Eligibility, female only, with HIV or Pregnancy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Receiving Complete PMTCTPrimary· 7-15 months (PMTCT enrollment date through 6 months postpartum)
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.
Group
Value
95% CI
Intervention Arm (HITSystem 2.1)
60
Control Arm (Standard of Care)
22
Viral SuppressionPrimary· 1-9 months
Number of clients with a suppressed viral load(\<1000 copies/mL) at delivery
Group
Value
95% CI
Intervention Arm (HITSystem 2.1)
655
Control Arm (Standard of Care)
535
PMTCT Retention Duration (Weeks)Secondary· 7-15 months (PMTCT enrollment date through 6 months postpartum)
The number of weeks women were engaged in PMTCT services
Group
Value
95% CI
Intervention Arm (HITSystem 2.1)
48.4
± 9.6
Control Arm (Standard of Care)
47.2
± 8.1
Antenatal Viral Load (VL) Test CoverageSecondary· Within one month of enrollment in PMTCT
The number of women receiving viral load testing upon enrolling in prevention of mother to child transmission of HIV services (PMTCT).
Group
Value
95% CI
Intervention Arm (HITSystem 2.1)
330
Control Arm (Standard of Care)
137
Postnatal Viral Load (VL) Test CoverageSecondary· Between delivery and 7 months postpartum
The number of women receiving postpartum viral load testing per the Kenyan national guidelines.
Group
Value
95% CI
Intervention Arm (HITSystem 2.1)
518
Control Arm (Standard of Care)
371
Viral Load Test UtilitySecondary· PMTCT enrollment date through 6 months postpartum
Number of detectable viral load results with clinical action per guidelines, such as: intensified adherence counseling and/or ARV regimen change
Group
Value
95% CI
Intervention Arm (HITSystem 2.1)
28
Control Arm (Standard of Care)
18
Turnaround Time of Viral Load Sample Collection to Patient NotificationSecondary· PMTCT enrollment date through 6 months postpartum
The median number of days from the date of VL sample collection to patient notification, among all viral load tests
Group
Value
95% CI
Intervention Arm (HITSystem 2.1)
35
21 – 56.5
Control Arm (Standard of Care)
35
23 – 48.3
Antiretroviral Therapy (ART) AdherenceSecondary· 7-15 months (PMTCT enrollment date through 6 months postpartum)
The number of participants with ART adherence \> 95%
Group
Value
95% CI
Intervention Arm (HITSystem 2.1)
466
Control Arm (Standard of Care)
200
Adverse events — posted to ClinicalTrials.gov
Time frame: We collected information on adverse events from the time of participant enrollment through 6 months postpartum, up to a total of 15 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The goal of this project is to rigorously evaluate the efficacy of HIV Infant Tracking System 2.1 (HITSystem, an eHealth intervention that uses short message service (SMS) texts to patients and algorithm-driven electronic alerts for providers) to increase retention in guideline-adherent prevention of mother-to-child transmission of HIV services (PMTCT) and to increase viral suppression and appropriate clinical action through the extended period of 6 months postpartum, compared to standard of care PMTCT services in a matched, cluster randomized controlled trial.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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· recruiting
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· recruiting
NCT07226128 — The Effects of Cognitive Behavioral Therapy on Insulin Resistance in People With HIV
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· recruiting
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· Phase 1
· recruiting
NCT07390955 — A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Kansas Medical Center
Last refreshed: 10 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04571684.