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 CareConekta: A Smartphone App to Improve Engagement in HIV Care (NCT03836625), a randomized na study. The primary outcome is Mobility Prevalence.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03836625 |
| Phase | NA |
| Condition | HIV/AIDS, Pregnancy Related |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 200 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Vanderbilt University |
| Results posted | Yes |
2. Clinical Question
Population
Pregnant and postpartum women in South Africa receiving HIV care are the population of interest. The study addresses mobility during the peripartum period and its possible relationship to engagement in HIV care. The primary endpoint description concerns participants who reported travel during the study period, defined as 3 or more nights away from home; the denominator is participants who completed follow-up.
Intervention
The intervention arm received CareConekta with added text notifications about nearby ART facilities when a participant had traveled >50 km from the study site for >7 days. Participants in this arm could also opt in at enrollment to phone call(s) and/or WhatsApp message(s); the registry description does not complete the statement about who would send those contacts.
Comparator
The control arm received standard CareConekta, described as tracking participants’ mobility without the added features. The record identifies randomized allocation and a parallel design, but does not report further details about how the randomization sequence was generated or concealed.
Primary question
The stated primary endpoint is mobility prevalence: the number of participants who traveled during the study period, among participants who completed follow-up. The registry describes this measure but does not report the observed count, denominator, or an arm-to-arm analysis for it. It therefore does not establish from the posted results whether mobility differed between the randomized groups.
3. Trial Design
The registry describes CareConekta as a randomized, parallel-arm pilot study. Its official title identifies the focus as a smartphone app intended to improve engagement in postpartum HIV care in South Africa. The listed phase is NA, and the status is completed. Enrollment is listed as 200. The study start date is 2019-12-09, and the primary completion date is 2021-11-30.
Both arms received CareConekta. The control arm received the app’s mobility-tracking function without additional features. The intervention arm received that standard app plus text notifications about nearby ART facilities when participants traveled >50 km from the study site for >7 days. The description also says participants in the intervention arm could opt in at enrollment to phone call(s) and/or WhatsApp message(s), but the statement about the sender is incomplete in the registry record. Masking is listed as none.
The primary endpoint is described as a count of participants who reported travel during the study period, with travel defined as 3 or more nights away from home. The planned reporting denominator is participants who completed follow-up. Its timeframe is baseline to end of study, up to 2 years. Other listed outcomes address travel timing and permanent moves, app feasibility and use, maternal engagement in HIV care, and infant outcomes.
The registry record does not report the allocation ratio, randomization procedures, concealment methods, participant flow, or a detailed intervention-fidelity assessment. The enrollment entry alone does not establish how many participants completed follow-up or contributed data to the primary endpoint. No analysis results are reported for the primary mobility endpoint.
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
| Stage | Control | Intervention |
|---|---|---|
| STARTED | 99 | 101 |
| COMPLETED | 84 | 89 |
| NOT COMPLETED | 15 | 12 |
Reasons for not completing this period:
| Reason | Control | Intervention |
|---|---|---|
| Lost to Follow-up | 9 | 9 |
| Investigator withdrawn at/near time of enrollment | 6 | 1 |
| Death | 0 | 1 |
| Refused follow-up | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: The number of participants who reported travel during the study period (defined as 3 or more nights away from home)
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: Total excludes 7 participants withdrawn by investigators at/soon after enrollment. Data were not included in analyses.
| Characteristic | Unit | Control | Intervention | Total |
|---|---|---|---|---|
| Participants analysed | 93 | 100 | 193 | |
| Age, Continuous | years | 32 (28 to 36) | 31 (28 to 35) | 32 (28 to 36) |
| Age, Customized: Age 18-24 years | Participants | 10 | 14 | 24 |
| Age, Customized: Age 25-29 years | Participants | 22 | 21 | 43 |
| Age, Customized: Age 30-34 years | Participants | 29 | 39 | 68 |
| Age, Customized: Age 35 years and older | Participants | 32 | 26 | 58 |
| Sex: Female, Male: Female | Participants | 93 | 100 | 193 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: South Africa | Participants | 93 | 100 | 193 |
| Education: Never completed primary school | Participants | 1 | 1 | 2 |
| Education: Primary school only | Participants | 5 | 3 | 8 |
| Education: Some high school | Participants | 50 | 54 | 104 |
| Education: Completed high school | Participants | 31 | 37 | 68 |
| Education: Any tertiary education | Participants | 6 | 5 | 11 |
| Employment: Currently employed | Participants | 34 | 42 | 76 |
| Employment: Not currently employed | Participants | 59 | 58 | 117 |
| On antiretroviral therapy prior to first antenatal visit: No | Participants | 25 | 20 | 45 |
| On antiretroviral therapy prior to first antenatal visit: Yes | Participants | 65 | 76 | 141 |
| On antiretroviral therapy prior to first antenatal visit: Missing | Participants | 3 | 4 | 7 |
| Birthplace: Western Cape Province, South Africa | Participants | 33 | 27 | 60 |
| Birthplace: In South Africa, but not Western Cape Province | Participants | 57 | 70 | 127 |
| Birthplace: Outside of South Africa | Participants | 3 | 3 | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Mobility Prevalence, measured over Baseline to End of Study (up to 2 years).
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is mobility prevalence, described as the number of participants who traveled during the study period. Travel is defined as spending 3 or more nights away from home. The denominator is all participants who completed follow-up, and the stated timeframe runs from baseline to the end of study, up to 2 years.
A prevalence measure is used to describe how common a characteristic or experience was in a specified group over a defined period. In this study, it is intended to quantify reported travel among follow-up completers. Mobility is relevant to the study’s aims because the registry describes population movement as a research concern in relation to engagement in HIV care, particularly during pregnancy and postpartum. The endpoint is a measure of travel, not itself a direct measure of care engagement or of whether participants used an app feature.
The record does not report the observed number who traveled, the number completing follow-up, or a result comparing the randomized arms for this endpoint. It also does not describe how travel reports were gathered or how missing follow-up information was handled. As a result, the endpoint’s operational definition is available, but its observed prevalence and precision are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the trial design, intervention features, and intended primary endpoint, but it does not report the primary endpoint’s observed result. In particular, no count of participants reporting travel, follow-up denominator, arm-specific mobility result, or uncertainty estimate is reported in the registry record. The record lists zero analyses. Consequently, the posted information does not support a statistical conclusion about the prevalence of travel in the enrolled participants or a difference in mobility between the randomized arms.
The distinction between a planned endpoint and an observed result matters. The primary endpoint is defined as the number of participants who traveled, using a threshold of 3 or more nights away from home, among participants who completed follow-up. That definition tells readers what the investigators intended to measure; it does not tell them how many participants met the definition. Nor does it show whether the app affected mobility or care engagement. The endpoint concerns travel, while engagement in HIV care is a broader topic represented among the listed secondary outcomes.
The enrollment entry is 200, but this should not be substituted for the endpoint denominator. The endpoint denominator is described as participants who completed follow-up, and the number completing follow-up is not reported in the registry record. Likewise, the randomized design does not by itself supply an effect estimate, confidence interval, or test of an arm difference. None of those results for the primary endpoint is reported in the registry record.
The adverse-event entries report zero serious events in both groups and zero other events in both groups, with 93 participants at risk in the control group and 100 in the intervention group. The record also lists zero deaths in control and one death in the intervention group. No cause, timing, or relationship to the intervention is reported in the registry record, so those counts alone do not establish attribution. The safety entries should be read as descriptive counts, not as a comparative safety analysis.
Overall, the available record is informative about the question the pilot set out to address and the broad contrast between the app arms. It is not an outcome report capable of quantifying mobility prevalence, estimating intervention effects, or describing precision. Those conclusions would require the relevant outcome data and analysis, which are not reported in the registry record.
9. Statistical Methods Explained
The registry identifies a randomized, parallel-arm design with no masking. In a randomized study, participants are assigned to groups by a random process, with the aim of making the groups comparable on average before the intervention is delivered. Randomization helps support a causal comparison when allocation is implemented as intended and outcomes are assessed and analyzed appropriately. It does not guarantee that the groups will be identical, and it cannot substitute for reporting the actual results. The record does not describe the sequence-generation or allocation-concealment methods.
What does the primary endpoint count?
The primary endpoint is a participant count for reported travel during the study period. A participant meets the stated travel definition after 3 or more nights away from home. The planned denominator is participants who completed follow-up. This is a binary classification at the participant level for the defined period: each participant is classified according to whether travel meeting the definition was reported. The endpoint is expressed as a count, rather than a continuous measurement such as distance traveled.
Counts need a denominator to be interpreted in context. A count without the number of people assessed cannot indicate how common the event was in the group. Here, the registry specifies follow-up completers as the denominator, but does not report how many people completed follow-up or how many reported qualifying travel. Therefore, the prevalence cannot be described from the posted endpoint information. No percentage is calculated in this analysis.
What would an arm comparison require?
A comparison between randomized arms would require outcome data for each group, with denominators defined for the analysis. A statistical analysis could then estimate how the groups differ and quantify uncertainty. A confidence interval, in general, is a range of values compatible with the observed data under the assumptions of the analysis; it communicates precision as well as the direction and magnitude of an estimate. The registry record does not report an effect estimate or confidence interval for the mobility endpoint, so no such interpretation is possible for this trial from the posted endpoint data.
The description of a count endpoint does not identify a particular statistical test or model. The registry record does not report the statistical methods used for the primary endpoint, whether analyses were adjusted, or whether the outcome was compared between arms. It would be inappropriate to infer a planned model from the outcome type alone. A simple count, a proportion, and an arm-level treatment contrast are related but not interchangeable summaries.
Why does follow-up matter?
The endpoint uses participants who completed follow-up as its denominator. If participants with incomplete follow-up differ in mobility from those with complete follow-up, a completer-only summary may not represent all randomized participants. This is a general concern in clinical studies, not evidence that such bias occurred. The registry record does not give the number or characteristics of participants with incomplete follow-up, reasons for missingness, or methods used to address missing data. It therefore does not allow readers to assess whether the reported endpoint population represents the full randomized cohort.
The stated timeframe extends from baseline to the end of study, up to 2 years. A period-based endpoint combines the question of whether travel occurred with the period over which it was observed. The record does not detail how travel was measured, how often it was assessed, or how reports were verified. Those details would help readers assess the reliability and consistency of classification, but they are not reported in the registry record.
What can be inferred from the design?
The randomized allocation and parallel structure identify how the groups were intended to be compared. The control group received standard CareConekta with mobility tracking, while the intervention group had added facility notifications under the stated travel conditions. Because both groups received the app, the contrast is between these app features, not between receiving an app and receiving no app. The record lists masking as none, so participants and study personnel were not described as masked. Whether outcome assessors were masked is not reported in the registry record.
The word pilot describes the study’s framing, but it does not reveal the statistical plan. The registry record does not report a sample-size justification, assumptions used to plan enrollment, interim analyses, stopping rules, or a prespecified analysis plan. The enrollment listing of 200 is a study descriptor and should not be treated as proof of a particular statistical power or of the number analyzed. No observed-power claim can be made, especially in the absence of a reported effect estimate.
General statistical interpretation depends on both the estimated result and its uncertainty, alongside the design and quality of measurement. Since the primary outcome analysis is not reported in the registry record, there is no basis to assess precision, statistical significance, or the compatibility of the data with different effect sizes. The methods information available defines a research question and design; it does not provide the numerical evidence needed to answer that question.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 13 outcome measures, including the primary mobility-prevalence endpoint and secondary outcomes related to travel, app feasibility and use, maternal engagement in HIV care, and infant outcomes. When a study assesses multiple outcomes, multiplicity is a general statistical consideration: the more questions tested, the greater the chance that at least one result may appear notable by chance if each is interpreted without accounting for the overall testing context. The registry record does not report a multiplicity adjustment, a hierarchy among secondary outcomes, or a plan for interpreting multiple comparisons.
The record lists zero analyses. It does not report results for the primary endpoint or the listed secondary outcomes, nor does it describe which outcomes were analyzed. Therefore, the presence of multiple registered outcomes should not be taken to mean that results were available or that any particular testing strategy was used.
Missing-data handling is also not reported in the registry record. The primary endpoint is defined using participants who completed follow-up, but the record does not state how many completed follow-up, how many were missing, why observations were missing, or whether missingness differed between arms. It does not describe imputation, sensitivity analyses, or alternative analysis populations. These omissions prevent assessment of how follow-up loss may affect the endpoint estimate.
The analysis population is not described beyond the endpoint’s denominator definition. The registry record does not say whether an intention-to-treat population, per-protocol population, or another analysis set was used. Such labels describe which participants are included in a particular analysis; they cannot be assigned based only on the randomized design. The actual analysis population and handling of departures from assigned treatment are not reported in the registry record.
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 |
|---|---|---|---|
| Control | 0 | 93 | 0.0% |
| Intervention | 0 | 100 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Control | 0 of 93 |
| Intervention | 1 of 100 |
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 |
|---|---|
| Control | 0 of 93 |
| Intervention | 0 of 100 |
The registry’s adverse-event entries list 93 participants at risk in the control group and 100 in the intervention group. Serious events affecting participants are recorded as zero in each group, and other events affecting participants are also recorded as zero in each group. Deaths are listed separately: zero in the control group and one in the intervention group.
These are descriptive counts in the registry record. They do not provide event narratives, timing, causes, severity details beyond the serious-event category, or an assessment of whether an event was related to study participation or the app. The record does not state whether the listed death was considered intervention-related. A count by itself cannot establish causation, and the entries do not constitute a statistical comparison of safety between groups.
Zero reported events should be interpreted as no events recorded in these registry fields, not as proof that no adverse experiences occurred. The record does not explain the event-collection procedures or provide additional detail about safety monitoring. The listed at-risk counts also should not be assumed to equal the number who completed follow-up for the primary endpoint, because that endpoint denominator is not reported.
12. What the Result Does, and Does Not, Mean
The registry record establishes that CareConekta was studied in a randomized, parallel-arm pilot focused on mobility and postpartum HIV care in South Africa. It describes a control condition with standard mobility tracking and an intervention condition that added notifications about nearby ART facilities after travel beyond the stated distance and duration thresholds. It also defines the primary endpoint as the count of follow-up completers reporting travel of 3 or more nights away from home.
Those details clarify the intended research question and the contrast between study arms. They do not establish whether the intervention changed mobility, improved engagement in HIV care, or affected infant outcomes. The primary endpoint result and results for the listed secondary outcomes are not reported in the registry record. No effect estimates or measures of precision are available for interpretation.
The trial’s focus on mobility is statistically important because a measure of travel can help describe a participant experience relevant to continuity of care. However, the primary endpoint counts travel, not missed care, retention in care, medication use, or any other direct clinical outcome. Although maternal engagement in HIV care is listed among secondary outcomes, its observed result is not reported in the registry record. The endpoint definition alone cannot establish a relationship between travel and care engagement.
The registry’s safety counts also have limited meaning without contextual details. It lists no serious events in either group and one death in the intervention group, but does not report the death’s cause, timing, or relationship to the intervention. These entries should not be used to infer causation or to claim that the app is either safe or unsafe.
In short, the record documents a study design and a set of intended outcomes, but does not provide the outcome evidence needed to quantify an effect. The absence of a reported result is not evidence that there was no effect; it means that the effect and its uncertainty cannot be assessed from the registry record.
13. Why This Trial Matters Statistically
This trial raises a statistical question that is also a measurement question: how should mobility be defined and counted when studying engagement in care? The registry uses a concrete threshold—3 or more nights away from home—and specifies a follow-up-completer denominator. A clear operational definition can make an outcome easier to interpret and compare, but its usefulness still depends on how consistently travel is captured and how missing follow-up is handled. Those measurement and missing-data details are not reported in the registry record.
The app’s design also links mobility information with a potential service-navigation feature. The control arm tracks mobility, while the intervention arm adds notifications about nearby ART facilities after travel beyond the specified thresholds. This distinction matters when interpreting any eventual comparison: it would concern the added app features relative to standard CareConekta, not app use versus no app. Because no primary outcome analysis is reported, the record does not quantify the consequences of that contrast.
For biostatisticians and clinical researchers, the record illustrates why registration and results reporting answer different questions. Registration identifies intended outcomes and design features. An analysis requires observed counts, denominators, a defined analysis population, and appropriate methods. Without those results, readers cannot assess precision, missingness, multiplicity, or the magnitude of an arm difference. The randomized design is valuable context, but it cannot replace the reporting of outcomes.
The pilot framing makes transparent reporting particularly useful: readers need to distinguish descriptive feasibility information from evidence about efficacy. The listed secondary outcomes span app use, travel patterns, maternal engagement, and infant outcomes, but their results are not reported in the registry record. Thus the trial’s statistical contribution in this record is chiefly its stated question, endpoint definition, and intervention contrast, rather than an estimate of an effect.
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 central limitation for interpretation is that the primary mobility outcome is defined but its observed result is not reported in the registry record. The number reporting travel, the number completing follow-up, and any comparison between groups are absent. No estimate of uncertainty is reported, so neither the magnitude nor precision of an effect can be assessed.
The endpoint depends on participant travel reports and a threshold of 3 or more nights away from home. The registry record does not describe the data-collection method, timing of assessments, verification procedures, or handling of ambiguous reports. It is therefore not possible to assess measurement reliability from the record. The specified denominator includes follow-up completers, but the record does not give completion counts, missingness reasons, or methods for addressing incomplete data.
The intervention description is incomplete regarding the optional phone call(s) and/or WhatsApp message(s): it does not identify who would send them or provide further details. The record also does not report treatment adherence, app usage intensity, notification delivery, or intervention fidelity. These details would help characterize what participants actually received, but their absence does not establish that delivery failed.
Randomized allocation and no masking are reported, but sequence generation, allocation concealment, outcome-assessor masking, and the analysis plan are not. The record does not report a sample-size justification, interim analyses, or methods for multiplicity. Although 13 outcome measures are listed, their analysis results are not reported. The enrollment entry of 200 should not be confused with the number analyzed for the primary endpoint.
Finally, the adverse-event entries lack information about event timing, causes, attribution, and collection procedures. The single death listed in the intervention group cannot be interpreted causally from the available information. These reporting gaps limit what can be concluded about both effectiveness and safety from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: CareConekta: A Smartphone App to Improve Engagement in HIV Care — NCT03836625.
- Registry record last updated 2023-02-01; status last verified 2023-01.
- Results first posted 2023-02-01.
- 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
CareConekta is listed as a completed, randomized, parallel-arm pilot study of a smartphone app intended to support engagement in postpartum HIV care in South Africa. Enrollment is listed as 200. The control arm received standard CareConekta mobility tracking; the intervention arm received added notifications about nearby ART facilities under stated travel conditions. Masking is listed as none.
The primary endpoint is mobility prevalence, defined as the number of participants reporting travel of 3 or more nights away from home among participants who completed follow-up. Its timeframe is baseline to end of study, up to 2 years. The record lists 13 outcome measures and zero analyses, and does not report the primary endpoint result or secondary outcome results.
Adverse-event entries list zero serious events and zero other events in each group, with one death in the intervention group and none in control. Cause and attribution are not reported. Overall, the registry record describes the study question and design, but does not provide the outcome analyses needed to estimate effects or their precision.