This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Multilevel Family Planning Intervention (NCT04262882), a randomized na study. The primary outcome is Number of Couples With Uptake of Any High Efficacy Contraceptive Method.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04262882 |
| Phase | NA |
| Condition | Contraceptive Usage |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 160 |
| Arms in the primary outcome | n/a |
| Lead sponsor | The University of Texas at San Antonio |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns couples in rural Uganda with an unmet need for family planning. The registry describes couples as the unit of analysis, with one primary outcome per couple. It does not report more detailed eligibility criteria, such as the ages or other characteristics of eligible couples, or how couples were recruited. The registry lists enrollment as 160; that figure alone does not establish how many couples contributed data to any particular analysis.
Intervention
The intervention is a multilevel, community-based family planning program delivered to groups of couples. Its stated aims include increasing contraceptive uptake, reducing discontinuation and unintended pregnancy, and improving knowledge, attitudes, perceived norms, communication, and equity. The registry also describes evaluation of acceptability and feasibility. It does not report enough detail to reconstruct the intervention sessions, their delivery schedule, or which components each couple received.
Comparator
The comparison group received a time- and attention-matched community sanitation intervention delivered to groups of couples. Its stated purpose was to increase hygiene practices at home and in the community. This active comparator provides an alternative group activity rather than a no-intervention comparison. The registry does not report whether the amount of contact or attendance was equivalent in practice, or how adherence to either intervention was assessed.
Primary question
The primary question is whether the groups differed in the number of couples with uptake of any high-efficacy contraceptive method at the reported follow-up points. The outcome is measured at 7-months and 10-months follow-up. High-efficacy methods are defined using typical-use efficacy and include pills, injection, intrauterine device, implant, tubal ligation, and vasectomy. Uptake was measured through women's self-report and validated through clinic records and men's self-report. The registry record does not report the group-specific outcome counts or an estimated comparison, so it does not establish the direction or precision of any difference.
3. Trial Design
The registry describes a randomized, double-masked, parallel-group trial. It lists two behavioral interventions: the Multilevel Family Planning Intervention and a time and attention-matched control. The family planning intervention was community-based and delivered in groups of couples; the control was a community sanitation intervention delivered in groups of couples. The record does not explain how the random sequence was generated, how assignment was concealed, or which participants or study personnel were masked. Those details are not reported in the registry record.
Enrollment is listed as 160. The record does not provide an analyzed sample size or explain whether enrollment refers to participants enrolled, couples, or another registry convention. Couples are explicitly identified as the unit of analysis for the primary outcome, with one outcome per couple. The number contributing data to each follow-up or analysis is not reported in the registry record, so enrollment should not be interpreted as the denominator for every outcome.
The study is marked completed. Its listed start date is 2021-05-14, and its primary completion date is 2022-05-03. The phase is recorded as NA. The sponsor is The University of Texas at San Antonio. The listed condition is Contraceptive Usage. The registry describes the study's purpose as developing and evaluating an intervention intended to address couples' unmet family planning needs in rural Uganda.
The primary endpoint is assessed at 7-months and 10-months follow-up. The registry also lists secondary measures concerning contraceptive discontinuation, unintended pregnancy, knowledge, attitudes, perceived norms, intentions, fertility desires, and fertility discordance between partners. The record does not describe the timing or analytic treatment of every secondary measure beyond the stated outcome descriptions. Detailed operational procedures, allocation methods, follow-up completion, and analysis populations 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
| Stage | Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention | Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene) |
|---|---|---|
| STARTED | 84 | 76 |
| COMPLETED | 69 | 70 |
| NOT COMPLETED | 15 | 6 |
Reasons for not completing this period:
| Reason | Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention | Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene) |
|---|---|---|
| Investigator withdrawal due to non-attendance of session 1 (at least 1 person in couple) | 14 | 6 |
| Lost to Follow-up | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Couple is the unit of analysis; one outcome per couple
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: The baseline sample excludes the participants withdrawn and replaced by investigators, considered the final sample of 140 individuals, or 70 couples. Individual participants are nested within couples. The unit of analysis, however, for all baseline data presented is the individual, as all demographic measures were collected from individuals.
| Characteristic | Unit | Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention | Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene) | Total |
|---|---|---|---|---|
| Participants analysed | 70 | 70 | 140 | |
| Age, Continuous | years | 29.01 (SD 6.79) | 30.77 (SD 8.27) | 29.89 (SD 7.59) |
| Sex: Female, Male: Female | Participants | 35 | 35 | 70 |
| Sex: Female, Male: Male | Participants | 35 | 35 | 70 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 70 | 70 | 140 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Religion: Catholic, Protestant, and Other | Participants | 36 | 22 | 58 |
| Religion: Muslim | Participants | 34 | 48 | 82 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Couples With Uptake of Any High Efficacy Contraceptive Method, measured over 7-months and 10-months follow-up.
| Element | Registry entry |
|---|---|
| Result type | Count Of Units |
| Measure of spread | not applicable |
| Unit | Couple |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of couples with uptake of any high-efficacy contraceptive method. The couple, rather than an individual partner, is the unit of analysis, and the registry specifies one outcome per couple. This measure is evaluated at 7-months and 10-months follow-up. It counts uptake, rather than measuring the degree of use or a continuous change in contraceptive behavior.
The record defines high-efficacy methods according to efficacy for typical use, not perfect use. The listed methods are pills, injection, intrauterine device, implant, tubal ligation, and vasectomy. Women's self-report is used to measure the outcome, with validation through clinic records and men's self-report. The registry does not describe how conflicting reports were resolved, how missing validation sources were handled, or whether the outcome was defined as uptake by either partner or another specific rule.
This endpoint is used to assess a central stated aim of the intervention: increasing contraceptive uptake. A count of couples meeting the uptake definition is interpretable as an event count, but its meaning depends on the denominator and follow-up completeness. Comparisons also require a clearly specified time point and a statistical method suited to the outcome and design. Although the registry lists both follow-up points, it does not report an endpoint result or a single comparison reduced across the listed time points. The observed counts, treatment contrast, and uncertainty are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record describes a trial intended to evaluate family planning outcomes, but it does not report comparative outcome results. In particular, it gives no group-specific counts for the primary endpoint, no estimated treatment contrast, and no confidence interval or p-value for that comparison. The direction, size, and precision of any observed difference therefore cannot be determined from the registry record. A completed status and an enrollment listing are not substitutes for results.
The primary endpoint concerns the number of couples with uptake of any high-efficacy contraceptive method, measured at 7-months and 10-months follow-up. The record indicates that the outcome includes methods defined by typical-use efficacy and that self-report was validated using clinic records and men's self-report. These measurement features describe how the endpoint was intended to be assessed; they do not reveal the observed uptake or whether ascertainment was complete in either group.
The registry lists 12 outcome measures and 28 analyses. That breadth means the overall set of findings would need to be read with attention to which outcomes and analyses were designated as primary, how comparisons were defined, and whether multiplicity was addressed. The registry record does not report a statistical analysis plan, multiplicity procedure, or the results of the analyses. It also does not indicate which of the listed analyses were conducted or whether all were reported.
The listed enrollment is 160, but the number with observed primary outcome data at either follow-up is not reported in the registry record. Without outcome denominators and missing-data information, the completeness of follow-up cannot be assessed. Nor can enrollment alone establish the precision of the estimated comparison. Precision would ordinarily be assessed from an estimate together with its confidence interval, neither of which is reported for the primary endpoint.
The registry includes planning assumptions for an illustrative sample-size calculation: two-sided significance level 0.05, equal allocation between the two arms, and a normal approximation. The illustration is described as based on a fraction of the observed effect and not on the trial's own design. These assumptions should not be read as the study's prespecified design choices, and any planning illustration is not observed power. The effect estimate and sample-size outputs are not reported in the registry record, so the calculation cannot be interpreted as evidence about the trial's actual precision or outcome.
Overall, the record supports a description of the question, interventions, outcomes, and design, but not a conclusion about the comparative results. It cannot establish whether the groups differed, how large any difference was, or how compatible the data were with a range of effects. Those judgments require outcome estimates and uncertainty measures that are not reported in the registry record.
9. Statistical Methods Explained
Random allocation is intended to create groups that are comparable, on average, with respect to both measured and unmeasured characteristics at the start of a trial. It does not guarantee identical groups in a particular study, and the way allocation was generated and concealed matters for assessing risk of bias. The registry identifies the allocation as randomized but does not report the sequence-generation or concealment procedures. It therefore does not permit a detailed assessment of how randomization was implemented.
What does double masking mean?
Masking is intended to reduce the influence of knowledge about assigned intervention on behavior, outcome assessment, or analysis. The registry labels the study double-masked but does not identify which people were masked or explain how masking was maintained. Because the interventions involve group-based community activities with distinct content, the record alone does not clarify what masking meant operationally. No conclusion about the success of masking can be drawn from the designation by itself.
How should a count endpoint be understood?
The primary outcome is a count of couples meeting a specified uptake definition. A count is not the same as a continuous measurement, such as a change score, and it is not automatically a rate. Interpretation depends on the number of couples observed and on the time point and outcome definition. The registry describes one outcome per couple and two follow-up points. It does not report a count model, a denominator for each follow-up, or a rate-based comparison. General statistical consideration: count outcomes can be analyzed with methods that reflect their discrete nature, and the choice of method should be justified by the distribution and design. No specific model is reported in the registry record.
General statistical consideration: count data can show over-dispersion, meaning that their variability exceeds what a chosen model expects. If over-dispersion is present and ignored, standard errors and confidence intervals can be misleading. The registry does not report whether over-dispersion was assessed or how it was handled. It also does not report a statistical model for the primary endpoint, so no model choice should be inferred from the outcome's count format alone.
What do estimates and confidence intervals contribute?
General statistical explanation: an estimated treatment contrast describes the observed difference between groups according to a stated comparison. A confidence interval communicates the uncertainty around that estimate under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, but precision is not the same as importance, and an interval does not by itself establish a causal interpretation. The registry record does not report an estimate or confidence interval for the primary endpoint. A p-value, if reported, would address compatibility with a specified null hypothesis under the statistical model; it would not measure the size or practical importance of an effect. No primary-endpoint p-value is reported in the registry record.
The primary outcome is listed at 7-months and 10-months follow-up, rather than as a single comparison. The registry's note says the primary outcome has several categories or time points and is not reduced to one comparison. This means a reader should not treat the endpoint description as though it were one pooled result. The record does not specify whether the time points were analyzed separately, jointly, or under another prespecified approach. Nor does it identify which estimate, if any, was intended to serve as the principal treatment comparison.
What do the sample-size assumptions describe?
The registry gives assumptions for a planning illustration: a two-sided significance level of 0.05, equal allocation between the arms, and a normal approximation. The target effect is described as a stated fraction of the observed effect. These are planning assumptions for an illustration, not evidence that the trial was designed using that calculation. The registry explicitly distinguishes the illustration from the trial's own design. Any calculated sample size should be understood as participants per arm for a stated power target, where applicable, and not as observed power. A planned sample size or retrospective illustration cannot replace an estimate and confidence interval from the observed data. The calculation's effect value and outputs are not reported in the registry record.
General statistical explanation: a sample-size calculation depends on assumptions about the effect to detect, variability, allocation, significance level, and desired power. Changing those assumptions changes the planning result. Retrospective calculations based on an observed effect are especially dependent on that estimate and do not provide a direct measure of the reliability of the trial result. Because the observed effect and calculation outputs are not reported in the registry record, this illustration cannot be independently interpreted from the record.
How do the intervention groups affect analysis?
Both interventions are described as delivered in groups of couples. General statistical consideration: when outcomes of people receiving an intervention together may be correlated, an analysis may need to account for that clustering. The registry does not report whether couples were assigned individually or by group, whether outcomes were clustered in delivery groups, or whether any analysis accounted for dependence. This is an important design and analysis detail, but the record does not support a claim that clustering occurred or that a particular adjustment was used.
In short, the registry identifies broad design features and outcomes but does not report the detailed statistical methods needed to evaluate the treatment comparison. The model, estimand, treatment of repeated follow-up, adjustment strategy, uncertainty estimates, and diagnostic checks are not reported in the registry record. Statistical explanations above are general concepts, not claims about methods used in this trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 12 outcome measures and 28 analyses, including the primary uptake outcome and measures of discontinuation, unintended pregnancy, knowledge, attitudes, norms, intentions, fertility desires, and fertility discordance between partners. When many outcomes, time points, or analyses are examined, the chance of finding a result that appears notable by chance can increase. General statistical practice may address this through prespecified outcome hierarchies, adjustments, or careful emphasis on estimates and uncertainty. The registry record does not report a multiplicity strategy or identify how the 28 analyses relate to the listed outcomes.
The primary outcome is described at 7-months and 10-months follow-up, and the record notes that it has several categories or time points and is not reduced to one comparison. It does not state how those time points were handled statistically, which one was primary for inference, or whether a joint or separate analysis was planned. No result should therefore be selected as the definitive comparison on the basis of the registry description alone.
Missing-data handling is not reported in the registry record. It does not give follow-up completion by group, reasons for missing observations, imputation procedures, or sensitivity analyses. Analysis populations—such as whether analyses included all randomized couples or only couples with available outcome data—are also not reported. The enrollment listing does not answer these questions. Without the denominators and analysis-population definitions for each endpoint, readers cannot assess attrition, compare data completeness, or determine how missing observations may affect interpretation.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention | 0 | 84 | 0.0% |
| Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene) | 0 | 76 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention | 0 of 84 |
| Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene) | 0 of 76 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 4% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention | 0 of 84 |
| Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene) | 0 of 76 |
The registry lists serious adverse event figures for the two intervention groups. For the Multilevel Family Planning Intervention group, it reports 84 at risk and 0 serious events, 84 at risk and 0 other events, and 0 deaths. For the time- and attention-matched comparator group, it reports 76 at risk and 0 serious events, 76 at risk and 0 other events, and 0 deaths. No serious-event terms are listed.
These are the figures recorded for the reported categories; they do not establish that no adverse experiences of any kind occurred. The record does not provide event definitions, ascertainment procedures, follow-up duration for safety reporting, or additional detail about events beyond the listed categories. The at-risk figures should not be assumed to be the number analyzed for the primary endpoint. Zero reported events in these categories is not proof of absence of risk, and the registry information alone does not support a broader safety conclusion.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, double-masked, parallel trial compared a group-delivered multilevel family planning intervention with a group-delivered sanitation control. Its stated primary outcome was the number of couples with uptake of any high-efficacy contraceptive method at 7-months and 10-months follow-up. It also identifies a set of secondary outcomes addressing contraceptive behavior and intermediate family planning measures. These registry entries describe the study question and its planned measurement framework.
The record does not report the group-specific primary outcome counts, a treatment-effect estimate, or its uncertainty. It therefore does not show whether uptake differed between groups, how large any difference might have been, or how precisely it was estimated. The listed completed status does not fill this results gap. Nor can the enrollment listing be used to infer an outcome effect, follow-up completeness, or statistical power.
The endpoint focuses on uptake of methods classified by typical-use efficacy, as measured through women's self-report and validated using clinic records and men's self-report. It does not, by itself, describe every dimension of family planning or health. The listed secondary outcomes broaden the study's scope, but no comparative results for those outcomes are reported in the registry record. The record also does not provide enough detail to evaluate intervention fidelity, adherence, or the handling of missing follow-up data.
For these reasons, the record supports a description of what the investigators sought to evaluate, but not a conclusion about whether the intervention achieved its intended outcomes. It also does not establish the intervention's effect in settings beyond the study population. Any interpretation of benefit, lack of benefit, or comparative effectiveness would require the actual outcome estimates, denominators, analysis methods, and uncertainty measures, none of which are reported for the primary comparison in the registry record.
13. Why This Trial Matters Statistically
Statistically, the study brings together an intervention delivered to couples in community groups and an outcome defined at the couple level. That alignment is important: the primary endpoint is explicitly one outcome per couple, while the intervention is delivered to groups of couples. Assessing the analysis requires knowing how assignment and delivery groups relate to one another and whether the statistical method accounts for any dependence among observations. Those details are not reported in the registry record, so the design raises questions that cannot be resolved from the available description.
The outcome also has more than one follow-up point. A clear interpretation depends on knowing whether the time points answer separate questions or form part of a common analysis. The registry notes that the primary outcome has several categories or time points and is not reduced to one comparison. This makes a prespecified estimand and a transparent account of multiplicity particularly relevant. Neither a single comparative estimate nor a multiplicity approach is reported in the registry record.
The study's stated aims extend beyond contraceptive uptake to continuation, unintended pregnancy, knowledge, attitudes, norms, communication, equity, and feasibility. Such a broad set of aims can capture different dimensions of an intervention, but it also makes it important to distinguish primary questions from exploratory analyses and to report uncertainty for each. The registry lists 12 outcome measures and 28 analyses but does not report how those analyses were prioritized or interpreted.
Finally, the registry offers planning assumptions but does not report comparative outcome results. This illustrates why design descriptions and planning calculations cannot stand in for observed estimates. Statistical interpretation depends on the effect estimate, its precision, the analysis population, and the assumptions used to obtain them. Those elements are not reported for the primary endpoint, limiting what can be learned about the study's result from the registry record alone.
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 most important limitation for interpreting this trial record is the absence of comparative outcome results. Although the study is marked completed and the primary endpoint is described, group-specific counts, denominators, effect estimates, confidence intervals, and p-values are not reported in the registry record. The direction and precision of any primary comparison cannot be assessed.
The registry lists enrollment as 160, but does not report the number of couples with outcome data at either follow-up or the number included in each analysis. It also does not report the analysis populations, follow-up losses, reasons for missingness, or procedures for handling missing data. Consequently, it is not possible to assess whether outcome availability differed between groups or how missing observations might affect estimates.
Several design and analysis details are also not reported: random-sequence generation, allocation concealment, the people covered by double masking, intervention adherence, outcome adjudication procedures, the statistical model, and any adjustment for group-based delivery. The record describes 7-months and 10-months follow-up for the primary outcome but does not explain how those time points were analyzed. With 12 outcome measures and 28 analyses listed, the absence of a reported multiplicity approach further limits interpretation of any individual finding.
The registry identifies high-efficacy methods using typical-use efficacy and describes validation of self-report, but does not explain how discordant reports or missing validation sources were handled. Finally, results for the listed secondary outcomes are not reported. These limitations concern the information available in the registry record; they do not establish that the corresponding methods or analyses were absent from the study itself.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Multilevel Family Planning Intervention — NCT04262882.
- Registry record last updated 2024-04-25; status last verified 2024-04.
- Results first posted 2023-11-15.
- 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.
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18. Record Summary
The registry describes NCT04262882, titled “Multilevel Family Planning Intervention,” as a randomized, double-masked, parallel behavioral trial sponsored by The University of Texas at San Antonio. It is marked completed, with enrollment listed as 160, a start date of 2021-05-14, and a primary completion date of 2022-05-03. The phase is recorded as NA.
The study compares a community-based multilevel family planning intervention delivered in groups of couples with a time- and attention-matched community sanitation intervention. The primary endpoint is the number of couples with uptake of any high-efficacy contraceptive method at 7-months and 10-months follow-up. The registry also lists secondary outcomes concerning contraceptive discontinuation, unintended pregnancy, and family planning and fertility measures.
Although the design and outcome definitions are described, comparative outcome estimates and detailed analysis methods are not reported in the registry record. The record therefore supports a summary of the trial's question and structure, but not an assessment of the primary treatment effect.