Adapting the HITSystem to Support Prevention of Mother-to-child HIV Transmission
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|ClinicalTrials.gov Identifier: NCT02726607|
Recruitment Status : Completed
First Posted : April 1, 2016
Last Update Posted : April 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: HIV Infant Tracking System (HITSystem) 2.0 Behavioral: Standard of PMTCT care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||157 participants|
|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)|
|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|
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
- 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.
- 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).
- 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
- 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.
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
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Bungoma County Hospital|
|Bungoma, Nandi, Kenya, 30301|
|Kapsabet, Nandi, Kenya, 30300|
|Principal Investigator:||Sarah F Kessler, PhD, MPH||University of Kansas Medical Center|