Identification and Treatment of Cervical Abnormalities in Perú Through Integration of Pocket Colposcopy and Telemedicine: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Identification and Treatment of Cervical Abnormalities in Perú Through Integration of Pocket Colposcopy and Telemedicine (NCT05340322), a na na study. The primary outcome is Number of HPV Positive Women Examined.

2. Clinical Question

The study record lists cervical cancer, HPV infection and HIV infections as conditions. Its brief summary describes plans for community health workers to distribute self HPV test kits and for HPV-positive participants to be invited to the pocket colposcopy study. Those plans provide context, but they are not outcome results. The registry record does not report the number of women examined for the primary outcome, so the primary clinical question cannot be answered from the posted outcome information.

3. Trial Design

This is a completed, single-group device study sponsored by Duke University. The registry lists enrollment as 503, phase as not applicable, allocation as not applicable, and masking as none. The listed intervention is colposcopy using a pocket colposcope and thermocoagulator. The arm description says that the cervix was visualized and that abnormalities, if present, were treated with standard-of-care thermocoagulation.

The registry gives a start date of 2022-05-01 and a primary completion date of 2023-04-15. Its status is completed. These dates describe the record's study timeline; they do not establish that every participant completed the intended procedures or follow-up. The enrollment figure is not, by itself, the number examined for the primary outcome or the number with complete outcome data.

The brief summary describes an implementation context: approximately 10,000 women were expected to receive self HPV test kits through community health workers, approximately 1,000 HPV-positive participants were expected to be invited to the study, and approximately 500 participants might require thermocoagulation. These are stated approximate plans, not observed counts in the posted results. The registry record does not report a control group, a randomized comparison, or a separate arm-level comparison. The study therefore cannot estimate a treatment contrast between randomized groups from the design information reported.

The primary outcome is a participant count, and the secondary outcome concerns HPV-positive women completing follow-up after evaluation and treatment. Although the record lists two outcome measures, it does not report their numerical results. It also lists no analyses. Design features beyond those recorded, including detailed eligibility criteria and the statistical analysis plan, are not reported in the registry record.

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

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 Number of HPV Positive Women Examined, measured over up to approximately 1 year.

The primary endpoint is titled Number of HPV Positive Women Examined. It measures the total number of HPV-positive women who went to a Peruvian health center for treatment and were examined using the pocket colposcope. The stated timeframe is up to approximately 1 year. This endpoint is a count of participants meeting the description; it is not a measure of the proportion examined, a comparison between study groups, or a measure of treatment effect.

A count can describe how many people reached a specified stage of a care pathway. In this setting, it can indicate the volume of examinations recorded under the outcome definition. To interpret that count as coverage or uptake, readers would also need a clearly defined eligible or invited population and information about how outcomes were ascertained. Those details and the observed primary count are not reported in the registry record.

The endpoint is relevant to the study's stated aim of bringing colposcopy capability to communities in Peru. However, the count alone cannot establish why some participants were or were not examined, whether abnormalities were detected, or whether treatment was received. The arm description mentions treatment when abnormalities are present, but the primary endpoint itself records examination, not treatment completion or clinical benefit.

The registry also names a secondary outcome concerning completion of the 6 Month follow-up after evaluation and treatment. Its result is not reported in the registry record. Without posted numerical results for either outcome, the endpoint definitions describe what was intended to be measured, not what the study observed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome as a count of HPV-positive women examined using the pocket colposcope at a Peruvian health center for treatment. The endpoint's unit is participants, and its timeframe is up to approximately 1 year. A count is a descriptive summary of how many participants satisfy the outcome definition. It differs from a proportion, which would require both a numerator and a stated denominator, and from a comparative effect, which would require a contrast between groups or another defined comparison.

What can a single-group design estimate?

The record describes a single-group study, with allocation not applicable and no masking. In general, a single-group study can describe outcomes observed among participants who receive the intervention. Without a concurrent comparator, it cannot isolate the effect of the intervention from other explanations for an outcome. This matters especially when a reader wants to attribute a change or clinical outcome to a device or treatment. Here, the primary endpoint is a count of examinations, and no comparison is reported.

The arm description states that abnormalities, if present, were treated with standard-of-care thermocoagulation. The record does not state how many participants had abnormalities, how many were treated, or how those decisions were analyzed. The endpoint definition should therefore be read narrowly as examination, not as detection, treatment, or successful follow-up.

What do the missing estimates mean?

No primary outcome result, effect estimate, confidence interval, or p-value is reported in the registry record. General statistical explanation: an estimate describes the observed quantity or contrast, while a confidence interval conveys uncertainty around an estimate under specified assumptions. A p-value evaluates compatibility between data and a statistical null model under a specified test; it is not a measure of effect size or clinical importance. Since none of these results is listed for the primary endpoint, there is no inferential statistic to interpret. The registry also lists no analyses, and details of the statistical plan are not reported in the registry record.

A participant count can still be useful as a descriptive implementation measure, but interpreting reach requires knowing the relevant population at risk of being examined. For example, an invited population and a completed-examination population answer different operational questions. The brief summary gives approximate planning expectations, not observed denominators. They cannot be used to turn the primary count into a completion rate or to infer the number examined.

How should planning illustrations be read?

The record's planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect defined as a stated fraction of an observed effect. They also distinguish total events for time-to-event illustrations from participants per arm for other illustrations. These assumptions are not a description of the registered single-group design. Any sample-size values based on those assumptions are hypothetical planning illustrations, not the study's actual design and not observed power. The record does not report a sample-size justification for this study.

General statistical explanation: a planning calculation asks what sample size might be needed under specified assumptions about an effect, variability, allocation, and error rates. Its result depends on those assumptions and does not show whether a completed study had adequate power after the fact. Observed power is not a substitute for reporting the outcome estimate and its uncertainty. Because the primary result and observed effect are not reported in the registry record, readers cannot assess the assumptions against the study outcome from this record.

What does dispersion add?

The primary endpoint is a participant count, and no dispersion value is reported. General statistical explanation: for count outcomes, a statistical model may need to account for variability that exceeds the model's basic assumptions, a condition often called over-dispersion. Ignoring it can make uncertainty estimates too narrow. Whether that issue applies depends on the data and model. The registry record does not report the distribution of counts, a model, or an over-dispersion assessment, so no claim about its presence or handling is possible.

Overall, the record supports a description of the endpoint and design, but not a reconstruction of an analysis. The underlying data, analysis population, missing-data procedures, and model specifications are not reported in the registry record.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("HPV+ Pap Smear")
n      <- c(503)
events <- c(503)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  HPV+ Pap Smear  503  503  100.0  99.3  100.0  99.2  100.0  99.3  100.0

11. Multiplicity, Missing Data and Analysis Populations

The record lists two outcome measures: the primary count of HPV-positive women examined and a secondary outcome concerning the number completing the 6 Month follow-up after evaluation and treatment. It lists no analyses and reports no numerical results for either outcome. The registry record does not state whether the outcomes were tested, whether a hierarchy or multiplicity adjustment was planned, or whether any interim analyses were conducted. These details are not reported in the registry record.

General statistical explanation: when several outcomes or hypotheses are tested, the chance of at least one apparently positive result can increase if each is evaluated separately without adjustment. A prespecified hierarchy or an adjustment can address some multiplicity concerns, but the appropriate approach depends on the analysis plan and question. No approach can be attributed to this study from the available record.

The record does not describe missing-data handling, exclusions, withdrawals, or the number of participants with outcome data. It also does not define an analysis population beyond the endpoint's description. Enrollment is reported as 503, but the record does not establish how many participants contributed to each outcome or whether follow-up was complete. The completed study status does not establish complete data capture.

General statistical explanation: missing outcomes can affect interpretation when the likelihood of missingness is related to participant characteristics or outcomes. Analysts may use different methods depending on the data and assumptions, but those methods should be reported because each has limitations. No missing-data method or sensitivity analysis is reported in the registry record. As a result, the extent and potential effect of missing outcome data cannot be assessed from the posted record.

12. 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 safety listing reports 503 participants at risk for serious adverse events and 0 with serious adverse events in the HPV+ Pap Smear group. It also reports 503 at risk for other adverse events and 0 with other adverse events, with 0 deaths. No serious adverse event terms are listed.

These are the posted counts, not evidence that no adverse events occurred outside the registry's reporting definitions or observation process. The record does not provide event descriptions, follow-up completeness, timing, severity details beyond the serious-event category, or an explanation of how events were collected. It also does not report a separate safety analysis.

General statistical explanation: a zero event count is a descriptive observation. Its interpretation depends on the population observed, duration and completeness of follow-up, and the way events were defined and recorded. A zero count does not by itself establish that an intervention has no risk. Since the record gives no comparator group, these figures also do not permit a comparative safety estimate. The reported at-risk counts should not be treated as proof that every participant had complete safety follow-up.

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

The record establishes that a completed, single-group study was registered to evaluate use of a pocket colposcope and thermocoagulator in a Peruvian care setting. It defines a primary outcome that counts HPV-positive women examined at a health center and lists a secondary follow-up outcome. It also reports enrollment and safety counts. These details describe the study and the outcomes it intended to record.

The posted record does not report the primary endpoint count or the secondary outcome result. It therefore does not show how many women were examined, how many completed the stated follow-up, or what proportion of any eligible or invited population those counts represent. The approximate plans in the brief summary are not observed outcome data. The enrollment number is not interchangeable with either outcome.

The record also does not provide a comparative result. With a single group and no reported comparator, the study description does not support an estimate of how outcomes would differ under another approach. No reported analysis, confidence interval, or p-value allows a reader to quantify statistical uncertainty around the primary result.

The safety listing reports zero serious adverse events, zero other adverse events, and zero deaths in the recorded group, alongside the stated at-risk counts. Those figures should be read as registry-reported counts, not as proof of absence of risk or complete safety follow-up.

In short, the record describes an implementation-oriented study and its intended measurements, but does not provide the outcome data needed to determine the observed examination count, follow-up completion, or statistical precision. No conclusion about treatment benefit or lack of benefit can be drawn from the missing outcome results.

14. Why This Trial Matters Statistically

This study is statistically notable for the distinction between an implementation count and a treatment-effect estimate. The primary endpoint counts HPV-positive women examined using the pocket colposcope. Such a count can describe activity in a care pathway, but its interpretation depends on the eligible population and outcome completeness. Neither a denominator for uptake nor the observed count is reported in the registry record.

The single-group design fits a descriptive question about use of the device in the recorded setting, but it does not create a randomized comparison. Readers should distinguish the aim of extending examination capacity from evidence of a causal effect on clinical outcomes. The record's intervention description includes treatment when abnormalities are present, but the primary outcome measures examination rather than treatment or subsequent clinical outcomes.

The study also illustrates why registration status and posted results are different kinds of information. The record is marked completed and gives enrollment and study dates, yet it does not report numerical primary or secondary outcome results or any analyses. A completion status cannot replace estimates, denominators, or uncertainty measures when assessing what was observed.

Finally, the planning assumptions described for sample-size illustrations use a two-arm framework, while the registered study is single-group. Keeping planning assumptions separate from the actual design is essential: hypothetical calculations are not the study's sample-size rationale and are not observed power. The record does not report the study's own sample-size justification. These distinctions help prevent descriptive plans, registered design details, and outcome evidence from being treated as equivalent.

15. 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 record is that it does not report numerical results for either listed outcome. The primary examination count and secondary follow-up count are therefore unavailable, as are estimates of uncertainty. The enrollment figure does not resolve this gap because the record does not state how many enrolled participants contributed data to either endpoint.

The single-group design has no reported comparator, so it cannot provide a randomized estimate of differences between intervention strategies. The record also does not report detailed eligibility criteria, the number invited, a defined denominator for examination uptake, or the flow of participants through screening, examination, treatment, and follow-up. Approximate figures in the brief summary describe expectations rather than observed results.

Important analysis details are not reported in the registry record, including the statistical analysis plan, analysis populations, missing-data methods, multiplicity approach, and whether any interim analyses occurred. The record lists no analyses. As a result, it is not possible to assess whether outcome definitions or analyses changed, how incomplete follow-up was handled, or whether uncertainty estimates account for the data structure.

The safety information is limited to aggregate counts. Event definitions, collection procedures, timing, and completeness of safety follow-up are not reported. The planning assumptions for sample-size illustrations describe two-arm calculations, which do not match the registered single-group design; they should not be mistaken for the trial's design or its own sample-size justification.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Identification and Treatment of Cervical Abnormalities in Perú Through Integration of Pocket Colposcopy and Telemedicine — NCT05340322.
• Registry record last updated 2024-07-23; status last verified 2024-07.
• Results first posted 2024-07-23.
• 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.

19. Record Summary

The registry describes a completed, single-group device study in Perú, sponsored by Duke University, with enrollment of 503. The listed intervention was colposcopy using a pocket colposcope and thermocoagulator. The primary outcome was the count of HPV-positive women examined at a Peruvian health center, with a timeframe of up to approximately 1 year.

The record lists a secondary outcome about 6 Month follow-up and reports safety counts of 0 serious adverse events, 0 other adverse events, and 0 deaths. It does not report numerical results for either outcome or list any analyses. No randomized comparator is reported, and the record does not provide the analysis population, missing-data approach, or statistical plan. Consequently, the design and intended measurements can be described, but the primary examination result and its statistical precision cannot be assessed from the registry record.