NCT02726607

Adapting the HITSystem to Support Prevention of Mother-to-child HIV Transmission

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HIV

Interventions

Type	Name	Description
BEHAVIORAL	HIV Infant Tracking System (HITSystem) 2.0	The HITsystem 2.0 intervention will be designed to: (1) utilize electronic prompts to notify providers and program managers when actions are required, and (2) send text messages to women's mobile phones to (a) motivate adherence to medication, (b) remind women of antenatal (ANC) appointments and medication refills, (c) prompt preparation for a hospital delivery, and (d) support early infant testing. Given advancements in the approach and protocols for care, HITSystem 2.0 will continue to engage mothers and encourage postnatal medication adherence. The researchers will design HITSystem 2.0 to integrate seamlessly into the existing HITSystem to link PMTCT and early infant diagnosis (EID) services through one coordinated system-level intervention.
BEHAVIORAL	Standard of PMTCT care	Pregnant women enrolled in PMTCT services at the control site will receive the current standard of PMTCT care and will not be enrolled in the HITSystem 2.0.

Timeline

• Start date: 2015-08-15
• Primary completion: 2019-07-30
• Completion: 2020-03-20
• First posted: 2016-04-01
• Last updated: 2020-04-01

Locations

3 sites across 2 countries: United States, Kenya