Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya

NCT04571684 | Completed Results DMC

• 1 other identifier: R01MH121245
• Study Type: interventional
• Target: 1,639
• Locations: 1 country
• Sites: 12

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.

Conditions

HIV; Pregnancy

Keywords

Prevention of mother-to-child transmission (PMTCT) services; maternal viral load monitoring; early infant diagnosis (EID); Kenya; perinatal HIV transmission

Outcome Measures

Primary Outcomes (2)

• Number of Participants 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

  Number of clients with a suppressed viral load(\<1000 copies/mL) at delivery

  1-9 months

Secondary Outcomes (6)

• PMTCT Retention Duration (Weeks)

  7-15 months (PMTCT enrollment date through 6 months postpartum)

• Antenatal Viral Load (VL) Test Coverage

  Within one month of enrollment in PMTCT

• Postnatal Viral Load (VL) Test Coverage

  Between delivery and 7 months postpartum

• Viral Load Test Utility

  PMTCT enrollment date through 6 months postpartum

• Turnaround Time of Viral Load Sample Collection to Patient Notification

  PMTCT enrollment date through 6 months postpartum

Study Arms (2)

Intervention Arm (HITSystem 2.1)

EXPERIMENTAL

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

Control Arm (Standard of care)

NO INTERVENTION

Participants enrolled at control sites will receive standard of care PMTCT services, with no HITSystem 2.1 tracking or follow up.

Interventions

HITSystem 2.1 OTHER

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.

Intervention Arm (HITSystem 2.1)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Kenya Medical Research Institute: collaborator
• Children's Mercy Hospital Kansas City: collaborator
• Global Health Innovations Foundation - Kenya: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (12)

Mariakani Subcounty Hospital

Mariakani, Kilifi County, Kenya

Location

Mtwapa Subcounty Hospital

Mtwapa, Kilifi County, Kenya

Location

Vipingo Subcounty Hospital

Vipingo, Kilifi County, Kenya

Location

Likoni Subcounty Hospital

Likoni, Mombasa County, Kenya

Location

Ambira Subcounty Hospital

Ambira, Siaya County, Kenya

Location

Bondo Subcounty Hospital

Bondo, Siaya County, Kenya

Location

Malanga Subcounty Hospital

Malanga, Siaya County, Kenya

Location

Sigomere Health Center

Sigomere, Siaya County, Kenya

Location

Ukwala Subcounty Hospital

Ukwala, Siaya County, Kenya

Location

Yala Subcounty Hospital

Yala, Siaya County, Kenya

Location

Akala Subcounty Hospital

Siaya, Kenya

Location

Siaya County Hospital

Siaya, Kenya

Location

Related Publications (2)

• Wexler C, Maloba M, Mokua S, Babu S, Maosa N, Staggs V, Goggin K, Acharya H, Hurley EA, Finocchario-Kessler S. Assessing COVID-related concerns and their impact on antenatal and delivery care among pregnant women living with HIV in Kenya: a brief report. BMC Pregnancy Childbirth. 2024 Jan 9;24(1):46. doi: 10.1186/s12884-023-06216-x.

  PMID: 38195390 DERIVED

• 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.

  PMID: 35881649 DERIVED

Results Point of Contact

• Title: Principal Investigator
• Organization: University of Kansas Medical Center

skessler2@kumc.edu

913-945-7709

Study Officials

• Sarah Finocchario-Kessler, PhD, MPH

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Matched, cluster randomized controlled design

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 1, 2020
• Study Start: October 5, 2020
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: July 10, 2025
• Results First Posted: July 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

KE (12)