Dissemination and Implementation of a Web-based Relationship Safety App, myPlanKenya, for Women at Risk for Intimate Partner Violence in Nairobi, Kenya: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Dissemination and Implementation of a Web-based Relationship Safety App, myPlanKenya, for Women at Risk for Intimate Partner Violence in Nairobi, Kenya (NCT05609786), a na na study. The primary outcome is Resilience as Assessed by Connor-Davidson Resilience Scale.

2. Clinical Question

The study asks whether referral to myPlanKenya is associated with changes in resilience, health, and safety among women at risk for intimate partner violence (IPV). The clinical trial portion enrolled women referred to the app by disseminators after IPV disclosure or assessment of IPV-related risks. The study description frames the work as an effectiveness-implementation hybrid-3 study, with dissemination through formal and informal sectors.

Resilience is the named primary outcome, assessed with the Connor-Davidson Resilience Scale. Safety Strategy Score and IPV recognition assessed by the Abusive Behaviors Scale are listed as secondary outcomes. The registry summary also describes broader aims concerning health and safety, but it does not report results for those aims.

Because the study has no randomized comparison in the registry record, its clinical question is not a randomized estimate of the app’s effect relative to another intervention. A change over time within a cohort can describe participants’ observed outcomes, but by itself it cannot separate the app’s contribution from other influences on those outcomes.

3. Trial Design

The registry identifies this as a completed, single-group study with no masking. Allocation is listed as not applicable, and the study phase is listed as not applicable. The registry record gives an enrollment of 440. Johns Hopkins Bloomberg School of Public Health is the sponsor. The intervention is a behavioral intervention named “Personalized safety planning tool”; the arm description identifies the myPlan Kenya web-based application.

The broader study is described as an effectiveness-implementation hybrid-3 study. Its stated focus includes dissemination, implementation, and effectiveness. Dissemination was planned through formal and informal sectors, with women at risk for IPV referred to myPlanKenya by disseminators. This trial portion concerns the referred women’s resilience, health, and safety. The record does not provide further details about how the formal and informal dissemination routes operated.

The primary outcome is resilience assessed at baseline, 6-month, and 12-month time points, among participants with data collected. Safety Strategy Score and IPV recognition are named as secondary outcomes. The registry lists 7 outcome measures and 8 analyses, but the analysis descriptions and the prespecified statistical plan are not reported in the registry record.

The study is marked completed. Its listed start date is 2022-06-22, and its primary completion date is 2024-12-31. These dates describe the registry timeline; they do not establish when each participant completed follow-up.

This design can describe outcomes in the enrolled cohort and may inform implementation questions. It does not create a randomized, like-for-like comparison. The registry record therefore does not support interpreting a within-group change as a controlled treatment effect. Details such as recruitment procedures, eligibility criteria, retention, and whether the cohort was analyzed as planned 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

Analysis population for the primary outcome, as defined in the registry: Participants with data collected

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 Resilience as Assessed by Connor-Davidson Resilience Scale, measured over Baseline, 6-month, 12-month.

The primary endpoint is resilience measured with the Connor-Davidson Resilience Scale. The registry describes a 10-item instrument using a 5-point Likert scale scored from 0-4. The total score ranges from 0-40; higher scores indicate greater resilience and lower scores indicate lower resilience. The listed outcome parameter is the mean, with standard error as the stated measure of dispersion.

Resilience is used because it is the study’s named primary outcome and its description identifies it as a central aspect of the intended assessment of health and safety among women referred to myPlanKenya. A scale score turns responses to multiple items into a quantitative measure that can be summarized across participants and assessed over time. The scale’s direction is important for interpretation: a higher score corresponds to greater resilience according to the registry description.

The outcome is scheduled at baseline, 6-month, and 12-month assessments. Those repeated time points could describe the cohort’s score pattern over follow-up, but the registry record does not report the mean scores, standard errors, changes, or statistical tests. It also does not report a threshold for a clinically meaningful difference or explain whether the primary analysis compares follow-up scores with baseline scores.

Consequently, the measure’s definition and intended direction are available, but its observed result is not. A reader cannot infer the amount or precision of any change from the scale description alone.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a continuous primary outcome summarized as a mean, with standard error as the stated dispersion measure. Understanding what these summaries convey helps distinguish a score’s observed level from the uncertainty around an estimated average. The record does not report the actual means or standard errors, so those quantities cannot be interpreted for this cohort.

What does a mean describe?

In general, a mean describes the central level of a quantitative measure across the observations included in an analysis. For this study, the measure is a score on the Connor-Davidson Resilience Scale, with a stated range of 0-40. A mean alone does not show how scores vary among participants; different distributions of individual scores can have the same mean. The registry record does not report additional distributional summaries for the primary outcome.

What does a standard error describe?

In general, a standard error describes the sampling uncertainty of an estimated statistic, such as a mean. It is not the same as the spread of individual participants’ scores. A confidence interval, when reported, uses an estimate and its uncertainty to express a range of values compatible with the data under the specified statistical method. The registry record does not report confidence intervals for resilience, nor does it report the standard errors themselves.

How should repeated assessments be understood?

Assessing the same outcome at baseline, 6-month, and 12-month time points makes the data longitudinal in intent. In general, measurements from the same participant are related rather than independent. Analyses of repeated outcomes need to account for that relationship when estimating changes and their uncertainty. The registry record does not state which model or method was used, how within-participant correlation was handled, or whether the primary comparison was a change from baseline, a contrast between time points, or another summary.

The population for the primary outcome is described as participants with data collected. This wording identifies the outcome population but does not explain how participants with missing follow-up data were handled. It also does not indicate whether analyses used all available observations, imputed missing values, or restricted the analysis to a defined set of participants. Those details are not reported in the registry record.

What does the design imply for comparison?

In general, a randomized comparison can support an estimate of the difference between assigned groups by balancing measured and unmeasured influences on average, subject to the trial’s conduct and analysis. This registry describes a single-group study, with allocation listed as not applicable. It therefore does not report a randomized control-group contrast. A change within the cohort would describe what happened to measured scores over time, but would not, on its own, identify what would have happened without the app.

The registry describes the study as an effectiveness-implementation hybrid-3 study and reports dissemination through formal and informal sectors. That framing brings implementation questions alongside effectiveness questions. Statistical evaluation of implementation could involve measures such as whether services reached intended users or were adopted, but specific implementation outcomes and their methods are not reported in the registry record. The overall study label does not establish which statistical procedures were used.

What can the planning assumptions tell readers?

The registry describes a sample-size planning illustration based on the observed effect, rather than the trial’s own design. Its stated assumptions include a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. The registry also distinguishes illustrations expressed as participants per arm from time-to-event illustrations expressed as a total number of events.

These assumptions are planning conventions, not evidence that the study itself randomized participants or used that design. In particular, the record describes a single-group study, and no observed primary effect estimate is reported in the registry record. Without that estimate and the calculated planning values, no numerical planning illustration can be interpreted. Such a calculation, when available, would be a planning aid, not observed power and not a replacement for the trial’s actual analysis.

Finally, the registry lists 8 analyses and 7 outcome measures, but the statistical methods for those analyses are not reported in the registry record. It is not possible to determine the model, inferential tests, covariate adjustments, or multiplicity strategy. General statistical principles can clarify what such methods would address, but they cannot fill in missing trial-specific methods or results.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 7 outcome measures and 8 analyses. It names resilience as the primary outcome and identifies Safety Strategy Score and IPV recognition assessed by the Abusive Behaviors Scale as secondary outcomes. The statistical plan, including how analyses were assigned to outcomes and whether any tests were designated as confirmatory, is not reported in the registry record.

In general, testing many outcomes or contrasts can increase the chance that at least one result appears notable by chance. Statistical plans sometimes address this through a prespecified hierarchy or adjustment for multiple comparisons. Whether either approach was used in this study is not reported in the registry record. No p-values or outcome estimates are reported in the registry record, so multiplicity cannot be evaluated from reported findings.

The primary outcome population is described as participants with data collected. The registry record does not report the number contributing data at each assessment, the amount or pattern of missingness, reasons for missing observations, or methods for handling missing data. It also does not state whether analyses followed an intention-to-treat, complete-case, or other defined analysis population.

These omissions affect interpretation. If follow-up data are incomplete, the analyzed participants may differ from those without observed data. General methods for missing-data analysis rely on assumptions, and the choice of method can influence estimates and uncertainty. Without the missing-data description and analysis details, readers cannot assess the robustness of the primary result. No sensitivity analyses are reported in the registry record.

The stated sample-size illustration is separate from the trial’s own design and does not resolve these uncertainties. The record does not report a sample-size justification for the study or an interim-analysis plan.

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 reports safety figures for the myPlanKenya group. It lists 440 participants at risk for serious adverse events and 0 affected, 440 at risk for other adverse events and 0 affected, and 0 deaths. These are recorded counts, not estimates of comparative risk.

Because the study is described as single-group, these figures do not compare the app with a randomized control group. A zero count in the registry means that no affected participants are recorded for the listed categories in this entry; it does not establish that no unrecorded or unmeasured events occurred. The registry record does not provide event narratives, follow-up-specific safety summaries, or additional context for interpreting ascertainment.

No serious adverse event terms are listed among the top terms. The record’s safety entries should therefore be read narrowly as the posted counts, rather than as evidence about comparative safety or a guarantee that risk is absent. They also do not replace the missing outcome results for resilience, health, or safety.

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

The registry record describes a completed study of a web-based personalized safety planning tool for women at risk for IPV in Nairobi, Kenya. It identifies resilience as the primary outcome, specifies the Connor-Davidson Resilience Scale, and lists assessments at baseline, 6-month, and 12-month time points. It also identifies Safety Strategy Score and IPV recognition as secondary outcomes and describes dissemination through formal and informal sectors.

What the record does not establish is the observed change in resilience. Means, standard errors, confidence intervals, and statistical test results are not reported in the registry record. The record likewise does not report numerical results for the secondary outcomes. It is therefore not possible to determine from this information whether scores changed, the direction of any change, or the precision of an estimate.

Even if a within-cohort change were reported, a single-group design would not by itself show that myPlanKenya caused that change. Participants’ circumstances and other influences can change over time. Without a randomized comparison or a suitably justified alternative comparison, an observed before-and-after pattern cannot be cleanly separated from those influences.

The record is also insufficient to assess implementation performance. It states that the study evaluates dissemination and implementation, but implementation findings and the methods used to assess them are not reported in the registry record. The study’s hybrid-3 description conveys its broad scope, not evidence of a particular result.

Thus, the meaningful conclusion is limited to the study’s design, outcome definitions, and recorded safety counts. The record identifies what investigators intended to assess, but it does not provide outcome estimates that would support a conclusion about effectiveness or the magnitude and precision of any change.

13. Why This Trial Matters Statistically

This study is statistically notable for combining an effectiveness question with dissemination and implementation aims. The registry describes referral to a web-based tool through formal and informal sectors, linking a clinical outcome assessment to the ways an intervention is disseminated. Such questions can be relevant to researchers who need to understand both participant outcomes and the context in which an intervention reaches users.

The primary endpoint also illustrates an important distinction between measurement and evidence. A defined scale, score range, direction, and assessment schedule make an outcome interpretable in principle. But the usefulness of those definitions for judging the study depends on reporting the observed scores and their uncertainty. Those numerical primary results are not reported in the registry record.

The single-group design highlights a central issue in causal inference. Repeated observations can document how a cohort’s measured outcomes vary over time, but they do not automatically establish what caused a change. Without a like-for-like comparison, changes may reflect influences beyond the intervention. This limitation is especially important when a study’s stated aims include effectiveness.

Finally, the record names multiple outcomes and analyses without reporting the analysis plan, missing-data approach, or multiplicity strategy. Clear reporting of those methods would help readers understand how estimates were produced and how much confidence to place in them. Here, the registry supports a description of the intended assessment, but not a statistical judgment about its outcome findings.

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 main trial-specific limitation of the available record is the absence of numerical outcome results. Although resilience is identified as the primary endpoint and the assessment schedule is stated, the registry record does not report means, standard errors, confidence intervals, or tests. Results for the listed secondary outcomes are also not reported in the registry record.

The single-group design limits causal interpretation. The record does not describe a randomized comparator or another control group that would provide a like-for-like estimate of what might have occurred without referral to myPlanKenya. Any change over time in the cohort would therefore need cautious interpretation.

Several details needed to assess the analysis are not reported in the registry record: the statistical model, the handling of repeated measurements, covariate adjustments, missing-data methods, analysis populations, and multiplicity procedures. The number of participants contributing data at each assessment and reasons for missing data are also not reported in the registry record.

The record identifies a broad dissemination and implementation purpose but does not report implementation outcomes or methods. It does not provide further detail about referral pathways, recruitment, retention, intervention use, or fidelity. The registry’s safety counts are limited to the posted categories and do not include event narratives or more detailed safety context. These gaps constrain both statistical interpretation and assessment of how the study was conducted.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Dissemination and Implementation of a Web-based Relationship Safety App, myPlanKenya, for Women at Risk for Intimate Partner Violence in Nairobi, Kenya — NCT05609786.
• Registry record last updated 2026-07-31; status last verified 2026-07.
• Results first posted 2026-07-31.
• 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

This completed, single-group study evaluates dissemination, implementation, and effectiveness of the myPlan Kenya web-based application for women at risk for IPV in Nairobi, Kenya. The registry reports enrollment of 440 and identifies Johns Hopkins Bloomberg School of Public Health as sponsor.

Resilience assessed by the Connor-Davidson Resilience Scale is the primary outcome, measured at baseline, 6-month, and 12-month time points. Safety Strategy Score and IPV recognition are listed as secondary outcomes. The intervention is a personalized safety planning tool. No randomized comparison is described.

Numerical outcome estimates, detailed statistical methods, and missing-data procedures are not reported in the registry record. Safety entries record 0 affected participants for serious and other adverse events and 0 deaths.