N/A Completed N=1,639 Randomized Health Services Research

Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya

HIV · Pregnancy

Source: ClinicalTrials.gov NCT04571684 ↗

Enrolled (actual)

1,639

Serious AEs

5.0%

Results posted

Jul 2025

Primary outcomePrimary: Number of Participants Receiving Complete PMTCT — 60; 22 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Receiving Complete PMTCT	60; 22	—
PRIMARY Viral Suppression	655; 535	—
SECONDARY PMTCT Retention Duration (Weeks)	48.4; 47.2	—
SECONDARY Antenatal Viral Load (VL) Test Coverage	330; 137	—
SECONDARY Postnatal Viral Load (VL) Test Coverage	518; 371	—
SECONDARY Viral Load Test Utility	28; 18	—
SECONDARY Turnaround Time of Viral Load Sample Collection to Patient Notification	35; 35	—
SECONDARY Antiretroviral Therapy (ART) Adherence	466; 200	—

Eligibility Criteria

Inclusion Criteria

Pregnant women living with HIV who present for care at one of the study hospitals by 36 weeks gestation and provide written informed consent are eligible for enrollment in the study.

Exclusion Criteria

Pregnant women living with HIV will be excluded from study participation if she has any condition (including drug abuse, alcohol abuse, or psychiatric disorder) that study or hospital staff feel precludes her from providing informed consent.
Women who transfer care from one study site to another during their PMTCT services will be ineligible for enrollment at their new facility.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04571684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.