This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care (NCT04199052), a randomized na study. The primary outcome is Number of HIV Care Visits.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04199052 |
| Phase | NA |
| Condition | HIV/AIDS |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 53 |
| Arms in the primary outcome | 2 |
| Lead sponsor | University of California, San Diego |
| Results posted | Yes |
2. Clinical Question
Population
Black women living with HIV who are affected by interpersonal violence are the population of interest. The registry describes LinkPositively as culturally tailored and trauma-informed. The record reports enrollment of 53, while its brief summary describes planned assignment counts of 40 in each arm. The number contributing to the primary endpoint differs by arm and is reported with the results.
Intervention
LinkPositively is a technology-delivered peer navigation and social networking intervention using a smartphone app. The intervention description says participants would have access to four app components and be introduced to a virtual Peer Navigator. Further component details are not reported in the registry record.
Comparator
The comparator is standard of care, described in the brief summary as Ryan White standard of care. The control-arm description mentions treatment as usual at a participant’s HIV care service provider, but the registry record’s description is truncated. Further details of the care received are not reported in the registry record.
Primary question
The primary endpoint is the median number of HIV care visits at 3 Months Post-Baseline. The registry reports a median of 1.0 visits in the Standard of Care arm and 3.0 in the LinkPositively Intervention arm, with interquartile range limits reported for each. These are arm-level summaries; a comparative effect estimate, confidence interval, and statistical test are not reported in the registry record.
3. Trial Design
LinkPositively (NCT04199052) is a completed randomized, parallel-group trial of a behavioral intervention for Black women living with HIV who are affected by interpersonal violence. The registry lists the study phase as NA and describes masking as single. Which people were masked is not reported in the registry record. The record lists the start date as 2021-09-14 and the primary completion date as 2023-10-31.
The intervention was access to the LinkPositively smartphone app, described as technology-delivered peer navigation and social networking. The comparison arm received standard of care, identified in the brief summary as Ryan White standard of care. The record says participants would be randomly assigned and follow-up would occur at 3- and 6- months. The reported primary endpoint, however, is specifically at 3 Months Post-Baseline.
The registry reports enrollment of 53. Its brief summary describes planned arm counts of 40 for LinkPositively and 40 for control, while the primary endpoint results report 9.0 participants in the intervention arm and 11.0 in the control arm. These figures refer to different record entries and should not be treated as interchangeable. The reasons that the endpoint counts differ from the planned counts are not reported in the registry record.
Six secondary outcome entries are listed: PTSD, depression, and anxiety scores, each appearing twice. The timing and interpretation of those repeated entries are not reported in the registry record. The study is described as a pilot test intended to examine preliminary effects on HIV care and mental health outcomes. The record does not report enough detail to establish how randomization was generated, how allocation was concealed, or which analysis population was intended.
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: Although 53 participants were eligible and enrolled into the study, 10 elected not to participate following the informed consent process, resulting in a total of 43 participants continuing on in the study.
Overall Study
| Stage | Standard of Care | LinkPositively Intervention |
|---|---|---|
| STARTED | 17 | 26 |
| Completed Intervention Period | 17 | 26 |
| Completed 3-month Follow-up | 11 | 9 |
| COMPLETED | 6 | 8 |
| NOT COMPLETED | 11 | 18 |
Reasons for not completing this period:
| Reason | Standard of Care | LinkPositively Intervention |
|---|---|---|
| Lost to Follow-up | 11 | 18 |
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.
| Characteristic | Unit | Standard of Care | LinkPositively Intervention | Total |
|---|---|---|---|---|
| Participants analysed | 17 | 26 | 43 | |
| Age, Continuous | years | 49.50 (35.25 to 54.00) | 48.00 (33.50 to 55.25) | 49.00 (34.00 to 55.00) |
| Sex: Female, Male: Female | Participants | 17 | 26 | 43 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 2 | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 17 | 24 | 41 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 15 | 22 | 37 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 2 | 3 | 5 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 17 | 26 | 43 |
| Number of participants who have ever experienced physical violence | Participants | 12 | 19 | 31 |
| Number of participants who have ever experienced sexual assault | Participants | 15 | 19 | 34 |
| Number of participants who have ever experienced forced sexual activity | Participants | 14 | 20 | 34 |
| Number of participants who have ever experienced emotional abuse | Participants | 17 | 25 | 42 |
| Number of participants who have ever experienced attempts to control you | Participants | 13 | 22 | 35 |
| Number of participants who have experienced threats of physical violence | Participants | 13 | 18 | 31 |
| Number of HIV Care Visits in Past Year | HIV care visits | 3.00 (2.00 to 4.50) | 2 (2.00 to 4.00) | 2.00 (2.00 to 4.00) |
| HIV Adherence Self-Efficacy | units on a scale | 8.67 (5.17 to 9.67) | 8.17 (6.45 to 9.69) | 8.25 (6.33 to 9.67) |
| National Stress Events Survey PTSD Short Scale | units on a scale | 13.00 (6.00 to 19.50) | 10.00 (7.00 to 19.00) | 11.00 (7.00 to 19.00) |
6. Primary Endpoint
The registry lists the primary outcome as Number of HIV Care Visits, measured over 3 Months Post-Baseline.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | HIV Care Visits |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the median number of HIV care visits at 3 Months Post-Baseline. A visit count is a measure of contact with HIV care services during the stated follow-up period. The registry identifies HIV Care Visits as the unit and describes the summary as the median with an interquartile range.
The median is the middle of the ordered observations and can describe a typical count without relying on the arithmetic mean. The interquartile range describes the spread of the middle portion of the observations. As a general statistical consideration, count outcomes can be skewed, and a median with an interquartile range can be a useful descriptive summary when observations are not symmetrically distributed. The distribution itself is not reported in the registry record, so its shape cannot be assessed from these summaries alone.
The reported median is 1.0 visits in Standard of Care, with interquartile range limits of 1.0 to 2.0, and 3.0 visits in LinkPositively Intervention, with limits of 0.5 to 3.0. These summaries describe the observed arm-level results. They do not by themselves quantify uncertainty around the difference between arms or establish that any difference is attributable to the intervention. A between-arm estimate and its uncertainty are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
At 3 Months Post-Baseline, the registry reports a median of 1.0 HIV care visits in Standard of Care and 3.0 in LinkPositively Intervention. The reported interquartile range limits are 1.0 to 2.0 for Standard of Care and 0.5 to 3.0 for LinkPositively Intervention. The endpoint summaries are based on 11.0 participants in Standard of Care and 9.0 in LinkPositively Intervention.
These are descriptive results, not a reported test of the intervention against standard care. The registry does not provide a between-arm difference, confidence interval, or p-value for the primary endpoint. It therefore does not report the precision of a comparative effect estimate or whether a prespecified statistical criterion was met. The difference between the arm medians should not be treated as a calculated treatment effect.
The interquartile ranges convey variability in the observed visit counts, but they are not confidence intervals. A confidence interval, as a general statistical concept, expresses uncertainty about an estimated quantity; an interquartile range instead describes the spread of observed values. Without a confidence interval or another comparative uncertainty measure, the precision of the contrast between arms cannot be evaluated from the posted results.
The primary endpoint counts are smaller than the planned arm counts described in the brief summary. The registry does not explain why fewer participants appear in the endpoint summaries, whether all randomized participants were followed, or how missing endpoint observations were handled. That limits interpretation of the summaries and their representativeness of the randomized groups.
The record lists six secondary outcome entries for PTSD, depression, and anxiety scores, but it does not report numerical results for them in the available record. It also lists no analyses. Accordingly, the primary endpoint summaries should be read as a limited descriptive account of the posted result, not as a complete evaluation of the trial’s stated HIV care and mental health aims.
In short, the posted results show different arm-level medians for visits, alongside overlapping ranges of the middle observations. They do not establish the size or uncertainty of an intervention effect. The trial’s randomized design is relevant to a causal comparison in principle, but the reported summaries alone do not provide the analysis needed to make that comparison.
9. Statistical Methods Explained
The registry identifies the study as randomized, single-masked, and parallel-group. These design labels describe the intended structure: participants are assigned by randomization, the groups proceed alongside one another, and some party is masked to assignment. The party masked, the randomization procedure, and allocation concealment are not reported in the registry record. These details matter because they help readers assess how assignment and knowledge of assignment might affect the conduct or interpretation of a trial.
Why report a median and interquartile range?
The primary endpoint is a count of HIV care visits, summarized by a median and interquartile range. In general, the median is less affected by unusually high or low observations than the mean. The interquartile range communicates how broadly observations vary around the center. These are descriptive statistics: they summarize each arm but do not, by themselves, provide an estimated between-arm effect or its uncertainty.
The registry gives the median and the interquartile range limits for each arm. It does not provide the underlying distribution, a model for the count outcome, or a test comparing arms. General methods for count data can account for properties such as skew or over-dispersion, where variability exceeds what a simple model assumes. Whether such a property was present or whether any such method was used is not reported in the registry record. It would be inappropriate to infer a model from the reported summaries.
What would a comparative analysis add?
A comparative analysis would estimate how the outcome differs between randomized groups and express uncertainty around that estimate. Depending on the chosen method, it might report a difference in a suitable summary, a model-based contrast, and a confidence interval. A confidence interval is a general tool for showing the range of values compatible with an estimate under a specified analysis. The registry does not report a comparative estimate or confidence interval for this endpoint, so the precision of the arm contrast cannot be assessed.
A p-value, if reported, would address compatibility between the observed data and a specified null model; it would not describe the size or practical importance of a difference. No p-value for the primary comparison is reported in the registry record. Neither statistical significance nor its absence can therefore be inferred from the posted medians.
How should the endpoint counts be read?
The primary endpoint summaries list 11.0 participants for Standard of Care and 9.0 for LinkPositively Intervention. The brief summary describes planned assignment counts of 40 in each arm, and the registry reports overall enrollment of 53. Those entries are not equivalent measures: one concerns enrollment, one describes the planned arm counts in the summary, and one gives the counts attached to the primary endpoint summaries. The registry does not explain the differences. It does not report whether the endpoint counts reflect missing observations, eligibility for a particular analysis, or another reason.
For a randomized comparison, an analysis population and a clear account of missing observations help readers understand how the results relate to assignment. The population used for the primary result and the method for handling missing data are not reported in the registry record. No assumptions about either should be made.
What is not available about the statistical plan?
The registry record does not report the method used to analyze the primary endpoint, an adjustment strategy, an interim analysis plan, or a sample-size justification. It lists zero analyses and identifies other endpoints for which values are missing or not estimable for a two-arm comparison. Thus, no analysis method or comparative result for those endpoints can be described.
As a general point, a prespecified analysis plan helps distinguish planned decisions from choices made after reviewing results. Likewise, a sample-size justification explains what target effect and assumptions informed recruitment planning. The available record does not report those details. Any sample-size planning illustrations should not be mistaken for observed power or evidence that a result is conclusive; the record does not report such an interpretation for this trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists six secondary outcome entries: two entries each for PTSD, depression, and anxiety scores. Numerical secondary results are not reported in the record, and it is not clear from the entries how the repeated measures correspond to follow-up times. The record’s brief summary mentions follow-up at 3- and 6- months, but the timing attached to each secondary entry is not reported in the registry record.
When several outcomes or time points are examined, the chance of obtaining at least one apparently notable result can increase. As a general statistical practice, investigators may define a primary outcome, specify which secondary comparisons are confirmatory, and describe any adjustment or other approach to multiplicity. A multiplicity plan or adjustment is not reported in the registry record. No inference about how multiple testing was handled is possible.
The primary endpoint result includes fewer participants per arm than the planned assignment counts described in the brief summary. The reasons are not reported. The record does not say whether outcome data were missing, whether participants withdrew, or whether a particular missing-data method was applied. It also does not report the analysis population, such as whether results were intended to include everyone randomized or only participants with observed endpoint data. These details are necessary to judge how missing outcomes may affect interpretation.
There is no reported account of protocol deviations, exclusions after randomization, or sensitivity analyses. Their presence or absence is not reported in the registry record. The posted results therefore do not allow an assessment of whether missingness or analysis choices could have influenced the arm-level summaries.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Standard of Care | 0 | 17 | 0.0% |
| LinkPositively Intervention | 0 | 26 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Standard of Care | 0 of 17 |
| LinkPositively Intervention | 0 of 26 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Standard of Care | 0 of 17 |
| LinkPositively Intervention | 0 of 26 |
The registry reports zero serious adverse events among 17 participants at risk in Standard of Care and zero among 26 at risk in LinkPositively Intervention. It also reports zero other adverse events among 17 at risk in Standard of Care and zero among 26 at risk in LinkPositively Intervention. Deaths are reported as zero in each arm. No top serious adverse event terms are listed.
These figures describe the events recorded in the registry, not proof that no adverse events occurred outside the recorded categories or observation period. The registry does not report how adverse events were defined, how they were collected, the duration of safety observation, or whether event ascertainment differed by arm. The number at risk for these safety summaries also differs from the endpoint counts, and the record does not explain why.
As a general statistical consideration, a zero count in a study does not establish that the underlying event risk is zero. Interpretation depends on the number observed, follow-up, and completeness of event collection. The posted figures should therefore be read narrowly as no serious or other adverse events and no deaths recorded in the listed groups, rather than as a definitive safety comparison.
12. What the Result Does, and Does Not, Mean
The primary result describes the observed number of HIV care visits at 3 Months Post-Baseline. The median was 1.0 visits in Standard of Care and 3.0 in LinkPositively Intervention. The interquartile range limits show the spread of the middle observations in each arm. These are useful descriptive summaries of the endpoint, but they are not a quantified comparison between treatments.
The record does not report a comparative effect estimate, confidence interval, or p-value. It therefore does not establish the magnitude or precision of a difference between randomized groups. Nor do the posted summaries alone establish that any observed difference was caused by the intervention. A randomized design can support causal inference when analyzed appropriately, but the relevant analysis and its assumptions are not reported.
The result also does not address the full set of goals described in the trial summary. The study aimed to examine HIV care and mental health outcomes, while the posted primary result concerns visit counts. Although PTSD, depression, and anxiety score entries are listed, their numerical findings are not reported in the registry record. The record also does not clarify the timing represented by those repeated entries.
The endpoint summaries should be interpreted with attention to the reported counts: 11.0 for Standard of Care and 9.0 for LinkPositively Intervention. These differ from the planned assignment counts of 40 in each arm described in the brief summary. The registry reports enrollment of 53 but does not explain the relationship among enrollment, planned assignment, and the participants represented in the endpoint summaries.
The appropriate conclusion is limited: the registry posts different arm-level medians for HIV care visits, with no reported statistical comparison. The available results do not demonstrate the degree of uncertainty, explain missing data, or provide numerical results for the listed secondary outcomes. They should not be used to claim either a definitive benefit or lack of benefit.
13. Why This Trial Matters Statistically
This trial is statistically notable because it combines a randomized parallel-group design with a pilot focus and a primary endpoint summarized as a visit count. Such outcomes can have distributions that are not well described by a mean and standard deviation alone. Reporting a median and interquartile range gives readers a direct description of the center and spread of the observed counts.
At the same time, descriptive summaries are only one part of a randomized comparison. To assess the evidence about differences between groups, readers need an estimate of the contrast and a measure of its uncertainty. The registry does not report those for the primary endpoint. This distinction is important: arm-level values can describe what was observed without establishing the precision or causal meaning of a between-arm difference.
The record also makes transparent that different entries refer to different stages of the study: overall enrollment, planned assignment counts in the brief summary, endpoint-specific counts, and safety counts. Keeping these quantities distinct is essential when interpreting trial results. The record does not explain why they differ, which limits assessment of the completeness and analysis population.
Finally, the study’s stated aims span HIV care and mental health, while numerical results are available for the primary visit endpoint only. The absence of reported secondary values and analysis details leaves important questions unanswered. For biostatisticians and clinical researchers, this illustrates why outcome definitions, time points, denominators, missing-data handling, and comparative estimates should accompany outcome summaries. The registry record gives a useful descriptive starting point, but not a full statistical account of the trial.
14. 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 summaries are based on 11.0 participants in Standard of Care and 9.0 in LinkPositively Intervention, whereas the brief summary describes planned counts of 40 in each arm. The registry reports enrollment of 53 but does not explain the difference among these figures. Without an account of participant flow or endpoint availability, it is difficult to assess whether the reported summaries represent the randomized groups.
The registry gives arm-level medians and interquartile range limits but no comparative estimate, confidence interval, or p-value. It does not state the analysis method or the intended analysis population. Missing-data handling, exclusions after randomization, and sensitivity analyses are also not reported. These omissions limit assessment of both statistical uncertainty and potential bias.
The single-masked designation does not identify who was masked. The randomization procedure and allocation concealment are not reported. Further details of the app components and the control care are limited; the arm descriptions are truncated in the record. These gaps make it harder to assess implementation and how similar the groups’ care was beyond their assigned condition.
Although six secondary outcome entries are listed, the record does not report their numerical results or clarify their time points. A multiplicity strategy is not reported. Safety summaries list zero events in the categories shown, but event definitions and observation details are not reported. These limits mean the posted record supports a narrow description of the primary endpoint and recorded safety counts, rather than a comprehensive evaluation of all trial outcomes.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care — NCT04199052.
- Registry record last updated 2025-07-03; status last verified 2025-06.
- Results first posted 2025-07-03.
- 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.
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18. Record Summary
LinkPositively (NCT04199052) is a completed randomized, parallel-group study listed as single-masked. It examines a technology-delivered peer navigation and social networking intervention for Black women living with HIV who are affected by interpersonal violence. The registry reports enrollment of 53 and identifies the primary endpoint as the median number of HIV care visits at 3 Months Post-Baseline.
The posted primary summaries are a median of 1.0 visits in Standard of Care and 3.0 in LinkPositively Intervention, with interquartile range limits of 1.0 to 2.0 and 0.5 to 3.0, respectively. The corresponding endpoint counts are 11.0 and 9.0. No comparative effect estimate, confidence interval, or p-value is reported. Secondary outcomes are listed, but numerical results are not reported in the registry record.