Enhancing Male Participation in Interventions to Prevent Unintended Pregnancy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Enhancing Male Participation in Interventions to Prevent Unintended Pregnancy (NCT03514914), a randomized na study. The primary outcome is Number of Non-pregnant Couples With Modern Contraceptive Use in Past 3 Months.

2. Clinical Question

3. Trial Design

NCT03514914, titled “Enhancing Male Participation in Interventions to Prevent Unintended Pregnancy,” is recorded as a completed randomized, parallel trial. Its enrollment is listed as 2402. The study start date is 2018-06-07 and the primary completion date is 2020-12-16. The phase is listed as NA, and masking is listed as none.

The trial compares CHARM2 intervention clusters with control clusters receiving standard of care. The design note identifies the study as cluster-randomized. In this design, assignment occurs at a group level rather than separately for each participant. Outcomes from people within the same cluster may be more alike than outcomes from people in different clusters. Consequently, an analysis that treats every couple as independently randomized can give misleading estimates of uncertainty. The registry note cautions against a simple individual-level re-analysis and says to use the sponsor’s own analysis. The sponsor’s analysis results are not reported in the registry record.

CHARM2 involves family-planning and gender-equity counseling for couples, with sessions for men delivered by male providers and sessions for women delivered by female providers. The registry describes the intervention as tailored to gender, culture and context. It does not provide further details about provider training, intervention fidelity, cluster formation, or the number of clusters.

The primary outcome is assessed at 18 months. The record also lists two secondary outcomes: the number of couples reporting marital sexual violence and the number reporting unintended pregnancy during follow-up. Arm-specific results for these outcomes are not reported in the registry record. The planned sample-size illustration is described as using a two-sided significance level of 0.05, equal allocation, and a normal approximation. It is an illustration based on the observed effect, not the trial’s own design justification.

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: This outcome is analyzed at the couple level, based on wife report (wife report has been shown to be most reliable). This outcome includes only non-pregnant couples. Pregnant couples are excluded from this outcome. The outcome is also missing if only husband provided survey data at 18 months (N=9 intervention, N=6 control)

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 Non-pregnant Couples With Modern Contraceptive Use in Past 3 Months, measured over 18 months.

The primary endpoint is the number of non-pregnant couples reporting modern contraceptive use in the past 3 months, measured at 18 months. It is based on a wife’s self-report in a survey asking which form of contraception was used. The response options include traditional and modern contraceptives; the measure is constructed by classifying use of modern contraception as yes or no. The registry says this measure is drawn from the Demographic and Health Survey and has been used in India’s DHS for decades.

The endpoint focuses on modern contraceptive use rather than on all contraceptive methods together. Reporting a count of couples meeting this yes-or-no definition can describe how common the outcome is in the assessed groups. Comparing those counts could address whether the groups differ on this measured behavior, but interpretation depends on an appropriate analysis that accounts for the cluster-randomized design.

The outcome is limited to couples who are not pregnant at the assessment; currently pregnant couples are excluded. The record also says the outcome is missing when only the husband provided survey data at 18 months. The registry record does not report arm-specific counts, an estimated effect, or an uncertainty interval for the endpoint. It therefore does not establish the direction, magnitude, or precision of a group difference.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a cluster-randomized design imply?

In an individually randomized trial, assignment is made person by person. In a cluster-randomized trial, groups are assigned, and members of a group can have outcomes that are related to one another. For example, they may share a provider or local service environment. This dependence is important because the number of independent pieces of information is not simply the number of people measured. Statistical methods need to account for clustering when estimating uncertainty.

The registry note explicitly warns that a simple individual-level re-analysis would be misleading and specifies that the sponsor’s own analysis is used. The registry record does not report the clustering adjustment, model, variance estimator, or other details of that analysis. It is therefore not possible to independently evaluate whether the reported method handled the cluster structure appropriately, and no sponsor estimate is available in the record to interpret.

How should a count outcome be understood?

The primary outcome is a count of couples classified as reporting modern contraceptive use, after applying the stated eligibility and response rules. The underlying response for each couple is yes or no, while the endpoint is expressed as a number of couples meeting the definition. Counts can be analyzed in different ways, depending on how the data were collected and what comparison is intended. A statistical model for counts may need to account for the amount of observation, the distribution of outcomes, and clustering.

As a general statistical point, a Poisson model is one possible approach to count data, but it assumes a particular relationship between the mean and variability. If variability is greater than that assumption allows, over-dispersion can make standard errors too small unless the method accommodates it. Other approaches may be appropriate depending on the design and data. This is general context, not a description of the analysis used in this trial: the model and treatment of over-dispersion are not reported in the registry record.

What would an effect estimate and confidence interval convey?

In general, an effect estimate describes the observed contrast between groups on a defined scale. The scale matters: a contrast might be expressed as a difference in counts or through another model-based measure. A confidence interval describes the uncertainty associated with an estimate under the assumptions of the analysis. A narrower interval indicates greater precision, while a wider interval indicates less precision. It does not guarantee that the true effect lies within the interval, nor does it address bias or limitations in the study design.

Neither an estimated contrast nor a confidence interval for the primary outcome is reported in the registry record. A p-value is also not reported. Without these results, the direction and magnitude of the estimated comparison and its statistical uncertainty cannot be assessed. A p-value, if available, would not by itself describe the magnitude or practical importance of an effect.

What is the role of the planning illustration?

The registry describes sample-size illustrations based on the observed effect. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. For a specified fraction of the observed effect, the illustration concerns participants per arm for 80% or 90% power; time-to-event illustrations instead give total events. These are planning calculations, not observed trial results, and they should not be interpreted as observed power.

In general, a planning calculation estimates the amount of information needed to detect a target effect under assumptions about variability, allocation, and the testing procedure. A calculation based on an observed effect is particularly dependent on that effect estimate and does not establish that the study was designed around that target. The registry record does not report the original design’s sample-size justification, the underlying inputs beyond the stated assumptions, or the numerical outputs of the illustrations in the registry record for this explanation.

What can be inferred from the listed outcomes?

The primary outcome and two secondary outcomes describe different questions. The primary endpoint concerns modern contraceptive use among non-pregnant couples. The secondary outcomes concern couples reporting marital sexual violence and unintended pregnancy during follow-up. A result for one outcome would not automatically answer the others. Their outcome definitions, estimates, uncertainty intervals, and statistical tests are not reported in the registry record.

The registry lists three outcome measures and no analysis records. This means the record does not provide the inferential results needed to assess the primary comparison or the secondary comparisons. The distinction is important: a registered outcome definition describes what was to be measured, while an analysis result reports what was observed and how uncertain the group comparison was.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists three outcome measures: the primary contraceptive-use outcome and secondary outcomes concerning marital sexual violence and unintended pregnancy. When several outcomes are tested, the chance of at least one apparently unusual result can increase if each is assessed separately without accounting for multiplicity. General approaches include defining a primary outcome in advance, adjusting the testing procedure, or clearly treating other analyses as exploratory. The statistical plan for handling multiple outcomes is not reported in the registry record, so it is not possible to determine what approach was used.

Missingness is relevant to the primary endpoint. The registry says that the outcome is missing if only the husband provided survey data at 18 months, and that currently pregnant couples are excluded from this outcome. It also says the outcome is based on the wife’s report. The accompanying description is truncated after “N=9 in”; the context and full missing-data detail are therefore not reported in the registry record.

Missing-data methods can affect an estimate if the couples with missing outcomes differ systematically from those with observed outcomes. General approaches range from analyzing only observed outcomes to using model-based methods or sensitivity analyses, with assumptions that need to be stated. The registry record does not report the method used, the overall extent of missingness by group, or any sensitivity analysis.

The registry does not report whether the analysis followed an intention-to-treat population, how exclusions were handled, or which couples were included in each analysis. These analysis-population details are not reported in the registry record. The registry lists no analysis records, so there are no reported estimates with which to assess the consequences of missing data or outcome multiplicity.

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.

The registry records zero serious adverse events among 1200 at risk in the CHARM2 group and zero among 1202 at risk in control. It also records zero affected in the other adverse-event category for each group, with 1200 and 1202 listed at risk, respectively. These are counts as recorded; no rates or comparisons are calculated.

The record reports 3 deaths in the CHARM2 group and 3 in control. Those figures should be read as reported death counts, not as evidence that the intervention caused or prevented deaths. Whether the deaths were related to the intervention, their timing, and their causes are not reported in the registry record. The record also lists no serious adverse-event terms.

Zero recorded events in a category do not prove that the underlying risk is zero. Safety interpretation depends on how events were defined, collected, and attributed, as well as on the amount of follow-up. Details on those procedures are not reported in the registry record. These safety counts do not provide results for the primary contraceptive-use outcome.

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

The record establishes the trial’s comparison, its cluster-randomized design, and the definition of the primary outcome. It indicates that CHARM2 counseling was compared with standard of care and that the outcome was the number of non-pregnant couples reporting modern contraceptive use in the past 3 months at 18 months. It also describes a measurement rule based on the wife’s report.

However, the record does not report the arm-specific primary outcome counts, a sponsor-reported effect estimate, or its uncertainty. It therefore cannot show from the registry record whether the groups differed, how large any estimated difference was, or how precisely it was measured. Neither a conclusion of benefit nor a conclusion of no effect can be drawn from the outcome definition alone.

The listed secondary outcomes identify questions about marital sexual violence and unintended pregnancy, but their comparative results are not reported in the registry record. The safety counts document no recorded serious adverse events in either group and report 3 deaths in each group; they do not establish a causal relationship between the intervention and any event.

The sample-size illustrations are planning calculations based on the observed effect and stated assumptions. They are not observed power and do not replace an outcome analysis. Overall, the record conveys what the study intended to compare and how its primary endpoint was defined, but not the statistical results needed to judge the comparative findings.

13. Why This Trial Matters Statistically

This trial raises a statistical issue that is central to interpreting many community and service-delivery studies: assignment at the cluster level changes how outcome data should be analyzed. Couples within the same cluster may be correlated, so a method that treats every couple as independently assigned can understate uncertainty. The registry note recognizes this concern and cautions against a simple individual-level re-analysis.

The endpoint also illustrates the difference between an individual response and a group-level count. Modern contraceptive use is classified for each eligible couple using a yes-or-no response, then described as a number of couples meeting the definition. A comparative estimate needs to respect the outcome’s construction, the exclusions, and the cluster design. Merely defining an endpoint does not supply the evidence needed to evaluate a group difference.

The distinction between a registered outcome and a posted result is consequential. This record specifies a primary outcome and two secondary outcomes, but does not report their comparative estimates. Without those results, readers cannot assess magnitude, precision, or the role of chance in the primary comparison. The sample-size illustrations also serve a different purpose from an analysis: they describe planning under assumptions and are not observed power.

Finally, the safety counts demonstrate why event counts should be interpreted separately from efficacy outcomes and with attention to attribution. Zero recorded serious events and the reported death counts are descriptive figures; they do not establish causation. The record’s design and outcome definitions are informative, while the absence of reported analysis results limits what can be concluded statistically.

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 central limitation of the registry record for statistical interpretation is that it does not report arm-specific primary outcome results or a sponsor analysis estimate. It also does not report a confidence interval or p-value. The direction, magnitude, and precision of the primary comparison are therefore not available.

The cluster-randomized design requires methods that account for within-cluster dependence. The registry warns that an individual-level re-analysis would be misleading and directs readers to the sponsor’s own analysis, but the analysis results and method details are not reported in the registry record. The number of clusters, clustering adjustment, and model specification are not reported either.

The primary outcome excludes currently pregnant couples and is missing when only the husband provided survey data at 18 months. The record does not provide a complete account of missingness by group or the method used to handle missing outcomes. The outcome description’s final text is truncated after “N=9 in,” leaving its context incomplete. The record also does not report the analysis population or whether exclusions were applied consistently across groups.

The statistical plan for multiple outcomes, the original sample-size justification, and any interim analyses are not reported in the registry record. Although three outcomes are listed, comparative results for the secondary outcomes are not reported. These gaps limit assessment of both the primary inference and how it relates to the broader set of study questions. Safety-event attribution and the causes of the reported deaths are also not reported.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Enhancing Male Participation in Interventions to Prevent Unintended Pregnancy — NCT03514914.
• Registry record last updated 2022-09-06; status last verified 2022-08.
• Results first posted 2022-09-06.
• 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

NCT03514914 is a completed, randomized, parallel, unmasked trial with a cluster-randomized design. It lists enrollment of 2402 and compares CHARM2 family-planning and gender-equity counseling with standard of care. The primary outcome is the number of non-pregnant couples reporting modern contraceptive use in the past 3 months at 18 months, based on the wife’s report.

The registry lists secondary outcomes concerning marital sexual violence and unintended pregnancy during follow-up. It reports zero serious adverse events in each group and 3 deaths in each group. Primary and secondary comparative analysis results are not reported in the registry record. The record also does not report the statistical model, multiplicity approach, or full missing-data methods. Its sample-size material is described as a planning illustration, not as observed power.