Simulation Training for Labor and Delivery Providers to Address HIV Stigma During Childbirth in Tanzania: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Simulation Training for Labor and Delivery Providers to Address HIV Stigma During Childbirth in Tanzania (NCT05271903), a na na study. The primary outcome is Change in Respectful Maternity Care.

2. Clinical Question

3. Trial Design

This completed study was registered as a single-group behavioral intervention study of simulation and experiential learning for labor and delivery providers in Tanzania. The intervention is named MAMA. Enrollment was 60. The registry record lists phase as NA, allocation as NA, and masking as none. Those entries do not describe a randomized, masked comparison with a separate control group.

The listed study dates are 2022-01-31 for start and 2023-06-01 for primary completion. The record describes the project as developing and pilot testing an intervention to address HIV stigma during childbirth. Its brief summary says the primary endpoint would compare patient-rated respectful maternity care among women delivering in pre-intervention and post-intervention periods. However, the description for the listed primary outcome says the population includes only the health care providers (n=60) who received the intervention. It describes provider practices, rather than a patient-rated between-period comparison. The record does not explain this difference in population and framing.

The registry record lists one outcome measure and zero analyses. It does not report an outcome estimate, a comparison estimate, a confidence interval, or a p-value. Therefore, the design description establishes the broad intervention and intended topic, but it does not establish how the planned comparison was conducted or what numerical change was observed. Details about recruitment, the number of women in each period, provider-level follow-up, and the analysis population beyond the stated provider group 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.

Before assignment: In this pilot trial, the primary outcome measure (change in respectful maternity care score) was assessed with the health care providers (n=60) who were enrolled and exposed to the MAMA training intervention.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Includes only the health care providers (n=60) who received the intervention.

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 Change in Respectful Maternity Care, measured over 3 months.

The primary outcome is titled Change in Respectful Maternity Care and is described as a mean score on a scale, with standard deviation as the stated measure of dispersion. The measure is identified as the Person-centered maternity care scale, validated by Afulani et al. In Kenya and Ghana. It includes nine questions about how often person-centered practices were used in the past month. Each item has four response options, from never to always, and the item responses are summed. The possible scale range is 0 to 27; higher scores reflect more respectful care.

This type of measure is intended to turn reported care practices into a consistent score that can be described and compared. In general, a summed scale can capture several aspects of a construct, while its interpretation depends on the questions, response options, respondent, and assessment period. The registry record lists a timeframe of 3 months, but does not explain how that timeframe relates to the scale's past-month questions or whether it marks time since the intervention.

The brief summary describes patient-rated changes across pre-intervention and post-intervention delivery periods. The primary outcome description instead identifies the 60 providers who received the intervention and describes their practices. The registry record does not reconcile these accounts. It also does not report the observed mean, change, or variability, so the endpoint's direction and magnitude cannot be assessed from the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean score represent?

The primary outcome is described as a mean of a continuous measure. In general, a mean is the arithmetic average of recorded scores and provides a measure of the center of a distribution. Here, the scale sums responses to nine questions about the frequency of person-centered practices in the past month. Responses range from never to always, and the total score can range from 0 to 27, with higher values representing more respectful care. The registry record does not provide the observed mean score or a change in that mean.

The outcome description names standard deviation as the measure of dispersion. In general, a standard deviation describes how spread out individual observations are around the mean. It is not the same as a confidence interval: the standard deviation describes variation among observations, while a confidence interval describes uncertainty around an estimated quantity. Neither an observed standard deviation nor a confidence interval is reported for the primary outcome.

What would an intervention comparison estimate?

The brief summary frames the primary endpoint as a comparison between women delivering in the pre-intervention period and women delivering in the post-intervention period. The listed outcome description instead identifies providers who received the intervention as the outcome population. The registry record does not say whether provider scores, patient ratings, or both were used to form a comparison estimate. Without that clarification and the numerical results, a reader cannot determine the estimand—the specific quantity the analysis was intended to estimate.

In general, a mean difference compares average scores between groups or periods. Its interpretation depends on who contributes observations, when measurement occurs, and whether observations are independent or linked across time. A comparison of different groups of women across periods is not the same as measuring the same providers before and after training. The registry record does not report whether observations were paired, how repeated observations were handled, or whether clustering by provider or facility was considered.

How should uncertainty be understood?

In general, an estimate is more informative when paired with an uncertainty measure. A confidence interval conveys the precision of the estimate under the analysis assumptions; it is not a guarantee that the true value lies within the interval. A p-value, when reported, summarizes how compatible the observed data are with a specified null hypothesis under the statistical model. Neither a p-value nor a confidence interval can replace the estimated effect or explain the design limitations. No outcome estimate, uncertainty interval, or p-value is reported in the registry record, so statistical significance and precision cannot be assessed.

The record gives no statistical model, covariate adjustment, or missing-data procedure. These methods are not interchangeable: adjustment can account for measured characteristics under stated assumptions, while missing-data methods address incomplete outcome observations under their own assumptions. In general, conclusions can depend on those choices, particularly if the analyzed participants differ from those with missing measurements. The record does not report the number of completed outcome measures or whether any participants were excluded from the outcome analysis.

What do the planning assumptions mean?

The record describes planning calculations as an illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not a description of the study's actual single-group design. The record does not list numerical planning counts in the material describing the study result, and no such count should be read as the number enrolled or analyzed.

In general, a sample-size calculation asks how many observations a proposed design would need to detect a specified effect under chosen assumptions. Such a calculation is conditional on the assumed effect, variability, significance level, allocation, and statistical model. A planning illustration is not observed power, which is not a substitute for reporting the effect estimate and its uncertainty. The stated equal allocation between two arms also differs from the registry's single-group design description; it should not be mistaken for evidence that this study enrolled randomized arms.

Why can variation affect analysis?

In general, if outcome variability is larger than a model assumes, estimates may be less precise than expected. For count outcomes, over-dispersion means the observed variation exceeds what a simple count model allows; it can lead to underestimated uncertainty if ignored. The primary outcome is described as a continuous scale score, not a count outcome, and the registry record does not report an over-dispersion assessment or a model. This concept therefore explains a general modeling issue rather than a reported feature of this analysis.

For any statistical analysis, the model should correspond to the outcome and comparison actually observed. The record does not provide enough analysis detail to assess model choice, assumptions, diagnostics, or robustness. It also does not report whether the stated scale was analyzed as a continuous score or in another way. Those details are not reported in the registry record, so the outcome definition can be described, but the analysis cannot be independently evaluated from the posted results.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("MAMA Training")
n   <- c(60)
m   <- c(21.8)
sp  <- c(3.1)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  MAMA Training  60  21.800  3.100  20.999  22.601

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists one outcome measure and zero analyses. It does not report a multiplicity strategy, such as how the interpretation would account for testing several outcomes, time points, or subgroups. With one listed outcome measure, it is not possible to infer whether additional analyses were planned or conducted; those details are not reported in the registry record.

Missing-data methods and the number of outcome observations available for analysis are not reported in the registry record. Enrollment is 60, and the outcome description identifies the 60 providers who received the intervention, but the record does not say whether every enrolled provider completed the scale or contributed a result. It does not describe imputation, complete-case analysis, reasons for missing observations, or sensitivity analyses. In general, missingness can affect an estimate if the observed participants differ systematically from those without measurements. The available record does not permit assessment of that possibility.

The analysis population is also unclear because the brief summary describes patient-rated comparisons between pre-intervention and post-intervention delivery periods, whereas the listed outcome population is the providers who received the intervention. The record does not identify the number of women in each period or state which population was used for a numerical analysis. No analysis estimate is reported. Therefore, neither the handling of multiplicity nor the effects of missing data or population selection can be evaluated from the registry 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 registry record lists the intervention group with 60 participants at risk for serious adverse events and zero affected. It also lists 60 at risk for other adverse events and zero affected, with zero deaths. No serious adverse event terms are listed. These are reported counts; the record does not provide further detail about event definitions, monitoring, collection periods, or ascertainment.

In general, a zero count means that no events of the specified type were recorded in the stated group and reporting period. It does not prove that the underlying event risk is zero, and it does not establish that all possible harms were assessed or absent. The serious adverse event counts should not be interpreted as a complete account of every adverse event, because the record lists no event terms and does not describe broader safety reporting. The figures also do not provide a comparative safety estimate, since the study is listed as single group and no control group is reported. No medical conclusion about safety follows from these counts alone.

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

The registry record identifies a study of simulation and experiential learning for labor and delivery providers in Tanzania, with the aim of addressing HIV stigma during childbirth. It defines a respectful maternity care measure and describes the intervention group as 60 providers. It also gives a brief-summary question about patient-rated care before and after the intervention. These details establish the intended topic, but not the observed effect.

The primary outcome's numerical result is not reported in the registry record. There is no posted mean, change estimate, standard deviation, confidence interval, or p-value. As a result, the available record does not show whether the score increased, decreased, or remained similar, nor how precisely any change was estimated. The lack of a reported result is not evidence of no effect.

The study is listed as single group, with no masking and allocation recorded as NA. Its brief summary proposes a comparison across pre-intervention and post-intervention periods, but the outcome description identifies providers receiving the intervention rather than the women in those periods. The record does not clarify the analysis population or provide a concurrent control group. In general, a change across time can be associated with an intervention without establishing that the intervention caused the change; other influences and differences in the measured groups may also matter.

The safety entries report zero serious adverse events and zero deaths among 60 at risk in the intervention group. Those counts describe the registry entries and do not establish that all adverse events were absent. Overall, the record supports a description of the study's purpose, intervention, and intended outcome, but does not support a conclusion about effectiveness, magnitude of change, precision, or causal attribution.

14. Why This Trial Matters Statistically

This study raises a statistical question that is central to evaluating behavioral interventions: what was measured, in whom, and across which comparison? The registry's brief summary focuses on patient-rated respectful maternity care across pre-intervention and post-intervention periods. The listed outcome description instead focuses on practices reported by the 60 providers who received the intervention. Distinguishing these populations and measurement approaches is essential because they represent different outcomes and analyses.

The study is listed as single group, rather than as a randomized comparison. That design information matters when interpreting changes over time: a pre/post difference, if reported, would not by itself separate intervention-related change from other changes between periods. In general, statistical interpretation depends not only on a score and p-value but also on the design that generated the observations and the assumptions behind the comparison.

The scale description provides useful interpretive context: it has nine questions, four response options, and a possible range of 0 to 27, with higher scores representing more respectful care. Yet a defined measure is not a result. Because no outcome estimate or uncertainty measure is reported in the registry record, readers cannot assess magnitude or precision. This distinction is important in clinical research: a clear endpoint and completed study status do not substitute for a transparent analysis of the observed outcome.

The record also illustrates why enrollment and analysis populations should be distinguished. Enrollment is 60, but the record does not report how many outcome observations were analyzed or how missing data were handled. Without those details, a reader cannot assess whether the observed population represented all enrolled participants or how the intended comparison was implemented. These statistical reporting questions are consequential for understanding what a study can establish.

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.

Several limitations are specific to the information reported for this study. First, the registry gives two different descriptions of the primary outcome population. The brief summary describes patient ratings among women delivering before and after the intervention, while the outcome description says the population consists only of the 60 providers who received the intervention and describes their use of person-centered practices. The record does not clarify which population generated the primary outcome.

Second, the design is listed as single group, allocation NA, and masking none. The record does not identify a concurrent control group or explain the comparison implied by the pre-intervention and post-intervention summary. If different people were observed in the two periods, their characteristics and experiences could differ; if the same providers were measured repeatedly, the analysis would need to account for that structure. The registry record does not say which situation applies.

Third, no numerical primary outcome result or analysis details are reported. Means, dispersion, effect estimates, confidence intervals, p-values, model specifications, and adjustment methods are absent. The record also does not report missing-data handling, outcome completion, or the number of observations included in an analysis. These omissions prevent assessment of precision, robustness, and the population represented by any estimate.

Finally, the scale timeframe is listed as 3 months while its questions ask about practices in the past month; the relationship between those periods is not explained. The record describes the study as completed but does not provide a numerical outcome analysis. These limitations concern what can be understood from the registry record and do not establish what occurred outside the information recorded there.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Simulation Training for Labor and Delivery Providers to Address HIV Stigma During Childbirth in Tanzania — NCT05271903.
• Registry record last updated 2025-10-20; status last verified 2025-10.
• Results first posted 2025-10-20.
• 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 record describes a completed, single-group behavioral study in Tanzania of the MAMA simulation and experiential learning intervention for labor and delivery providers. Enrollment was 60; masking was listed as none, and allocation and phase were listed as NA. The study aimed to address HIV stigma during childbirth.

The primary outcome is change in respectful maternity care, measured with the Person-centered maternity care scale, a summed score ranging from 0 to 27. The record's brief summary describes patient-rated comparisons across pre-intervention and post-intervention periods, while the outcome description identifies providers who received the intervention. This difference is not explained. The record lists one outcome measure and zero analyses, and does not report the numerical outcome result or its precision. Safety entries list zero serious adverse events and zero deaths among 60 at risk in the intervention group.