Incidence and Prevalence of Cancer in People Living With HIV/AIDS at Cancer Centers in Latin America: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Incidence and Prevalence of Cancer in People Living With HIV/AIDS at Cancer Centers in Latin America (NCT04089488), a registered phase not stated study. The primary outcome is Estimates of Site-specific Incident Cases and Site-specific Prevalence of Cases Presenting With Human Immunodeficiency Virus (HIV) and Cancer Presenting Over 9 Months at the Clinical Sites.

2. Clinical Question

The clinical question is descriptive rather than causal. It concerns the occurrence and profile of cancer cases among people living with HIV/AIDS who present to these particular cancer centers. It does not ask whether a treatment changes cancer risk, whether one care strategy is better than another, or whether the observed cases represent all people living with HIV/AIDS in Latin America.

The registry lists HIV infection, HIV-1 positivity, malignant neoplasm, and recurrent malignant neoplasm among the conditions. The secondary outcomes concern diagnostic testing, HIV treatment and disease characteristics, cancer treatment, CD4, and HIV viral load among HIV-positive individuals diagnosed with cancer. These topics indicate that the study record covers both cancer occurrence and clinical characteristics, but numerical findings for those outcomes are not reported in the registry record.

3. Trial Design

This is a completed prospective observational study sponsored by the AIDS Malignancy Consortium. The registry lists an enrollment of 175 and an overall status of COMPLETED. The recorded study start is 2020-01-17, and the primary completion date is 2021-10-18. The title describes a study of incident and prevalent cancer cases in people living with HIV/AIDS at cancer centers in Latin America.

Participants were not assigned to treatment groups in the design described by the record. The listed activities are medical chart review and survey administration. The arm description says that participants respond to surveys and/or undergo medical record review at baseline and at 4 weeks. This wording does not establish that every participant completed both activities or that each participant had the same data-collection experience.

The endpoint population description identifies five study sites: Complexo Hospitalar; Hospital Fernandez; Hospital Roff0; Instituto Nacional De Cancer Brazil; and Instituto de Oncologia. Site-specific summaries are central to the objective, rather than a randomized comparison between groups. The registry does not report how participants were selected at each center, whether recruitment was consecutive, or what criteria were used to define eligibility beyond the population and conditions described.

The timing language is not fully consistent. The primary outcome title refers to cases presenting over 9 months, while its description specifies 1 year, 9 months (21 months); the timeframe field says Up to 21 months. The registry record does not explain this difference, so the observation period should be read with that ambiguity in mind.

The registry lists 10 outcome measures, but the analysis count is 0. Numerical endpoint estimates and detailed analysis results are not reported in the registry record. The record therefore supports a description of the planned observational design and outcomes, but does not allow an assessment of the observed site-specific findings.

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

Analysis population for the primary outcome, as defined in the registry: There are five study sites (Complexo Hospitalar; Hospital Fernandez; Hospital Roff0; Instituto Nacional De Cancer Brazil ; and Instituto de Oncologia). Given a study site, new diagnosis and existing cases(recurrence and surveillance) are summarized.

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 Estimates of Site-specific Incident Cases and Site-specific Prevalence of Cases Presenting With Human Immunodeficiency Virus (HIV) and Cancer Presenting Over 9 Months at the Clinical Sites, measured over Up to 21 months.

The primary endpoint is intended to estimate site-specific incident and prevalent cancer cases among people living with HIV/AIDS presenting at the clinical sites. Incident cases refer to new diagnoses. The description also includes existing cases, specifically recurrence and surveillance. The population wording says that these cases are summarized given a study site, making site the organizing unit for the endpoint.

The endpoint is expressed as a count of participants. The title uses the language of estimates of site-specific frequency and prevalence, while the parameter is identified as a count. A count can describe how many participants met a case definition in the observed study population, but by itself it is not a rate or a prevalence proportion. A rate or proportion would require a clearly defined denominator and, for a rate, a defined time-at-risk basis. Those calculation details are not reported in the registry record.

Descriptive case counts are useful when the goal is to characterize the types and frequency of cases appearing at particular clinical sites. Such information can help describe the clinical workload and identify questions for future research. However, results from the participating cancer centers would describe people presenting at those centers; the record does not establish that they represent the wider population of people living with HIV/AIDS in the region.

The endpoint’s time window is stated in more than one way: the title says over 9 months, while the description and timeframe field refer to Up to 21 months and to 1 year, 9 months (21 months). The registry record does not clarify which wording governs the endpoint. No numerical primary endpoint estimates are reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Understanding the statistical methods begins with the study’s descriptive aim. The primary outcome concerns site-specific counts of incident and prevalent cancer cases among people living with HIV/AIDS. This differs from a randomized efficacy question, where outcomes are compared across groups assigned to different interventions. Here, the registry describes chart review and surveys, not treatment assignment or a control group.

What does a count measure?

In general, a count records the number of participants meeting a specified condition in a defined population and observation period. Counts are often a direct way to describe how many cases a service or study observed. They do not automatically express the probability of having a condition. To interpret a count as a proportion, a denominator must be defined; to interpret it as a rate, the time at risk must also be specified. The primary endpoint is identified as a count of participants, but the calculation details and denominators are not reported in the registry record.

Site-specific reporting can retain differences between clinical centers rather than hiding them in a single pooled summary. In general, this can be important when sites differ in the people they serve, their referral patterns, or their case-finding practices. Such differences are potential explanations for variation in counts, not conclusions established by this record. The registry names five centers, but it does not report their individual counts or describe site-specific recruitment and ascertainment methods.

How should incident and prevalent cases be distinguished?

In general, an incident case is newly diagnosed during a defined period. A prevalent case is an existing case identified in a population at a specified time or during a specified period. The endpoint description further includes recurrence and surveillance among existing cases. Because these categories represent different case histories, their interpretation relies on consistent definitions and rules for assigning participants to categories. The registry record does not report those operational rules or say whether categories could overlap.

Time windows are essential to descriptive endpoints because they define which observations count. In this record, the title says over 9 months, while the description says 1 year, 9 months (21 months), and the timeframe field says Up to 21 months. The record does not reconcile these statements. It is therefore not possible to determine from the registry record whether the title’s shorter wording is an error, refers to a distinct period, or has another explanation.

What do uncertainty intervals contribute?

In general, a confidence interval describes the range of values compatible with the observed data under a stated statistical model and procedure. It communicates precision as well as the point estimate: a wider interval reflects greater uncertainty, while a narrower interval reflects greater precision, conditional on the method’s assumptions. An interval is not a guarantee that the true value lies within its limits, nor does it resolve limitations in study selection or measurement. No confidence intervals or other uncertainty estimates are reported in the registry record.

For count data, general statistical methods may need to account for how variable counts are across observations or sites. Over-dispersion occurs when count variation exceeds what a simple model assumes. If present, failing to account for it can make uncertainty estimates too small. This is general guidance, not a description of an analysis performed in this study: the registry does not report a count model, a dispersion estimate, or a statistical analysis plan.

What can the planning illustration establish?

The planning assumptions describe an illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is framed as a stated fraction of the observed effect. The record explicitly characterizes this as a planning illustration, not the study’s own design. It should not be interpreted as observed power or as evidence that the observational study was planned around a two-arm randomized comparison.

In general, sample-size illustrations show how a hypothetical future design might need to be sized under specified assumptions. Such estimates depend on the effect chosen, the statistical test, the allocation, and other design features. They do not change the observed data or establish the probability that a result is true. The numeric illustration values and an observed effect estimate are not reported in the registry record, so no such values can be assessed.

The registry does not report its statistical analysis plan, model specifications, handling of clustering by site, multiplicity procedures, or interim analyses. It also does not report the definitions used for denominators, missing data, or analysis populations. These omissions prevent replication of the endpoint calculations and limit assessment of whether the methods matched the study’s descriptive objective.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures, including the primary site-specific cancer endpoint and secondary measures concerning diagnostic testing, HIV treatment and disease characteristics, cancer treatment, CD4, and HIV viral load. When a study examines several outcomes, the chance of observing an apparently notable result by chance can increase if many statistical tests are performed. In general, multiplicity procedures can address that issue by controlling how results are interpreted across a family of tests. The registry record does not report a multiplicity plan, and it lists 0 analyses, so no adjustment method or set of reported tests can be assessed.

Missing-data methods are also not reported in the registry record. Chart review and surveys can involve information that is absent, incomplete, or not collected consistently, but the record does not describe whether such gaps occurred, how they were handled, or whether missingness differed across sites or outcome measures. These possibilities are general concerns for studies using records and surveys, not evidence that data were missing in this study.

The analysis populations are not specified. The record lists an enrollment of 175, but it does not state how many participants were included in each endpoint analysis, whether all enrolled participants had evaluable records, or how participants with incomplete cancer information were treated. Enrollment should therefore not be assumed to equal the denominator for any site-specific outcome.

The statistical analysis plan, interim analyses, and sample-size justification are not reported in the registry record. The separate planning assumptions are labeled as an illustration based on an observed effect, not as the trial’s own design. In general, these are distinct matters: planning assumptions describe a hypothetical design, while missing-data and multiplicity procedures describe how collected observations and multiple outcomes are handled.

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

The registry record describes a prospective observational study of cancer cases among people living with HIV/AIDS presenting at cancer centers in Latin America. Its primary objective is to estimate site-specific incident and prevalent cases, with existing cases including recurrence and surveillance. The record also identifies secondary topics related to HIV disease characteristics, diagnostic testing, and cancer treatment.

What the record does not establish is the numerical frequency of cancer at any site. No primary endpoint estimates, site-specific counts, denominators, or uncertainty intervals are reported in the registry record. The listed enrollment of 175 describes study enrollment, not the number contributing data to a particular outcome or the size of the population served by a center.

The record cannot establish that the observed cases represent all people living with HIV/AIDS in Latin America. Participants came from five named cancer centers, and the registry does not report the sampling or referral processes needed to assess representativeness. Nor can the study, as described, establish that HIV status or a particular cancer treatment caused an outcome. There is no randomized treatment comparison or stated allocation.

In general, a descriptive count can help characterize the participants and clinical settings observed. It is not interchangeable with a population prevalence or incidence rate unless the relevant population, denominator, and observation-time definitions are clear. Those details are not reported in the registry record, and the stated endpoint period is inconsistent across the title and description.

The study is marked COMPLETED, but completion is not the same as a reported statistical result. The registry lists 10 outcome measures and 0 analyses. The documented safety fields contain zero entries, but the record does not explain whether these are verified event counts or reflect unavailable information. They should not be taken as evidence that a treatment is safe or that no adverse events occurred.

Overall, the record communicates the study’s purpose and observational approach, but it does not provide the outcome data needed to judge the size, precision, or broader relevance of its findings.

12. Why This Trial Matters Statistically

Site-specific descriptive studies address a different statistical need from randomized comparisons. Cancer centers may wish to understand the kinds of cases presenting in their settings, including newly diagnosed disease and existing cases under recurrence or surveillance. Carefully defined counts can provide a useful starting point for describing that clinical caseload and for identifying questions for later research.

The design also highlights why the choice of summary measure matters. A count can be informative about observed cases, but it is not automatically a prevalence proportion or incidence rate. Those interpretations depend on a well-defined denominator and time frame. The primary outcome uses count language while also describing estimates of frequency and prevalence, and its time wording is inconsistent. This makes clear definitions and transparent reporting important to sound interpretation.

Chart review and survey administration can bring together information about cancer and HIV-related characteristics. The registry’s secondary outcome topics include diagnostic testing, HIV treatment and disease characteristics, cancer treatment, CD4, and HIV viral load. Such measures can describe the clinical context of cases, although their value for inference depends on consistent ascertainment and clear analysis populations.

The record also illustrates the distinction between an observational study’s aims and hypothetical sample-size planning. An illustration based on an observed effect and equal allocation between two arms does not turn a one-group observational design into a comparative trial, and it is not observed power. Statistical summaries should be interpreted according to the design that generated the data.

These contributions remain prospective rather than demonstrated in the registry record: numerical results are not reported there. Transparent reporting of site-specific counts, denominators, definitions, missingness, and uncertainty would be needed to evaluate how informative the findings are and what further studies might reasonably address.

13. 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 the registry record is the absence of numerical outcome results. Although the study is marked COMPLETED and lists 10 outcome measures, the analysis count is 0. The record does not report site-specific case counts, estimates, denominators, or measures of precision, so the primary objective cannot be evaluated quantitatively.

The primary endpoint’s timing is ambiguous. Its title refers to cases presenting over 9 months, while the description specifies 1 year, 9 months (21 months), and the timeframe field says Up to 21 months. The record does not clarify which period was used. This matters because the definition of the observation window affects which diagnoses and existing cases are included.

The endpoint description includes new diagnoses and existing cases, including recurrence and surveillance, but does not report detailed case definitions or whether these categories were mutually exclusive. It also does not provide denominators or explain how the word prevalence is operationalized. Counts alone cannot establish population prevalence or incidence rates without those details.

Enrollment is reported as 175, but site-level enrollment and outcome-specific analysis populations are not reported. Participant selection, recruitment procedures, missing-data handling, and the completeness of chart and survey information are also not described. As a result, representativeness, possible selection effects, and the precision of site-specific estimates cannot be assessed.

The observational design has no stated allocation and no comparator. It can support descriptive aims but does not establish causal effects of treatment or allow a randomized comparison. Finally, the record lists zero in adverse-event fields without explaining the meaning of those entries, and it does not report an analysis plan, multiplicity procedure, or statistical model.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Incidence and Prevalence of Cancer in People Living With HIV/AIDS at Cancer Centers in Latin America — NCT04089488.
• Registry record last updated 2023-09-01; status last verified 2023-08.
• Results first posted 2023-08-22.
• 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.

17. Record Summary

NCT04089488 is a completed prospective observational study sponsored by the AIDS Malignancy Consortium. It examines site-specific incident and prevalent cancer cases among people living with HIV/AIDS at cancer centers in Latin America. The record lists an enrollment of 175, a start date of 2020-01-17, and a primary completion date of 2021-10-18.

Study activities are medical chart review and survey administration. The arm description says surveys and/or medical record review occur at baseline and at 4 weeks. The primary endpoint concerns counts or estimates of new and existing cancer cases by site, including recurrence and surveillance. Its time window is described inconsistently as over 9 months and as 1 year, 9 months (21 months), with a timeframe of Up to 21 months.

The registry lists 10 outcome measures and 0 analyses. Numerical outcome estimates and their precision are not reported in the registry record. The study is descriptive and observational, with no stated allocation or comparator.