Case Managers for CVD Risk Reduction in HIV Clinic: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Case Managers for CVD Risk Reduction in HIV Clinic (NCT03839394), a randomized na study. The primary outcome is Change in Ambulatory Systolic Blood Pressure.

2. Clinical Question

3. Trial Design

This was a completed, randomized, parallel-group study with no masking. The registry lists the phase as NA and enrollment as 50. The record identifies Duke University as the sponsor and describes a clinic-based telephone intervention intended to address cardiovascular disease risk among people living with HIV. The study summary describes the educational curriculum as administered by a case manager or social worker.

The two arm labels distinguish Educational Pamphlets + Telephone from Educational Pamphlets. The available record does not describe the allocation sequence, concealment procedures, recruitment process, eligibility criteria, clinic location, or the exact content and delivery of the pamphlets and telephone curriculum. Those details are not reported in the registry record. The absence of masking is recorded, but the record does not specify which study roles knew the assigned group.

The primary outcome is change in ambulatory systolic blood pressure. Its stated timeframe includes baseline, 24 weeks, 48 weeks, and 72 weeks, while the posted primary result is specifically the change from baseline to 72 weeks. The primary analysis population is described as participants with data collected at both timepoints. The registry reports 19 participants in the pamphlets-plus-telephone arm and 14 in the pamphlets-only arm for this outcome.

The record also lists total change in body weight and change in 10-year ASCVD risk score as secondary outcomes. It reports five outcome measures and five analyses, although only two secondary outcomes are represented in the available posted secondary results. The trial's original sample-size assumptions and statistical-analysis plan are not reported in the registry record. The planning illustrations are separate from the trial's own design rationale and use assumptions stated with those illustrations.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Participants with data collected at both timepoints.

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 Change in Ambulatory Systolic Blood Pressure, measured over Baseline, 24 weeks, 48 weeks, 72 weeks.

The primary endpoint is change in ambulatory systolic blood pressure, measured in mmHg. The registry describes systolic blood pressure change as an absolute continuous variable and also mentions a proportion of people achieving a reduction greater than 5 mmHg from baseline. The posted primary result is the continuous change from baseline to 72 weeks, rather than the proportion meeting that threshold.

A continuous measure retains the size and direction of each participant's change, rather than reducing the outcome to whether a threshold was crossed. In general, a mean summarizes the average change in a group, while the standard deviation describes how spread out individual measurements are around that mean. These summaries help readers distinguish the average group result from the variation among participants.

Ambulatory systolic blood pressure is the outcome selected in this record to assess cardiovascular risk-related change. The registry does not explain why this endpoint was selected over other measures, nor does it report a detailed rationale for the timing of the 72-week comparison. The measure should therefore be interpreted as the posted endpoint, not as a complete description of cardiovascular health or of every outcome the study may have assessed.

The primary analysis includes participants with data at both baseline and 72 weeks. That definition identifies the observations contributing to the reported change, but the record does not explain why other participants lack paired measurements. It also does not state whether additional approaches were used to address missing measurements or whether the threshold-based outcome was analyzed.

7. Results Posted in the Registry

• Educational Pamphlets: mean -10.70 versus 1.90 on control; difference -12.60 (95% CI -21.44 to -3.76), standardized effect d = -0.94; z-test p = 0.005.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Total Change in Body Weight

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Educational Pamphlets: mean -2.10 versus -1.80 on control; difference -0.30 (95% CI -3.70 to 3.10), standardized effect d = -0.06; z-test p = 0.863.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Educational Pamphlets and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary outcomes cover total change in body weight and change in 10-year ASCVD risk score, although numerical results are available for body weight only. The overall pattern should therefore be interpreted cautiously: the available secondary comparison does not show the same kind of group separation as the primary ambulatory systolic blood pressure result, and the ASCVD risk-score result cannot be described from the posted numerical information.

Secondary outcomes can help assess whether an observed primary result is accompanied by changes in related measures. In this record, the available body-weight comparison has a mean difference of -0.3 kg, with a 95% confidence interval from -3.703 to 3.103 kg; the unadjusted p-value is 0.863. The interval includes values on either side of no difference. This result does not establish that body weight was identical between groups, and it does not confirm or refute the primary blood pressure comparison.

The registry lists five outcome measures and five analyses, but only two secondary outcome titles are posted in the secondary outcome information. The exact status and results of all other measures or analyses are not reported in the registry record. The absence of a posted numerical result for the ASCVD risk score means its direction, magnitude, and uncertainty cannot be assessed.

Unadjusted secondary findings generally carry less weight than a prespecified primary analysis because multiple outcomes and comparisons create more opportunities for apparently notable results by chance. This is a general statistical concern, not a claim about the investigators' analysis choices. The registry does not report a multiplicity adjustment, a hierarchy of secondary hypotheses, or a detailed analysis plan. As a result, secondary results are best treated as supporting context rather than independent confirmation of the primary finding.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Total Change in Body Weight
• Change in 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score

9. Statistical Interpretation

10. Statistical Methods Explained

The primary measure is continuous, and the registry describes it using group means and standard deviations. A mean provides a concise account of the average observed change within an arm. A standard deviation describes the distribution's spread around that mean. It is not the uncertainty of the mean itself: standard errors and confidence intervals address uncertainty in estimated quantities, whereas standard deviations describe participant-level variability.

What does the mean difference represent?

The comparison is expressed as the mean change in Educational Pamphlets minus the mean change in Educational Pamphlets + Telephone. The recalculated estimate is -12.6 mmHg. Its sign depends on the order of subtraction, so it should be read alongside the arm labels. In this comparison order, a negative estimate means the average change was lower in the pamphlets-only arm. It does not mean that every participant in that arm had a lower value.

The calculation is an unadjusted comparison of the posted group summaries. It does not account for participant-level covariates or other factors beyond the quantities used in the summary-statistic calculation. The registry's reported method is a two-sided t-test. A two-sided test assesses evidence of a difference in either direction, rather than testing only for a difference in a prespecified direction. The registry does not report whether covariate adjustment, stratification, or other procedures were also used.

How should the p-values be read?

The posted registry analysis gives p = 0.012 for a two-sided t-test. The unadjusted recalculation gives p = 0.005. A p-value describes how compatible the observed data are with a specified null model of no group difference, under the assumptions of the test. It is not the probability that the null hypothesis is true, nor does it measure the size or practical importance of the difference. The two reported values should be kept distinct because the record does not explain their difference. The methods and data used for any additional sponsor-side calculation are not reported in the registry record.

The p-value is only one part of interpretation. The estimated mean difference communicates the direction and size of the observed contrast, while the confidence interval communicates uncertainty around that estimate. A small p-value does not show that the estimate is precise, free of bias, or representative of all participants who enrolled. Similarly, a p-value that does not meet a conventional threshold would not prove there is no difference.

Why does the analysis population matter?

The registry defines the primary outcome population as participants with data at both timepoints. That means the posted change summarizes paired observations from those participants. The outcome counts are 19 and 14 in the two arms, while the registry's total enrollment is 50. The record does not say how missing measurements were handled, why they were absent, or whether the paired-data population differs from the randomized population in relevant ways.

In general, an analysis restricted to participants with complete observations can be affected if the presence of measurements is related to participant characteristics or outcomes. This is a general concern, not evidence that such a relationship occurred in this study. Without information about missingness, imputation, or other analysis populations, readers cannot assess how sensitive the result may be to incomplete follow-up.

What is the role of the standard deviation?

The primary arm standard deviations are 15.0 mmHg and 10.9 mmHg. They indicate that participant changes varied around their respective group means. The recalculation uses the pooled standard deviation of 13.43 mmHg as part of its standardized comparison, with a reported standardized effect of -0.938. These standardized quantities describe the contrast relative to the observed spread in these data. They do not replace the mmHg estimate, which remains more directly tied to the measurement scale.

In general, standard deviations can differ across groups, and a pooled summary represents a combined spread under assumptions used in the calculation. The registry record does not report a diagnostic assessment of the distribution, variance assumptions, or sensitivity analyses. Nor does it report an adjusted model for the continuous endpoint. Such details should not be inferred from the presence of group means, standard deviations, and a t-test result.

What do the planning calculations assume?

The planning illustrations use the observed effect or stated fractions of that effect, two-sided significance level 0.05, equal allocation between arms, and a normal approximation. They express the resulting requirements as participants per arm for these continuous-outcome calculations. In general, a normal approximation uses a simplified mathematical distribution to estimate how much information a future comparison may need under the chosen assumptions. It is a planning device, not evidence about the actual design choices made for this trial.

Over-dispersion is a general issue for count outcomes when observed variability exceeds what a simple count model assumes. It is not the basis of the primary continuous-outcome comparison described in this record. The primary measure is a mean change, and no count-outcome model or over-dispersion adjustment is reported for it. More broadly, the record does not provide enough detail to reconstruct the full analysis plan, assess all assumptions, or determine whether additional analyses were conducted.

11. Confidence Intervals and Precision

The primary recalculated mean difference is -12.6 mmHg, with a 95% confidence interval from -21.44 to -3.763 mmHg. The interval represents uncertainty around the estimated difference under the unadjusted calculation and its assumptions. Its endpoints describe values compatible with the data and method at the stated confidence level; they are not a guarantee that the true difference lies within those limits.

The interval is entirely below zero. In the comparison order used, that means the estimates within the interval favor a lower mean change in the Educational Pamphlets arm than in the Educational Pamphlets + Telephone arm. The interval is still broad enough to include a range of possible differences, so the single estimate should not be read as an exact or highly certain magnitude. The result is more informative when the estimate, interval, arm means, and outcome-specific sample sizes are considered together.

Confidence intervals are generally affected by both the variability of observations and the amount of information available. Here, the primary analysis uses 19 and 14 participants with paired measurements, and the reported standard deviations are 15.0 mmHg and 10.9 mmHg. The interval therefore reflects uncertainty in a comparison based on these observed groups; it does not represent the distribution of individual responses.

The registry's reported analysis gives p = 0.012, while the unadjusted recalculation gives p = 0.005. The confidence interval belongs to the recalculation and should not be assumed to be the interval from the registry's t-test, because the record does not post an interval for that analysis. Differences in analysis details may affect estimates of uncertainty, but the reason for the p-value difference is not reported. The interval also does not address possible bias from missing data, lack of masking, or generalizability.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning calculations are expressed as participants per arm, not total events. They are illustrations based on the observed effect and stated fractions of it, rather than a reconstruction of the original trial design. The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The original study's own sample-size assumptions and justification are not reported in the registry record.

The 80% power column describes the estimated participants per arm under which a future comparison would have an 80% chance of detecting the chosen effect, if the planning assumptions and effect model were correct. The 90% power column describes the corresponding requirement for a 90% chance. These are design probabilities under assumptions, not guarantees for a particular trial and not measures of the probability that a finding is true.

For the primary outcome, planning for 100% of the observed effect gives 18 participants per arm for 80% power and 24 participants per arm for 90% power. Planning for 75% of the observed effect gives 32 participants per arm for 80% power and 43 participants per arm for 90% power. Planning for 50% of the observed effect gives 72 participants per arm for 80% power and 96 participants per arm for 90% power. The pattern illustrates a general principle: smaller effects are harder to detect and require more participants, all else being equal.

These figures are planning illustrations, not observed power. They do not tell readers the probability that the completed trial detected an effect, and they do not alter the interpretation of the outcome data. Because they depend on the observed effect, they can also be sensitive to how accurately that effect represents what a future study might observe. The registry does not report the assumptions used when the trial was originally planned.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -12.600; pooled standard deviation σ = 13.434.
2. n = 2 × (1.96 + 0.842)² × 13.434² / -12.600² = 17.8, rounded up to 18 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -12.6                      # observed difference in means
sigma <- 13.4338642868469                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(3839394)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 18 (80% power), 24 (90% power)
 75% of observed effect: n per arm = 32 (80% power), 43 (90% power)
 50% of observed effect: n per arm = 72 (80% power), 96 (90% power)
power.t.test: 18.9 
Simulated power at n = 18 per arm: 0.778 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry reports the sponsor's primary comparison as a two-sided t-test with p = 0.012. It does not post an estimated difference or confidence interval for that analysis. The unadjusted recalculation from the posted arm summaries gives a mean difference of -12.6 mmHg, a 95% confidence interval from -21.44 to -3.763 mmHg, and p = 0.005.

Both analyses describe a difference in the same direction when the comparison is Educational Pamphlets versus Educational Pamphlets + Telephone. However, the p-values are not identical. The registry record does not state why they differ, so it is not possible to attribute the difference to a particular method, data subset, or adjustment. The recalculation is a simple unadjusted calculation from the posted summary statistics; it is not a replacement for the registry's reported analysis.

Because the registry does not provide enough detail to reconcile the values, they should be presented as separate results rather than combined or treated as interchangeable. The sponsor-reported p-value comes from the posted t-test. The recalculated estimate and interval provide additional context about the contrast and its uncertainty, but they do not supply missing details about the sponsor's analysis.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures and five analyses. It identifies ambulatory systolic blood pressure change as the primary outcome and lists total change in body weight and change in 10-year ASCVD risk score as secondary outcomes. Only the body-weight comparison has numerical secondary results in the record. The results and analysis details for other listed measures are not reported in the registry record.

When a study evaluates several outcomes or performs several statistical comparisons, the chance of obtaining at least one apparently strong result by chance can increase. This is the general issue of multiplicity. Statistical plans may address it by specifying a primary outcome, ordering secondary tests, or adjusting inference, but the registry record does not report whether any such procedure was planned or used. No correction should be assumed from the count of posted analyses alone.

The primary endpoint population is participants with data at both baseline and 72 weeks. The record does not state how many randomized participants lacked those paired observations, why data were missing, whether missingness differed between arms, or whether an intention-to-treat analysis was conducted. It also does not describe imputation, sensitivity analyses, or other methods for handling missing measurements. These details are not reported in the registry record.

In general, complete-case analyses can be difficult to interpret if participants with observed outcomes differ systematically from those without them. This is a limitation of what can be assessed from the available record, not evidence that missingness biased this result. The arm-specific counts for the primary endpoint and overall enrollment provide some context, but do not establish the characteristics or outcomes of participants who were not included in the paired-data analysis.

The record also does not provide a full statistical-analysis plan, identify any interim analyses, or explain whether the reported comparison was adjusted for baseline values or other variables. Those details should not be inferred from the reported t-test. Without them, readers can describe the posted analysis and its uncertainty but cannot evaluate all decisions that may affect interpretation.

16. 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: incarcerated inguinal hernia (4.2%), deep venous thrombosis (4.2%), epididimytis (4.2%), stroke (4.0%), suicidal ideation (4.0%).

The registry reports serious adverse events for 3 of 25 participants at risk in the Educational Pamphlets + Telephone group and 3 of 24 at risk in the Educational Pamphlets group. It reports other adverse events for 9 of 25 and 3 of 24 participants at risk, respectively. No deaths are reported in either group. These counts are safety summaries, separate from the participants included in the primary outcome analysis.

The registry also lists serious-event terms with percentages: incarcerated inguinal hernia, 4.2%; deep venous thrombosis, 4.2%; epididimytis, 4.2%; stroke, 4.0%; suicidal ideation, 4.0%; and auditory hallucinations, 4.0%. The record does not provide enough detail to determine the relationship of each listed term to a particular participant, arm, or intervention beyond the associated safety information.

These figures describe events recorded in the registry; they do not establish that an intervention caused an event or that one arm is safer. The record does not provide event timing, duration of observation for safety, severity definitions beyond the serious-event category, or a comparative statistical analysis of adverse events. Differences in counts should therefore be read descriptively and in the context of the reported at-risk group sizes.

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

The posted primary data show a difference in mean change in ambulatory systolic blood pressure between the analyzed groups. The unadjusted recalculated estimate is -12.6 mmHg for Educational Pamphlets compared with Educational Pamphlets + Telephone, with a 95% confidence interval from -21.44 to -3.763 mmHg. The registry's own two-sided t-test reports p = 0.012. Those statistics describe the observed comparison among participants with paired data; they do not, by themselves, establish a causal explanation.

Randomization is a design feature intended to support comparisons between groups, but the registry record does not give enough information to assess allocation procedures, completeness of follow-up, or the impact of missing data. The primary analysis is limited to participants with measurements at both timepoints. It is not reported how those participants compare with the full group enrolled or with those who did not contribute paired data.

The result does not show that every participant changed in the same way. Group means and standard deviations summarize the distributions, while the confidence interval concerns uncertainty in the estimated group contrast. Individual outcomes may vary, and the record does not provide participant-level data or a detailed distribution of changes.

The result also does not establish effects on every aspect of cardiovascular health. Blood pressure is the stated primary measure, and the available secondary information is incomplete. The body-weight comparison is additional context, while numerical results for the ASCVD risk-score outcome are not reported in the registry record. Safety counts are descriptive and do not establish causation or comparative safety.

Finally, the findings should not automatically be extended to populations, clinics, or intervention formats not described in the record. The registry describes people living with HIV receiving clinic care and a telephone educational approach, but does not provide enough detail to determine how similar other settings or participant groups would be. The statistics are best read as a bounded account of the posted data, not as a universal conclusion.

18. Why This Trial Matters Statistically

This trial is statistically informative because it makes a randomized comparison of a clinic-based educational approach and reports a continuous primary outcome over a stated follow-up interval. The contrast is expressed in the measurement's original units, mmHg, so readers can interpret the direction and scale of average change without relying only on a standardized effect or p-value.

The result also illustrates why estimates and uncertainty matter together. The mean difference and confidence interval convey more about the possible range of the group contrast than a significance test alone. The registry's reported p-value and the unadjusted recalculated p-value are not identical, which underscores the importance of distinguishing the posted sponsor analysis from a calculation based on summary statistics rather than treating a single p-value as a complete account.

The record offers an opportunity to consider analysis populations. The primary result is based on participants with data at baseline and 72 weeks, while enrollment is larger than the outcome-specific counts. Reporting the analysis population helps readers see the basis of the estimate; missing-data details would be needed to assess how incomplete follow-up might affect interpretation.

There is also a clear distinction between observed findings and planning illustrations. The participant requirements calculated from the observed effect can help demonstrate how effect size and desired power relate in future planning. They do not reveal the original study's sample-size rationale or the probability that the completed trial detected an effect.

More broadly, the registry record shows why transparent reporting of outcome definitions, analysis methods, missing data, and secondary results matters. The available statistics permit a focused interpretation of the primary comparison, but unanswered reporting questions limit broader conclusions. Recognizing both what can be learned and what remains uncertain is central to sound clinical-trial interpretation.

19. 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.

Several limitations are specific to the information recorded for this trial. Although the study is randomized, the registry does not describe the sequence-generation method, allocation concealment, recruitment procedures, or eligibility criteria. It also records no masking but does not specify which roles were aware of assigned group. The available information therefore does not support a detailed appraisal of how allocation and outcome assessment were conducted.

The primary outcome analysis includes only participants with measurements at baseline and 72 weeks. The record reports 19 and 14 participants in the respective arms, but does not describe missing observations, reasons for missingness, or any methods used to address it. This makes it difficult to judge whether the paired-data results represent all randomized participants.

The registry's reported primary analysis includes a two-sided t-test and p = 0.012, but does not post its estimate or confidence interval. The unadjusted recalculation gives a separate estimate and interval, and the record does not explain the difference between the two p-values. The original statistical-analysis plan, any covariate adjustments, interim analyses, and the trial's sample-size justification are not reported in the registry record.

The secondary outcome information is incomplete: the record lists two secondary outcome titles, but numerical results are available for only body weight. Results for change in 10-year ASCVD risk score are not reported in the registry record. The record also does not explain how multiple outcomes were handled statistically.

Finally, the intervention descriptions are brief. The curriculum content, telephone-contact schedule, adherence, and details of the pamphlets are not reported. Safety information is limited to event counts and listed terms, without detailed timing or comparative analysis. These gaps restrict assessment of intervention delivery, missing-data effects, multiplicity, and generalizability.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Case Managers for CVD Risk Reduction in HIV Clinic — NCT03839394.
• Registry record last updated 2024-09-24; status last verified 2024-08.
• Results first posted 2024-09-24.
• 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.

23. Record Summary

NCT03839394 is a completed randomized, unmasked, parallel-group study sponsored by Duke University, with enrollment of 50. It compares Educational Pamphlets + Telephone with Educational Pamphlets among people living with HIV in a clinic-based cardiovascular risk-reduction study.

The primary endpoint is change in ambulatory systolic blood pressure from baseline to 72 weeks among participants with data at both timepoints. The arm means are 1.9 mmHg and -10.7 mmHg. The registry reports a two-sided t-test with p = 0.012; the unadjusted recalculation gives a mean difference of -12.6 mmHg, with a 95% confidence interval from -21.44 to -3.763 mmHg and p = 0.005.

Body-weight change is the only secondary outcome with numerical results posted in the record. Further details about missing data, multiplicity, the original analysis plan, and the ASCVD risk-score result are not reported in the registry record.