HIV+ Substance Users Released From Jail: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for HIV+ Substance Users Released From Jail (NCT03834779), a randomized na study. The primary outcome is Number of Participants With Undetectable HIV Viral Load.

2. Clinical Question

The trial addresses a re-entry and continuity-of-care question. Its project summary describes a goal of improving HIV and substance use outcomes and reducing recidivism, with individualized assistance navigating social and medical services as the proposed approach. The primary outcome reported in the registry record is specifically about viral load; it does not, by itself, measure substance use, recidivism, or the broader set of re-entry needs.

The comparison is randomized, with the intervention evaluated against treatment as usual. The registry record does not give enough statistical results to determine the precision of a group contrast or whether a difference is compatible with chance. The clinical question should therefore be read as the trial's intended comparison, while the posted primary outcome is interpreted descriptively from the participant counts.

3. Trial Design

The registry record describes a randomized, parallel-group trial with no masking. Its status is completed. The listed enrollment is 31. The primary completion date is 2021-04-29, and the start date is 2019-05-29. The record identifies the sponsor as University of Texas Southwestern Medical Center and lists phase as NA.

The two groups are DOORS-CHW Intervention and Treatment As Usual. The intervention description says that participants meet with a Community Health Worker and an Unlocking DOORS staff member. The Unlocking DOORS broker completes a needs assessment, develops an individualized re-entry plan and makes referrals. Treatment as usual is described as passive referral by jail medical staff to the outpatient HIV clinic. The record does not provide further operational detail about how consistently these activities were delivered.

The project summary describes development and refinement of a collaborative Community Health Worker and re-entry program, followed by a pilot randomized trial. It states an intended comparison of the intervention with treatment as usual using n=40 in each group. That is the aim described in the summary, not the enrollment reported for the completed record. Reasons for the difference between the stated aim and recorded enrollment are not reported in the registry record.

The primary outcome is assessed at 6 months after enrollment. The results list 10 participants in the intervention group and 8 in treatment as usual for this outcome. These are the group-specific outcome counts shown with the posted results; the registry record does not explain the difference between these counts and the overall enrollment. No masking is listed, and details of allocation concealment, implementation fidelity, or protocol deviations 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.

Before assignment: 31 individuals enrolled and assigned to study arms, all 31 who were enrolled were deemed eligible

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All participants who had viral load completed at 6 months

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: Analysis population same as assigned treatment group

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Undetectable HIV Viral Load, measured over At 6 months after enrollment.

The primary endpoint is the number of participants with an undetectable HIV viral load at 6 months after enrollment. The record defines undetectable as <200 copies/mL and says the measure is assessed via blood work. The outcome is a participant count: it records how many people meet the threshold, rather than the actual viral-load value for each participant or the size of a change from baseline.

Viral load is used in this trial as a biomedical indicator related to HIV outcomes. In statistical terms, turning the measure into an undetectable/not-undetectable classification makes the endpoint binary for each assessed participant. The posted group summaries are counts of participants meeting the threshold, with 2 of 10 listed for DOORS-CHW Intervention and 3 of 8 for Treatment As Usual. These counts do not provide a group-level estimate of the underlying probability of meeting the threshold, and no confidence interval or inferential comparison is posted.

The stated endpoint population is all participants who had viral load completed at 6 months. That wording matters: it does not establish that every randomized participant contributed an endpoint value. The registry record does not report why endpoint data are absent for other participants, how missing measurements were handled, or whether the listed analysis followed the randomized assignment regardless of intervention participation.

The endpoint captures a specific clinical measure at a specified follow-up time. It does not directly summarize the intervention's social-service components, substance use, or recidivism. The registry record lists substance-use status assessed via urine drug screen as a secondary outcome, but the primary result under discussion is the viral-load count.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is binary at the participant level: a participant either meets the registry's undetectable viral-load threshold or does not. The displayed outcome is a count of participants meeting the threshold. A count is not the same as a rate, risk difference, risk ratio, or odds ratio. To compare groups, an analysis would ordinarily use the number meeting the threshold together with the number assessed in each group, then report an estimate and its uncertainty. The registry record supplies the group counts and assessed group sizes but says values are missing or not estimable for a two-arm comparison. It does not post a comparative estimate.

What does a confidence interval communicate?

In general, a confidence interval describes uncertainty around an estimated quantity under the assumptions of the statistical method. It can show whether the data support a narrow or broad range of plausible group contrasts. A point estimate alone does not show that uncertainty, and a confidence interval is not a guarantee that the true effect lies inside its endpoints. No confidence interval is reported for this primary endpoint, so precision cannot be quantified from the posted comparative results.

Why does a binary outcome need a comparison method?

With a binary outcome, the information is in both the event count and the number assessed. The same event count can convey a different observed frequency when the assessed group size differs. Statistical methods for binary outcomes account for this structure and can estimate a group contrast with uncertainty. Sparse outcome data can make estimates unstable or prevent a registry system from calculating some measures. The record's note that values are missing or not estimable indicates that a two-arm result is not available; it does not identify the technical reason, so the cause is not reported in the registry record.

What does randomization contribute?

Random allocation is intended to make assigned groups comparable, on average, with respect to factors known and unknown at assignment. It does not ensure that the groups will be balanced in a small trial, nor does it remove uncertainty from limited outcome data. The record identifies the allocation as randomized and the model as parallel. It does not report the method used to generate the allocation sequence, allocation concealment, stratification, or other design details. Those features cannot be inferred from the word randomized alone.

How should the planning illustration be read?

The registry record describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. The assumed effect to detect is expressed as a stated fraction of the observed effect. These are planning assumptions, not evidence that the original trial used that design or analysis. Any resulting sample-size value is a planning illustration, not observed power. Sample-size planning asks what enrollment might be needed under specified assumptions; it does not show the probability that a completed study has detected a true effect.

The planning framework is also distinct from the clinical trial's own design justification. The record says the illustration is not the trial's own design. A design justification, including any original sample-size calculation, is not reported in the registry record. Since the primary binary comparison is marked as not estimable, numerical planning outputs cannot be interpreted as a reliable, independently established effect estimate. They depend on the effect assumption and the calculation method, and a planning illustration based on an observed effect can be sensitive to random variation in a pilot.

What can be concluded from the analysis listing?

The record lists 0 analyses. This means no analysis results are posted in that registry field; it does not establish that no analysis was performed outside the registry. The listed primary outcome summaries remain descriptive counts. No adjustment method, regression model, test statistic, p-value, or confidence interval is reported. The registry record also does not state whether the primary comparison was prespecified in a statistical analysis plan or how any departures from such a plan were handled.

General statistical interpretation therefore separates the randomized design from the results actually available. Randomization can support a causal comparison when analysis and follow-up preserve the design and address missing data appropriately. Here, the posted outcome summaries do not give the information needed to evaluate those conditions or quantify an intervention contrast. The result can be described accurately as a pair of observed endpoint counts, but an inferential claim requires more than those counts.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("DOORS-CHW Intervention", "Treatment As Usual")
n      <- c(10, 8)
events <- c(2, 3)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  DOORS-CHW Intervention  10  2  20.0  2.5  55.6  5.7  51.0  6.0  51.8
ARM  Treatment As Usual  8  3  37.5  8.5  75.5  13.7  69.4  13.7  70.1

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 4 outcome measures and 1 posted secondary outcome. The secondary outcome concerns the number of participants positive or negative for substance use as assessed via urine drug screen. The primary outcome addressed in these results is the count with undetectable HIV viral load at 6 months. The record does not describe a multiplicity strategy, such as a hierarchy of outcomes or an adjustment for testing several outcomes. Whether multiplicity was addressed in a protocol or analysis plan is not reported in the registry record.

Missing data are relevant because the primary endpoint population is defined as all participants who had viral load completed at 6 months. The listed outcome groups include 10 intervention participants and 8 treatment-as-usual participants. The registry record does not provide a participant flow accounting for missing viral-load measurements, reasons for missingness, or the timing and availability of other measurements. It also does not report imputation, sensitivity analyses, or assumptions about missing outcomes.

The analysis population is not specified beyond the endpoint population wording. The record does not say whether participants were analyzed according to randomized group, whether any participants were excluded after randomization, or whether the analysis was intention-to-treat, per-protocol, or another approach. The randomization label alone does not establish which population was used for the posted summaries.

The registry record lists 0 analyses, and the binary comparison is marked as missing or not estimable. Thus there is no posted inferential analysis to assess for multiplicity, adjustment, or handling of missing outcomes. These omissions limit interpretation of both the primary endpoint and the broader set of outcomes.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: hospitalization (70.6%).

The safety record reports serious adverse-event figures separately by group. For DOORS-CHW Intervention, 17 participants are listed as at risk for serious adverse events and 12 as affected. For Treatment As Usual, 14 are listed as at risk and 6 as affected. The record also reports 17 and 14 participants at risk for other adverse events, respectively, with 0 affected in each group. Deaths are listed as 1 in the intervention group and 2 in treatment as usual.

These are registry counts, not a comparative safety analysis. The record does not report confidence intervals, tests, adjusted estimates, event timing, or detailed case descriptions. It also does not explain the relationship between the serious-adverse-event affected counts and the listed deaths. The top serious term shown is Hospitalization, with 70.6%; the denominator and the exact interpretation of that percentage are not reported in the registry record. It should not be treated as a group-specific rate or assumed to describe every serious event.

Counts across groups should not be interpreted as evidence that one intervention caused more or fewer events. The record does not provide attribution, severity detail beyond the serious classification, or sufficient context for a causal safety comparison. These figures describe what the registry reports, not a complete assessment of safety.

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

The posted result establishes that the registry records 2 participants with an undetectable viral load in DOORS-CHW Intervention and 3 in Treatment As Usual among the participants listed as having completed viral-load assessment at 6 months. The threshold is <200 copies/mL. These are the available descriptive outcome counts; a comparative effect estimate and its precision are not posted.

The result does not establish that the groups had the same outcome, nor does it establish that the intervention improved or worsened the outcome. The absence of an estimable two-arm comparison is an absence of a reported inferential result, not proof that a difference is absent. Without a confidence interval or other comparative analysis, the size and uncertainty of a group contrast cannot be evaluated from the registry record.

The counts also do not establish what happened to participants without a completed viral-load result at 6 months. The record does not report reasons for missing measurement or how those participants were handled analytically. Since the stated endpoint population includes participants with a completed assessment, it is not safe to assume that the displayed counts represent all randomized participants.

The endpoint has a narrower scope than the project goals. It records a threshold-based HIV outcome and does not directly answer whether the intervention changes substance use, recidivism, continuity of care, or other re-entry outcomes. A secondary substance-use outcome is listed, but a result for it is not described in the registry record for this interpretation.

Finally, this is described as a pilot randomized trial, and the project summary frames the work as developing and testing a collaborative approach for possible later implementation at larger scale. The posted counts can inform a descriptive account of this trial, but they are not enough to make a precise or definitive claim about the intervention's effect. A stronger interpretation would require clearly reported group comparisons, uncertainty estimates, and details about analysis populations and missing outcomes.

14. Why This Trial Matters Statistically

This trial is statistically notable because it combines a randomized design with a pilot setting and a binary primary endpoint. Randomization is important for structuring a fair comparison, but the strength of the conclusion depends on how many outcome measurements are available and how they are analyzed. Here, the registry provides group-specific counts but does not provide an estimable two-arm result.

The mismatch between the summary's intended group sizes and the completed record's enrollment is also relevant to interpretation. The summary describes an aim of n=40 in each group, while the registry record lists enrollment of 31. This distinction illustrates why planned enrollment and actual recorded enrollment should not be conflated. The record does not explain the difference or give a sample-size justification for the completed trial.

For biostatistical interpretation, the endpoint population deserves particular attention. The primary outcome is defined among participants with viral load completed at 6 months, and the displayed group sizes are 10 and 8. Those figures make it important to understand follow-up, missingness, and analysis population before drawing a group-level inference. The registry record does not report those details.

The trial also demonstrates why a planning illustration is not a substitute for trial results. Planning estimates depend on assumptions about the effect and analysis; they are not observed power and do not provide evidence that an intervention effect has been demonstrated. The registry's planning assumptions should be read separately from the descriptive primary outcome counts.

More broadly, pilot studies can help identify practical and statistical questions for future evaluation, while their estimates may remain imprecise. This record describes a community-clinic collaboration aimed at a population facing re-entry challenges, but the statistical result available for the primary endpoint remains limited to counts without a comparative estimate. That distinction is central to an accurate reading of the evidence.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The primary result is limited by the lack of a reported comparative estimate for the binary endpoint. The registry record states that values are missing or not estimable for a two-arm comparison and lists 0 analyses. No confidence interval, test result, adjusted analysis, or model specification is reported. The group counts therefore support descriptive reporting, but not a quantified conclusion about the difference between assigned groups.

The endpoint is available for a stated subset: participants with viral load completed at 6 months. The record lists 10 participants in the intervention group and 8 in treatment as usual, but does not describe participant flow, reasons for missing measurements, or missing-data methods. It is not reported whether the summaries include everyone randomized or follow another analysis-population definition.

The record lists total enrollment of 31, whereas the project summary describes an intended comparison using n=40 in each group. It does not explain this difference, report the completed trial's sample-size justification, or state whether recruitment ended as planned. The trial is identified as randomized, parallel, and unmasked, but details about sequence generation, allocation concealment, adherence, intervention delivery, and protocol deviations are not reported in the registry record.

The registry record also gives limited context for broader outcomes and safety. It lists a secondary substance-use outcome but no corresponding results in the registry record. It reports adverse-event counts and a serious-term percentage, without enough context to assess event attribution, timing, or comparative risk. Multiplicity handling and the statistical analysis plan are not reported. These gaps constrain interpretation of both effectiveness and safety.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: HIV+ Substance Users Released From Jail — NCT03834779.
• Registry record last updated 2023-02-13; status last verified 2023-01.
• Results first posted 2023-02-13.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT03834779 is a completed randomized, parallel-group trial with no masking, sponsored by University of Texas Southwestern Medical Center. The record lists enrollment of 31 and phase as NA. It compares the behavioral DOORS-CHW Intervention with Treatment As Usual, described as passive referral to an outpatient HIV clinic.

The primary endpoint is the count of participants with an undetectable viral load (<200 copies/mL) at 6 months after enrollment, among those with viral load completed. The posted counts are 2 of 10 for the intervention group and 3 of 8 for treatment as usual. The registry record says a two-arm comparison is not estimable and lists 0 analyses, so no comparative effect estimate or precision measure is available.

The project summary describes a pilot intervention-development effort and an intended larger-scale pathway. Reasons for the difference between the stated aim and recorded enrollment, missing-outcome handling, analysis populations, and multiplicity methods are not reported in the registry record.