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

Sponsor

University of Kansas Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02726607

Collaborator

National Institute of Mental Health (NIMH) (NIH), Kenya Medical Research Institute (Other), Global Health Innovations (Other), Children's Mercy Hospital Kansas City (Other)

157

Enrollment

Locations

Arms

55.2

Actual Duration (Months)

52.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV	Behavioral: HIV Infant Tracking System (HITSystem) 2.0 Behavioral: Standard of PMTCT care	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

157 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

We employed a matched randomized pilot study design in two government hospitals; one randomized to receive the HITSystem 2.0 intervention while the other maintained standard of care PMTCT services.We employed a matched randomized pilot study design in two government hospitals; one randomized to receive the HITSystem 2.0 intervention while the other maintained standard of care PMTCT services.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 15, 2015

Actual Primary Completion Date :

Jul 30, 2019

Actual Study Completion Date :

Mar 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Active Comparator: 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.	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. Other Names: no HITSystem 2.0 intervention

Arm

Intervention/Treatment

Experimental: 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.

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.

Active Comparator: 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.

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.

Other Names:

no HITSystem 2.0 intervention

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
2	Bungoma County Hospital	Bungoma	Nandi	Kenya	30301
3	Kapsabet Hospital	Kapsabet	Nandi	Kenya	30300