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The purpose of this study is to modify the HITSystem to engage and retain HIV+ pregnant women before, during and after delivery and evaluate the HITSystem impact on prevention of mother-to-child transmission (PMTCT) related behaviors and outcomes. HITSystem 2.0 intervention will support a range of PMTCT outcomes including retention in care, ART adherence, and integration of maternal and pediatric HIV services in low-resource settings.
The study will be conducted in three phases: Phases 1: The researchers will conduct formative research (focus groups and interviews) with HIV+ pregnant women and PMTCT providers to customize communication strategies for text messaging and inform patient flow and optimal implementation across the various PMTCT-related services at the intervention site. Phase 2: The researchers will design and refine the HITSystem 2.0 technical components to support PMTCT outcomes guided by clinical content experts, technology analysts, and findings from Phase 1. Phase 3: The researchers will implement HITSystem 2.0 at one hospital over an 18 month period, and compare targeted PMTCT outcomes to those at a matched control hospital. The study will be conducted at two government hospitals in Kenya. HIV+ pregnant women will be enrolled in the HITSystem 2.0 at Kapsabet Hospital. HIV+ pregnant women receiving the current standard of PMTCT care at Nandi Hills Hospital will be the comparison group.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
University of Kansas Medical Center
Kansas City, Kansas, United States
Bungoma County Hospital
Bungoma, Nandi, Kenya
Kapsabet Hospital
Kapsabet, Nandi, Kenya
Start Date
August 15, 2015
Primary Completion Date
July 30, 2019
Completion Date
March 20, 2020
Last Updated
April 1, 2020
157
ACTUAL participants
HIV Infant Tracking System (HITSystem) 2.0
BEHAVIORAL
Standard of PMTCT care
BEHAVIORAL
Lead Sponsor
University of Kansas Medical Center
Collaborators
NCT01875588
NCT07071623
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04929028