Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men (YMSM): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men (YMSM) (NCT03414372), a randomized na study. The primary outcome is Number of Participants With Suppressed Viral Load.

2. Clinical Question

3. Trial Design

NCT03414372, titled Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men, was a randomized, single-masked, parallel-group study. The registry lists an enrollment of 156 and describes the study as completed. The sponsor was the University of North Carolina, Chapel Hill. The study began on 2019-05-07, and primary completion was recorded as 2022-04-07. The phase is listed as NA.

Three behavioral groups were included: Tough Talks Online, Tough Talks Clinic, and Standard of Care. The online group used Tough Talks Online; the clinic group received Tough Talks in a clinic; and the comparison group received standard of care. The intervention summary describes an opportunity to practice disclosing HIV status to romantic partners using different strategies and to encounter possible partner responses. The record does not report further details about the setting, session schedule, or delivery procedures in the registry record for this analysis.

The primary outcome was assessed at Month 6. Its reported population consists of participants with a Month 6 viral load assessment, rather than a stated analysis of every enrolled participant. The primary outcome counts participants with viral load suppression. The arm-level assessment counts were 39 for Tough Talks Online, 39 for Tough Talks Clinic, and 41 for Standard of Care. The registry record does not report why these assessment counts differ from the enrollment figure or provide a fuller account of participant flow.

The record lists secondary outcomes concerning condomless anal intercourse with a potentially susceptible partner, disclosure intentions, self-efficacy, perceived costs and rewards of disclosure, and disclosure self-regulation with family, peers, and sexual partners. Statistical analyses specified in the original trial plan, including any adjustment strategy or sample-size justification, 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: Data are reported for those participants who had a Month 6 viral load assessment.

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 Participants With Suppressed Viral Load, measured over Month 6.

The primary endpoint is the number of participants with suppressed viral load at Month 6. Suppression is defined in the registry as HIV RNA below the lower limit of detection for the laboratory at each clinical site. The endpoint is therefore a participant count classified according to a laboratory-based threshold, rather than a continuous measure of viral load.

Viral load suppression is used as an outcome because it provides a defined clinical measure at the follow-up assessment. The registry specifies that viral load information could come from chart review or be drawn for the study. That description identifies the potential sources of the measurement, but the registry record does not report the number obtained by each route or further laboratory procedures.

The reported counts are 29 of 39 assessed participants in Tough Talks Online, 31 of 39 in Tough Talks Clinic, and 30 of 41 in Standard of Care. These are Month 6 assessment counts, not counts for everyone enrolled. The record does not describe how participants without a Month 6 viral load assessment were handled in the primary analysis. Nor does it report a broader analysis population definition, such as whether assignment to groups was retained regardless of intervention participation.

The endpoint’s threshold depends on the lower limit of detection used at each clinical site. The registry does not provide site-specific thresholds or additional detail about how variation between laboratories was addressed. Interpretation should therefore stay with the endpoint definition and results as posted, without assuming unreported laboratory or missing-data procedures.

7. Results Posted in the Registry

• Tough Talks Online: 74.4% (29/39) versus 73.2% (30/41) on control; risk difference 1.2 percentage points (95% CI -18.1 to 20.5), risk ratio 1.02 (0.78–1.32); unadjusted two-proportion z-test p = 0.904.
• Tough Talks Clinic: 79.5% (31/39) versus 73.2% (30/41) on control; risk difference 6.3 percentage points (95% CI -12.2 to 24.9), risk ratio 1.09 (0.85–1.39); unadjusted two-proportion z-test p = 0.507.

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 Had Condomless Anal Intercourse With a Potentially Susceptible Partner

• 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:
  • Tough Talks Online: 37.9% (11/29) versus 32.0% (8/25) on control; risk difference 5.9 percentage points (95% CI -19.5 to 31.4), risk ratio 1.19 (0.57–2.48); unadjusted two-proportion z-test p = 0.649.
  • Tough Talks Clinic: 27.3% (6/22) versus 32.0% (8/25) on control; risk difference -4.7 percentage points (95% CI -30.8 to 21.4), risk ratio 0.85 (0.35–2.08); unadjusted two-proportion z-test p = 0.724.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Tough Talks Online and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Tough Talks Clinic and the control. The interval gives the range of effects that remain compatible with the data.

Mean Intention to Disclose Score

• 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:
  • Tough Talks Online: mean 1.45 versus 1.15 on control; difference 0.30 (95% CI 0.11 to 0.49), standardized effect d = 0.69; z-test p = 0.002.
  • Tough Talks Clinic: mean 1.33 versus 1.15 on control; difference 0.18 (95% CI -0.00 to 0.36), standardized effect d = 0.43; z-test p = 0.054.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Tough Talks Online than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Tough Talks Clinic and the control. The interval gives the range of effects that remain compatible with the data.

Mean Disclosure Self-Efficacy Score

• 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:
  • Tough Talks Online: mean 22.89 versus 25.64 on control; difference -2.75 (95% CI -6.15 to 0.65), standardized effect d = -0.37; z-test p = 0.113.
  • Tough Talks Clinic: mean 23.03 versus 25.64 on control; difference -2.61 (95% CI -5.78 to 0.56), standardized effect d = -0.38; z-test p = 0.106.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Tough Talks Online and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Tough Talks Clinic and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary results cover a mix of behavioral outcomes and disclosure-related scores. Across the results described in the record, estimates do not all point in the same direction: some point estimates are higher in an intervention group than in Standard of Care, while others are lower. The intervals vary in width, and several include the null value for their comparison. This broad pattern does not provide a single consistent signal across different measures.

These outcomes address related but distinct questions. A measure of disclosure intention or self-efficacy is not the same endpoint as Month 6 viral load suppression, and reported condomless anal intercourse is a behavioral outcome rather than a laboratory measure. They may help describe different aspects of the intervention’s intended context, but they do not substitute for the primary endpoint or explain its result.

The primary result is itself uncertain, with broad intervals around both comparisons. Secondary findings should therefore be interpreted as complementary, exploratory context rather than as a resolution of uncertainty in the primary comparison. The registry does not report a formal analysis that combines secondary outcomes with the primary endpoint.

The record lists multiple secondary outcomes and posts unadjusted comparisons, while the registry entries do not report a multiplicity plan or adjusted secondary analyses. When many outcomes or comparisons are examined, some results may appear notable by chance alone. Without a prespecified hierarchy or multiplicity adjustment described in the record, individual unadjusted secondary p-values carry less weight than a result from a clearly specified primary analysis. The record also does not list reported analyses for the secondary outcomes, so the posted summaries should not be taken as a complete account of inferential analyses undertaken.

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

• Number of Participants Who Had Condomless Anal Intercourse With a Potentially Susceptible Partner
• Mean Intention to Disclose Score
• Mean Disclosure Self-Efficacy Score
• Mean Consequences of Disclosure (Cost) Score
• Mean Consequences of Disclosure (Rewards) Score
• Mean Disclosure Self-Regulation (Family) Score
• Mean Disclosure Self-Regulation (Peers) Score
• Mean Disclosure Self-Regulation (Sexual Partners) Score

9. Statistical Interpretation

10. Statistical Methods Explained

What does a risk difference describe?

General explanation. A risk difference compares the proportion of participants with an event in one group with the proportion in another group. A value of zero corresponds to equal observed proportions; positive and negative values indicate which group had the higher observed proportion according to the comparison’s direction. For the primary outcome, the event is viral load suppression. The registry’s posted risk differences compare each Tough Talks group with Standard of Care.

The comparisons also include risk ratios and odds ratios. These express group differences on other scales: a risk ratio compares the event proportions, while an odds ratio compares the odds of the event. Because the measures use different scales, their numerical values are not interchangeable. The corresponding intervals are useful for seeing the uncertainty attached to each estimate.

How should intervals be read?

General explanation. An interval around an estimate describes a range of values compatible with the data under the method used to construct it. A narrow interval indicates greater precision than a broad one. When an interval for a difference includes zero, the data do not rule out equal group proportions at the interval’s stated level. The registry record does not state the confidence level for the posted intervals in the registry record for this analysis, so no particular level should be assumed.

For the primary endpoint, the interval for each comparison includes zero and extends to values on both sides of zero. The intervals therefore reflect substantial uncertainty about the direction and size of the differences. An interval’s inclusion of zero is not proof that the groups are identical, just as an interval excluding zero would not by itself establish clinical importance.

What does an unadjusted p-value add?

General explanation. A p-value describes how unusual data at least as incompatible with a specified null model would be, if that model and the analysis assumptions were correct. It does not measure the probability that the null hypothesis is true, the probability that a result occurred by chance, or the size of an effect. The posted p-values are explicitly unadjusted. The registry record does not report whether the investigators used other analyses or adjustments.

The unadjusted p-values for the primary comparisons are 0.904 and 0.507. These values should be considered alongside the estimates and intervals, rather than used as a stand-alone decision rule. They also do not account for the full set of endpoints or comparisons unless an adjustment was made; whether any such adjustment was planned or conducted is not reported in the registry record.

Why does the assessed population matter?

The primary endpoint reports participants with a Month 6 viral load assessment. The reported denominators are 39, 39, and 41 across the three groups. That population is distinct from the registry’s overall enrollment of 156. The registry record does not report the disposition of participants who were enrolled but lack a Month 6 assessment, nor does it explain whether missing outcomes were handled using imputation, a complete-case method, or another approach. Without that information, the possible effect of missing assessments on the comparisons cannot be evaluated from the posted results alone.

The record states that viral load information could be obtained from chart review or drawn for study. It does not report additional details on outcome ascertainment, laboratory thresholds by site, or whether assessors were masked to group assignment. Such details may affect how confidently readers can assess consistency of measurement, but should not be inferred from the masking label alone.

What is and is not established about the analysis?

The registry lists a randomized, single-masked, parallel design and posts group counts and unadjusted comparisons. It does not report the original statistical analysis plan, a primary sample-size justification, the planned handling of repeated or multiple outcomes, any interim analyses, or a model-based adjusted analysis. No reported analyses are listed for the secondary outcomes. These absences mean the posted summaries cannot be used to reconstruct the investigators’ full analysis process.

General explanation. Random assignment can support fair comparisons when allocation is implemented as intended and the analysis preserves the randomized groups, but the registry entries do not detail allocation procedures or the analysis population. A parallel-group design assigns participants to a group and compares outcomes across groups. Single masking indicates one party was masked, but the registry record does not identify who was masked. The design labels alone do not resolve questions about adherence, missing outcomes, or measurement procedures.

Accordingly, the clearest statistical reading is descriptive: the registry reports the observed Month 6 counts and unadjusted comparisons for the two intervention-versus-control contrasts. The interval estimates communicate substantial uncertainty, while the unadjusted p-values offer a related but different summary. Neither should be interpreted as a complete record of the trial’s full statistical analysis.

11. Confidence Intervals and Precision

The primary estimates have broad intervals relative to their point estimates. For Tough Talks Online versus Standard of Care, the posted risk difference is 0.012, with an interval from -0.181 to 0.205. For Tough Talks Clinic versus Standard of Care, it is 0.063, with an interval from -0.122 to 0.249. Each interval spans zero and includes values in both directions. Thus, the data are compatible with a range of possible group differences, rather than pinning down a precise effect.

General explanation. An interval communicates statistical precision: narrower ranges indicate more precise estimates, while wider ranges leave more uncertainty about the underlying value. It is not a guarantee that the true value lies within the interval, and its interpretation depends on the construction method and confidence level. The registry record does not report the confidence level or method for these intervals in the registry record for this analysis.

The assessed group sizes for the primary endpoint were 39, 39, and 41. The intervals should be read in the context of these observed assessment counts and the fact that the full enrollment was 156. Because the record does not describe missing outcome handling or participant flow, the intervals alone cannot address whether the assessed participants represent all randomized participants.

The registry also reports intervals for risk ratios and odds ratios, but these alternate scales do not remove the underlying uncertainty. A point estimate near a null value is not enough to conclude equivalence, and an interval crossing a null value is not evidence that there is no difference. The primary comparisons are best described as imprecise, with neither direction nor magnitude established conclusively by the posted data.

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 sample-size illustrations show participants per arm for the binary and continuous comparisons. They are not total event counts. The registry’s planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect used for planning is a stated fraction of the observed effect. The original trial’s own design assumptions and sample-size justification are not reported in the registry record.

Each planning row asks how many participants per arm would be needed under those assumptions to have 80% or 90% power for the specified effect. In plain language, 80% power is the chance, under the assumed effect and statistical model, of detecting an effect at the chosen significance threshold; the 90% column represents a higher chance under those same assumptions. These are prospective planning quantities, not descriptions of what happened in the completed study.

Rows using a smaller fraction of the observed effect show larger required sample sizes. This is expected: smaller differences are harder to distinguish from random variation, so more participants are generally needed for the same target power. The observed estimates themselves may be imprecise, particularly when based on limited assessment counts, and planning based on an observed effect is sensitive to that uncertainty.

These figures are planning illustrations, not observed power. They do not establish the probability that the trial’s result is correct, and they do not replace the actual estimates and intervals. The registry record does not report whether these illustrations match the assumptions used when the trial was originally designed.

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, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.732; treatment proportion p₁ = 0.744; average p̄ = 0.738.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6221 = 1.2194.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6221 = 0.5236.
4. n = (1.2194 + 0.5236)² / (0.0119)² = 21,514.8, rounded up to 21,515 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
p0 <- 0.731707317073171                          # control proportion
p1 <- 0.743589743589744                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^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 (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(3414372)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 21,515 (80% power), 28,802 (90% power)
 75% of observed effect: n per arm = 38,389 (80% power), 51,391 (90% power)
 50% of observed effect: n per arm = 86,687 (80% power), 116,049 (90% power)
power.prop.test: 21514.8 
Simulated power at n = 21,515 per arm: 0.802 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-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. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary endpoint and multiple secondary outcomes. The registry entries available for this analysis do not describe a hierarchy among the secondary outcomes, a family-wise error strategy, a false-discovery approach, or another multiplicity procedure. They also do not report whether an adjustment was planned for the two primary comparisons against Standard of Care. The posted p-values are unadjusted, so they should not be interpreted as if they account for testing across multiple outcomes or contrasts.

Missing outcome handling is also not described. The primary endpoint population includes participants with a Month 6 viral load assessment, and the posted denominators differ from the overall enrollment. The registry does not report the number missing by reason, whether missingness differed by group, whether any outcomes were imputed, or whether a sensitivity analysis was conducted. Without this information, the potential influence of missing assessments on the results remains uncertain.

The registry record does not state whether the primary analysis used an intention-to-treat population, a per-protocol population, or another definition. It does not report whether participants were analyzed according to random assignment regardless of intervention receipt. These distinctions matter because analysis-population choices can affect the interpretation of randomized comparisons, especially when outcome assessments or intervention participation are incomplete.

The record also does not report the original statistical analysis plan, interim analyses, or a prespecified approach to subgroup analyses. These omissions do not establish that such procedures were absent; they mean that their use cannot be assessed from the registry record. Readers should distinguish the posted descriptive summaries and unadjusted comparisons from a fully documented analysis plan.

15. 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 reports serious adverse events and other adverse events by group. For serious adverse events, the posted count was 0 in Tough Talks Online, 0 in Tough Talks Clinic, and 0 in Standard of Care. The corresponding groups at risk were 53, 51, and 52. The record reports 0 other adverse events in each group as well. One death is recorded in Standard of Care, and 0 deaths are recorded in each Tough Talks group.

These figures are counts as recorded, with the listed groups at risk. They should not be treated as evidence that no adverse events occurred outside the registry’s reporting definitions or observation period. The registry entries available for this analysis do not specify the safety observation period, event definitions beyond the serious-adverse-event label, severity breakdown, or relationship of events to study participation.

The adverse-event group counts differ from the Month 6 primary outcome assessment counts. The registry does not explain the relationship between these populations, so the safety denominators should not be substituted for primary endpoint denominators. The posted figures describe what is recorded in the registry and do not by themselves establish comparative safety.

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

The posted primary outcome shows Month 6 viral load suppression counts of 29 of 39 in Tough Talks Online, 31 of 39 in Tough Talks Clinic, and 30 of 41 in Standard of Care. The unadjusted risk-difference comparisons are 0.012 for Online versus Standard of Care and 0.063 for Clinic versus Standard of Care. Both corresponding intervals include zero and extend to values on either side. The registry data therefore do not establish a clear difference between either Tough Talks format and Standard of Care on this endpoint.

This does not mean the groups have been shown to be equivalent. Establishing equivalence would require a defined equivalence margin and an analysis designed for that question; neither is reported in the registry record. Nor do the results establish that there is no possible effect. The intervals leave room for differences in both directions, and the estimates are not precise enough to identify a narrow range of plausible values.

The results also do not provide a direct comparison between Tough Talks Online and Tough Talks Clinic. Their separate contrasts with Standard of Care cannot be used as a substitute for a reported head-to-head test. The findings do not show whether one delivery format is preferable to another.

Interpretation is limited to the reported endpoint and its Month 6 assessment population. The record does not describe missing data handling, full participant flow, analysis-population rules, or adjusted analyses. It also does not report a multiplicity strategy for the wider set of outcomes. These gaps limit how completely the posted summaries can be interpreted as evidence from the full randomized study.

The statistical results are not medical advice and do not determine what care an individual should receive. They describe the recorded group data and the uncertainty around the registry’s unadjusted comparisons. The registry record does not support a broader conclusion about all disclosure outcomes, all participants, or clinical practice beyond the results it reports.

17. Why This Trial Matters Statistically

This trial is statistically instructive because it places a behavioral intervention alongside a defined laboratory outcome. The intervention was designed to support HIV disclosure practice, while the primary endpoint was viral load suppression at Month 6. Those are related to the study’s clinical context but represent different constructs. Distinguishing an intervention’s intended behavioral focus from the measured primary endpoint is essential when interpreting what a result addresses.

The study also illustrates why estimates should be read with their uncertainty. The two posted comparisons have point estimates on the positive side, but their intervals include zero and span values in both directions. A point estimate alone can suggest a direction without demonstrating that the direction is well established. The intervals make the uncertainty visible and discourage an overconfident reading of the observed differences.

Another statistical issue is the difference between enrollment and the population contributing to the primary outcome. The registry reports enrollment of 156, while the primary outcome is reported for participants with a Month 6 viral load assessment. Without participant flow and missing-data details, readers cannot determine how those populations relate or assess the possible consequences of missing assessments.

Finally, the record includes multiple secondary outcomes and unadjusted comparisons but does not report a multiplicity plan. This highlights why a collection of exploratory findings should not be treated as a set of independent confirmations. A complete interpretation benefits from a prespecified analysis plan, clear population definitions, and transparent handling of missing outcomes; those details are not reported in the registry record.

18. 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 primary endpoint is reported among participants who had a Month 6 viral load assessment, and the registry does not provide a participant-flow account explaining how this group relates to all enrolled participants. Reasons for missing assessments and methods for handling missing outcomes are not reported in the registry record. This limits assessment of possible selection or attrition effects.

The endpoint uses a lower limit of detection defined by the laboratory at each clinical site. The record does not report site-specific thresholds or how differences between laboratories were addressed. Viral load information could come from chart review or be drawn for study, but the number obtained through each source and any related measurement procedures are not reported.

The registry labels the trial single-masked but does not identify who was masked. It does not provide further details about randomization procedures, intervention adherence, contamination between groups, or how participants received the assigned intervention. These omissions limit assessment of implementation and measurement context; they should not be read as evidence that a procedure was or was not used.

The posted comparisons are unadjusted, and the original analysis plan, multiplicity strategy, and rationale for the trial’s original sample size are not reported in the registry record. The primary comparisons are against Standard of Care; a direct comparison between Tough Talks Online and Tough Talks Clinic is not posted. The results therefore answer a narrower question than a complete evaluation of differences among all three groups might address.

The registry lists several secondary outcomes, but the registry entries available for this analysis do not provide detailed results for every listed measure. The number and scope of posted secondary summaries should not be assumed to represent a complete account of all analyses conducted.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men (YMSM) — NCT03414372.
• Registry record last updated 2023-03-06; status last verified 2023-02.
• Results first posted 2023-03-06.
• 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.

22. Record Summary

NCT03414372 is a completed randomized, single-masked, parallel-group study sponsored by the University of North Carolina, Chapel Hill. The registry lists enrollment of 156 and three behavioral groups: Tough Talks Online, Tough Talks Clinic, and Standard of Care.

The primary endpoint was the number of participants with suppressed viral load at Month 6, defined using the laboratory’s lower limit of detection. The posted assessment counts were 29 of 39, 31 of 39, and 30 of 41, respectively. Unadjusted comparisons against Standard of Care have intervals that include zero and are broad, leaving substantial uncertainty about the size and direction of differences.

The registry also lists secondary outcomes and adverse-event counts. Details about missing data, the original analysis plan, multiplicity procedures, and the trial’s original sample-size justification are not reported in the registry record.