Clinical Trials

MainTitle

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

This study has been enrolling by invitation
Sponsor
University of Kansas Medical Center

Collaborator
National Institute of Mental Health (NIMH)
Kenya Medical Research Institute
Global Health Innovations
Children's Mercy Hospital

Information provided by (Responsible Party)
Sarah Kessler, PhD, MPH, University of Kansas Medical Center

ClinicalTrials.gov Identifier
NCT02726607

First received: March 24, 2016
Last updated: April 18, 2017
Last Verified: April 2017
History of Changes
Purpose

Purpose

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 Intervention
HIV

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adapting the HITSystem to Support Prevention of Mother-to-child HIV Transmission

Further study details as provided by Sarah Kessler, PhD, MPH, University of Kansas Medical Center:

Primary Outcome Measures

  • Complete PMTCT retention [ Time Frame: 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:
  • Antiretroviral therapy (ART) adherence [ Time Frame: up to 36 weeks ]
    The primary measure for ART adherence will be viral load at 36 weeks gestation. Recognizing routine viral load testing at 36 weeks is a fairly new guideline, the researchers will assess other measures of adherence as well: the proportion of medication refill appointments kept (kept/scheduled), self-report of missed doses in the 7 days prior to appointment (taken/prescribed), and pill counts conducted by site pharmacists (dispensed/returned). The researchers will calculate the proportion of patients who report >85% adherence to doses prescribed (7-day self-report) and pharmacist pill count.
  • First infant HIV DNA Polymerase Chain Reaction (PCR) test result [ Time Frame: obtained by 12 weeks postnatal ]
    Test results will be reported as negative, positive or indeterminate

Estimated Enrollment: 162
Study Start Date: August 2015
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name: no HITSystem 2.0 intervention

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: No  

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:

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02726607

Locations

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Kenya
Kapsabet Hospital
Kapsabet, Nandi, Kenya, 30300
Nandi Hills Hospital
Nandi Hills, Nandi, Kenya, 30301

Sponsors and Collaborators

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

Investigators

Principal Investigator: Sarah F Kessler, PhD, MPH University of Kansas Medical Center
More Information

More Information


Responsible Party: Sarah Kessler, PhD, MPH, Associate Professor, University of Kansas Medical Center  
ClinicalTrials.gov Identifier: NCT02726607   History of Changes  
Other Study ID Numbers: STUDY00002009  
  R34MH107337-01  
Study First Received: March 24, 2016  
Last Updated: April 18, 2017  
Individual Participant Data    
Plan to Share IPD: No  

Keywords provided by Sarah Kessler, PhD, MPH, University of Kansas Medical Center:

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

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.