Multi-component Intervention to Train Providers to Promote PrEP for Girls and Women in the Deep South: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Multi-component Intervention to Train Providers to Promote PrEP for Girls and Women in the Deep South (NCT06487390), a na na study. The primary outcome is Feasibility of Intervention Implementation.

2. Clinical Question

3. Trial Design

This completed study tested a behavioral training program for family medicine resident trainees. Its stated purpose was to adapt an evidence-based curriculum on HIV epidemiology and PrEP prescription for use in training providers to take thorough sexual histories and discuss HIV and STI prevention options with adolescent patients in Alabama. The intervention, PrEP Pro, included training on sexual history taking and HIV prevention options, including PrEP prescription and management.

The registry lists the design as single-group, with no masking and allocation recorded as NA. The intervention group is described as resident trainees who received the training. There is no like-for-like control group and no randomized treatment comparison. Participants were asked to complete a pre-training survey at enrollment and a post-training survey 6 months after enrollment. The registry summary says these surveys were intended to assess differences in knowledge and practice before and after training, as well as acceptability and feasibility after training. A subset of participants was also expected to complete qualitative in-depth interviews about their program experiences and possible adaptations.

The registry reports enrollment of 46. The study started on 2023-04-21, reached primary completion on 2024-09-04, and is listed as completed. The conditions recorded are HIV infections and sexually transmitted diseases. The sponsor is the University of Alabama at Birmingham.

The registry lists feasibility and acceptability as primary outcomes in its study summary. The primary outcome measure described in detail is feasibility of intervention implementation, measured at 6 months with a score on a scale. Secondary outcome areas include HIV epidemiology knowledge, sexual history taking, PrEP knowledge and prescribing practices, and HIV and STI screening practices. The record does not describe a randomized comparison, a control condition, or the statistical analysis used to evaluate changes over time.

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: Due to a technical error in the questionnaire software, among the 32 exit questionnaire participants, 17 completed the acceptability, feasibility, and appropriateness measures.

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 Feasibility of Intervention Implementation, measured over 6 months.

The primary outcome measure is feasibility of intervention implementation at 6 months. The measure is described as a four-item scale using five response points, with scale values from 1-5. Higher scores indicate that the intervention is considered more feasible to implement. The registry specifies a mean and standard deviation as the summary statistics for this continuous measure.

Feasibility is relevant to an intervention intended for provider training because it concerns whether the program can be put into practice in the setting and population of interest. A score on a feasibility measure can describe participants’ reported perceptions of implementation, but it does not by itself establish that the training changes clinical practice or patient outcomes. The registry separately lists acceptability as a primary outcome in its study summary, while the detailed primary measure is feasibility; a numerical acceptability result is not reported in the registry record.

There is an important qualification to interpreting the planned measure. The registry states that a technical error in the questionnaire software affected the exit questionnaire. Among the 32 participants who completed that questionnaire, 17 completed the acceptability, feasibility, and appropriateness measures. The registry does not report the mean, standard deviation, or distribution of feasibility scores. It also does not explain whether the reported measure was calculated for all completed responses or how incomplete responses were handled. The outcome definition therefore identifies what was intended to be assessed, but the posted record does not provide the numerical result needed to describe the observed level of feasibility.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Design and comparison. The registry describes a single-group study with no masking and allocation recorded as NA. General statistical interpretation: a single-group pre-training and post-training design can describe how measured responses differ over time among participants with observations at both time points. Without a separate control group, it cannot distinguish an intervention-related change from changes that might have occurred for other reasons. This is different from a randomized comparison, where groups are assigned to different conditions and compared under a specified analysis.

The stated survey schedule was a pre-training survey at enrollment and a post-training survey 6 months after enrollment. The registry describes changes in knowledge and practice as an aim, but the posted record does not report the actual analysis used to compare survey responses. It is therefore not possible to determine whether the analyses used paired observations, how they handled participants with responses at only one time point, or whether any adjustment was made for other factors. These details are not reported in the registry record.

Scale summaries. The primary outcome measure is feasibility of intervention implementation. It is described as four items on a five-point Likert scale with values from 1-5, where a higher score means greater perceived feasibility. The registry identifies the summary as a mean with a standard deviation. General explanation: a mean gives a measure of the central level of recorded scores, while a standard deviation describes how spread out scores are around that mean. Neither summary alone shows the full pattern of responses. For a multi-item scale, interpretation also depends on how the items were combined and how incomplete item responses were handled. The registry does not report those scoring details or the observed mean and standard deviation.

General explanation: Likert responses represent ordered categories. Summarizing a scale with a mean can be useful for compact description, but readers should know how the scale was constructed and how its responses were processed. The registry specifies the scale range and direction, but does not report reliability, validation results, item-level findings, or the rule used to create a total score. Those details are not reported in the registry record and should not be inferred from the stated scale description.

Missing responses. The record notes a technical error in the questionnaire software. Of the 32 exit questionnaire participants, 17 completed the acceptability, feasibility, and appropriateness measures. This is a specific report of incomplete measure data. It does not establish why each participant did not complete the measures, whether missingness was related to participant characteristics or responses, or how the analysis treated missing data. General explanation: missingness can affect estimates when the people with recorded outcomes differ systematically from those without them. A complete-case summary describes respondents with observed data, while imputation or other approaches require explicit assumptions. The registry does not report an approach to missing data.

Multiplicity and analysis plan. Several outcome areas are named: feasibility, acceptability, HIV epidemiology knowledge, sexual history taking, PrEP knowledge and prescribing practices, and HIV and STI screening practices. The registry lists seven outcome measures and no analyses. General explanation: when multiple outcomes are assessed, the chance of at least one apparently unusual finding can depend on how many comparisons are made and how the analysis is planned. A prespecified hierarchy or multiplicity adjustment can help frame interpretation. The registry record does not report whether outcomes were prioritized beyond the descriptions, whether any adjustment was planned, or what statistical tests were used. No p-values, confidence intervals, or model estimates are reported in the registry record.

Planning illustrations. General explanation: a sample-size calculation depends on design assumptions and a target effect. The planning assumptions described for the accompanying illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is expressed as a fraction of an observed effect. Those assumptions describe a planning illustration, not the design of this single-group study. They should not be interpreted as an observed power calculation or as evidence that the study had a particular probability of detecting an effect. The registry record does not report a sample-size justification for the trial, and the numerical planning outputs and observed effect needed to interpret such illustrations are not reported in the registry record.

Precision and uncertainty. General explanation: a confidence interval describes a range of values compatible with the data and the statistical procedure used, under its assumptions. Its width reflects precision; a wider interval indicates greater uncertainty about the estimated quantity. The registry does not report confidence intervals for the primary or secondary outcomes. Because numerical outcome estimates and their uncertainty are absent, the precision of any change or feasibility estimate cannot be evaluated from the registry record.

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.

R code and output

arm <- c("PrEP Pro participants (Pilot Test)")
n   <- c(17)
m   <- c(4.28)
sp  <- c(0.42)
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  PrEP Pro participants (Pilot Test)  17  4.280  0.420  4.064  4.496

11. Multiplicity, Missing Data and Analysis Populations

The study summary identifies feasibility and acceptability as primary outcomes. The detailed primary measure describes feasibility, while the listed secondary outcome areas cover HIV epidemiology knowledge, sexual history taking, PrEP knowledge and prescribing practices, and STI and HIV screening practices. The registry lists seven outcome measures, but no analyses. The record does not report a statistical analysis plan, a hierarchy for testing outcomes, or a method for controlling multiplicity. General explanation: when several outcomes are assessed, the interpretation of individual findings depends in part on whether the outcome priorities and any adjustment strategy were set in advance. Without that information, a collection of separate results can be difficult to interpret as a whole.

Missingness is directly relevant to the feasibility measure. The registry reports that 17 of the 32 exit questionnaire participants completed the acceptability, feasibility, and appropriateness measures because of a technical error in the questionnaire software. The record does not explain which items or response fields were affected, whether the issue affected other outcomes, or whether the available responses were analyzed as complete cases. It also does not report imputation, sensitivity analyses, or another method for handling missing responses. General explanation: a missing-data method cannot remove uncertainty without assumptions about why responses are absent and how absent responses relate to observed information.

The planned pre-training and post-training surveys imply that some analyses could involve repeated observations, but the registry does not define an analysis population or state how participants with incomplete surveys would be handled. It does not report whether all enrolled trainees, all survey respondents, or only participants with paired data were included in any analysis. Since no analyses are listed, the analysis population and missing-data procedures 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 46 participants at risk for serious adverse events and reports 0 participants with a serious adverse event. It reports 0 deaths. For other adverse events, it lists 46 participants at risk and 0 affected. No serious adverse event terms are listed.

These are safety-record entries, not a comparison between intervention and control groups. The study has a single group, so the figures do not estimate a difference in event rates between treatments. The registry does not describe the adverse-event observation period or provide additional detail about how events were collected, assessed, or attributed. The zero counts should therefore be read as the recorded counts in the registry, not as proof that no event of any kind occurred or that every possible event was captured.

General explanation: safety counts are most informative when read alongside the number of participants assessed, the period of observation, definitions of events, and the process used to collect them. The registry gives counts and participants at risk, but the additional details needed to assess the completeness and context of safety surveillance are not reported in the registry record. These figures do not answer the study’s main feasibility and acceptability questions.

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

The record describes a pilot intended to adapt and assess a provider-training intervention. Its primary focus is implementation feasibility and acceptability among family medicine resident trainees, with further interest in knowledge and reported clinical practices. The outcome definitions make the intended questions clear, including the direction of the feasibility scale and the planned follow-up at 6 months.

However, the registry does not report numerical results for feasibility, acceptability, or the secondary outcomes. It therefore does not show the observed average feasibility score, the spread of participant scores, or whether trainee knowledge or reported practices changed between enrollment and follow-up. The software error affecting completion of the exit measures also limits what can be learned from the posted record: only 17 of 32 exit questionnaire participants completed the acceptability, feasibility, and appropriateness measures. The registry does not report an analysis of the possible effect of missing responses.

The single-group design sets another boundary on interpretation. The study has no randomized control group, so before-and-after observations, if available, would not by themselves establish that training caused a change. The record also does not report patient outcomes, so it cannot establish whether the intervention altered patient-level screening, prevention, or health outcomes. Its listed safety counts are not evidence of efficacy and do not establish that all potential adverse events were captured.

In short, the registry record documents the intended intervention, study population, outcome domains, and some implementation and safety details. It does not provide the results or analysis details needed to estimate the magnitude or precision of any outcome. General interpretation should separate the study’s implementation aims from claims about changes in practice or patient health, and should treat unreported estimates and methods as unknown rather than assume that they were favorable or unfavorable.

14. Why This Trial Matters Statistically

This study is statistically notable for asking an implementation question in a defined provider-training setting. Feasibility and acceptability are important concepts when an intervention is being adapted for use with a particular group of trainees and in a particular context. A study may need to establish whether participants can engage with the training and how they perceive it before broader questions about practice change can be addressed. The registry’s outcome areas reflect both implementation and possible changes in provider knowledge and reported behavior.

The study also illustrates why design and outcome reporting matter. A single-group pre-training and post-training approach can describe observed patterns over time, but it does not provide a control-group comparison. In addition, the record does not report numerical outcome estimates or the analyses used. Without those results, readers cannot assess the magnitude, direction, or precision of changes in knowledge, practice, or feasibility. The explicit report of a questionnaire software error is useful context, but the record does not provide enough information to understand the effects of incomplete responses on any outcome estimate.

General statistical perspective: implementation measures and clinical outcome measures answer different questions. A favorable feasibility score, if reported, would describe participants’ perceptions of implementation; it would not alone demonstrate improved clinical practice or patient outcomes. Likewise, provider knowledge or self-reported practice measures are not interchangeable with observed patient outcomes. Keeping those distinctions clear prevents a pilot’s intended purpose from being mistaken for evidence about questions it was not designed to answer.

The record can therefore inform readers about the study’s goals, design, and outcome definitions, while leaving important evidence questions unresolved. Numerical results, analysis methods, and fuller reporting of missing data would be needed to evaluate what the trainees reported and how precisely those findings were estimated.

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 most immediate limitation in interpreting the registry record is that it does not report numerical outcome results. The primary feasibility measure is described, but its mean and standard deviation are absent. Acceptability and the listed secondary outcomes also have no numerical findings in the record. The statistical analyses are not listed, so the methods used to assess pre-training and post-training responses are unknown.

The study is single-group, with no randomized comparator. This is consistent with a pilot and implementation focus, but it limits the ability of any before-and-after change to separate an intervention-related effect from other changes over time. The registry does not report a statistical analysis plan, an analysis population, or a sample-size justification. The planning assumptions described for illustrations involving two arms do not match the listed single-group study design, and the registry does not report the numerical outputs needed to assess those illustrations.

Missing measure data are another specific limitation. The registry reports that a technical error in the questionnaire software meant that, among the 32 exit questionnaire participants, 17 completed the acceptability, feasibility, and appropriateness measures. It does not report how missing responses were handled, whether missingness was examined, or whether sensitivity analyses were conducted. This leaves uncertainty about the representativeness of the completed measures.

The registered outcomes include knowledge and reported practices, but the record does not report patient outcomes or observed patient-level changes. The qualitative interviews are described as planned for a subset, but interview findings and the number of interview participants are not reported in the registry record. These limits concern what can be concluded from the posted information; they do not establish that unreported analyses or findings were absent from other sources.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Multi-component Intervention to Train Providers to Promote PrEP for Girls and Women in the Deep South — NCT06487390.
• Registry record last updated 2025-12-09; status last verified 2025-09.
• Results first posted 2025-12-09.
• 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

NCT06487390 is a completed, single-group behavioral study of PrEP Pro training for family medicine resident trainees. The intervention aimed to adapt training in sexual history taking, HIV and STI prevention, and PrEP prescription and management. The registry reports enrollment of 46, a study start date of 2023-04-21, and primary completion on 2024-09-04. The sponsor is the University of Alabama at Birmingham.

The primary measure described in detail is feasibility of intervention implementation at 6 months, using a four-item, five-point scale with higher scores indicating greater feasibility. The study summary also identifies acceptability as a primary outcome. Secondary domains include knowledge and reported sexual history, PrEP, HIV screening, and STI screening practices. A technical questionnaire error affected completion of the exit measures: 17 of 32 exit questionnaire participants completed the acceptability, feasibility, and appropriateness measures.

The registry reports zero serious adverse events, zero deaths, and zero participants affected by other adverse events among 46 participants at risk. Numerical outcome results, statistical analyses, missing-data methods, and the analysis population are not reported in the registry record.