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

NCT02726607 | Completed

• 2 other identifiers: STUDY00002009R34MH107337-01
• Study Type: interventional
• Target: 157
• Locations: 2 countries
• Sites: 3

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.

Conditions

HIV

Keywords

Prevention of mother-to-child transmission (PMTCT); Kenya; HITSystem 2.0; retention through PMTCT cascade of care; Early Infant Diagnosis; eHealth system-level intervention

Outcome Measures

Primary Outcomes (1)

• Complete PMTCT retention

  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.

  first PMTCT visit during pregnancy to the return of the infant's first HIV DNA PCR test result by 12 weeks postnatal

Secondary Outcomes (3)

• 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.

• Infant HIV status

  Results obtained by 12 weeks postnatal

• Number of antenatal PMTCT appointments attended

  First antenatal PMTCT appointment through delivery date

Study Arms (2)

HITSystem 2.0

EXPERIMENTAL

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

Standard of PMTCT Care

ACTIVE COMPARATOR

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

Interventions

HIV Infant Tracking System (HITSystem) 2.0 BEHAVIORAL

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.

HITSystem 2.0

Standard of PMTCT care BEHAVIORAL

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.

Also known as: no HITSystem 2.0 intervention

Standard of PMTCT Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator
• Kenya Medical Research Institute: collaborator
• Global Health Innovations: collaborator
• Children's Mercy Hospital Kansas City: collaborator

Study Sites (3)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Bungoma County Hospital

Bungoma, Nandi, 30301, Kenya

Location

Kapsabet Hospital

Kapsabet, Nandi, 30300, Kenya

Location

Related Publications (2)

• Finocchario-Kessler S, Maloba M, Brown M, Gautney B, Goggin K, Wexler C, Mabachi N, Odeny B, Lagat S, Koech S, Dariotis JK, Odeny TA. Adapting the HIV Infant Tracking System to Support Prevention of Mother-to-Child Transmission of HIV in Kenya: Protocol for an Intervention Development Pilot Study in Two Hospitals. JMIR Res Protoc. 2019 Jun 8;8(6):e13268. doi: 10.2196/13268.

  PMID: 31199305 BACKGROUND

• Mabachi NM, Brown M, Sandbulte M, Wexler C, Goggin K, Maloba M, Finocchario-Kessler S. Using a Social Support Framework to Understand How HIV Positive Kenyan Men Engage in PMTCT/EID Care: Qualitative Insights From Male Partners. AIDS Behav. 2020 Jan;24(1):18-28. doi: 10.1007/s10461-019-02451-6.

  PMID: 30877581 RESULT

Study Officials

• Sarah F Kessler, PhD, MPH

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: April 1, 2016
• Study Start: August 15, 2015
• Primary Completion: July 30, 2019
• Study Completion: March 20, 2020
• Last Updated: April 1, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

KE (2); US (1)