Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya

Evaluating the HITSystem to Improve PMTCT Retention and Maternal Viral Suppression in Kenya

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy; HIV
• Intervention / Treatment: Other: HITSystem 2.1

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.

• Study Type: Interventional
• Enrollment (Actual): 1648
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Finocchario-Kessler, PhD, MPH; Phone Number: 913-945-7077; Email: skessler2@kumc.edu
• Study Contact Backup: Name: Catherine Wexler, MPH; Email: cwexler@kumc.edu

Study Locations

• Kenya
  • Siaya, Kenya
    • Akala Subcounty Hospital
  • Siaya, Kenya
    • Siaya County Hospital
  • Kilifi
    • Mariakani, Kilifi, Kenya
      • Mariakani Subcounty Hospital
    • Mtwapa, Kilifi, Kenya
      • Mtwapa Subcounty Hospital
    • Vipingo, Kilifi, Kenya
      • Vipingo Subcounty Hospital
  • Mombasa
    • Likoni, Mombasa, Kenya
      • Likoni Subcounty Hospital
  • Siaya
    • Ambira, Siaya, Kenya
      • Ambira Subcounty Hospital
    • Bondo, Siaya, Kenya
      • Bondo Subcounty Hospital
    • Malanga, Siaya, Kenya
      • Malanga Subcounty Hospital
    • Sigomere, Siaya, Kenya
      • Sigomere Health Center
    • Ukwala, Siaya, Kenya
      • Ukwala Subcounty Hospital
    • Yala, Siaya, Kenya
      • Yala Subcounty Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion receiving complete PMTCT	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.	7-15 months (PMTCT enrollment date through 6 months postpartum)
Viral suppression	the proportion of clients with a suppressed viral load(<1000 copies/mL) at delivery and within 6 months postpartum	1-15 months, (first VL test and followed through 6 months postpartum)
Cost-effectiveness	Quality of Life Years Saved for infants and mothers	Years 2 and 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PMTCT retention duration (weeks)	The number of weeks women were engaged in PMTCT serves	7-15 months (PMTCT enrollment date through 6 months postpartum)
Antiretroviral therapy (ART) adherence	The proportion with ART adherence > 95%	7-15 months (PMTCT enrollment date through 6 months postpartum)
Viral load test coverage	The proportion of women receiving baseline and repeat viral load tests per guidelines.	7-15 months (PMTCT enrollment date through 6 months postpartum)
Viral load test utility	Proportion of detectable viral load results with clinical action per guidelines, such as: intensified adherence counseling and/or ARV regimen change	7-15 months (PMTCT enrollment date through 6 months postpartum)
Turnaround time of viral load results and patient notification	The number of weeks from the date of sample collection to results	7-15 months (PMTCT enrollment date through 6 months postpartum)
Turnaround time of viral load patient notification	The number of weeks from the date of results to the date of patient notification	7-15 months (PMTCT enrollment date through 6 months postpartum)
Moderators of HITSystem 2.1 effectiveness	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.	Baseline, delivery, 6 months postpartum (participants), Pre and post study implementation (provider and facility assessment)
Mediators of HITSystem 2.1 effectiveness	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.	Baseline, delivery, 6 months postpartum (participants), Pre and Post study implementation (providers)

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: National Institute of Mental Health (NIMH); Children's Mercy Hospital Kansas City; Kenya Medical Research Institute; Global Health Innovations Foundation - Kenya
• Investigators: Principal Investigator: Sarah Finocchario-Kessler, PhD, MPH, University of Kansas Medical Center

Publications and helpful links

General Publications

• Mokua S, Maloba M, Wexler C, Goggin K, Staggs V, Mabachi N, Maosa N, Babu S, Hurley E, Finocchario-Kessler S. Evaluating the efficacy of the HITSystem 2.1 to improve PMTCT retention and maternal viral suppression in Kenya: Study protocol of a cluster-randomized trial. PLoS One. 2022 Jul 26;17(7):e0263988. doi: 10.1371/journal.pone.0263988. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Estimated): January 29, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Kenya; Prevention of mother-to-child transmission (PMTCT) services; maternal viral load monitoring; early infant diagnosis (EID); perinatal HIV transmission
• Other Study ID Numbers: R01MH121245 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.

• IPD Sharing Time Frame: After participant follow up is complete, data is cleaned, and the final data set is locked
• IPD Sharing Access Criteria: Upon request from users who can show proof of human subject's training and only under a data-sharing agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No