PrEP4Her: Developing a Novel Strategy to Implement PrEP Into Women's Healthcare: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for PrEP4Her: Developing a Novel Strategy to Implement PrEP Into Women's Healthcare (NCT07209722), a registered phase not stated study. The primary outcome is PrEP Prescriptions.

2. Clinical Question

3. Trial Design

PrEP4Her is registered as a study of a strategy to implement PrEP into women’s healthcare. Its stated purpose is to learn about health care providers’ experiences and perspectives on prescribing HIV pre-exposure prophylaxis. Providers and patients in gynecology clinics were interviewed and completed surveys intended to measure feasibility and preference. The registered intervention is identified as behavioral, and the record describes PrEP4Her as part of routine standard gynecologic care for women receiving care at the clinic.

The registry lists two groups: Sexual Health-PRO, for patients seen during a routine gynecology clinic visit, and a post-visit fidelity survey group, for patients who completed a survey outside the clinic visit. Allocation is not stated. The record specifically cautions that the groups are not a like-for-like control comparison. Their descriptions reflect different circumstances of survey completion; they do not establish that the groups were assigned to alternative treatments or that their outcomes can be interpreted as a causal contrast.

The registered enrollment is 1377. The study start date is 2023-09-22, the primary completion date is 2025-08-16, and the status is completed. Those registry entries describe the study record, but they do not establish how many participants contributed to each specific analysis or whether all enrolled participants completed every activity. The record does not report the allocation process, a control condition, or a detailed statistical analysis plan. The posted primary outcome is a count of participants receiving a new PrEP prescription during the 8-month timeframe, but no analysis result is listed.

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: All women who received care at the GYN clinic during the study period received the PrEP4Her intervention as a component of their routine standard of gynecologic care.

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 PrEP Prescriptions, measured over 8 months.

The primary endpoint is titled PrEP Prescriptions. It measures the number of participants who received a new PrEP prescription during the recruitment period; its recorded timeframe is 8 months. The registry defines the population as women receiving care at the gynecology clinic during the study period, with the PrEP4Her intervention included as a component of routine standard gynecologic care.

A count endpoint can describe the observed reach of a prescribing strategy: it records how many people meet the stated outcome definition. It is not, by itself, a measure of the proportion of all eligible people prescribed PrEP, because such a proportion would require a clearly defined denominator and a reported result. Nor does the count alone describe whether prescriptions were filled, whether PrEP was used, or whether HIV-related outcomes changed. Those are different outcomes and are not reported as the primary endpoint in the registry record.

The registry lists one outcome measure and no analysis entries. It does not report the observed prescription count, a denominator for an outcome rate, or uncertainty around the endpoint. Consequently, the endpoint’s intended meaning can be described, but its observed value and precision cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The main registered outcome is a count of participants with a new PrEP prescription. In general, a count endpoint records how many times a defined event occurs in the group under study. Here the event is participant-level receipt of a new prescription, as specified by the registry. The endpoint is not an individual clinical response measure and does not by itself describe the timing of prescriptions, continued use, or any later health outcome.

Interpreting a count usually depends on clear information about the population observed and the period over which the count was collected. The record gives the outcome timeframe as 8 months and describes the population as women receiving care at the gynecology clinic during the study period. It does not report the observed count, an analysis denominator, or the count’s uncertainty. Without those results, the outcome cannot be converted into a reported rate or compared quantitatively across groups.

In general, an estimate describes the data observed, while a confidence interval describes the range of values compatible with the data and the statistical method, under its assumptions. A confidence interval can communicate precision as well as the direction and scale of uncertainty. It does not make a non-randomized comparison causal, and it does not resolve bias in how participants entered groups or how outcomes were recorded. No confidence interval for the primary endpoint is reported in the registry record.

Different statistical models may be used for counts, depending on how the data are structured and how much variability they contain. A simple count model may be unsuitable if the observed variability is greater than the model expects; this is one reason analysts assess dispersion. Over-dispersion means that count outcomes vary more than a chosen model allows, which can make standard errors too small and intervals too narrow if ignored. This is a general statistical consideration, not a claim about the PrEP4Her data. The registry record does not identify a count model or report a dispersion assessment.

The record also lists 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 using a stated fraction of the observed effect. These are not reported as the trial’s original design assumptions or as a statistical plan. The registry record does not report a protocol justification for sample size, an observed effect estimate, or a sample-size calculation result. Planning illustrations based on an observed effect are not observed power and should not be treated as evidence that the study had a particular probability of detecting an effect.

In general, a significance test evaluates how compatible data are with a specified null hypothesis under a chosen statistical model. A p-value does not measure the size or importance of an effect, and it does not establish causality. A confidence interval and the underlying estimate are needed to assess magnitude and precision. No primary-outcome test, p-value, or interval is reported in the registry record, so none should be inferred from enrollment or study status.

Comparative interpretation is especially limited by the group descriptions. A randomized design uses an allocation process to support balanced comparisons, on average, between assigned groups. The registry does not state that allocation was randomized and explicitly describes these groups as not being a like-for-like control comparison. Differences in survey setting or group membership may be entangled with outcome differences. Statistical adjustment, if any, cannot be assumed: the record does not report an adjustment model, covariates, or analysis methods.

Finally, the study includes interviews and surveys as well as a prescribing endpoint. These forms of evidence answer different questions. Quantitative outcome analysis can estimate the occurrence of prescriptions, while interviews and survey responses can describe experience or preference according to their measures and analysis. The registry record gives the aims but no findings for these measures. Statistical methods and results for them are not reported in the registry record.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Sexual Health-PRO", "Post Visit (Fidelity) Survey")
n      <- c(1135, 242)
events <- c(11, 0)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Sexual Health-PRO  1135  11  1.0  0.5  1.7  0.5  1.7  0.5  1.7
ARM  Post Visit (Fidelity) Survey  242  0  0.0  0.0  1.5  0.0  1.6  0.0  1.5

11. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when several outcomes, comparisons, time points, or statistical tests are examined. Without a plan, repeated testing can make apparently notable results more likely to occur by chance. A prespecified hierarchy or adjustment can help control this issue, but the record does not describe such a plan. It lists one outcome measure and no analysis entries; that does not establish whether additional analyses were conducted outside the registry record or how any multiplicity was handled.

The primary outcome result is not reported in the registry record. Nor does the record describe missing-data rules, how incomplete survey responses were handled, or how participants with unavailable prescription information were treated. Missingness can affect interpretation if the availability of an outcome is related to participants’ characteristics or experiences. The direction and extent of any such effect cannot be assessed without information about data completeness and the analysis approach.

The record also does not define analysis populations for the primary endpoint, such as which participants were included in the outcome analysis or how exclusions were handled. Registered enrollment of 1377 should not be taken as the endpoint denominator or as proof that every enrolled participant contributed data. The two listed groups have distinct descriptions, and the record cautions against treating them as a randomized control comparison. No adjustment for group differences or missing data is reported.

These omissions limit evaluation of both the statistical credibility and the generalizability of the outcome. They do not demonstrate that missing data or multiplicity problems occurred; they mean the relevant procedures and results are not reported in the registry record.

12. 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 lists serious adverse event and other adverse event counts for each of the two groups. For Sexual Health-PRO, the at-risk count is 1135 for serious events and 1135 for other events; the reported affected counts are 0 and 0, respectively. For Post Visit (Fidelity) Survey, the at-risk count is 242 for serious events and 242 for other events; the reported affected counts are 0 and 0. Deaths are recorded as 0 in each group, and no top serious-event terms are listed.

These figures describe what the registry records for the stated categories and groups. An at-risk count is not necessarily the number of people included in every other study analysis, and the groups are not described as a randomized comparison. The counts therefore should not be interpreted as comparative safety evidence or as proof that no adverse experiences occurred outside the recorded categories, period, or reporting process.

The record does not provide further detail about adverse-event collection, attribution, follow-up, or missing safety information. Zero reported affected counts should be read as zero in these registry entries, not as a guarantee of absence of risk. They also do not establish a treatment benefit or answer the primary prescription question.

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

The registry record describes an implementation study focused on PrEP prescribing in gynecology care, with provider and patient interviews and surveys addressing experience, perspective, feasibility, and preference. Its primary outcome is the count of participants receiving a new PrEP prescription during the recruitment period, with an 8-month timeframe. These details establish what the study set out to measure; they do not provide the outcome value.

Because the primary result is not reported in the registry record, the record cannot establish the number of new prescriptions, the precision of that count, or the extent to which prescribing changed. It also cannot establish whether the intervention was feasible or preferred by patients or providers, because the results of the interviews and surveys are not reported. A completed status is a registry status, not a substitute for outcome findings.

The endpoint concerns new prescriptions. It does not, on its own, measure whether a prescription was filled, whether PrEP was taken, or whether HIV-related health outcomes changed. Those would require distinct measures and results. The registry record does not report those outcomes as the primary endpoint.

The group descriptions do not support a randomized treatment-effect interpretation. Allocation is not stated, and the record cautions that the groups are not like-for-like controls. Consequently, even if group summaries are available elsewhere, differences could not be attributed to the intervention solely on the basis of these descriptions. The registry record also does not provide the statistical analysis methods or uncertainty needed to assess a comparative estimate.

The appropriate conclusion is therefore narrow: PrEP4Her registered an approach to integrating PrEP into routine gynecologic care and defined a prescription-count outcome, but the registry record does not report results that quantify that outcome or establish an effect. This distinction separates the study’s purpose and measurement plan from evidence about what was observed.

14. Why This Trial Matters Statistically

Implementation research asks not only whether an intervention is defined, but also how it is incorporated into ordinary care and how patients and providers experience that process. PrEP4Her’s stated focus on gynecology clinics and prescribing experiences makes the implementation context central to the research question. A prescription count can describe uptake in that setting, while interviews and surveys can address questions of feasibility and preference that a count alone cannot answer.

Statistically, those outcomes need to be kept distinct. A count of new prescriptions is a quantitative outcome with a specific event definition. Survey responses and interview accounts represent other forms of evidence and require their own measures and analytic descriptions. Combining them into a single claim would obscure what each can support. The registry record states these aims but does not report the corresponding results.

The group structure also matters. The registry describes a routine-visit group and a post-visit survey group, while warning that they are not like-for-like controls and leaving allocation unstated. This makes careful descriptive reporting especially important: group labels alone do not create a causal comparison. Without clear allocation and analysis methods, a difference between groups would not automatically represent an intervention effect.

Finally, a completed study record with an enrollment of 1377 can still leave the central result unavailable for interpretation. Transparent reporting of outcome counts, analysis populations, missing data, and uncertainty would allow readers to judge both the observed prescribing outcome and its precision. The absence of those details in the registry record limits statistical interpretation; it does not itself establish that the implementation strategy succeeded or failed.

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.

A central limitation of the registry record is that it does not report the primary prescription outcome, despite listing it as the sole outcome measure. There is no observed count, analysis denominator, or interval from which to assess the result’s size or precision. The stated timeframe is 8 months, but the result for that period is not reported.

The record does not state how participants were allocated to the listed groups. It describes one group as patients seen during a routine gynecology visit and the other as patients completing a fidelity survey outside the visit. It also warns that the groups are not like-for-like controls. This limits any interpretation of between-group contrasts as an intervention effect.

Methods information is sparse. The registry record does not report a detailed statistical analysis plan, a sample-size justification for the study’s original design, an analysis model, or rules for missing data. It also does not specify the analysis population for the primary outcome. Enrollment therefore cannot be assumed to equal the number analyzed for that outcome.

The study’s aims include provider and patient experiences, feasibility, and preference, but the registry record does not report interview or survey findings or explain their analysis. Safety entries report zero affected counts for listed serious and other events, but the record does not describe collection procedures or the scope of follow-up. These reporting limitations mean the registry record supports a description of the study and its intended measures, not a full evaluation of implementation outcomes, comparative effects, or safety.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: PrEP4Her: Developing a Novel Strategy to Implement PrEP Into Women's Healthcare — NCT07209722.
• Registry record last updated 2026-01-26; status last verified 2026-01.
• Results first posted 2026-01-26.
• 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.

19. Record Summary

PrEP4Her is a completed study sponsored by the University of Alabama at Birmingham, registered with enrollment of 1377. The record lists a start date of 2023-09-22 and a primary completion date of 2025-08-16. Its purpose is to examine provider and patient experiences with PrEP prescribing in gynecology clinics, including feasibility and preference.

The primary outcome is the number of participants receiving a new PrEP prescription during the 8-month timeframe. The registry describes PrEP4Her as part of routine standard gynecologic care and lists routine-visit and post-visit survey groups. Allocation is not stated, and the groups are not described as a like-for-like control comparison.

The registry lists one outcome measure and no analysis entries. It does not report the primary prescription result or the findings from interviews and surveys. Safety entries report zero affected counts for serious and other adverse events in both listed groups, with zero deaths recorded. These registry entries do not provide a quantified estimate of prescribing or its precision.