MedTrace Logo

Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya

NCT04571684 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1639

Last updated 2025-07-10

Study results available
· View outcomes & findings →

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.

Conditions

  • HIV
  • Pregnancy

Interventions

OTHER

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.

Sponsors & Collaborators

  • Kenya Medical Research Institute

    collaborator OTHER

  • Children's Mercy Hospital Kansas City

    collaborator OTHER

  • Global Health Innovations Foundation - Kenya

    collaborator UNKNOWN

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Sarah Finocchario-Kessler, PhD, MPH · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-05
Primary Completion
2024-03-01
Completion
2024-04-01

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04571684 on ClinicalTrials.gov