Cervical Cancer Prevention for Black Adults: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Cervical Cancer Prevention for Black Adults (NCT04927494), a na na study. The primary outcome is Number of Participants That Completed HPV Self-sampling.

2. Clinical Question

3. Trial Design

The registry describes a completed, two-phase study of Health is Wealth: A Cervical Health Program. Its stated goal was to develop and pilot test a program intended to promote cervical cancer screening and reduce perceived screening barriers. The study is classified as single-group, with no masking and no randomized comparison. The registry reports enrollment of 288 and a start date of 2023-01-01; primary completion is listed as 2025-05-10.

Phase 1 included a cross-sectional survey with Black men and women to examine factors that may affect cervical cancer screening, as well as a focus-group activity described as a quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention. The intervention group is described as Black women receiving the Health is Wealth program. The registry's summary also describes a pilot aim among 30 AA and 30 SAI women using a quasi-experimental design. These descriptions indicate distinct study activities, not randomized treatment and control arms.

The registry record does not report how participants were recruited, how the intervention was delivered, the duration or frequency of program activities, or how eligibility was determined. It also does not report a protocol-based sample-size justification or explain how the overall enrollment relates to the smaller group described for the pilot aim and the baseline self-sampling count. Those details are not reported in the registry record. The listed status is completed, but the record does not establish that every planned activity or outcome was analyzed or that all enrolled participants contributed data to each measure.

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:

Analysis population for the primary outcome, as defined in the registry: Phase 1 survey and Phase 1 focus group participants did not receive self sampling kits. Out of the 60 participants enrolled in baseline only 35 participants opted to self-sample. Out of those 35, 25 completed and returned the self-sample kits.

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 Participants That Completed HPV Self-sampling, measured over Baseline.

The primary endpoint is the number of participants who completed HPV self-sampling. The registry defines completion as returning a self-sample kit, and lists the timeframe as baseline. Its description says Phase 1 survey and focus-group participants did not receive kits. Among the 60 participants enrolled at baseline, 35 opted to self-sample and 25 returned kits.

A count endpoint describes how many participants experienced a defined event—in this case, kit return. It can document whether self-sampling was taken up and completed within the group eligible to receive a kit. This is a practical measure of participation in a screening-related activity, and it is distinct from a measure of cervical cancer incidence, diagnostic accuracy, or change in screening behavior over time. The registry does not report a rate or a comparison for this endpoint, and no such quantity should be inferred from the count alone.

The measure is also limited by its denominator and the study’s different activity groups. The registry reports the number who enrolled at baseline, the number who opted to self-sample, and the number who returned kits, but does not describe a comparison group receiving an alternative approach. It does not report reasons for declining self-sampling or failing to return a kit. As a result, the count records completion but cannot by itself explain why some participants did not return kits or establish what would have happened under another program or screening option.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry classifies the study as single-group, with allocation not applicable and no masking. It also cautions that the study is not a randomized comparison and that its arms are not like-for-like control groups. Those design features shape what can be concluded from the posted result: a count of kit returns describes what occurred among the participants noted in the outcome description, but does not isolate an intervention effect from other influences.

What does a single-group result describe?

In general, a single-group study can characterize outcomes among participants who take part in a program or activity. If a result is simply a count, it reports the observed number meeting the endpoint definition. It does not establish what the same participants would have experienced without the program. A comparison group can help address that question when its design and analysis make the groups meaningfully comparable. The registry does not describe a randomized control group for this study, and explicitly warns against treating its arms as a like-for-like comparison.

Here, the primary endpoint is the number who returned HPV self-sampling kits. The outcome description reports 25 returned kits, and identifies 35 participants as having opted to self-sample among 60 enrolled at baseline. These counts answer a descriptive question about uptake and completion in the group described. They do not quantify a difference between the program and an alternative, nor do they show that the program caused participants to return kits.

What would uncertainty measures add?

In general, a confidence interval expresses the range of values compatible with an estimate under a specified statistical model and sampling process. For a count or proportion, uncertainty depends on the defined population, the denominator, and the method used. A narrow interval would indicate greater statistical precision under that model; a wide interval would indicate less precision. An interval does not correct biases in selection, measurement, or study design. The registry record does not report a confidence interval or an inferential analysis for the primary endpoint, so its statistical precision is not presented.

Similarly, a hypothesis test evaluates data relative to a specified null hypothesis and model. Its interpretation depends on the planned question, assumptions, and analysis population. The registry record does not report a hypothesis test for kit return, a statistical analysis plan, or interim analyses. It is therefore not possible to describe a prespecified test or to interpret a p-value for this endpoint from the posted results.

How should planning illustrations be read?

General sample-size calculations describe how many participants might be needed under stated assumptions for a planned comparison. They are planning illustrations, not observed findings and not evidence that a study had a particular probability of detecting an effect. The registry’s sample-size note describes illustrations based on an observed effect, with two-sided significance level 0.05, equal allocation between two arms, and a normal approximation; it specifies that the effect to detect is a stated fraction of the observed effect. These are calculation assumptions, not a reported design justification for this single-group study. The registry record does not report its own sample-size justification. Without a valid comparison and a defined effect estimate for the relevant endpoint, such illustrations should not be interpreted as a trial-specific power analysis.

General principle: over-dispersion occurs when outcome variability is greater than assumed by a simple model. If present, it can make model-based uncertainty estimates too small unless the analysis accounts for the extra variability. The primary outcome is reported as a count of participants, and the record gives no dispersion estimate, model, or fitted analysis. There is therefore no basis in the registry record to assess over-dispersion or to claim that a particular count model was used.

What can be said about the posted analysis?

The registry record lists nine outcome measures and no analyses. That means the posted record does not provide inferential results for the stated primary or secondary outcomes. The primary count can be described as reported, but it should not be recast as an effect estimate, adjusted result, or evidence of statistical significance. The record does not describe how missing endpoint data were handled, whether any participants were excluded from analyses, or which analysis population was used. Those details 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("Black Women Cervical Cancer Screening")
n      <- c(35)
events <- c(25)
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  Black Women Cervical Cancer Screening  35  25  71.4  53.7  85.4  54.9  83.7  54.8  83.7

11. Multiplicity, Missing Data and Analysis Populations

The registry lists nine outcome measures, including a primary count of participants returning HPV self-sampling kits and secondary outcomes concerning changes in perceived benefits of Pap testing, perceived susceptibility and seriousness of cervical cancer, and perceived cervical cancer risk factors. It does not report inferential analyses for these measures. A multiplicity adjustment or other approach to controlling the interpretation of multiple statistical tests is not reported in the registry record. Without posted tests or a statistical analysis plan, it is not possible to determine whether multiple comparisons were planned or how they would have been handled.

The primary endpoint description reports the baseline enrollment count, the number who opted to self-sample, and the number who returned kits. It does not explain how participants with unavailable or incomplete endpoint information were handled. Reasons for not opting in or not returning a kit are not reported in the registry record. The record also does not specify whether missing data were imputed, whether analyses used complete cases, or whether sensitivity analyses were conducted.

The registry’s descriptions refer to multiple study activities and participant groups: a cross-sectional survey, a focus group, and a group receiving the behavioral intervention. The primary outcome description clarifies that survey and focus-group participants did not receive self-sampling kits. However, the analysis population for each outcome and the relationship between the reported enrollment of 288, the 60 baseline participants, and the pilot aim are not explained. Those details are not reported in the registry record.

General statistical principle: multiplicity can increase the chance of a false-positive finding when many hypotheses are tested, while missing-data methods can affect estimates if the observed participants differ from those without outcome information. Neither issue can be evaluated from counts alone. No analysis population, missing-data strategy, or multiplicity procedure is reported for the posted results.

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

The posted primary outcome records that 25 participants returned HPV self-sampling kits. The registry also states that 35 of the 60 participants enrolled at baseline opted to self-sample, and that Phase 1 survey and focus-group participants did not receive kits. These observations describe participation in the self-sampling activity. They do not establish an intervention effect, explain why participants did or did not return kits, or determine whether self-sampling changed cervical cancer screening behavior.

The broader study aimed to develop and pilot test a cervical health program and to examine awareness, cultural factors, barriers and facilitators, feasibility, acceptability, and preliminary efficacy. A kit-return count addresses only one part of that set of questions. The listed secondary outcomes concern perceptions, but numerical results for those measures are not reported in the registry record. The posted information therefore cannot establish whether perceptions changed or whether the program was feasible or acceptable according to defined criteria.

General statistical principle: an observed result and a causal conclusion are different. To attribute an outcome to an intervention, the design and analysis need to address what would have occurred without that intervention and other explanations for the observed result. The registry describes no randomized control comparison and warns that the arms are not like-for-like. The count should therefore not be interpreted as proof that the program caused kit return, or as evidence about how a different screening approach would perform.

The registry lists the study as completed and reports enrollment of 288, but the primary outcome description concerns a baseline group of 60. The record does not explain how those counts relate. No inferential analysis or uncertainty estimate is reported. The result should be understood as a descriptive count in the group identified in the outcome description, not as a precise estimate for all enrolled participants or for the wider communities named in the study.

13. Why This Trial Matters Statistically

Statistically, the registry record illustrates the importance of aligning a study question, design, endpoint, and analysis. The stated program aims concern screening promotion and perceived barriers, while the posted primary measure is a count of returned HPV self-sampling kits. That count offers a concrete description of participation, but it does not by itself answer whether the program changed screening behavior or outperformed another approach.

The record also describes distinct phases and participant activities. Survey and focus-group participants did not receive kits, while the intervention group is described as receiving the behavioral program. Treating such groups as interchangeable controls would ignore their different roles. The registry explicitly notes that the study is not a randomized comparison and that its arms are not like-for-like. This makes careful definition of the outcome population and denominator especially important.

Another statistical issue is the distinction between enrollment and analysis. The record reports 288 enrolled participants, a baseline count of 60 in the self-sampling description, and a pilot aim involving 30 AA and 30 SAI women. It does not explain how these counts relate. Nor does it report inferential analyses, uncertainty estimates, or a statistical analysis plan. Consequently, the posted result is useful as a record of observed kit returns, but it does not provide an estimate of precision or a basis for causal inference.

For clinical research, transparent reporting of who was eligible for each activity, who received the intervention or kit, which participants contributed to each outcome, and how incomplete data were handled helps readers assess what a result means. Those details are not reported in the registry record. The study’s focus on screening barriers and program development makes these design and reporting distinctions central to interpreting its descriptive result without extending it beyond what the record documents.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The primary result is descriptive and lacks a randomized comparison. The registry states that allocation is not applicable, classifies the design as single-group, and cautions that the arms are not a like-for-like control comparison. The posted count therefore cannot isolate an intervention effect or support a causal comparison with another screening approach.

The outcome description distinguishes participants who opted to self-sample from participants who returned kits, but does not report why participants declined or did not complete kit return. It also does not describe whether all eligible participants were offered a kit or how eligibility was determined. Phase 1 survey and focus-group participants did not receive kits, which means the full enrolled population is not necessarily the relevant denominator for this endpoint.

Several enrollment descriptions appear in the record: overall enrollment of 288, a baseline group of 60 in the primary outcome description, and a pilot aim among 30 AA and 30 SAI women. The registry does not explain how these figures relate or which participants were included in each analysis. It also does not report recruitment methods, intervention delivery details, analysis populations, handling of missing data, or numerical results for the listed secondary outcomes.

No inferential analyses, uncertainty estimates, or statistical analysis plan are reported in the registry record. The record does not provide a protocol-based sample-size justification. The listed completed status does not resolve these limitations, and the posted count cannot establish the result’s precision, representativeness, or causal meaning.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Cervical Cancer Prevention for Black Adults — NCT04927494.
• Registry record last updated 2026-07-31; status last verified 2026-05.
• Results first posted 2026-07-01.
• 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

NCT04927494 is a completed, single-group study titled “Cervical Cancer Prevention for Black Adults,” with an official title focused on promoting cervical cancer screening among African American and Sub Saharan African immigrants. The registry lists a behavioral intervention, Health is Wealth: A Cervical Health Program, and describes a two-phase study intended to develop and pilot test the program. Enrollment is listed as 288; the start date is 2023-01-01 and primary completion is 2025-05-10.

The primary outcome counts participants who completed HPV self-sampling, defined as returning a kit. The description reports that 35 of 60 baseline participants opted to self-sample and that 25 returned kits. Phase 1 survey and focus-group participants did not receive kits. The record lists secondary outcomes concerning perceived benefits of Pap testing, perceived susceptibility and seriousness of cervical cancer, and perceived risk factors, but their numerical results are not reported in the registry record.

No inferential analyses are reported. The registry describes no randomized control comparison and cautions that the study groups are not like-for-like controls. The relationship among the different enrollment and pilot counts is not reported in the registry record.