Comparison · NCT04571684-c7e260c8
Intervention Arm (HITSystem 2.1) vs Control Arm (Standard of Care): Number of Participants Receiving Complete PMTCT
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Intervention Arm (HITSystem 2.1) vs Control Arm (Standard of Care): Number of Participants Receiving Complete PMTCT. Trial comparisons, record NCT04571684-c7e260c8. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04571684-c7e260c8
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0782 | 0.0613 | 0.0994 | wilson | |
| Risk in group 2 | 0.0351 | 0.0233 | 0.0526 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0431 | 0.0188 | 0.0674 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.23 | 1.38 | 3.59 | log | |
| Odds ratio, group 1 over group 2 | 2.33 | 1.41 | 3.85 | log | |
| Number needed to treat, for one more participant with the outcome on Intervention Arm (HITSystem 2.1) than on Control Arm (Standard of Care) | 23.2 | 14.8 | 53.2 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Intervention Arm (HITSystem 2.1) | Participants enrolled at intervention sites will received HITSystem 2.1-supported PMTCT services through 6 months postpartum. Interventions received will include: text messages to patients to support medication adherence, appointment attendance, and hospital delivery and algorithm-driven alerts to notify providers when follow up services are missed.~HITSystem 2.1: HITSystem 2.1 is an intervention that tracks HIV+ pregnant women and their infants to improve the completeness and efficiency of PMTCT services. Key intervention features include: (1) SMS messages sent to enrolled women and mothers to support essential PMTCT services, (2) automated, algorithm-driven alerts for providers when per-guidelines PMTCT services are missed, and (3) automatic enrollment of infants into early infant diagnosis (EID) and linkage with maternal PMTCT file at documentation of infant birth to improve the continuum of care for HIV+ mothers and HIV-exposed infants. The HITSystem 2.1 intervention aims to facilitate complete PMTCT retention and viral load (VL) monitoring with prompt clinical action (adherence support, antiretroviral therapy (ART) regimen change) in the antenatal, delivery, and 6-month postpartum periods to increase viral suppression during windows critical for HIV prevention. | 60 | 767 | OG000 |
| Group 2 | Control Arm (Standard of Care) | Participants enrolled at control sites will receive standard of care PMTCT services, with no HITSystem 2.1 tracking or follow up. | 22 | 627 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Receiving Complete PMTCT
- Description
documented receipt of all of the following: maternal ART initiation, antenatal appointment attendance, facility delivery, EID linkage by 7 weeks of age, maternal viral load testing and clinical action per national guidelines through 6 months postpartum (Table 6). Participants who receive all indicated services per guidelines will be coded as 1 or 'yes'. Participants missing \> 1 service will be coded as 0 or incomplete PMTCT services.
- Time frame
- 7-15 months (PMTCT enrollment date through 6 months postpartum)
- Population
Source ClinicalTrials.gov
Trial
- Title
- Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya
- NCT number
- NCT04571684
- Phases
- NA
- Conditions
- HIV, Pregnancy
- Interventions
- HITSystem 2.1
- Lead sponsor
- University of Kansas Medical Center
- Results first posted
- 2025-07-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04571684?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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