CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,815 enrolled
Drug / intervention
HITSystem +1 moreother
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/NCT02072603
NCT02072603N/ACompleted
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Evaluation of the HITSystem to Improve Early Infant Diagnosis Outcomes in Kenya

Sarah Kessler, PhD, MPH·interventional·Posted Feb 26, 2014·Updated Jul 13, 2020

In Brief

A clinical study evaluating HITSystem and Standard of Care for HIV. Completed, enrolled 1,815 participants across 2 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine the effectiveness of the HITSystem in maximizing early infant diagnosis (EID) service utilization for HIV-exposed infants and early antiretroviral therapy (ART) initiation for infants diagnosed with HIV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesKenya, United States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 26, 2014
Enrollment StartMar 30, 2014
Primary CompletionSep 30, 2018
Study CompletionApr 30, 2020
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 12.3 years ago

Interventions

HITSystemother

Online, automated program designed to overcome current EID barriers by providing efficient prospective tracking of HIV-exposed infants and triggering electronic action "alerts" for both EID providers and lab technicians when time sensitive interventions are overdue for specific infants.

Standard of Careother

current procedures that follow Kenyan National EID guidelines to diagnose and manage HIV infection among HIV-exposed infants.