Treatment of Early Hypertension Among Persons Living With HIV in Haiti: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Treatment of Early Hypertension Among Persons Living With HIV in Haiti (NCT04692467), a randomized phase 2 study. The primary outcome is Change in Mean Systolic Blood Pressure (SBP).

2. Clinical Question

This is a comparison of two treatment strategies, not simply a comparison of medication with no medication throughout follow-up: participants in standard care could begin amlodipine if they developed hypertension. The primary endpoint therefore addresses the contrast between starting treatment early and waiting until the specified hypertension threshold is met.

The registry describes a pilot randomized trial with enrollment of 250. The primary endpoint is a continuous measure, mean systolic blood pressure change, which retains information about the size of changes rather than reducing the outcome to whether each participant crossed a single threshold. The study also listed outcomes concerning viral suppression, antiretroviral adherence, adverse events, and retention. Numerical results for most of those outcomes are not reported in the registry record.

3. Trial Design

The registry describes a phase 2, randomized, unblinded, parallel-group pilot trial. It enrolled 250 participants and is marked completed. The study dates listed in the record are 2021-02-26 for the start and 2023-06-30 for primary completion. The sponsor is Weill Medical College of Cornell University.

Participants were recruited from the GHESKIO HIV clinic. The trial description specifies people living with HIV aged 18-65 years who were receiving antiretroviral therapy care, were virally suppressed, and had pre-hypertension. The registry characterizes pre-hypertension as systolic blood pressure 120-139 mmHg or diastolic blood pressure 80-89 mmHg. The study followed participants for 12 months.

In the early-treatment arm, participants began amlodipine 5mg daily immediately; the dose could increase to 10 mg if systolic blood pressure was greater than 130 mmHg after 1 month. In the standard-of-care arm, participants did not initially receive medication and could begin amlodipine if systolic blood pressure reached at least 140 mmHg or diastolic blood pressure reached at least 90 mmHg. Thus, the randomized contrast concerns early treatment versus treatment triggered by reaching the stated hypertension threshold.

The posted primary outcome is change in mean systolic blood pressure from baseline to 12 months, reported in mmHg. The record gives 124 participants in the intervention arm and 126 in standard care for the primary outcome. For the 12-month visit, the outcome description reports that 122 of 124 intervention participants and 120 of 126 standard-care participants had a visit. The record does not report the original sample-size justification, details of sequence generation or allocation concealment, or a fuller account of the analysis population. Those design details are 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

Analysis population for the primary outcome, as defined in the registry: For participants receiving Standard of Care, 120 of the 126 (95.2%) had a 12-month visit. For the participants receiving the intervention, 122 of the 124 (98.4%) had a 12-month visit.

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.

Population: In intention-to-treat analysis, the analysis population is the same as the assignment under randomization.

6. Primary Endpoint

The registry lists the primary outcome as Change in Mean Systolic Blood Pressure (SBP), measured over Baseline, 12 months.

The primary endpoint is change in mean systolic blood pressure from baseline to 12 months, measured in mmHg. Systolic blood pressure is the pressure recorded during the heart’s contraction. The endpoint summarizes how the group mean at follow-up differs from its baseline level; negative values in the posted results indicate a decrease. The reported mean changes were -10.58 mmHg in the early-treatment arm and -4.65 mmHg in standard care.

A continuous endpoint is useful for comparing the average magnitude of change across randomized groups. Unlike a threshold-only outcome, it can reflect changes across the observed range of systolic blood pressure. The endpoint aligns with the trial’s central comparison: initiating amlodipine before the hypertension threshold versus waiting until that threshold is reached.

The registry reports standard deviations of 11.01 mmHg and 11.41 mmHg for the intervention and standard-care groups, respectively. These describe variation in individual changes around each group’s mean; they do not indicate that every participant changed by the group average. The primary outcome description identifies baseline and 12 months as the assessment timeframe and reports the number of participants with a 12-month visit in each arm.

The registry’s sponsor analysis is labeled as a mixed models analysis of mean difference in final values. The record does not explain how that analysis handled repeated measurements or missing follow-up data. The endpoint is therefore clear at the level of the stated outcome, but the detailed analytic implementation is not reported in the registry record.

7. Results Posted in the Registry

• Intervention (Early Hypertension): mean -10.58 versus -4.65 on control; difference -5.93 (95% CI -8.71 to -3.15), standardized effect d = -0.53; z-test p = <0.001.

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.

Number of Participants Who Are Enrolled at Baseline and Remain in the Study by 12 Months

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Intervention (Early Hypertension): 98.4% (122/124) versus 96.8% (120/124) on control; risk difference 1.6 percentage points (95% CI -2.2 to 5.4), risk ratio 1.02 (0.98–1.06); unadjusted two-proportion z-test p = 0.408.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intervention (Early Hypertension) and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists 12 secondary outcome measures, including remaining in the study by 12 months, HIV viral suppression, antiretroviral medication adherence, and adverse events related to amlodipine. It posts numerical arm-level results for retention, but does not report numerical results for most of the listed secondary outcomes. A broad pattern across all secondary endpoints therefore cannot be established from the registry record.

The posted retention outcome counts 122 intervention participants and 120 standard-care participants among arm denominators of 124 in each group. Its unadjusted risk difference is 0.016, with a confidence interval from -0.022 to 0.054 and p = 0.408. The outcome description for the primary endpoint separately reports 122 of 124 intervention participants and 120 of 126 standard-care participants with a 12-month visit. The different standard-care denominator is present in the registry entries; the record does not explain the difference.

Retention is relevant to understanding whether participants remained available for follow-up, but it is not a substitute for the primary blood-pressure endpoint. The primary result concerns mean systolic blood pressure change; retention describes study participation. The registry’s listed HIV-related and safety outcomes could provide complementary context, but their numerical findings are not reported in the registry record in a way that supports an overall comparison.

Secondary results generally carry less weight than a prespecified primary endpoint when many outcomes are examined. Multiple comparisons increase the chance that some results may appear notable by chance, particularly when no adjustment is made. The registry does not report a multiplicity adjustment or a hierarchy for interpreting the secondary outcomes. The listed secondary outcomes should therefore be treated as supporting or exploratory information, not as independent confirmation of the primary result.

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

• Change in Number of Participants With HIV Viral Suppression as Measured by HIV-1 RNA Viral Loads < 1,000 Copies/mL
• Change in HIV Medication Adherence as Measured by Number of Participants With > 90% Adherence Using 4-day Pill Recalls
• Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.
• Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.
• Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.
• Adverse Events
• Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.
• Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.

9. Statistical Interpretation

10. Statistical Methods Explained

What does a mean difference describe?

A mean difference compares the average outcome in one group with the average in another. For this trial, the unadjusted recalculation uses the posted mean changes: -10.58 mmHg for early treatment and -4.65 mmHg for standard care. The resulting difference is reported as -5.93 mmHg. The negative sign is meaningful: the average change was more negative in the intervention group. It does not mean that every participant experienced a decrease of that size.

The reported standard deviations, 11.01 mmHg and 11.41 mmHg, describe the spread of participant-level changes around their respective group means. Variation matters because a mean difference is estimated from observations that vary between participants. Larger variation generally makes an estimate less precise when other features are held constant. The pooled standard deviation used for the standardized effect calculation is 11.21 mmHg, and the standardized mean difference is -0.529. These are summary descriptions of the observed contrast, not separate clinical endpoints.

How should the confidence interval be read?

A confidence interval gives a range of estimates compatible with the data and the method used, under that method’s assumptions. The unadjusted 95% confidence interval for the difference in mean change is -8.709 to -3.151 mmHg. It expresses uncertainty around the point estimate rather than a range containing most individual participants’ changes. It also does not guarantee that the true effect lies within that particular interval. The sponsor’s mixed models analysis reports a separate 95% interval, from -8.77 to -3.01.

For a two-sided comparison, an interval that excludes zero corresponds to evidence against a zero difference at the matching conventional significance level under the interval’s assumptions. The registry reports p < 0.001 for the unadjusted recalculation and p < 0.001 for the sponsor analysis. The registry’s p-value is not the probability that the null hypothesis is true, nor does it measure the clinical importance of the estimate.

Why distinguish the sponsor analysis from recalculation?

The sponsor analysis is reported as a mixed models analysis of mean difference in final values. A mixed model is a general statistical approach that can represent dependence among repeated measurements and can incorporate multiple measurements in a model. The registry does not report the model specification, included covariates, covariance structure, or missing-data assumptions, so those features cannot be described for this trial.

The recalculation is a simple, unadjusted comparison based on the posted arm-level summaries. It does not reproduce an unreported model or adjust for other variables. Its purpose is to provide a transparent comparison using the group means and standard deviations in the record. The sponsor’s analysis remains the trial’s reported analysis; when a discrepancy is marked, the sponsor’s own analysis takes precedence. No discrepancy is marked in this record.

What does randomization contribute?

Random assignment is intended to make treatment groups comparable on average at the start of a trial, including with respect to measured and unmeasured characteristics. It does not ensure that the groups are identical, and a trial’s actual conduct and analysis remain important. This record identifies the design as randomized but does not report details of sequence generation or allocation concealment. The parallel design means participants were assigned to one of the two strategies rather than crossing between them.

The trial was unblinded. Awareness of assignment can affect behavior, care decisions, reporting, or outcome assessment in some settings. Systolic blood pressure is a measured outcome, but the registry does not describe who measured it or whether measurement procedures were standardized between arms. These are general considerations; the specific procedures are not reported in the registry record.

Why does over-dispersion matter?

Over-dispersion is a general issue for outcomes modeled as counts or binary events when their variability is greater than the model assumes. It can make standard errors too small if not addressed. The primary outcome is continuous, so over-dispersion is not the central concern for interpreting its mean difference. For secondary binary outcomes, the registry record does not provide enough model detail to assess whether over-dispersion was relevant or addressed.

For the continuous endpoint, the key considerations include the spread of participant changes, the adequacy of the model, follow-up completeness, and how repeated or missing values were handled. The record reports standard deviations and a sponsor mixed-model result, but not the diagnostic checks or sensitivity analyses needed to evaluate all those aspects.

11. Confidence Intervals and Precision

The unadjusted estimate of the difference in mean systolic blood pressure change is -5.93 mmHg, with a 95% confidence interval from -8.709 to -3.151 mmHg. This interval expresses uncertainty in the estimated contrast, not the range of changes among individual participants. Its endpoints remain on the negative side of zero, indicating that the estimate is not especially close to a null difference under this calculation.

The sponsor’s mixed models analysis reports a mean difference in final values of -5.88, with a 95% confidence interval from -8.77 to -3.01. This interval also lies on the negative side of zero. The two intervals have similar locations and widths, but they arise from analyses described differently in the registry: a simple unadjusted recalculation of change summaries and the sponsor’s mixed models analysis of final values. The registry does not provide enough model detail to explain the exact relationship between the methods.

Precision is not the same as clinical importance. A confidence interval describes statistical uncertainty around an average contrast; it does not establish whether a particular difference matters to patients or predicts other outcomes. It also does not describe how much participants’ individual changes varied. The posted standard deviations, 11.01 mmHg and 11.41 mmHg, show that individual changes were dispersed around the group means.

Follow-up information is relevant to precision and possible bias. The primary outcome description reports a 12-month visit for 120 of 126 standard-care participants and 122 of 124 intervention participants. The registry does not report why other visits were unavailable, how missing measurements were handled, or whether sensitivity analyses produced similar estimates. Confidence intervals should therefore be interpreted as conditional on the analysis methods and their unreported assumptions, rather than as accounting automatically for every source of uncertainty.

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 figures are illustrations based on the observed effect, not the trial’s original design calculation. For this continuous outcome, the figures are participants per arm, not total events. The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to a stated fraction of the observed effect. The trial’s own original sample-size assumptions and justification are not reported in the registry record.

The 80% power column gives the illustrative participants per arm for a design that would have an 80% chance of detecting the specified effect if that effect were the true one and the planning assumptions held. The 90% power column gives the corresponding planning figure for a 90% chance. These are design probabilities under assumed conditions, not probabilities that the trial’s conclusion is correct. They are not observed power.

For planning at 100% of the observed effect, the figures are 57 participants per arm for 80% power and 76 participants per arm for 90% power. At 75% of the observed effect, they are 100 and 134 participants per arm. At 50% of the observed effect, they are 225 and 301 participants per arm. The progression illustrates a general principle: smaller effects are harder to distinguish from random variation, so detecting them at the same power generally requires more participants.

These calculations use an effect estimated from the trial itself. If that estimate is uncertain or not representative of a future study, the planning figures may not reflect the sample size needed for that study. They also do not replace a protocol-based calculation using the intended primary analysis, clinically relevant target effect, anticipated missing data, and other design assumptions. Those original assumptions are not reported in the registry record.

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 = -5.930; pooled standard deviation σ = 11.213.
2. n = 2 × (1.96 + 0.842)² × 11.213² / -5.930² = 56.1, rounded up to 57 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 <- -5.93                      # observed difference in means
sigma <- 11.213396509993                     # 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(4692467)
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 = 57 (80% power), 76 (90% power)
 75% of observed effect: n per arm = 100 (80% power), 134 (90% power)
 50% of observed effect: n per arm = 225 (80% power), 301 (90% power)
power.t.test: 57.1 
Simulated power at n = 57 per arm: 0.802 (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 sponsor’s reported analysis is a mixed models analysis of mean difference in final values. It gives an estimate of -5.88, a 95% confidence interval from -8.77 to -3.01, and p < 0.001. This is the trial’s own reported inferential analysis and should be distinguished from the simple unadjusted recalculation based on posted arm-level changes.

The recalculation compares the reported mean changes, -10.58 mmHg in the intervention arm and -4.65 mmHg in standard care. It estimates a mean difference of -5.93 mmHg, with a 95% confidence interval from -8.709 to -3.151 mmHg and p < 0.001. The recalculation does not reproduce the mixed model or account for model features that are not described in the registry.

The estimates are close, and the registry marks no discrepancy. The sponsor’s analysis and the recalculation nevertheless answer the comparison through different stated methods. The sponsor result is the appropriate reference for what the trial analysis reported; the unadjusted result is a transparent check based on the posted summary statistics. The registry does not report the full model specification, covariates, or missing-data assumptions, so the reasons for any small numerical differences cannot be determined from the record.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists 13 outcome measures and reports 1 analysis. The listed secondary outcomes include retention, viral suppression, medication adherence, and several adverse-event descriptions. When a study assesses multiple outcomes, the chance of obtaining an apparently unusual result by chance can increase. Statistical methods may address this through prespecified outcome hierarchies or adjustments for multiple testing, but the registry does not report whether either approach was used.

The primary outcome is identified as change in mean systolic blood pressure, which gives a clear main endpoint for interpreting the principal comparison. However, the registry does not report a detailed statistical analysis plan, analysis hierarchy, or multiplicity procedure. It is therefore not possible to determine from the record how confirmatory claims were separated from exploratory analyses or how the listed outcomes were prioritized.

The record reports 12-month visit counts for the primary endpoint, but does not describe reasons for missing visits, missing measurement patterns, or the method used to handle missing outcome data. A mixed models analysis can use repeated observations under particular assumptions, but the registry does not report the model specification or the assumptions applied in this trial. Sensitivity analyses for missing data are not reported in the registry record.

The registry does not provide a detailed definition of the analysis population, such as whether the sponsor’s analysis included all randomized participants or only participants with particular measurements. The posted arm sizes and follow-up counts do not, on their own, identify the exact analysis-population rule. The original sample-size justification and any interim analyses are also not reported in the registry record. These omissions limit assessment of how the analysis was planned and how robust it may be to missing observations or alternative analytic choices.

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: marked weakness (0.8%).

The registry reports 1 serious adverse event in the intervention group among 124 at risk and none in standard care among 126 at risk. The serious adverse event term listed is marked weakness, reported as 0.8%. The record reports no deaths in the intervention group and 2 in standard care.

These counts should be read as descriptive event totals during the recorded study, not as proof that an event was caused by or unrelated to amlodipine. The record does not provide enough detail about event timing, severity criteria, participant histories, or causal attribution to make that determination. Counts also do not establish comparative safety when the number of events is small and the study was a pilot trial.

The registry separately records 22 other adverse events in the intervention group and none in standard care. The record does not provide further event detail in the posted figures used for this comparison. The serious-event counts, other-event counts, and deaths are distinct summaries and should not be conflated. They do not replace a full assessment of event type, timing, duration, and relationship to treatment.

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

The primary endpoint estimates a difference between randomized groups in mean systolic blood pressure change over the study’s baseline-to-12-month timeframe. Both the unadjusted comparison and the sponsor’s reported mixed models analysis give a negative estimate, with their 95% confidence intervals lying below zero. In the posted analyses, the early-treatment group had a larger average decrease than the standard-care group.

This statistical finding does not mean every participant’s systolic blood pressure declined, nor does it quantify the probability that an individual will have a particular response. The group means do not show the full distribution of participant changes. The registry does not report the proportion of participants who experienced increases, reached a blood-pressure threshold, or had a specific clinically meaningful change.

The trial compared an early-treatment strategy with standard care that allowed amlodipine to begin if the hypertension threshold was reached. It did not compare early treatment with a strategy of never using medication. The distinction matters when interpreting the estimated contrast.

The primary endpoint does not establish effects on HIV viral suppression, medication adherence, cardiovascular outcomes, or longer-term health. The registry lists some of these as secondary outcomes, but numerical results for most are not reported in the registry record. The available follow-up is limited to the stated 12-month period, and the registry does not report detailed missing-data methods or a full analysis plan.

Finally, the findings describe this pilot trial’s participants and setting: people living with HIV receiving care at GHESKIO in Haiti who met the stated eligibility conditions. Generalization to other groups, health systems, or treatment circumstances requires evidence beyond this record. Statistical evidence about a group mean is informative, but it is not by itself a complete judgment about benefit, harm, or an individual’s care.

18. Why This Trial Matters Statistically

This trial illustrates how a randomized design can estimate the contrast between two care strategies rather than only comparing a drug with no treatment. The standard-care arm could begin amlodipine if participants reached the specified hypertension threshold, while the intervention arm started treatment immediately. That design makes the timing of treatment central to interpreting the primary mean difference.

The primary endpoint is continuous, allowing the analysis to compare average systolic blood pressure changes instead of relying only on a threshold event. The posted estimate is accompanied by confidence intervals, making uncertainty visible alongside the point estimate. The arm-level standard deviations also show that participant changes varied around the group means, an important part of interpreting an average effect.

The record demonstrates why a sponsor’s model-based analysis and an unadjusted recalculation should be identified separately. The sponsor reports a mixed models analysis, while the recalculation uses posted summaries. Their estimates are close, but their methods and assumptions are not interchangeable. Transparent distinctions help readers understand what each result does and does not represent.

The trial also highlights statistical questions that remain when registry reporting is incomplete. Follow-up counts are available, but missing-data handling, the original sample-size justification, the detailed analysis plan, and multiplicity procedures are not reported. Such information is important for assessing how an estimate was produced and how much confidence to place in its generalizability. The pilot setting and listed secondary outcomes make clear that statistical interpretation should distinguish the main endpoint from less completely reported supporting measures.

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.

This was an unblinded pilot randomized trial in a specific setting: the GHESKIO HIV clinic in Haiti. Its eligible population was people living with HIV receiving antiretroviral therapy, virally suppressed, and within the stated age and pre-hypertension criteria. Results may not apply to populations or care settings outside those criteria; the registry record does not establish broader generalizability.

The primary outcome description reports incomplete 12-month visits, with 120 of 126 standard-care participants and 122 of 124 intervention participants attending. The registry does not describe reasons for absent visits, missing blood-pressure measurements, the missing-data assumptions used, or sensitivity analyses. This leaves uncertainty about how missingness may have affected the estimate.

The sponsor analysis is described as a mixed models analysis of final values, but the model specification and analysis population are not reported. The registry also does not describe blood-pressure measurement procedures, assessor blinding, allocation concealment, or the original sample-size justification. These omissions limit independent assessment of the conduct and analysis.

Most listed secondary outcomes do not have numerical results reported in the registry record, and no multiplicity procedure is reported. The safety summaries include event counts but limited detail about timing, severity, and causal attribution. Finally, follow-up is described over 12 months, so the record does not establish longer-term outcomes.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Treatment of Early Hypertension Among Persons Living With HIV in Haiti — NCT04692467.
• Registry record last updated 2024-04-09; status last verified 2024-03.
• Results first posted 2024-04-09.
• 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.

23. Record Summary

NCT04692467 is a completed phase 2, randomized, unblinded, parallel-group pilot trial sponsored by Weill Medical College of Cornell University. It enrolled 250 people living with HIV and pre-hypertension at GHESKIO in Haiti. The comparison was immediate amlodipine treatment versus standard care, in which medication could begin if the hypertension threshold was reached.

The primary endpoint was change in mean systolic blood pressure from baseline to 12 months. The posted mean changes were -10.58 mmHg for early treatment and -4.65 mmHg for standard care. The unadjusted mean difference was -5.93 mmHg, while the sponsor’s mixed models analysis reported a mean difference in final values of -5.88, with a 95% confidence interval from -8.77 to -3.01 and p < 0.001.

The registry lists secondary outcomes, but numerical results for most are not reported. Important details about the original sample-size justification, missing-data handling, multiplicity, and full analysis specification are also not reported in the registry record.