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

University of Kansas

Status: Completed

Conditions: HIV

Treatments: Behavioral: HIV Infant Tracking System (HITSystem) 2.0; Behavioral: Standard of PMTCT care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02726607

STUDY00002009

R34MH107337-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 157 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Phase 3

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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157 participants in 2 patient groups

HITSystem 2.0

Experimental group

Description:

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.

Treatment:

Behavioral: HIV Infant Tracking System (HITSystem) 2.0

Standard of PMTCT Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard of PMTCT care