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Completed

NCT Number: NCT02726607

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

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bungoma County Hospital, Bungoma, Nandi, Kenya

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: no HITSystem 2.0 intervention

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

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

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Apr 1, 2016
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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