Parrying the Pitfalls of PrEP: Project PEACH: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Parrying the Pitfalls of PrEP: Project PEACH (NCT05072093), a na phase 4 study. The primary outcome is Number of Men Who Discontinue Daily Oral PrEP.

2. Clinical Question

The study follows participants who may change prevention choices during follow-up. The registry describes possible starts and stops of PrEP, switches between daily and on-demand oral PrEP, use of STI PEP, and injectable PrEP as an alternative to oral PrEP. The app is intended to support identification of possible PrEP discontinuation, share information about STI PEP, document patterns of on-demand oral PrEP and STI PEP use, and connect participants with support services.

The central statistical question is therefore descriptive: what number of participants taking daily oral PrEP discontinue it over the stated follow-up period? The registry record does not report that number. It also does not report a comparison of outcomes under different prevention choices, so it cannot establish how discontinuation differs between those choices. The study’s broader follow-up may describe changing prevention patterns, but the primary endpoint as registered is specifically the count of men discontinuing daily oral PrEP.

3. Trial Design

The registry describes Project PEACH as a prospective cohort with a single-group model. It records phase 4, an enrollment of 240, and a completed status. Emory University is listed as the sponsor. The study start date is 2021-11-20 and the primary completion date is 2025-03-31.

Participants were followed for 2 years, either in person at the PRISM Health Research Clinic, virtually through telehealth study visits, or through a combination of those approaches. Visits could occur as frequently as every 3 months or as appropriate to clinical needs related to HIV PrEP or STI PEP. Monthly app surveys were described for assessing intentions to stop PrEP among participants taking daily oral PrEP.

The registry lists a behavioral PrEP discontinuation intervention, offering on-demand oral PrEP, offering STI PEP, and injectable PrEP. The cohort design permits participants to consider changing prevention options during the study; the registry does not describe assignment to separate intervention and control arms. Allocation is recorded as not applicable, and masking is recorded as none. These features mean that the study is not a randomized comparison and does not supply a concurrent control group for estimating a treatment contrast.

The design is suited to following participants as their prevention choices and circumstances change. However, the registry record does not report a detailed statistical analysis plan, the criteria used to define the analysis population, or the methods for handling changes in prevention choice over follow-up. The primary endpoint is a count of participants discontinuing daily oral PrEP during the 24 month post intervention timeframe. The endpoint result itself is 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

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Number of Men Who Discontinue Daily Oral PrEP, measured over 24 month post intervention.

The primary endpoint is titled “Number of Men Who Discontinue Daily Oral PrEP.” Its unit is participants, and the registry classifies it as a count of participants with an event. The endpoint concerns MSM taking daily oral PrEP: monthly screener surveys through the study app assess intentions to stop, and participants identified early are described as receiving motivational interviewing (MI) intended to avoid discontinuation. The endpoint then measures participants who discontinue PrEP during the 24 month post intervention timeframe.

A participant count is useful for describing how many people in the relevant study population experienced the event. It is not, by itself, a rate or a comparison of risk between groups. Interpreting such a count requires knowing the number of participants who were taking daily oral PrEP and eligible for endpoint assessment, along with how follow-up and missing observations were handled. Those details and the observed primary endpoint count are not reported in the registry record.

The endpoint is relevant to the study’s stated focus on preventing premature PrEP discontinuation. The registry describes an approach that identifies intentions to stop and offers MI, but does not report whether the approach changed discontinuation. Without the observed count and an analysis that addresses the single-group design, the endpoint definition alone cannot establish the frequency of discontinuation or the effect of the intervention.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the study as a prospective cohort with a single-group model, allocation not applicable, and no masking. These design features define what kinds of statistical conclusions are supported. A cohort can follow participants over time and describe outcomes in the group observed. Without a separate control group or randomized assignment, it does not directly estimate a contrast between the intervention and a comparator group.

What does the primary count represent?

The primary measure is the number of participants who discontinue daily oral PrEP during the 24 month post intervention timeframe. A count answers how many participants had the event, according to the endpoint definition. A count is not equivalent to a risk or rate unless its denominator and observation period are also defined and reported. Here, the registry does not report how many participants were taking daily oral PrEP and eligible for the primary outcome, nor does it post the event count.

The registry describes monthly app-based screening for intentions to stop PrEP and MI after early identification. This is a process for identifying and responding to possible discontinuation, not itself a statistical analysis. The record does not state how the endpoint was operationally adjudicated, how an interruption or later restart would be classified, or how changes in PrEP regimen would be treated for the primary analysis.

Why does the cohort design matter?

In a randomized comparison, allocation can create groups intended to be comparable at baseline, allowing a direct comparison under the study’s analysis plan. This study is not described that way. Participants could change prevention options during follow-up, and the registry presents one cohort rather than a like-for-like control comparison. A simple before-and-after or within-cohort comparison, if conducted, would not automatically distinguish an intervention effect from changes over time or differences among participants. The registry record does not report such an analysis.

General statistical principle: a confidence interval describes uncertainty around an estimate under the assumptions of the analysis. It is informative only when an estimate and a method for calculating its uncertainty are available. Neither a primary endpoint estimate nor an interval is reported in the registry record, so its precision cannot be assessed.

What analyses are reported?

The registry lists 4 outcome measures and 0 analyses. It does not report a model, a statistical test, an adjustment strategy, or an analysis population for the primary endpoint. The statistical plan, including any prespecified handling of repeated observations or potential confounding, is not reported in the registry record. The record also does not report a sample-size justification or a planned precision target for the endpoint.

General statistical principle: a sample-size calculation is a planning exercise based on assumptions about the outcome and the analysis. It does not establish the observed effect, and it is not observed power. The registry’s recorded enrollment alone cannot show whether the primary endpoint was estimated precisely; that requires the outcome data and an analysis appropriate to the population at risk.

How should changing exposure be understood?

The study allows prevention choices to change during follow-up, including transitions between daily and on-demand oral PrEP and use of STI PEP or injectable PrEP. Those options describe the study context, but they do not create randomized comparison groups. Statistical interpretation would depend on how exposure periods and outcome status were defined, especially for participants who changed options. These details are not reported in the registry record.

General statistical principle: over-dispersion occurs when count variability is greater than a simple model assumes. It can make standard errors too small if the model does not accommodate the extra variability. The registry classifies the primary endpoint as a participant count but does not report a count model or dispersion estimate. There is therefore no basis for attributing a particular modeling choice to this study.

Overall, the posted methods describe the cohort and outcome definition but do not provide the inferential machinery needed to assess an effect or its uncertainty. Without the endpoint result, denominator, analysis population, missing-data approach, and statistical method, conclusions must remain descriptive and limited to what the record explicitly reports.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 4 outcome measures, but no analyses are listed. It does not report how the primary outcome was prioritized relative to other outcomes in the analysis, whether multiple statistical tests were planned, or whether any adjustment for multiplicity was used. A multiplicity strategy is not reported in the registry record. Since no inferential results are posted, the possible impact of multiple testing cannot be evaluated.

Missing-data handling is also not reported in the registry record. The study includes monthly app surveys and visits that could occur in person or virtually, but the registry does not say how incomplete surveys, missed visits, loss to follow-up, or unavailable outcome status were handled. It does not report whether participants with incomplete follow-up were included in the primary endpoint analysis or whether any imputation or sensitivity analysis was planned.

The primary endpoint applies to MSM taking daily oral PrEP, but the registry does not report the size or definition of that analysis population. The enrollment is recorded as 240; that figure does not establish how many participants were taking daily oral PrEP or had sufficient follow-up for endpoint assessment. The analysis population definition is not reported in the registry record.

These omissions matter because the endpoint is a count over follow-up, while prevention choices may change during the study. Without definitions for the eligible population, follow-up completion, and handling of changes in PrEP use, the endpoint’s denominator and interpretation cannot be independently assessed.

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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: nausea (0.4%), increased creatinine (0.4%).

The registry reports serious adverse events for 2 participants among 240 at risk in the all-men cohort. Other adverse events are reported for 21 participants among 240 at risk, and deaths for 0 participants among 240 at risk. The listed top serious adverse event terms are nausea at 0.4% and increased creatinine at 0.4%.

These figures are descriptive counts recorded for the cohort. The serious and other adverse event entries are separate categories in the record; they should not be combined or treated as a comparison of prevention options. The registry does not provide a control group, event-by-event timing, an exposure-specific breakdown, or an assessment of causal relationship in the information available for this analysis. The listed percentages should be read as registry-reported values, not as evidence that a particular intervention caused or prevented an event.

Safety counts also do not answer the primary question about discontinuation of daily oral PrEP. They represent reported safety events among the cohort and do not provide a measure of intervention effect. The record does not report additional detail on severity beyond the serious-event classification, duration, management, or whether events led to changes in prevention choices.

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

The record establishes that Project PEACH was registered as a prospective, single-group cohort of MSM, with an enrollment of 240 and a completed status. It describes follow-up through in-person and virtual visits, app-based monthly screening for intentions to stop daily oral PrEP, and a primary endpoint counting participants who discontinue daily oral PrEP during the 24 month post intervention timeframe. It also records safety counts for the cohort.

What the record does not establish is the observed frequency of primary endpoint events. The number of men who discontinued daily oral PrEP is not reported in the registry record. There is no posted endpoint estimate, confidence interval, or analysis of how discontinuation relates to MI, use of the app, or other prevention choices. The record therefore does not show whether the intervention reduced discontinuation, nor does it support a comparison of one prevention option with another.

The single-group design is important. Without a randomized comparator, observed events could not be attributed to a specific study component simply from their occurrence during follow-up. Participants could make changes in prevention options, and the record does not report an analysis that accounts for those changes. The primary endpoint definition and the fact that the study is marked completed are not substitutes for the missing outcome estimate.

The safety information indicates the number of participants recorded with serious events, other events, and deaths, but those counts do not establish causation. The registry’s event terms and percentages should be understood as descriptive records rather than comparative evidence.

In statistical terms, the study record identifies an important research question and a way the investigators intended to measure it. It does not provide enough endpoint or analysis information to quantify the result or its uncertainty. Any conclusion about the impact of the intervention on PrEP discontinuation would go beyond what is reported.

13. Why This Trial Matters Statistically

This study addresses a measurement problem that can be difficult to capture with a single visit: prevention choices and intentions may change during follow-up. The registry describes monthly app surveys to identify intentions to stop daily oral PrEP, as well as a cohort in which participants could consider different HIV and STI prevention options. The primary endpoint focuses attention on discontinuation as a participant-level event.

Statistically, the distinction between a clearly defined question and a reported estimate is essential. The record states what the primary outcome is intended to count, but does not post the count or an analysis. This makes transparent interpretation possible: readers can identify the question, recognize the design, and see what is still needed to assess the result. The absence of a control group also makes it important not to interpret a cohort outcome as a comparative treatment effect.

The study’s longitudinal and flexible approach may describe prevention patterns in a setting where participants can change choices. That context also creates analytical requirements: a report would need to explain the eligible population, how regimen changes were handled, how follow-up was assessed, and how incomplete outcome information was treated. Those details are not reported in the registry record.

The record additionally lists serious and other adverse event counts, illustrating that safety summaries and primary efficacy or behavior outcomes answer different questions. Neither can substitute for the other. Read together, the registered endpoint and design help clarify what future outcome reporting would need to show, while the currently posted information does not quantify the central discontinuation result.

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 direct limitation is that the primary endpoint result is not reported in the registry record. The record identifies the count to be measured and its timeframe, but does not report the number of participants who discontinued daily oral PrEP. The number taking daily oral PrEP and eligible for assessment is also not reported, so the endpoint denominator cannot be evaluated.

The single-group cohort design does not include a randomized comparator. It therefore cannot, on its own, separate the effect of the app or MI from other influences on participants’ decisions. The registry describes flexible changes in prevention options but does not report how those changes were incorporated into endpoint analyses.

Important analysis details are absent. The statistical analysis plan, analysis population, handling of missing data, approach to multiplicity, and statistical model are not reported in the registry record. The record lists 4 outcome measures and 0 analyses, and does not provide an estimate or uncertainty interval for the primary endpoint.

The study includes in-person and virtual follow-up and monthly app surveys, but the registry does not report adherence to these procedures, completion of surveys, or completeness of follow-up. It also does not state how discontinuation was distinguished from a temporary interruption or a switch to another prevention regimen. These limitations restrict interpretation of the endpoint’s measurement and prevent assessment of its precision.

The safety record provides cohort-level counts but no comparison by prevention option or reported causal assessment. Accordingly, those data cannot identify whether a particular component was associated with the recorded events.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Parrying the Pitfalls of PrEP: Project PEACH — NCT05072093.
• Registry record last updated 2026-04-01; status last verified 2026-03.
• Results first posted 2026-04-01.
• 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

Project PEACH is registered as a completed phase 4, prospective, single-group cohort study sponsored by Emory University. The registry records enrollment of 240, a start date of 2021-11-20, and a primary completion date of 2025-03-31. Participants were followed for 2 years through in-person or virtual visits, with monthly app surveys described for identifying intentions to stop daily oral PrEP.

The primary endpoint is the number of men who discontinue daily oral PrEP during the 24 month post intervention timeframe. The registry record does not report the observed endpoint count or an analysis. Serious adverse events were reported for 2 participants among 240 at risk, other adverse events for 21 participants among 240 at risk, and deaths for 0 participants among 240 at risk. The record lists nausea and increased creatinine at 0.4% each among the top serious adverse event terms.