Adapting the HITSystem to Support Prevention of Mother-to-child HIV Transmission
NCT ID: NCT02726607
Last Updated: 2020-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
157 participants
INTERVENTIONAL
2015-08-15
2020-03-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Present for first PMTCT appointment at one of the study Hospitals
* Own or have reliable access to mobile phone
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Kenya Medical Research Institute
OTHER
Global Health Innovations
OTHER
Children's Mercy Hospital Kansas City
OTHER
University of Kansas Medical Center
OTHER
Responsible Party
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Sarah Kessler, PhD, MPH
Associate Professor
Principal Investigators
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Sarah F Kessler, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Bungoma County Hospital
Bungoma, Nandi, Kenya
Kapsabet Hospital
Kapsabet, Nandi, Kenya
Countries
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References
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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.
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.
Other Identifiers
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STUDY00002009
Identifier Type: -
Identifier Source: org_study_id
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