Supporting Oral Pre-exposure Prophylaxis Decision Making Among Pregnant Women in Lilongwe, Malawi: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Supporting Oral Pre-exposure Prophylaxis Decision Making Among Pregnant Women in Lilongwe, Malawi (NCT06394323), a randomized na study. The primary outcome is Mean Acceptability of Intervention (AIM) Scale Score.

2. Clinical Question

3. Trial Design

This is a pilot study of a behavioral counseling intervention for HIV prevention decision making during pregnancy and breastfeeding. The registry identifies the allocation as randomized, the masking as none, and the model as parallel. The study title identifies Lilongwe, Malawi. Its stated overall objective is to evaluate the feasibility, acceptability, and appropriateness of the shared decision-making intervention and the associated study procedures.

The registry describes 100 HIV-negative pregnant women as the intended randomized study population. The enrollment field records 132 participants. Those figures describe different items in the record: the planned number of women in the study description and the recorded enrollment. The record also describes qualitative interviews with a subset of women, up to 20 male partners, and up to 15 study staff. Safety-group counts separately list 50 participants in each counseling arm, 20 male partners, and 12 clinicians and counselors.

Women were assigned to MyChoice or standard-of-care counseling. The MyChoice approach uses shared decision-making counseling from a trained counselor. Standard-of-care counseling is described as PrEP counseling according to national guidelines, also delivered by trained study staff. Women expressing interest in oral PrEP were to be referred to government PrEP services. The registry does not report how many women expressed interest or were referred.

The primary outcome is the mean AIM score, with assessments scheduled at enrollment and month 2. Only MyChoice participants with one or more completed AIM items were included in that outcome population; the control arm and interview groups were not asked to complete the AIM items. A secondary outcome is the mean Decisional Conflict Scale score. The record lists four outcome measures but does not provide their full results in the record.

The study is marked completed. The registry lists a start date of 2024-08-06 and a primary completion date of 2025-02-07. It identifies the study as phase NA. The record does not report details of the randomization procedure, allocation concealment, recruitment flow, or a full protocol-level statistical analysis plan.

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: Only participants that received the MyChoice intervention and had one or more completed items of the AIM scale were included. Participants in the Standard of Care (SOC) Control Arm, Male Partner In-Depth Interviews, and Clinician and Counselor In-Depth Interviews were not asked to complete these items.

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: Participants at baseline who were consented and enrolled.

6. Primary Endpoint

The registry lists the primary outcome as Mean Acceptability of Intervention (AIM) Scale Score, measured over enrollment visit (month 0), month 2 follow up visit.

The primary outcome is the mean Acceptability of Intervention Measure score. AIM is a validated four-item self-report scale intended to capture how agreeable, palatable, or satisfactory participants find an intervention. Each item uses a five-point Likert response, from 1, “Completely Disagree,” to 5, “Completely Agree.” For each participant at each time point, the item responses are combined into a mean score ranging from 1 to 5; higher scores indicate greater reported acceptability.

The registry defines the group-level outcome as the average of participants’ individual mean scores at each time point. It specifies a 95% confidence interval around that mean of means, calculated using the common standard error. Assessments were scheduled for the enrollment visit, identified as month 0, and the month 2 follow-up visit. The outcome population is restricted to participants who received MyChoice and had at least one completed AIM item. Standard-of-care participants and the qualitative interview groups were not asked to complete these items.

Acceptability is relevant to a pilot whose stated purpose includes evaluating whether the intervention is agreeable and satisfactory to participants. It describes participants’ perceptions, not the intervention’s effect on HIV acquisition, PrEP uptake, or clinical outcomes. The registry record does not report the AIM means, confidence intervals, or the number of participants contributing data at either time point.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a continuous measure: the AIM score can take values across a defined numerical scale, and the registered summary is a mean. A mean describes the average score in the participants included in the calculation. It does not show how scores are distributed across individuals. Two groups of participants could have the same mean while differing in how tightly or widely their individual responses are spread.

What does the confidence interval describe?

The registry specifies a 95% confidence interval around the mean of individual participants’ mean scores. In general, a confidence interval expresses uncertainty in an estimated population mean arising from sampling variability and the statistical method used. Under the method’s assumptions, intervals constructed in this way have a long-run coverage interpretation. It is not correct to read a particular interval as meaning that there is a 95% probability that the fixed population value lies within that already calculated interval.

The registry says the interval was calculated using the common standard error. A standard error describes uncertainty in an estimate, rather than the variability of individual scores themselves. The record does not give the numerical standard errors or AIM confidence limits, so the precision of the mean cannot be evaluated from the posted results. The exact implementation details beyond the stated common-standard-error approach are not reported in the registry record.

How is the AIM score formed?

The measure contains four self-reported items, with each response rated on a five-point scale from complete disagreement to complete agreement. For each participant at each assessment, the mean of completed AIM items is used, with a possible score from 1 to 5. The registry states that participants with one or more completed items could be included. It does not report how many items were completed by each participant, whether any item-level handling rules were applied, or how partial item completion affected the reported analysis.

At each time point, participants’ individual mean scores are then averaged to form the group mean. This makes the endpoint a summary of participant-level scores, rather than a count of favorable responses or a proportion meeting a threshold. The record does not report a threshold defining acceptable intervention, and none should be inferred from the scale range alone.

What does the design imply for comparisons?

Random assignment to two parallel counseling arms can support a randomized comparison when the same outcome is collected and analyzed comparably in both arms. Here, the registered primary AIM population includes only MyChoice participants, and the record says standard-of-care participants were not asked to complete the AIM items. Accordingly, the registered primary outcome is a description of intervention acceptability within the intervention group, not an AIM treatment contrast between randomized arms.

The two scheduled assessments could describe AIM scores at enrollment and month 2, but their timing alone does not define a statistical comparison. The registry record does not report whether the primary analysis compared those time points, treated them separately, or used another approach. The recorded note says the primary outcome has several categories or time points and was not reduced to one comparison. That means a single comparative effect should not be assumed from the registry summary.

What is not specified?

The record identifies one analysis but does not describe its model, adjustment variables, handling of repeated measurements, or approach to missing observations. It does not report a sample-size justification, a prespecified effect to detect, interim analyses, or a detailed multiplicity strategy. These aspects are not reported in the registry record, so no assumptions about them should be treated as part of the study’s confirmed analysis plan.

General statistical considerations still apply. Repeated measurements from the same participant are usually related, so an analysis comparing time points would need to account for that dependence. Missing responses can affect both the number of observations and the interpretation of the analyzed group, particularly if completion is related to participants’ views. Those are general considerations; the record does not specify how such issues were handled in this study.

The study is a pilot focused on implementation-related questions. In general, pilot studies can help assess procedures and generate estimates, but their findings do not automatically establish a clinical benefit or provide a definitive comparison. Any sample-size illustration based on an observed effect is a planning scenario, not observed power. The registry does not report a sample-size justification, and a planning calculation cannot substitute for the missing outcome estimates or a prespecified design rationale.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures, identifies the AIM mean as the primary outcome, and lists mean Decisional Conflict Scale score as a secondary outcome. It also records one analysis. These details do not provide a complete multiplicity plan. The registry record does not report how statistical testing across outcomes, time points, or any additional analyses was controlled or interpreted. Because the primary outcome is measured at enrollment and month 2, the handling of multiple time points is particularly relevant, but the record does not describe a single contrast or testing hierarchy.

The AIM analysis population is explicitly restricted to participants who received MyChoice and had at least one completed item. The standard-of-care arm and the qualitative interview groups were not asked to complete those items. The record does not report how many intervention participants completed AIM at either assessment, how many were missing, or why information might be missing. It also does not state whether the analysis used all available observations, required completion at both visits, or applied any imputation method.

In general, missing data can affect precision and can also affect interpretation if participants with observed scores differ from those without scores. The record does not provide enough information to assess whether missingness was substantial or related to acceptability. No missing-data method or sensitivity analysis is reported in the registry record.

The record does not describe a full analysis population for other outcomes, nor does it state whether analyses followed randomized assignment regardless of intervention receipt. The exact treatment of withdrawals, protocol deviations, and incomplete follow-up is not reported. These omissions limit assessment of the analysis procedures, but they do not establish that any particular method was or was not used outside the registry record.

11. 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.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: postpartum haemorrhage (2.0%).

The registry lists serious adverse event counts and deaths by participant group. In MyChoice, 0 of 50 participants were listed as having a serious adverse event, and 0 deaths were listed. In the standard-of-care control arm, 1 of 50 was listed as having a serious adverse event, and 1 death was listed. The male partner interview group lists 0 of 20 serious adverse event affected participants and 0 deaths; the clinician and counselor interview group lists 0 of 12 and 0 deaths.

The record lists postpartum haemorrhage among the leading serious adverse event terms, at 2.0%. It does not state which group this term belongs to in the summary, or provide additional event-level context. The registry record does not report whether the serious event or death was considered related to study participation or counseling. These counts therefore describe recorded events, not causal effects of either counseling approach.

Zero recorded events in a group does not establish that the risk is absent. Conversely, a recorded event in one arm does not establish that the intervention caused it. Interpretation depends on context, attribution, follow-up, and completeness of reporting, details that are not reported in the registry record. The qualitative interview groups are also listed in the safety data, but they are distinct from the randomized counseling arms and should not be treated as randomized treatment groups.

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

The registry record describes a randomized pilot comparing shared decision-making counseling with standard-of-care PrEP counseling among pregnant women, alongside qualitative interviews with male partners and study staff. Its primary outcome is designed to capture participants’ perceptions of MyChoice through a validated acceptability scale. The registered score range and higher-score interpretation clarify what the measure means, while the restricted outcome population clarifies whose perceptions it represents.

The record does not report the AIM means, their confidence intervals, or participant counts contributing to each time point. It therefore does not show the level or precision of observed acceptability. Nor does the primary outcome provide a randomized comparison of acceptability between counseling arms, because the standard-of-care participants were not asked to complete AIM. The registry description alone cannot establish whether MyChoice changes decisions, PrEP use, HIV prevention outcomes, or clinical outcomes.

The study’s pilot purpose is important for interpreting its scope. It is intended to examine feasibility, acceptability, and appropriateness of the intervention and study procedures. Without results on these outcomes, completion, or recruitment, the record does not establish whether those objectives were achieved. The listed secondary measure, decisional conflict, also has no reported score result in the record.

The safety figures indicate what was recorded in each group, but they do not establish causation. The record lists one serious adverse event affected participant and one death in the standard-of-care group, with none in MyChoice, while providing limited event context. Those counts should not be interpreted as evidence that one counseling approach is safer than the other.

In short, the registry supports describing the study design, outcome definition, and safety counts. It does not support a conclusion about the primary outcome’s observed value, a between-arm acceptability effect, or a clinical benefit. Those questions require outcome and analysis details that are not reported in the registry record.

13. Why This Trial Matters Statistically

This study raises a useful statistical distinction between an intervention’s acceptability and its comparative effect. AIM is intended to measure whether participants find MyChoice agreeable and satisfactory. That is an important implementation question, but it is conceptually different from asking whether the intervention changes behavior or clinical outcomes. Keeping those questions separate prevents a perception measure from being interpreted as evidence about HIV prevention effectiveness.

The study also illustrates why the outcome population and measurement schedule matter. AIM was asked only of participants who received MyChoice, with scores planned at enrollment and month 2. Because standard-of-care participants did not complete the measure, the primary endpoint as registered is not a head-to-head comparison. A randomized design alone does not make every collected outcome comparative; outcome measurement must also support the intended contrast.

Reporting the mean with a confidence interval is a way to communicate both the estimated average response and its precision. But the registry record gives no numerical AIM results, so readers cannot assess either. Reporting outcome estimates, uncertainty, and the number of contributing participants at each assessment would be necessary to evaluate acceptability and its precision.

The pilot framing further emphasizes the value of transparent reporting. Feasibility and acceptability studies can help clarify whether an intervention and its evaluation procedures are workable. Clear reporting of recruitment, follow-up, missing responses, and analysis populations would help readers understand how representative the observed responses are. Those results are not reported in the registry record. The study is therefore statistically informative as a design and measurement example, while its registered results do not permit conclusions about whether its pilot objectives were met.

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 limitations are specific to the information recorded for this study. First, the primary outcome results are not reported: there are no AIM means, confidence intervals, or assessment-specific participant counts. This prevents evaluation of the observed acceptability level and the precision of the estimates. The record identifies two planned time points but does not report a single comparison or explain how the time points were analyzed.

Second, AIM was collected only from the MyChoice group. This limits the primary outcome to a description of intervention participants and prevents a direct randomized comparison of AIM scores with standard-of-care counseling. The record also does not report the number of completed AIM items or the handling of partially completed scales beyond allowing participants with one or more completed items into the outcome population.

Third, the registry description states that 100 women were to be recruited for the pilot, while the enrollment field records 132 participants. Safety group counts list 50 participants in each counseling arm and separate qualitative groups of 20 male partners and 12 staff. The record does not reconcile these figures or report participant flow, including allocation, follow-up completion, or exclusions from the primary outcome population.

Finally, detailed statistical methods are not reported. The record does not describe missing-data handling, adjustment, repeated-measure modeling, multiplicity procedures, or a sample-size justification. Safety counts lack event-level context and attribution. These reporting limits do not establish that the study lacked such procedures; they mean those details are not reported in the registry record and cannot be assessed from it.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Supporting Oral Pre-exposure Prophylaxis Decision Making Among Pregnant Women in Lilongwe, Malawi — NCT06394323.
• Registry record last updated 2026-02-02; status last verified 2026-01.
• Results first posted 2025-12-24.
• 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

The registry identifies NCT06394323 as a completed randomized, open-label, parallel pilot study of MyChoice shared decision-making counseling versus standard-of-care PrEP counseling for pregnant women in Lilongwe, Malawi. The stated aim is to evaluate feasibility, acceptability, and appropriateness. The registry records enrollment of 132 and lists dates of 2024-08-06 for study start and 2025-02-07 for primary completion.

The primary outcome is mean AIM score at enrollment and month 2 among MyChoice participants with one or more completed items. The listed secondary outcome is mean Decisional Conflict Scale score. Numerical outcome results and a full statistical analysis plan are not reported in the registry record. Safety entries list one serious adverse event affected participant and one death in standard of care, and none in the MyChoice group; attribution is not reported.