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

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: Standard of PMTCT care; Behavioral: HIV Infant Tracking System (HITSystem) 2.0

• Registration Number: NCT02726607
• Lead Sponsor: University of Kansas Medical Center

Brief 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.

Study Timeline

• Study Start: 2015-08-15
• Study First Submitted: 2016-03-24
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-01
• Primary Completion: 2019-07-30
• Status Verified: 2020-03
• Study Completion: 2020-03-20
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 157

Inclusion Criteria

• HIV+ pregnant women
• Present for first PMTCT appointment at one of the study Hospitals
• Own or have reliable access to mobile phone

Exclusion Criteria

• N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of PMTCT Care	Standard of PMTCT care	Pregnant women who are eligible for PMTCT services will receive standard of care PMTCT services at the control hospital. The records of women enrolled during their first PMTCT appointment will be used to assess outcomes during the same follow-up period.
HITSystem 2.0	HIV Infant Tracking System (HITSystem) 2.0	Pregnant women who are eligible for PMTCT services will be enrolled in the HIV Infant Tracking System 2.0 (HITSystem 2.0) intervention during their first PMTCT appointment and followed until 12 weeks postpartum.

Primary Outcome Measures

Name	Time	Method
Complete PMTCT retention	first PMTCT visit during pregnancy to the return of the infant's first HIV DNA PCR test result by 12 weeks postnatal	The primary outcome is retention (complete or incomplete), measured from first PMTCT appointment until HIV status determination of the HIV-exposed infant at 12 weeks postnatal. This aggregate outcome includes completion of several intermediate outcomes throughout the PMTCT cascade of care, including: ART initiation (if not already on ART at time of pregnancy) (Yes/No), attendance at PMTCT appointments (Yes/No), a hospital delivery (Yes/No), infant enrollment in EID prior to hospital discharge (Yes/No), infant blood sample collected and HIV DNA PCR test result obtained (Yes/No). Complete retention requires completion of all of these steps.

Secondary Outcome Measures

Name	Time	Method
Duration of PMTCT Retention	Date of first PMTCT appointment through date of last PMTCT service. Final eligible service is date of infant HIV PCR test.	The mean (sd) duration of PMTCT retention (number of weeks from date of PMTCT enrollment to date of last documented PMTCT service).
Infant HIV status	Results obtained by 12 weeks postnatal	Result of infant HIV DNA Polymerase Chain Reaction (PCR) test: HIV-positive, HIV-negative, indeterminate, unknown, missing
Number of antenatal PMTCT appointments attended	First antenatal PMTCT appointment through delivery date	The mean (sd) number of ANC appointments attended, and the proportion of women who received the recommended 4 or more antenatal appointments prior to delivery.

Trial Locations

Locations (3)

Kapsabet Hospital; 🇰🇪 Kapsabet, Nandi, Kenya

Bungoma County Hospital; 🇰🇪 Bungoma, Nandi, Kenya

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States