participants but does not report how many contributed a primary endpoint score, whether follow-up differed between groups, or how missing data were handled. The analysis populations are not reported. These omissions prevent assessment of the amount of information available for the primary endpoint and the potential influence of missing observations.
The registry identifies 8 outcome measures and lists 0 analyses. It does not report a statistical analysis plan, multiplicity approach, interim analyses, or a sample-size justification for the trial’s own design. Although a planning illustration is described, it is explicitly not the trial’s own design calculation and does not replace observed outcome results.
Further context is also limited: the record does not report detailed eligibility criteria, participant characteristics, the content of standard care, or the intervention’s delivery procedures. For safety, it lists zero affected participants and zero deaths in both groups, but does not report the adverse-event observation period, collection procedures, or further event details. These limitations concern what is documented in the registry record and should not be taken as evidence that a particular procedure or analysis was absent from the study itself.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: InTSHA: Interactive Transition Support for HIV-infected Adolescents Using Social Media — NCT03624413.
- Registry record last updated 2023-10-23; status last verified 2023-09.
- Results first posted 2023-10-23.
- 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.
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18. Record Summary
NCT03624413, titled InTSHA: Interactive Transition Support for HIV-infected Adolescents Using Social Media, is recorded as a completed randomized, parallel-group study sponsored by Emory University. It enrolled 80 participants and compared a social media behavioral intervention with standard of care. The study summary describes adolescents living with HIV in South Africa and an intervention based on SMART.
The primary endpoint is the Acceptability of Intervention Measure score at Month 6, summarized by median and inter-quartile range. The record lists 8 outcome measures and 0 analyses. Primary and secondary outcome results, analysis populations, and missing-data methods are not reported in the registry record. The adverse-event entries list 0 affected participants and 0 deaths in each group.