Trial results for the HIV Infant Tracking System 2.1 (HITSystem 2.1) study, an eHealth intervention, were posted on ClinicalTrials.gov on 2025-07-10. The study, which enrolled 1639 participants, evaluated the system's efficacy in improving viral suppression and prevention of mother-to-child transmission (PMTCT) services for individuals with HIV, including those who are pregnant.
Background
Human Immunodeficiency Virus (HIV) remains a significant global health challenge, particularly in regions like Kenya. For pregnant individuals with HIV, prevention of mother-to-child transmission (PMTCT) services are critical to reduce vertical transmission rates. Ensuring adherence to PMTCT guidelines and achieving sustained viral suppression are key objectives in managing HIV during pregnancy and the postpartum period. eHealth interventions, such as those utilizing SMS texts and electronic alerts, offer potential solutions to improve patient retention in care and facilitate timely clinical actions, thereby enhancing PMTCT outcomes and viral suppression rates.
Trial design
This completed study, designated as Phase NA, enrolled 1639 participants in Kenya. The trial investigated the efficacy of the 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. The intervention aimed to increase retention in guideline-adherent prevention of mother-to-child transmission of HIV (PMTCT) services and to increase viral suppression and appropriate clinical action through the extended period of 6 months postpartum. The HITSystem 2.1 intervention was compared against standard of care PMTCT services in a matched, cluster randomized controlled trial. Conditions studied included HIV and Pregnancy.
Key results
The trial reported several key measurements comparing the HITSystem 2.1 intervention arm to the standard of care control arm:
- Number of Participants Receiving Complete PMTCT:
- Intervention Arm (HITSystem 2.1): 60 Participants
- Control Arm (Standard of Care): 22 Participants
- Viral Suppression:
- Intervention Arm (HITSystem 2.1): 655 Participants
- Control Arm (Standard of Care): 535 Participants
- PMTCT Retention Duration (Weeks):
- Intervention Arm (HITSystem 2.1): Mean 48.4 weeks (Standard Deviation 9.6)
- Control Arm (Standard of Care): Mean 47.2 weeks (Standard Deviation 8.1)
- Antenatal Viral Load (VL) Test Coverage:
- Intervention Arm (HITSystem 2.1): 330 Participants
- Control Arm (Standard of Care): 137 Participants
- Postnatal Viral Load (VL) Test Coverage:
- Intervention Arm (HITSystem 2.1): 518 Participants
- Control Arm (Standard of Care): 371 Participants
- Viral Load Test Utility:
- Intervention Arm (HITSystem 2.1): 28 Participants
- Control Arm (Standard of Care): 18 Participants
What this means
The results indicate that the HIV Infant Tracking System 2.1 (HITSystem 2.1) intervention demonstrated improvements across several key indicators for individuals with HIV, particularly those who are pregnant, compared to standard of care. The intervention arm showed a substantially higher number of participants receiving complete PMTCT services (60 vs 22) and achieving viral suppression (655 vs 535). Additionally, both antenatal and postnatal viral load test coverage were higher in the intervention group. While the mean PMTCT retention duration was only slightly higher in the intervention arm (48.4 weeks vs 47.2 weeks), the overall pattern suggests that eHealth interventions like HITSystem 2.1 can play a significant role in enhancing adherence to PMTCT guidelines and improving viral suppression rates in real-world settings.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04571684, titled "Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya", were posted on 2025-07-10 on clinicaltrials.gov.