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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02726607
Recruitment Status : Completed
First Posted : April 1, 2016
Last Update Posted : April 1, 2020
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Kenya Medical Research Institute
Global Health Innovations
Children's Mercy Hospital Kansas City
Information provided by (Responsible Party):
Sarah Kessler, PhD, MPH, 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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: HIV Infant Tracking System (HITSystem) 2.0 Behavioral: Standard of PMTCT care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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.
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 : August 15, 2015
Actual Primary Completion Date : July 30, 2019
Actual Study Completion Date : March 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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 Name: no HITSystem 2.0 intervention




Primary Outcome Measures :
  1. 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 :
  1. Duration of PMTCT Retention [ Time Frame: 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).

  2. Infant HIV status [ Time Frame: Results obtained by 12 weeks postnatal ]
    Result of infant HIV DNA Polymerase Chain Reaction (PCR) test: HIV-positive, HIV-negative, indeterminate, unknown, missing

  3. Number of antenatal PMTCT appointments attended [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02726607


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Kenya
Bungoma County Hospital
Bungoma, Nandi, Kenya, 30301
Kapsabet Hospital
Kapsabet, Nandi, Kenya, 30300
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 Kansas City
Investigators
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Principal Investigator: Sarah F Kessler, PhD, MPH University of Kansas Medical Center
Publications of Results:
Other Publications:
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Responsible Party: Sarah Kessler, PhD, MPH, Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02726607    
Other Study ID Numbers: STUDY00002009
R34MH107337-01 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
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