CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,639 enrolled
Drug / intervention
HITSystem 2.1other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04571684
NCT04571684N/ACompleted

Evaluating the HITSystem to Improve PMTCT Retention and Maternal Viral Suppression in Kenya

University of Kansas Medical Center·interventional·Posted Oct 1, 2020·Updated Jul 10, 2025

In Brief

A clinical study evaluating HITSystem 2.1 for HIV and Pregnancy. Completed, enrolled 1,639 participants across 12 sites.

Detailed Summary

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.

Study Details

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedOct 1, 2020
Enrollment StartOct 5, 2020
Primary CompletionMar 1, 2024
Study CompletionApr 1, 2024
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 5.8 years ago

Interventions

HITSystem 2.1other

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.