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Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya

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ClinicalTrials.gov Identifier: NCT04571684
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : November 6, 2020
Sponsor:
Collaborators:
Kenya Medical Research Institute
Children's Mercy Hospital Kansas City
Global Health Innovations Foundation - Kenya
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
The goal of this project is to rigorously evaluate the efficacy of HIV Infant Tracking System 2.1 (HITSystem, an eHealth intervention that uses short message service (SMS) texts to patients and algorithm-driven electronic alerts for providers) to increase retention in guideline-adherent prevention of mother-to-child transmission of HIV services (PMTCT) and to increase viral suppression and appropriate clinical action through the extended period of 6 months postpartum, compared to standard of care PMTCT services in a matched, cluster randomized controlled trial.

Condition or disease Intervention/treatment Phase
HIV Pregnancy Other: HITSystem 2.1 Not Applicable

Detailed Description:
Despite progress in providing comprehensive prevention of mother-to-child transmission of HIV (PMTCT) services, significant gaps in the timely uptake and provision of guideline-adherent services and maternal retention in care remain. Such gaps create missed opportunities for preventing mother-to-child transmission and result in nearly 6,100 infants becoming infected with HIV each year in Kenya. Effective interventions that routinize the delivery of evidence-based PMTCT services and foster consistent patient engagement are essential to close the remaining gaps and eliminate mother-to-child transmission of HIV. Building off of a successful R34 grant to develop and pilot test the HITSystem 2.0, an eHealth intervention targeting PMTCT services, the overall goal of this proposal is to use a cluster randomized control design at 12 Kenyan government hospitals to evaluate a modified HITSystem 2.1 intervention. HITSystem 2.1 reflects the 2018 Kenyan PMTCT guidelines, including routine viral load monitoring and interventions to suppress maternal viral load. The investigators aim to evaluate the impact of HITSystem 2.1 to optimize the provision of guideline-adherent services and viral suppression through the antenatal, delivery, and early postpartum periods. Aim 1 of the proposed study will assess the efficacy of the HITSystem 2.1 to increase the proportion of mothers who receive complete PMTCT services (including appointment attendance, medication adherence support, viral load testing, hospital-based delivery, and infant testing per Kenyan National Guidelines) through 6 months postpartum. The investigators hypothesize that mothers receiving the HITSystem 2.1 intervention will have a significantly higher completion rate for guideline-adherence PMTCT services compared to mothers receiving standard of care PMTCT services. In Aim 1b, the investigators will evaluate HITSystem 2.1 implementation using the RE-AIM model to inform sustainable scale up. Aim 2 will assess the efficacy of HITSystem 2.1 to increase viral suppression (<1,000 copies/mL) among pregnant and postpartum women, including those who disengage from care. The investigators hypothesize that mothers at HITSystem 2.1 sites will have higher rates of viral suppression at delivery and 6 months postpartum. Aim 3 will evaluate the cost-effectiveness of the HITSystem 2.1. Driven by differences in PMTCT retention, viral suppression, and modeled estimates of pediatric HIV infections averted, the investigators hypothesize that the HITSystem 2.1 will be cost-effective, based on World Health Organization criteria. This proposal is aimed at improving the quality of PMTCT services in the health facility setting. If efficacious and cost-effective, HITSystem 2.1 holds strong promise for national dissemination.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Matched, cluster randomized controlled design
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluating the HITSystem to Improve PMTCT Retention and Maternal Viral Suppression in Kenya
Actual Study Start Date : October 5, 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention Arm (HITSystem 2.1)
Participants enrolled at intervention sites will received HITSystem 2.1-supported PMTCT services through 6 months postpartum. Interventions received will include: text messages to patients to support medication adherence, appointment attendance, and hospital delivery and algorithm-driven alerts to notify providers when follow up services are missed.
Other: HITSystem 2.1
HITSystem 2.1 is an intervention that tracks HIV+ pregnant women and their infants to improve the completeness and efficiency of PMTCT services. Key intervention features include: (1) SMS messages sent to enrolled women and mothers to support essential PMTCT services, (2) automated, algorithm-driven alerts for providers when per-guidelines PMTCT services are missed, and (3) automatic enrollment of infants into early infant diagnosis (EID) and linkage with maternal PMTCT file at documentation of infant birth to improve the continuum of care for HIV+ mothers and HIV-exposed infants. The HITSystem 2.1 intervention aims to facilitate complete PMTCT retention and viral load (VL) monitoring with prompt clinical action (adherence support, antiretroviral therapy (ART) regimen change) in the antenatal, delivery, and 6-month postpartum periods to increase viral suppression during windows critical for HIV prevention.

No Intervention: Control Arm (Standard of care)
Participants enrolled at control sites will receive standard of care PMTCT services, with no HITSystem 2.1 tracking or follow up.



Primary Outcome Measures :
  1. Proportion receiving complete PMTCT [ Time Frame: 7-15 months (PMTCT enrollment date through 6 months postpartum) ]
    documented receipt of all of the following: maternal ART initiation, antenatal appointment attendance, facility delivery, EID linkage by 7 weeks of age, maternal viral load testing and clinical action per national guidelines through 6 months postpartum (Table 6). Participants who receive all indicated services per guidelines will be coded as 1 or 'yes'. Participants missing > 1 service will be coded as 0 or incomplete PMTCT services.

  2. Viral suppression [ Time Frame: 1-15 months, (first VL test and followed through 6 months postpartum) ]
    the proportion of clients with a suppressed viral load(<1000 copies/mL) at delivery and within 6 months postpartum

  3. Cost-effectiveness [ Time Frame: Years 2 and 4 ]
    Quality of Life Years Saved for infants and mothers


Secondary Outcome Measures :
  1. PMTCT retention duration (weeks) [ Time Frame: 7-15 months (PMTCT enrollment date through 6 months postpartum) ]
    The number of weeks women were engaged in PMTCT serves

  2. Antiretroviral therapy (ART) adherence [ Time Frame: 7-15 months (PMTCT enrollment date through 6 months postpartum) ]
    The proportion with ART adherence > 95%

  3. Viral load test coverage [ Time Frame: 7-15 months (PMTCT enrollment date through 6 months postpartum) ]
    The proportion of women receiving baseline and repeat viral load tests per guidelines.

  4. Viral load test utility [ Time Frame: 7-15 months (PMTCT enrollment date through 6 months postpartum) ]
    Proportion of detectable viral load results with clinical action per guidelines, such as: intensified adherence counseling and/or ARV regimen change

  5. Turnaround time of viral load results and patient notification [ Time Frame: 7-15 months (PMTCT enrollment date through 6 months postpartum) ]
    The number of weeks from the date of sample collection to results

  6. Turnaround time of viral load patient notification [ Time Frame: 7-15 months (PMTCT enrollment date through 6 months postpartum) ]
    The number of weeks from the date of results to the date of patient notification

  7. Moderators of HITSystem 2.1 effectiveness [ Time Frame: Baseline, delivery, 6 months postpartum (participants), Pre and post study implementation (provider and facility assessment) ]
    Identify potential patient factors (age, education, income, disclosure, PMTCT knowledge, motivation to engage and complete PMTCT, perceived partner support, depression [modified Edinburgh postnatal scale]) and/or provider factors (gender, age, knowledge of PMTCT guidelines, perceived complexity of guidelines, motivation to provide guideline adherent care, workload, perception of the quality of patient care), and facility factors (resource level, patient volume, number of providers), that moderate the primary outcomes of complete PMTCT retention and viral load suppression.

  8. Mediators of HITSystem 2.1 effectiveness [ Time Frame: Baseline, delivery, 6 months postpartum (participants), Pre and Post study implementation (providers) ]
    Identify potential patient factors (disclosure status, PMTCT knowledge, motivation to engage and complete PMTCT, perceived partner support, depression (modified Edinburgh postnatal scale) and/or provider factors (knowledge of PMTCT guidelines, perceived complexity of guidelines, motivation to provide guideline adherent care, workload, perception of the quality of patient care) that mediate the primary outcomes of complete PMTCT retention and viral load suppression.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women living with HIV who present for care at one of the study hospitals by 36 weeks gestation and provide written informed consent are eligible for enrollment in the study.

Exclusion Criteria:

  • Pregnant women living with HIV will be excluded from study participation if she has any condition (including drug abuse, alcohol abuse, or psychiatric disorder) that study or hospital staff feel precludes her from providing informed consent.
  • Women who transfer care from one study site to another during their PMTCT services will be ineligible for enrollment at their new facility.

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): NCT04571684


Contacts
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Contact: Sarah Finocchario-Kessler, PhD, MPH 913-945-7077 skessler2@kumc.edu
Contact: Catherine Wexler, MPH cwexler@kumc.edu

Locations
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Kenya
Mariakani Subcounty Hospital Recruiting
Mariakani, Kilifi, Kenya
Contact: May Maloba    +254720254069    maymcurtis@gmail.com   
Mtwapa Subcounty Hospital Recruiting
Mtwapa, Kilifi, Kenya
Contact: May Maloba    +254720254069    maymcurtis@gmail.com   
Vipingo Subcounty Hospital Recruiting
Vipingo, Kilifi, Kenya
Contact: May Maloba    +254720254069    maymcurtis@gmail.com   
Likoni Subcounty Hospital Recruiting
Likoni, Mombasa, Kenya
Contact: May Maloba    +254720254069    maymcurtis@gmail.com   
Ambira Subcounty Hospital Recruiting
Ambira, Siaya, Kenya
Contact: May Maloba    +254720254069    maymcurtis@gmail.com   
Bondo Subcounty Hospital Recruiting
Bondo, Siaya, Kenya
Contact: May Maloba    +254720254069    maymcurtis@gmail.com   
Malanga Subcounty Hospital Recruiting
Malanga, Siaya, Kenya
Contact: May Maloba    +254720254069    maymcurtis@gmail.com   
Sigomere Health Center Recruiting
Sigomere, Siaya, Kenya
Contact: May Maloba    +254720254069    maymcurtis@gmail.com   
Ukwala Subcounty Hospital Recruiting
Ukwala, Siaya, Kenya
Contact: May Maloba    +254720254069    maymcurtis@gmail.com   
Yala Subcounty Hospital Recruiting
Yala, Siaya, Kenya
Contact: May Maloba    +254720254069    maymcurtis@gmail.com   
Akala Subcounty Hospital Recruiting
Siaya, Kenya
Contact: May Maloba    +254720254069    maymcurtis@gmail.com   
Siaya County Hospital Recruiting
Siaya, Kenya
Contact: May Maloba    +254720254069    maymcurtis@gmail.com   
Sponsors and Collaborators
University of Kansas Medical Center
Kenya Medical Research Institute
Children's Mercy Hospital Kansas City
Global Health Innovations Foundation - Kenya
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Sarah Finocchario-Kessler, PhD, MPH University of Kansas Medical Center
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT04571684    
Other Study ID Numbers: R01MH121245 ( U.S. NIH Grant/Contract )
R01MH121245 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The investigators will make data collected for aims 1 & 2 available only upon request from users who can show proof of human subject's training and only under a data-sharing agreement that provides for: (1) use of the data only for research purposes, (2) exclusion of any identifying or potentially identifying information in shared analyses, publications, reports, etc., (3) appropriate storage and securing of the data to prevent authorized persons from accessing it, (4) a commitment to destroy or return the data after analyses are completed.

Data from aim 3 includes costing data for PMTCT services. These data will be shared openly at the dissemination meetings planned at the end of the study, which will include county and national health personnel. Furthermore, these data will be placed in a readily accessible public database.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: After participant follow up is complete, data is cleaned, and the final data set is locked
Access Criteria: Upon request from users who can show proof of human subject's training and only under a data-sharing agreement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Kansas Medical Center:
Prevention of mother-to-child transmission (PMTCT) services
maternal viral load monitoring
early infant diagnosis (EID)
Kenya
perinatal HIV transmission