Crowdsourcing to Reduce HIV Stigma Among Adolescents and Young Adults in Kazakhstan: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Crowdsourcing to Reduce HIV Stigma Among Adolescents and Young Adults in Kazakhstan (NCT05107401), a randomized na study. The primary outcome is Mean Score Change in Total HIV Stigma Scale.

2. Clinical Question

The study asks whether a digital intervention developed through a crowdsourcing approach can affect HIV stigma among adolescents and young adults in Kazakhstan, and whether it can promote HIV testing. The primary outcome is mean change in total HIV stigma scale score between baseline and 3 months. HIV testing, including uptake of HIV self-tests, is a secondary outcome, alongside several stigma subscales.

The intervention is intended to address stigma as a potential barrier to HIV testing. The registry record describes feasibility and acceptability as aims of the pilot and identifies stigma reduction as the primary outcome, with HIV testing as a secondary outcome. It does not report estimates comparing the two arms, so the direction and size of any difference cannot be assessed from the posted results.

3. Trial Design

The registry record describes the allocation as randomized and lists two arms: a crowdsourced intervention and standard of care. It also identifies the intervention as behavioral and masking as single. Which participants or study personnel were masked is not reported in the registry record. The design model is separately classified as single-group, which does not readily align with the randomized allocation and the two described arms. That design classification is an inconsistency in the record; it should not be silently resolved by assuming a particular analysis structure.

The intervention arm was to receive a digital crowdsourced intervention. The control arm was to receive standard HIV informational materials currently used by the Kazakhstan Ministry of Health. The project description says local adolescents and young adults and youth organizations would contribute to development through a national crowdsourcing contest. It describes the study as a pilot test of the resulting intervention.

The listed enrollment is 216. The registry record gives the start date as 2023-01-24, primary completion as 2023-08-22, and status as completed. These registry fields describe the study record and schedule; they do not establish how many participants completed follow-up or contributed to each outcome analysis. The serious and other adverse event listings give arm-specific numbers at risk, but those counts should not be used to infer the analysis population for the primary endpoint.

The primary outcome is a continuous measure: mean score change on the total HIV stigma scale, assessed from baseline to 3 months. Secondary outcomes include perceived HIV test stigma, HIV healthcare stigma, fear and judgement stigma, community HIV stigma, and HIV self-test uptake. The registry record does not report a detailed statistical analysis plan, the method used to handle repeated measurements, or the exact comparison model.

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:

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 Mean Score Change in Total HIV Stigma Scale, measured over Baseline and 3 months.

The primary endpoint is mean change in the total HIV stigma scale score from baseline to 3 months. The questionnaire has 17 items, each using a 5-point Likert scale; the total score ranges from 17-85. Higher scores indicate higher levels of stigma. The reported endpoint is change in the score, rather than the score at a single visit.

A change score can describe whether participants’ measured stigma scores shifted over the follow-up period. Comparing mean change between randomized arms can estimate how the average shift differed between the intervention and standard-care groups, subject to the analysis population, missing observations, and methods used. The scale’s stated direction is useful for interpreting absolute scores, but the registry record does not specify the subtraction convention for change. Therefore, the sign of a change cannot be translated confidently into improvement or worsening without that detail.

Stigma is the primary outcome because the project’s central stated aim is to reduce HIV-associated stigma. HIV testing is treated as a secondary outcome, including uptake of HIV self-tests. The registry record does not give a numerical estimate for the primary endpoint or a primary between-arm comparison. It also does not report a confidence interval or p-value for that comparison. The outcome definition alone describes what was intended to be measured; it does not establish what the study found.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous because it is a numerical scale score. The record specifies that the outcome is the mean change in the total HIV stigma scale from baseline to 3 months, with standard error as the dispersion measure. A mean describes the average score or average change in a group. A standard error describes the precision of an estimated mean; it is not the same as the spread of individual scores. Neither measure is reported numerically for the primary outcome in the registry record.

What does a mean change compare?

For a repeated measurement, each participant can have a baseline score and a follow-up score. A change score represents the difference between those measurements, using a defined subtraction order. A comparison of average change between intervention and standard-care groups focuses on whether the groups shifted differently on average. The registry record gives the time points but does not specify the subtraction order or state the model used to compare the groups.

In general, random assignment can make groups comparable on average at the start of a study, although it does not guarantee identical groups in a particular trial. Analysis should account for the randomized design and clearly define who is included. The record labels allocation randomized and gives descriptions for two arms, but its single-group model classification conflicts with that information. The analysis method and the reason for the classification are not reported in the registry record.

How should uncertainty be read?

In general, a confidence interval describes a range of effect estimates compatible with the data and the assumptions of the analysis. Its width conveys precision: a narrower interval indicates greater precision than a wider interval. A p-value, when reported, addresses compatibility between the data and a specified null hypothesis under the analysis assumptions; it does not measure the size or practical importance of an effect. The registry record does not report a confidence interval or p-value for the primary comparison, so neither significance nor precision can be assessed from the posted results.

Because no numerical effect estimate is reported, the scale range cannot be used to infer how large an observed shift might have been. A scale range tells readers the possible score span, not the actual distribution of participants’ scores. The record also does not report the standard deviation of scores, the standard error of the between-arm contrast, or an estimate of the primary effect.

What do the planning assumptions mean?

The stated sample-size illustration uses a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It considers effects expressed as stated fractions of the observed effect. These are assumptions for a planning calculation, not proof that the original trial was designed using those choices. The registry record does not report the study’s own sample-size justification, its prespecified target effect, or a planned power calculation. Any sample-size outputs based on the described illustration are planning values, not observed power.

In general, planning calculations depend on assumptions about the effect to detect, variability, allocation, significance level, and analysis. If those assumptions differ from what occurs, the resulting sample-size estimate may not describe the study’s achieved precision. A calculation based on an observed effect is especially dependent on that effect estimate and should not be mistaken for a prospective guarantee. The record gives no numerical primary effect to interpret alongside the planning assumptions.

Why can over-dispersion matter?

For a continuous score, variability reflects how much individual measurements differ around a group mean. General statistical models often rely on assumptions about that variability and the distribution of residuals. Over-dispersion most directly describes observed variability greater than a model expects, particularly for count outcomes. When relevant, ignoring it can make uncertainty appear too small. The primary endpoint is a continuous scale, and the registry record does not report a model or evidence of over-dispersion; no claim about its presence or treatment is warranted.

The secondary self-test uptake outcome differs in kind from a continuous stigma score and may require a method appropriate to its measurement. The exact definition of uptake, observation window, analysis method, and effect measure are not reported in the registry record. The other secondary measures are stigma subscales, but their scoring and analytic details beyond their titles are not given.

Interpretation also depends on missing observations and analysis populations. If follow-up scores are unavailable for some participants, the analyzed group may differ from the group initially assigned. General methods for missing data make different assumptions about why measurements are absent, and those assumptions can affect estimates. The registry record does not report the amount or handling of missing outcome data, whether analyses followed assignment regardless of intervention exposure, or which participants were included in each analysis.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists seven outcome measures and eight analyses. Multiple outcomes or analyses raise the general issue of multiplicity: the more comparisons examined, the greater the chance that at least one may appear noteworthy by chance if no adjustment or hierarchy is used. Whether that concern applies, and how it was addressed, depends on prespecified aims and the analysis plan. A multiplicity strategy is not reported in the registry record, so it is not possible to determine whether comparisons were adjusted, prioritized, or treated as exploratory.

The primary endpoint is described as mean change in the total HIV stigma scale from baseline to 3 months, but the record also indicates that the primary outcome has several categories or time points and was not reduced to one comparison. The precise primary contrast and any ordering among analyses are therefore not clear from the posted record. The listed secondary outcomes include several stigma subscales and HIV self-test uptake, but their role in a formal testing hierarchy is not reported.

Missing-data handling is not reported in the registry record. The record does not state how many participants had observed baseline and 3-month scores, why any measurements were missing, or whether any statistical method was used to address missingness. It also does not identify the analysis population for the primary comparison, such as whether participants were analyzed according to randomized assignment or according to intervention receipt.

These omissions matter because complete-case and model-based analyses can rely on different assumptions and may yield different estimates when follow-up data are absent. A transparent interpretation ordinarily needs outcome availability by arm, analysis inclusion rules, and the assumptions underlying missing-data methods. None of those details can be inferred from the listed enrollment or adverse-event counts.

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 serious adverse events, other adverse events, and deaths separately for the two arms. For the crowdsourced intervention arm, the reported numbers at risk are 111 for serious events and 111 for other events; the corresponding reported event counts are 0 and 0, with 0 deaths. For standard of care, the reported numbers at risk are 105 for serious events and 105 for other events; the corresponding reported event counts are 0 and 0, with 0 deaths.

These entries mean that the registry lists no serious events, other events, or deaths in the reported safety fields. They do not show that no symptoms or health events occurred in any broader sense. The record does not provide event definitions, collection procedures, exposure duration, severity details beyond the serious-event category, or a narrative explaining the safety data. It also does not establish whether these safety populations match the primary outcome analysis populations.

Counts at risk are safety reporting denominators, not a substitute for the number with complete primary outcome measurements. The arm-specific counts should be read as reported, without combining them or treating them as a reconciliation of the listed enrollment. A zero event count is a description of the registry entry, not proof that the intervention carries no risk.

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

The record establishes that the study was designed to examine a digital crowdsourced approach to HIV stigma reduction and HIV self-testing among adolescents and young adults in Kazakhstan. It identifies a continuous primary stigma outcome measured at baseline and 3 months and describes standard HIV informational materials as the comparator. These details clarify the intended question and the construct being measured.

The record does not report a numerical primary outcome estimate, a between-arm comparison, or uncertainty around an effect. It therefore cannot show whether average stigma scores changed, whether changes differed between arms, or how precisely any difference was estimated. It also does not report a numerical secondary outcome estimate for HIV self-test uptake. The endpoint description and study aims should not be mistaken for evidence of a particular result.

A statistical difference, if reported in a complete analysis, would still need to be interpreted in context. Scale changes require a clear subtraction convention and an assessment of uncertainty and practical importance. Conclusions would also depend on adherence to the randomized design, outcome availability, the analysis population, and methods for handling multiple comparisons. Those details are not reported in the registry record.

The safety entries list zero serious adverse events, zero other adverse events, and zero deaths in each arm’s reported fields. These entries do not by themselves establish absence of all harms or provide a full safety assessment. They should be understood as registry-reported counts, with the stated at-risk denominators, rather than as evidence about unreported events.

Thus, the record permits a careful description of the research question and selected design and safety information, but not a conclusion about the effect of the intervention. The distinction is important: a completed study record and a defined endpoint do not substitute for reported outcome estimates and the information needed to judge their precision and validity.

13. Why This Trial Matters Statistically

This trial is statistically interesting because it connects a community-developed digital intervention to outcomes at different measurement levels. HIV stigma is assessed with a multi-item continuous scale, while HIV self-test uptake is a distinct secondary outcome. Those outcomes address different questions and generally require different effect measures and analysis approaches. Keeping them separate avoids treating a change in a scale score as interchangeable with a testing behavior.

The study also highlights the importance of a clearly specified primary comparison. The record defines the stigma scale and follow-up interval, but it does not report a single numerical primary contrast and notes that the primary outcome has several categories or time points. A prespecified contrast makes it clearer which estimate is central, how uncertainty should be interpreted, and how secondary findings relate to the principal question.

Design consistency is another statistical concern. Randomized allocation and two described arms suggest a comparative evaluation, whereas the record’s single-group model classification suggests something different. Clear reporting is needed to establish the intended design, the assignment process, the analysis population, and how the analysis reflects allocation. Without that reconciliation, readers should not assume a particular comparison model.

Finally, the posted information illustrates why results reporting needs more than endpoint names and safety counts. Effect estimates, uncertainty, outcome availability, and missing-data methods are essential to judge what the data support. The registry record gives a useful account of the aims and measures, but those statistical results and analysis details are not reported.

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.

Several limitations are specific to the information recorded for this study. The primary endpoint is defined, but no mean changes, between-arm estimate, confidence interval, or p-value are reported. The direction convention for calculating change is also not stated. These omissions prevent interpretation of the magnitude, direction, and precision of the primary outcome.

The design description is internally difficult to reconcile: allocation is labeled randomized and the record describes an intervention arm and a standard-care arm, while the design model is classified as single-group. The record does not explain the discrepancy. It also does not identify who was masked despite the single-masking designation. These details limit the ability to assess how the reported design should inform an analysis.

The outcome listing indicates several categories or time points for the primary outcome but does not reduce them to one comparison. The record does not identify a prespecified testing hierarchy or a multiplicity adjustment. It lists several secondary outcomes, but does not provide their numerical results or enough detail about scoring and analysis to interpret them.

Outcome completion and missing-data handling are not reported in the registry record. The listed enrollment does not establish how many participants contributed to each outcome, and safety counts should not be substituted for those analysis populations. Eligibility details, intervention exposure or adherence, and follow-up completion are also not reported in the record.

Finally, the record describes a pilot and gives no sample-size justification for the study’s own design. Planning illustrations based on fractions of an observed effect are not a substitute for the original design rationale or for reported estimates and uncertainty. Together, these gaps restrict statistical interpretation to the study’s stated aims, measures, and recorded design information.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Crowdsourcing to Reduce HIV Stigma Among Adolescents and Young Adults in Kazakhstan — NCT05107401.
• Registry record last updated 2024-12-17; status last verified 2024-11.
• Results first posted 2024-12-17.
• 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 a completed randomized study of a digital crowdsourced HIV stigma reduction intervention for adolescents and young adults in Kazakhstan. The comparator is standard HIV informational materials currently used by the Kazakhstan Ministry of Health. Listed enrollment is 216, and the record gives a start date of 2023-01-24 and primary completion date of 2023-08-22.

The primary outcome is mean change in total HIV stigma scale score from baseline to 3 months. The scale contains 17 items, uses a 5-point Likert scale, and ranges from 17-85; higher scores indicate higher stigma. HIV self-test uptake and several stigma subscales are listed as secondary outcomes.

The record labels allocation randomized but also classifies the design model as single-group. It does not report a primary effect estimate, uncertainty interval, p-value, missing-data approach, or analysis population. Safety entries list zero serious adverse events, zero other adverse events, and zero deaths in both arms’ reported fields. These are registry-recorded counts and do not replace outcome results or a full account of safety and follow-up.