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 Incidence of HANA Conditions in HIV-infected Individuals (NCT03483584), a registered phase not stated study. The primary outcome is Prevalences of HIV-associated Non-AIDS Conditions (HANA).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03483584 |
| Phase | Phase not stated |
| Condition | HIV, Metabolic Syndrome, Osteopenia |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 215 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Chinese University of Hong Kong |
| Results posted | Yes |
2. Clinical Question
The study asks how frequently HIV-associated non-AIDS conditions occur in newly diagnosed people with HIV starting antiretroviral treatment, and whether the incidence of these conditions differs between people starting integrase inhibitor-containing regimens and those starting other regimens. The registry describes a prospective longitudinal cohort in Hong Kong.
The conditions of interest span several areas: hypertension; diabetes and insulin resistance; dyslipidemia; lipodystrophy; metabolic syndrome; osteopenia and osteoporosis; vitamin D deficiency; renal impairment and kidney tubular dysfunction; and liver fibrosis. The registry’s primary outcome is narrower in timing: it records prevalence at baseline for listed HANA conditions. The study summary also describes assessments before treatment and at 48 weeks and 96 weeks after treatment initiation, with the intention of determining incidence and comparing regimen groups.
Population
Newly diagnosed HIV-infected individuals in Hong Kong initiating antiretroviral treatment. The primary outcome description specifies participants assessed at baseline and at least one follow-up visit.
Intervention
INSTI-containing antiretroviral therapy regimens.
Comparator
Non-INSTI-containing antiretroviral therapy regimens. Allocation is not stated, so these are not randomized comparison groups.
Primary question
What is the baseline prevalence of the specified HANA conditions, and, as described in the study aim, how does subsequent incidence compare between regimen groups?
The registry record reports enrollment of 215, but the registry entries do not give the baseline prevalence estimates, incidence results, or comparative effect estimates. Therefore, the clinical question and planned follow-up can be described, but the magnitude or direction of any regimen-group difference cannot be assessed from the reported information.
3. Trial Design
This is a prospective longitudinal cohort study, not a randomized trial. The registry describes newly diagnosed HIV-infected individuals in Hong Kong who initiate antiretroviral treatment and are evaluated for HANA conditions. The record lists INSTI-containing and non-INSTI-containing regimens as the groups of interest. It does not state how regimen allocation occurred; accordingly, the groups should not be treated as randomized or like-for-like controls.
The study summary describes clinical assessments before treatment initiation, then at 48 weeks and 96 weeks after initiation. The stated aim is to evaluate incidence and compare conditions between people starting different regimen types. The primary outcome registered for the analysis is instead prevalence at baseline. It counts participants with each listed condition at that time, and its analysis population is described as participants who had baseline and at least one follow-up study visit. The registry also lists 2 outcome measures and 36 analyses.
Enrollment is recorded as 215. The listed study start is 2018-04-06, primary completion is 2024-03-31, and status is COMPLETED. Those record details describe the study’s administrative timeline; they do not establish that all planned assessments were completed for every participant or that every condition had complete follow-up.
Because treatment groups were not assigned through a stated randomization process, differences between them could reflect characteristics that influenced regimen choice as well as any association with treatment. The registry record does not report adjustment methods or other details needed to determine how such differences were addressed. The design supports describing a prospective observational comparison, but not interpreting any group contrast as an isolated causal effect of regimen type.
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 | INSTI | non-INSTI |
|---|---|---|
| STARTED | 183 | 32 |
| At year 1 | 131 | 22 |
| At year 2 | 110 | 21 |
| COMPLETED | 139 | 24 |
| NOT COMPLETED | 44 | 8 |
Reasons for not completing this period:
| Reason | INSTI | non-INSTI |
|---|---|---|
| Lost to Follow-up | 40 | 7 |
| Withdrawal by Subject | 4 | 1 |
Analysis population for the primary outcome, as defined in the registry: Participants who had baseline and at least one follow-up study visits were included in the analyses.
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.
Population: 215 participants were recruited into the study. Those participants who had baseline and at least one follow-up visit during the two-year follow-up period were included in the data analyses. Those who had only one study visits were excluded from final analyses.
| Characteristic | Unit | INSTI | Non-INSTI | Total |
|---|---|---|---|---|
| Participants analysed | 183 | 32 | 215 | |
| Age, Continuous | years | 46.3 (SD 14.5) | 48.8 (SD 12.7) | 46.7 (SD 14.2) |
| Sex: Female, Male: Female | Participants | 23 | 4 | 27 |
| Sex: Female, Male: Male | Participants | 160 | 28 | 188 |
| Race/Ethnicity, Customized: Chinese | Participants | 174 | 30 | 204 |
| Race/Ethnicity, Customized: Non-Chinese | Participants | 9 | 2 | 11 |
| Duration of HIV diagnosis | years | 0.8 (0.2 to 8.4) | 7.7 (0.5 to 14.0) | 1.0 (0.2 to 9.6) |
6. Primary Endpoint
The registry lists the primary outcome as Prevalences of HIV-associated Non-AIDS Conditions (HANA), measured over Baseline.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is the baseline prevalence of HIV-associated non-AIDS conditions. It is recorded as a count of participants for each condition, rather than as a continuous measurement or a time-to-event endpoint. The listed conditions include hypertension, diabetes mellitus, insulin resistance, dyslipidemia, metabolic syndrome, osteoporosis, osteopenia, vitamin D deficiency, renal disease, kidney tubular dysfunction, and liver fibrosis categories defined using FIB-4 thresholds of >1.3 and >2.67.
Prevalence describes the proportion of a defined population with a condition at a specified time. It is useful for characterizing the health profile of a cohort at treatment initiation and for identifying which conditions are present at baseline. It is distinct from incidence, which concerns new development over a period of follow-up. A baseline prevalence count alone cannot show when a condition began or whether it developed after antiretroviral treatment started.
The primary outcome description says participants assessed at baseline and at least one follow-up visit were included in the prevalence analysis. The registry record does not report the actual condition-specific counts or prevalence estimates, nor does it specify further operational details such as diagnostic criteria for each condition beyond the FIB-4 thresholds. Although the study summary describes follow-up assessment and an incidence comparison, the posted primary endpoint is explicitly baseline prevalence. These are related but different questions and should not be conflated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a cohort designed to examine HANA conditions in newly diagnosed people with HIV initiating antiretroviral therapy. It identifies a baseline prevalence outcome and a broader study aim that includes comparing incidence between INSTI-containing and non-INSTI-containing regimens over follow-up. However, the registry entries contain no condition-specific prevalence counts, incidence counts, effect estimates, confidence intervals, or p-values. Consequently, no direction, size, or precision of a regimen-group difference can be described.
That distinction matters because an outcome definition is not a result. The listed baseline conditions indicate what investigators assessed, but do not establish how common any condition was in the cohort. Similarly, the planned follow-up schedule at 48 weeks and 96 weeks does not establish that incidence was observed or that results at those visits were complete. The record is marked COMPLETED, but completion status alone does not provide outcome data.
Even if a group comparison is reported elsewhere, its interpretation would need to account for the observational design. Random allocation is not stated. In a cohort, clinical decisions and participant characteristics may be related to the regimen received and to the risk of HANA conditions. An unadjusted difference could therefore reflect baseline differences, follow-up patterns, or other factors in addition to regimen group. The registry record does not report covariate adjustment or enough analysis detail to evaluate these possibilities.
The registered baseline population includes participants with baseline and at least one follow-up visit. This criterion may differ from the population initially enrolled, and the record does not give condition-specific denominators or explain how missing assessments were handled. Readers should therefore avoid assuming that the enrollment figure represents the denominator for every outcome.
The serious adverse event fields list zero serious affected participants in both regimen groups, alongside the corresponding at-risk counts. These figures are a narrow safety summary and do not establish that no other adverse effects occurred or that all safety outcomes were captured. The record lists no serious-event terms. Overall, the information supports describing the study question, design, and registered outcome, but not judging the prevalence or comparative incidence findings.
9. Statistical Methods Explained
What does prevalence measure?
Prevalence describes how many participants in a defined analysis population have a condition at a particular point or period. For this study, the registered primary endpoint concerns conditions present at baseline. A count can be informative, but interpretation also depends on the denominator and on consistent case definitions. The registry describes the outcome as a participant count and states that participants had to have a baseline assessment and at least one follow-up visit to enter the prevalence analyses. It does not provide the condition-specific counts or denominators in the registry record.
Prevalence is not interchangeable with incidence. Incidence concerns new cases developing over follow-up among participants at risk of developing the condition. To interpret incidence, one needs a clear definition of new onset, an at-risk population, and sufficient information about observation time and missing follow-up. The study summary describes comparisons of incidence between regimen groups, while the registered primary outcome is baseline prevalence. Without reported incidence results and analysis details, the baseline outcome cannot answer the longitudinal incidence question by itself.
Why does the cohort design affect interpretation?
In a randomized study, assignment is intended to make treatment groups comparable at the outset, on average. In an observational cohort, treatment is received rather than assigned through a stated randomization procedure. Group differences can therefore reflect factors associated with regimen selection. General statistical practice may use adjustment for measured confounders, but adjustment cannot automatically remove bias from unmeasured factors, inaccurate measurements, or unsuitable modeling choices. The registry record does not report whether adjustment was used, which variables might have been included, or the statistical models applied.
The two regimen groups are not described as like-for-like controls, and allocation is not stated. Any comparative result should therefore be read first as an association in the observed cohort. A causal interpretation would require assumptions and design or analysis support beyond the group labels alone. Those assumptions and supporting details are not reported in the registry record.
How should precision be understood?
A confidence interval is a range of values compatible with the data under a specified statistical model and procedure. It communicates uncertainty in an estimate; it is not a guarantee that the true value lies within the particular interval. A narrow interval generally indicates greater precision than a wide interval, while the estimate itself describes the central result. The registry entries include no confidence intervals or estimates, so precision for prevalence or regimen comparisons cannot be assessed.
A p-value, when reported, addresses how compatible observed data are with a specified null model and its assumptions. It does not measure the size or clinical importance of an effect, and it does not by itself establish causation. No p-values are reported in the registry entries. Statistical significance or nonsignificance should therefore not be inferred.
What does over-dispersion mean in general?
For count outcomes, a simple model may assume a particular relationship between the expected count and its variability. Over-dispersion occurs when observed variability is greater than that assumption allows. If unaddressed, standard errors can be too small and confidence intervals too narrow. More flexible modeling or robust uncertainty estimates may be appropriate, depending on the data and design. The registry record does not identify a count model, describe a dispersion assessment, or report whether over-dispersion was relevant. This is a general statistical consideration, not a claim about the study’s data.
How should planning illustrations be read?
Any sample-size calculations associated with the posted results are planning illustrations based on an observed effect, not evidence of the study’s original design or observed power. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects defined as fractions of the observed effect. For non-time-to-event outcomes, the illustration reports participants per arm; time-to-event calculations are described as total event counts using the Schoenfeld approach. Such calculations depend on their assumptions and the selected effect to detect. They do not show that the study had a particular probability of detecting an effect after completion.
The registry record does not report the original sample-size justification or establish that these illustration assumptions governed study planning. It also does not provide actual outcome estimates in the registry record, so no planning result or detectable effect can be interpreted numerically.
What remains unknown about analysis?
The registry lists 36 analyses, but the methods for those analyses are not reported in the registry record. The record does not describe model specifications, covariate selection, handling of repeated assessments, missing-data methods, multiplicity correction, or sensitivity analyses. These details can affect estimates and uncertainty, especially when assessing multiple conditions across groups and follow-up times. General statistical principles can explain why these choices matter, but they cannot substitute for study-specific reporting.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 2 outcome measures and 36 analyses, with multiple HANA conditions named in the study summary and baseline outcome description. When many outcomes or comparisons are assessed, the chance of obtaining at least one apparently notable result by chance can increase. Common approaches include defining a primary comparison in advance, adjusting inferential thresholds, or interpreting results as exploratory. The registry record does not report whether multiplicity was addressed, which comparisons were considered primary beyond the registered baseline prevalence endpoint, or how the 36 analyses were organized.
Missing data are also important in a longitudinal cohort. The primary outcome description states that participants with a baseline assessment and at least one follow-up study visit were included in prevalence analyses. This defines an analysis population, but it does not explain how missing values for particular conditions or visits were handled. The registry record does not report the amount or pattern of missing data, imputation, complete-case procedures, or sensitivity analyses. Without those details, it is not possible to assess whether the analyzed participants differ systematically from those without usable assessments.
The enrollment figure of 215 should not automatically be treated as the denominator for every condition or comparison. The adverse-event record lists separate at-risk counts by regimen group, but those safety counts do not establish the analysis denominator for the primary endpoint. Condition-specific denominators and analysis populations are not reported in the registry record. Accordingly, the completeness and representativeness of each outcome analysis remain uncertain.
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 |
|---|---|---|---|
| INSTI | 0 | 139 | 0.0% |
| non-INSTI | 0 | 24 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| INSTI | 0 of 139 |
| non-INSTI | 0 of 24 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| INSTI | 0 of 139 |
| non-INSTI | 0 of 24 |
The registry’s serious adverse event summary lists the INSTI group with 139 participants at risk and 0 participants affected by serious events. The non-INSTI group is listed with 24 participants at risk and 0 participants affected by serious events. The death count is 0 in each listed group, and the record lists no serious adverse event terms.
These fields should be read as the registry’s reported serious-event counts for the listed groups, not as a complete account of every possible safety outcome. A zero count does not establish that no non-serious adverse events occurred, that every participant had complete safety follow-up, or that the regimens have identical safety profiles. The record does not provide event definitions, exposure duration, detailed safety monitoring methods, or additional event descriptions in the registry entries.
The at-risk figures are specific to this adverse-event summary and should not be substituted for the denominator of the baseline prevalence outcome or other analyses. The record does not report how the safety population relates to each efficacy or prevalence analysis population. These counts describe what is registered in the serious-event fields; they do not by themselves support a broad comparative safety conclusion.
12. What the Result Does, and Does Not, Mean
The study record identifies a clinically relevant observational question: how HANA conditions occur among newly diagnosed people with HIV starting antiretroviral therapy, and whether incidence differs between INSTI-containing and non-INSTI-containing regimens. It also specifies a baseline prevalence outcome and a cohort assessed over time. Those features clarify the intended scope of the research.
The registry entries do not include the condition-specific prevalence results, incidence results, comparative estimates, confidence intervals, or p-values. They therefore cannot show whether a condition was common or uncommon, whether incidence differed between regimen groups, or how precisely any difference was estimated. The study’s COMPLETED status and scheduled assessments do not fill that results gap.
The observational design also limits what a comparison could establish. Because randomization is not stated, regimen groups may differ in ways related to both treatment choice and HANA risk. If a difference were reported, it would be an association unless the analysis and assumptions justified a stronger interpretation. Adjustment could address measured differences, but the registry record does not report whether adjustment was performed or which factors were considered.
The serious adverse event summary records zero serious affected participants in both listed groups, but this is not evidence about every type of adverse event or all aspects of safety. Likewise, the baseline prevalence analysis population is specified as participants with baseline and at least one follow-up visit, but the record does not describe missing-data handling or provide condition-specific denominators.
In practical statistical terms, the available information establishes the research question, cohort framework, outcome definitions, and some registry-level study details. It does not establish the study’s substantive prevalence or incidence findings. Any conclusion about the comparative performance or safety of the regimen groups would require results and methodological details not reported in the registry record.
13. Why This Trial Matters Statistically
This study matters statistically because it illustrates the difference between a longitudinal research aim and the outcome registered as primary. The study summary describes assessment before treatment and at follow-up, with an aim to compare incidence. The primary endpoint, however, is baseline prevalence. Prevalence describes the burden of existing conditions at a time point, whereas incidence concerns newly developing conditions over follow-up. Keeping those measures distinct is essential when interpreting what a study can answer.
The cohort setting also highlights a central challenge in comparative effectiveness research. People receiving different regimens may differ before treatment, and regimen allocation is not stated as randomized. Consequently, a group contrast can mix treatment-related associations with differences in participant characteristics or clinical decisions. Statistical adjustment can be useful, but its adequacy depends on the variables measured and the model used; those details are not reported in the registry record.
The range of listed HANA conditions creates another important issue: multiplicity. Evaluating many conditions and analyses can produce a complex inferential picture. Clear prioritization, transparent reporting, and appropriate interpretation of uncertainty are important, yet the registry does not describe a multiplicity strategy. The record lists 36 analyses, but that count alone does not reveal the number of independent hypotheses or how conclusions were selected.
Finally, this record demonstrates why registry completion status is not a substitute for outcome reporting. The design and aims are documented, but the registry entries available do not include the prevalence or incidence estimates needed to evaluate the scientific findings. For researchers and readers, separating documented methods, stated aims, and reported results is a basic safeguard against overinterpretation.
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 trial-specific limitations constrain interpretation of the registry information. First, treatment allocation is not stated, and the record explicitly describes the arms as not being a like-for-like control comparison. Differences between regimen groups could therefore reflect selection or baseline characteristics as well as regimen association. The registry record does not report adjustment methods that would help assess this issue.
Second, there is a mismatch in emphasis between the study summary and the registered primary outcome. The summary describes assessing incidence over time, while the primary outcome is baseline prevalence. The registry entries do not provide the longitudinal incidence estimates or explain how incidence was operationalized, including how participants with pre-existing conditions were handled for each condition.
Third, outcome-specific denominators, estimates, and uncertainty measures are absent from the registry entries. Although the primary population is described as participants with baseline and at least one follow-up visit, the record does not report condition-specific missingness, losses to follow-up, or methods for handling missing assessments. This prevents assessment of the completeness and representativeness of each outcome analysis.
Fourth, the listed conditions are diverse and may require different measurement and classification procedures. The primary outcome description provides FIB-4 thresholds for fibrosis categories, but other diagnostic criteria and assessment procedures are not reported in the registry record. The record also lists 36 analyses without describing the statistical models, multiplicity handling, or sensitivity analyses.
Finally, the serious adverse event fields are limited to the posted counts and contain no listed event terms. They do not provide a comprehensive account of non-serious events or detailed exposure and monitoring information. These reporting limitations mean the record can characterize the study framework but cannot support broad efficacy or safety conclusions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Incidence of HANA Conditions in HIV-infected Individuals — NCT03483584.
- Registry record last updated 2025-12-09; status last verified 2025-11.
- Results first posted 2025-12-09.
- 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
The record concerns NCT03483584, titled “Incidence of HANA Conditions in HIV-infected Individuals,” sponsored by the Chinese University of Hong Kong. It describes a prospective longitudinal cohort of newly diagnosed HIV-infected individuals in Hong Kong initiating antiretroviral treatment, with comparisons between INSTI-containing and non-INSTI-containing regimens. Enrollment is recorded as 215; the status is COMPLETED.
The study summary describes assessments before treatment and at 48 weeks and 96 weeks after initiation. Its primary outcome is baseline prevalence of HANA conditions among participants with a baseline and at least one follow-up visit. The record lists 2 outcome measures and 36 analyses. It does not report the prevalence or incidence estimates in the registry record, nor the detailed statistical analysis plan, missing-data methods, or multiplicity approach.
The serious adverse event fields list 0 serious affected participants in each regimen group. These figures are limited safety data and should not be generalized to all adverse events. The record supports description of the study design and registered outcomes, but not conclusions about comparative incidence or the magnitude and precision of outcome differences.