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Principal Investigator: SARAH Finocchario KESSLER
Organization: UNIVERSITY OF KANSAS MEDICAL CENTER
Fiscal Year: 2024
Award: $149,420
Funding agency: National Institute of Mental Health
Abstract
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. We 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. We 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, we 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. We 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, we 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.
Terms: <2 arm RCT><2 arm randomized control trial><2 arm randomized controlled trial><AIDS><AIDS Virus><AIDS prevention><AIDS test><AIDS/HIV test><Acquired Immune Deficiency><Acquired Immune Deficiency Syndrome><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome><Acquired Immunodeficiency Syndrome Virus><Active Follow-up><Address><Adoption><Anti-HIV Positivity><Appointment><Breast Feeding><Breast fed><Breastfed><Breastfeeding><Caring><Cessation of life><Childhood><Clinical><Country><Data><Death><Documentation><Effectiveness><Enrollment><Ensure><Fostering><Gestation><Goals><Government><Grant><Guideline Adherence><Guidelines><HIV><HIV Infections><HIV Positive><HIV Positivity><HIV Prevention><HIV Seroconversion><HIV Seropositivity><HIV antibody positive><HIV diagnosis><HIV test><HIV-1 test><HIV-2 test><HIV/AIDS prevention><HTLV-III Infections><HTLV-III Seroconversion><HTLV-III Seropositivity><HTLV-III-LAV Infections><Health Facilities><Health care facility><Healthcare Facility><High Prevalence><Hospitals><Human Immunodeficiency Viruses><Human T-Lymphotropic Virus Type III Infections><Human immunodeficiency virus test><Infant><Interruption><Intervention><Intervention Strategies><Kenya><LAV-HTLV-III><Life><Lymphadenopathy-Associated Virus><Maintenance><Maternal Health><Measures><Modeling><Monitor><Mother-to-child HIV transmission><Mothers><On-Line Systems><Online Systems><Participant><Perinatal transmission><Post-partum Women><Postpartum Period><Postpartum Women><Pregnancy><Pregnant Women><Prevention><Provider><Proxy><RE-AIM><Randomized><Randomized, Controlled Trials><Reach, Effectiveness, Adoption, Implementation, and Maintenance><Regimen><Research Resources><Resources><Sampling><Schedule><Services><Site><System><Technology><Test Result><Testing><Text Messaging><Time><Transmission><Update><Vertical Disease Transmission><Viral><Viral Burden><Viral Load><Viral Load result><Virus-HIV><Visit><Woman><World Health Organization><active followup><antenatal><antepartum><antiretroviral therapy><antiretroviral treatment><arm><care facilities><clinical care><cost><cost effective><cost effectiveness><cost-effectiveness evaluation><design><designing><determine efficacy><develop therapy><drug adherence><drug compliance><e-Health><eHealth><early pregnancy><effective intervention><efficacy analysis><efficacy assessment><efficacy determination><efficacy evaluation><efficacy examination><electronic health><enroll><evaluate cost-effectiveness><evaluate efficacy><evidence base><examine efficacy><expectant mother><expecting mother><follow up><follow-up><followed up><followup><high risk><implementation fidelity><improved><internet-based intervention><intervention development><interventional strategy><medication adherence><medication compliance><mother to child transmission><online computer><participant engagement><patient engagement><patient retention><pediatric><pediatric HIV disease><pediatric HIV infection><pediatric human immunodeficiency virus disease><pediatric human immunodeficiency virus infection><perinatal HIV><pilot test><post-partum><pregnant mothers><prevent><preventing><prospective><public health relevance><randomisation><randomization><randomized control trial><randomly assigned><reach, efficacy, adoption, implementation, and maintenance><scale up><service delivery><short message service><standard of care><success><texting><therapy development><transmission process><treatment development><two arm RCT><two arm randomized control trial><two arm randomized controlled trial><uptake><web based><web-based intervention>