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 Sistas Informing Sistas on Topics About AIDS and Prevention (SISTA-P) (NCT06307028), a na na study. The primary outcome is Feasibility of the Intervention Scale.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06307028 |
| Phase | NA |
| Condition | Health Behavior, Risky, Health Knowledge, Attitudes, Practice, Health-Related Behavior |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 23 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Rutgers, The State University of New Jersey |
| Results posted | Yes |
2. Clinical Question
Population
Black women at high risk for HIV in Washington, D.C., Atlanta and New Orleans were the intended participants. The registry record lists 23 participants enrolled. It does not report the characteristics of the enrolled group, how many were eligible, or how participants were recruited.
Intervention
The intervention was SISTA-P, a behavioral HIV-prevention training and empowerment program. The record describes four sessions lasting up to three hours each over one week, led by two facilitators with a technical monitor and the principal investigator observing. Its description of the core activities is incomplete in the registry record.
Comparator
There was no control group or randomized comparison. The study is recorded as a single-group model with allocation listed as not applicable and masking as none. The registry record therefore does not support a like-for-like comparison with another intervention or usual care.
Primary question
The primary measure was the Feasibility of the Intervention Scale, a five-item scale with values from 1, strongly disagree, to 5, strongly agree. The registry describes it as measured at post-test, after 6 sessions. The observed mean and standard deviation are not reported in the registry record, so the degree of feasibility indicated by participants’ ratings cannot be determined from this record.
3. Trial Design
SISTA-P is registered as a completed, single-group behavioral study, with 23 participants enrolled. The record identifies Rutgers, The State University of New Jersey, as sponsor. The study began on 2024-01-08, and primary completion was recorded as 2024-11-13. The phase is listed as not applicable. Allocation is also listed as not applicable, and masking is listed as none.
The intervention description says participants would complete four sessions, each lasting up to three hours, during one week. Two facilitators would conduct the sessions, with a technical monitor and the principal investigator observing. The record’s brief summary describes training and empowerment sessions tailored to Black women. The fuller description of the intervention’s core activities is truncated in the registry record, so the remaining details are not reported in the registry record.
The primary endpoint’s timeframe is described as post-test after 6 sessions. That differs from the intervention description of four sessions. The registry record does not explain this discrepancy, so the timing of the primary assessment in relation to the described session schedule is unclear.
The study lists 10 outcome measures and 4 analyses, but the record does not provide the statistical analysis plan or the results for the primary endpoint. It also does not report whether the study used interim analyses, how participants were selected for each analysis, or whether any comparator was planned at an earlier stage. The planning assumptions attached to the sample-size material describe a two-arm comparison, whereas the registered design is single group. Those assumptions are not evidence that this study was designed or conducted as a two-arm trial.
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 | SISTA-P Intervention |
|---|---|
| STARTED | 23 |
| COMPLETED | 22 |
| NOT COMPLETED | 1 |
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.
| Characteristic | Unit | SISTA-P Intervention |
|---|---|---|
| Participants analysed | 23 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 23 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 43.48 (SD 12.11) |
| Sex: Female, Male: Female | Participants | 23 |
| Sex: Female, Male: Male | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 23 |
| Race (NIH/OMB): White | Participants | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | Participants | 23 |
| Pretest Behavioral Intentions | units on a scale | 2.96 (SD 1.33) |
6. Primary Endpoint
The registry lists the primary outcome as Feasibility of the Intervention Scale, measured over At the time of post-test (after 6 sessions).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the Feasibility of the Intervention Scale. The registry describes it as a five-item measure, with response values ranging from 1, strongly disagree, to 5, strongly agree. Lower values indicate less feasibility and higher values indicate more feasibility. The endpoint is reported as a mean, with standard deviation as its measure of dispersion, and is timed at post-test after 6 sessions.
Feasibility is an implementation outcome: it concerns whether an intervention is viewed as workable in the setting and population in which it is delivered. In general, a participant-reported feasibility measure can help describe how acceptable or practical an intervention seemed to the people who took part. It does not, by itself, establish that the intervention changes HIV-related behavior or health outcomes.
The registry record does not report the observed mean, standard deviation, or number of participants contributing data to this endpoint. It also does not report how the five items were combined, whether any items were missing, or whether the scale was analyzed in any additional way. Consequently, the direction and spread of the participants’ ratings cannot be assessed from the endpoint information in the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record establishes that SISTA-P was registered as a completed single-group study and that 23 participants were enrolled. It identifies the primary outcome as a mean score on a five-item feasibility scale. However, the mean and standard deviation for that outcome are not reported in the registry record. Without those values, there is no posted primary result to interpret as indicating greater or lesser perceived feasibility.
The scale’s direction is defined: higher values indicate more feasibility, and lower values indicate less. That definition explains how a score would be read if the score were available; it does not establish what participants actually reported. The record also does not provide an interval estimate or another measure of uncertainty for the primary outcome. In general, a confidence interval expresses a range of values compatible with the data and the method used to calculate it. No such interval can be interpreted for this endpoint from the registry record.
Because the study has no randomized comparison, the record cannot show whether changes in a measure were caused by SISTA-P, or whether the same changes would have occurred without it. A single-group feasibility study can describe observations among enrolled participants, but a causal comparison requires a suitable comparator and an analysis designed to compare groups. Neither is recorded.
The intervention schedule and primary endpoint timeframe also do not align as written: the intervention description specifies four sessions, while the primary measure is timed after 6 sessions. The registry record does not clarify whether these descriptions refer to different versions of the intervention, a change in delivery, or a reporting error. The discrepancy limits interpretation of what exposure preceded the endpoint assessment.
The record lists additional outcomes concerning enrollment, potential PrEP eligibility, acceptability, retention, PrEP uptake, and completion of post-intervention surveys. Their results are not reported in the registry record. The completion status should therefore not be treated as evidence that every outcome was measured successfully or that the intervention met a particular feasibility threshold. The available information documents the study’s design and planned measurement, but it does not provide the results needed to characterize participant experience or outcomes.
9. Statistical Methods Explained
For the primary outcome, the registry specifies a mean and standard deviation. In general, a mean describes the central value of a set of measurements. A standard deviation describes how spread out individual measurements are around that mean. Together, these statistics can summarize the average feasibility rating and the variability of participants’ ratings. They do not show the full distribution, and they do not indicate how precisely the mean has been estimated unless the sample size and an appropriate uncertainty measure are also considered.
The scale is described as having five items and response values from 1 to 5. Higher values are defined as indicating more feasibility. In general, analysis of a multi-item scale requires clarity about how item responses are combined, how missing item responses are handled, and whether the score is treated as a continuous measure. Those scoring and handling details are not reported in the registry record. The registry’s description of the outcome as a mean does not, on its own, establish the exact scoring procedure.
The primary endpoint is a continuous measure, rather than a count or a time-to-event outcome. For a continuous outcome, summaries such as a mean and standard deviation can be useful when the distribution is reasonably represented by those summaries. In general, unusual distributions or extreme observations can make a mean less representative of a typical participant. The registry record does not report the observed distribution, diagnostics, or any alternative summaries, so it is not possible to assess whether the reported analytic choice was appropriate in practice.
Uncertainty around a mean is often expressed with a confidence interval. In general, an interval gives information about the precision of an estimate under the statistical method used; it is not a guarantee that the true value lies within the interval. The registry record does not report a confidence interval for the feasibility measure. Nor does it report a hypothesis test or a prespecified threshold against which the mean should be judged. No claim about statistical significance or whether a feasibility target was achieved can therefore be made from the record.
The study’s single-group structure is central to interpretation. A single-group study can describe what was observed among those enrolled, including their ratings and retention, if those results are reported. It does not supply a concurrent control group for separating intervention-related changes from other influences. General changes over time, participant expectations, and the circumstances of study participation can affect observed responses. These are general considerations for single-group designs, not findings about this study.
The record’s sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They describe an effect to detect as a stated fraction of an observed effect. The record says that non-time-to-event illustrations are expressed as participants per arm. These assumptions do not match the registered single-group design, and the actual illustrated sample-size results are not reported in the registry record. The illustration should not be read as the trial’s original design justification, a description of its actual analysis, or observed power. A planning calculation asks what sample size could be needed under specified assumptions; it does not establish the probability that this completed study detected an effect.
In general, assumptions behind sample-size calculations matter because the calculated sample size depends on the outcome variability, effect size, significance level, power target, and design. Over-dispersion, when variation is greater than a model assumes, can make standard errors too small and conclusions too confident if it is not addressed. That general issue does not establish that over-dispersion occurred. The registry record does not report the sample-size justification for this study, its power target, or a statistical plan with model assumptions.
There are 4 analyses listed, but their methods and relationship to the 10 outcome measures are not described in the record. The record does not report whether analyses were adjusted, whether subgroup analyses were planned, or how estimates were calculated. It also does not report whether the primary outcome was analyzed for all enrolled participants or only those with post-test data. These omissions prevent a detailed assessment of the analysis beyond the endpoint’s stated summary type.
Multiplicity arises when multiple outcomes or tests are considered. In general, the more statistical tests performed, the greater the chance that at least one result may appear noteworthy by chance if no adjustment or hierarchy is used. Whether an adjustment is needed depends on the questions and analysis plan. Although multiple outcomes and analyses are listed, the registry record does not report a multiplicity strategy or identify which outcomes were confirmatory. It is therefore not possible to determine how multiplicity was handled.
10. Confidence Intervals for Each Arm
No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.
| Arm | Participants | Mean | Standard deviation | 95% CI for the mean |
|---|---|---|---|---|
| SISTA-P Intervention | 20 | 4.780 | 0.730 | 4.438 to 5.122 |
R code and output
arm <- c("SISTA-P Intervention")
n <- c(20)
m <- c(4.78)
sp <- c(0.73)
sd <- sp # posted standard deviations
for (i in seq_along(n)) {
se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}
CARM SISTA-P Intervention 20 4.780 0.730 4.438 5.12211. Multiplicity, Missing Data and Analysis Populations
The registry record lists 10 outcome measures and 4 analyses, including the primary feasibility measure and secondary measures relating to enrollment, potential PrEP eligibility, acceptability, retention, PrEP uptake, and survey completion. It does not report a statistical analysis plan specifying which outcomes were primary for inference, whether there was a testing hierarchy, or whether any multiplicity adjustment was used. In general, evaluating many outcomes without a prespecified strategy can make isolated findings harder to interpret. This is a general concern and not evidence that any particular result is misleading.
Missing-data methods are not reported in the registry record. The record does not say how participants with incomplete post-test surveys were handled, whether an outcome was calculated when some scale items were missing, or whether missingness was assessed. The number of participants contributing data to the primary endpoint is also not reported in the registry record. Enrollment of 23 participants does not establish that all 23 provided primary endpoint data.
Analysis populations are not described. The record does not specify whether analyses used all enrolled participants, only those who started or completed the intervention, or another defined group. It also does not report exclusions from analysis or the reasons for any exclusions. Without these details and the endpoint results, the extent to which missing data or participant flow could affect interpretation cannot be assessed.
The registry record does not report interim analyses or a plan for handling them. It also does not provide enough information to determine whether any analysis decisions were prespecified or made after examining results. These aspects should be regarded as unreported rather than assumed to have occurred or not occurred.
12. 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 |
|---|---|---|---|
| SISTA-P Intervention | 0 | 23 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| SISTA-P Intervention | 0 of 23 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| SISTA-P Intervention | 0 of 23 |
The adverse-event figures list 23 participants at risk for serious adverse events and 0 participants affected. The same group lists 23 participants at risk for other adverse events and 0 affected. The record lists 0 deaths, and no serious adverse-event terms are listed.
These entries describe what is recorded for the SISTA-P intervention group. A zero count means that no events of the relevant category are recorded among the listed participants; it does not establish that an event could not occur or that the intervention is free of risk. The record does not provide the duration or completeness of safety follow-up, the method used to collect adverse events, or additional detail about event definitions. Thus, the figures should be read as registry safety counts, not as a comprehensive estimate of risk.
The safety information is limited to the listed group and does not support a comparison with another group, because no comparator is recorded. The adverse-event counts also do not substitute for the missing primary feasibility result or for results on the other listed outcomes.
13. What the Result Does, and Does Not, Mean
The record documents a completed study of SISTA-P with 23 participants enrolled and identifies a participant-reported feasibility measure as the primary endpoint. The scale’s scoring direction is stated, and the intervention is described as a short series of group sessions. These details establish the study’s general focus: assessing feasibility in the context of an HIV-prevention intervention tailored to Black women.
The registry record does not report the primary mean or standard deviation, so it does not establish how participants rated feasibility. It also does not report the results of the listed secondary outcomes. Enrollment, completion status, and a stated endpoint are not substitutes for outcome results. In particular, the record does not show whether participants found the intervention acceptable, whether retention met any target, or whether PrEP uptake was observed.
The single-group design does not provide a basis for estimating an intervention effect relative to a control condition. Any outcome values, if available elsewhere, would describe the observed group unless accompanied by an appropriate comparison. The registered information does not support claims about effects on HIV transmission, prevention behavior, or health outcomes.
The distinction between feasibility and effectiveness matters. In general, feasibility measures concern implementation and participant perceptions, whereas effectiveness concerns whether an intervention changes a relevant outcome. A favorable feasibility rating would not itself prove effectiveness, and a missing feasibility result cannot be interpreted as favorable or unfavorable. The record also does not describe a prespecified benchmark for the scale that would define success.
The most defensible conclusion from this record is therefore limited: it records a completed, single-group study and its intended primary measure, but does not make the primary result available for interpretation. The mismatch between the stated session schedule and the endpoint timeframe adds uncertainty about the intervention exposure preceding the assessment. These limitations should be kept distinct from any conclusions drawn from other sources, which are not reported in the registry record.
14. Why This Trial Matters Statistically
Statistically, this study illustrates the distinction between a registered outcome and a reported result. Naming a primary measure and its scale gives readers information about what was intended to be assessed, but interpretation requires the observed estimate and some account of its variability. The registry record reports the measurement definition but not the primary estimate or its standard deviation.
The design also matters. A single-group feasibility study can be relevant for describing implementation and participant experience, but it cannot by itself distinguish intervention effects from other explanations for observed changes. That is not a defect in every feasibility study: feasibility questions can be different from causal-effect questions. It does mean that conclusions need to match the design and the outcomes actually reported.
The listed planning assumptions illustrate why design details cannot be separated from statistical calculations. A two-arm allocation assumption does not correspond to the single-group model recorded for SISTA-P. A sample-size illustration based on those assumptions should not be mistaken for the study’s design rationale or for evidence of observed power. The registry record does not report a trial-specific sample-size justification.
Finally, the record identifies multiple outcomes but does not describe the analysis plan, missing-data approach, or multiplicity handling. Those details influence how estimates and tests should be read. For this study, statistical transparency is limited by the absence of outcome results and analysis details, as well as the unresolved difference between four described sessions and an endpoint timed after 6 sessions.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for statistical interpretation is that the registry record does not report the primary endpoint result. Although the outcome is defined as a mean with standard deviation, neither statistic is available. Results for the listed secondary outcomes are also not reported in the registry record. Consequently, the evidence in this record cannot establish participants’ ratings, retention, acceptability, or other outcome findings.
The endpoint timeframe is described as post-test after 6 sessions, while the intervention description specifies four sessions over one week. The record does not explain this difference. It is therefore unclear how the endpoint timing relates to the stated intervention schedule.
The intervention description is incomplete: the list of core elements ends mid-description. The record also does not report participant characteristics, eligibility details beyond the general study description, recruitment methods, or the number of participants who completed the intervention or post-test. Enrollment alone does not establish how many contributed outcome data.
There is no comparator and no randomization. As a result, the registered design does not support a controlled estimate of intervention effects. The record does not report a statistical analysis plan, missing-data methods, analysis populations, multiplicity procedures, or a study-specific sample-size justification. The attached planning assumptions describe a two-arm illustration, which does not match the single-group study model.
Safety counts are listed, but follow-up duration and event-collection methods are not reported in the registry record. These limitations concern what can be learned from the record and do not establish that unreported procedures or results did not exist.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Sistas Informing Sistas on Topics About AIDS and Prevention (SISTA-P) — NCT06307028.
- Registry record last updated 2026-04-28; status last verified 2026-04.
- Results first posted 2026-04-28.
- 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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19. Record Summary
NCT06307028 is a completed, single-group behavioral study of SISTA-P, sponsored by Rutgers, The State University of New Jersey. The record lists 23 participants enrolled, no masking, and no randomized comparator. The intervention description specifies four sessions over one week, each lasting up to three hours. The primary outcome is a five-item feasibility scale, with a stated range of 1 to 5 and higher values indicating greater feasibility.
The record does not report the primary mean or standard deviation, or results for the listed secondary outcomes. It describes the primary assessment as occurring after 6 sessions, which does not align with the four-session intervention description; this discrepancy is not explained. Serious adverse events, other adverse events, and deaths are recorded as 0 in the listed group. Analysis details, missing-data procedures, and a study-specific sample-size justification are not reported in the registry record.