Utilizing the HITSystem for Optimizing Paediatric ART Retention and Adherence in Western Nyanza Province, Kenya

NCT03980119 | Unknown DMC

• 1 other identifier: HITSystem Peds Retention Kenya
• Study Type: interventional
• Target: 1,160
• Locations: 0 countries
• Sites: N/A

Brief Summary

Overall, there are an estimated 98,000 children living with HIV in Kenya. Children who are initiated on ART in Kenya and other low resource settings face several challenges with ongoing care due to current limitations of paediatric HIV treatment services. High quality paediatric HIV care requires routine monitoring of clinical and virologic status, support for ART adherence, and patient outreach to optimize retention in care. The HIV Infant Tracking System (HITSystem) is a web-based, system-level intervention that has dramatically improved EID HIV-related outcomes in Kenya, Tanzania, and Malawi. The objective of this study is to implement and evaluate the impact of HITSystem 3.0 on paediatric clinical outcomes, adherence, retention and viral suppression over 12 months among children in HIV care. Outcome measurements will be evaluated separately in children aged ≤2 years and in those aged 3-16 years. Primary Outcomes

1. 1.The proportion of HIV infected children in each arm who are retained in HIV care at 12 months. Retention will be defined as regular engagement with HIV care, as measured by having attended the last three scheduled monthly appointments on time (see section 3.3 for further description).
2. 2.The proportion of HIV infected children who are virally suppressed (VL \<50) at the end of the 12-month follow-up period.

Conditions

Pediatric HIV Infection

Outcome Measures

Primary Outcomes (2)

• Pediatric ART Retention

  The proportion of HIV infected children in each arm who are retained in HIV care at 12 months. Retention will be defined as regular engagement with HIV care, as measured by having attended the last three scheduled monthly appointments on time.

  12 months

• Pediatric Viral Load Suppression

  The proportion of HIV infected children who are virally suppressed (VL \<50) at the end of the 12-month follow-up period.

  12 months

Secondary Outcomes (3)

• Missed ART

  12 months

• Medication Ratio >90%

  12 months

• Viral Load Testing

  Baseline, 6 months, 12 months

Study Arms (2)

HITSystem 3.0 Intervention

EXPERIMENTAL

All HIV-positive children and their caregivers attending health facilities randomized to the HITSystem intervention arm will be monitored by the HITSystem. In the event that the child misses an appointment or a scheduled laboratory test, or the child's laboratory results suggest ART treatment failure, an automated SMS text message and alert will be generated in the HITSystem that will notify the child's health care provider. The child's caregiver will also receive a text message asking them to return to the clinic with the child. If the child is 16 years of age and considered an independent adolescent without a caregiver, the same process will be implemented, with the text messages being sent directly to the child. If the child's caregiver, or the independent adolescent, does not have a mobile phone, the health care provider will notify the community health worker (CHW) to trace the individual and visit them in their home.

Other: HITSystem 3.0

Control

NO INTERVENTION

All HIV-positive children and their caregivers attending health facilities randomized to the Control arm will receive HIV/AIDS standard of care.

Interventions

HITSystem 3.0 OTHER

The HITSystem 3.0 is a web-based intervention that aims to improve pediatric ART retention and adherence, and viral suppression. The HITSystem 3.0 is accessed online through a computer, using mobile broadband modems that respond to a cellular signal. The primary components include: (1) action alerts to complete time-sensitive interventions; (2) real time communication of HIV PCR results to hospitals to reduce turn-around time; (3) continuous follow-up for timely ART initiation among HIV-infected infants; (4) promotion of retention in EID care via SMS text messaging and/or patient tracing; and (5) an automated and individualized SMS text messaging component to communicate with mothers. The HITSystem has a unique dashboard that proactively monitors time-sensitive interventions along the EID cascade of care, alerting clinics, laboratories and mothers when an intervention has been missed.

HITSystem 3.0 Intervention

Eligibility Criteria

• Age: 1 Day - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Health facilities must meet the following criteria to be eligible for the trial:
• Level 3-5 and located in the Western Nyanza Province.
• Currently provide PMTCT, EID and paediatric ART programmes.
• Either government or private not-for-profit
• Agreement to participate, which will be granted by both Kisumu County minister of health, as well as the facility Director of Medical Operations (DMO).

You may not qualify if:

• Facilities that are classified as Level 1-2.
• Facilities that are participating in other research involving paediatric ART programmes.
• Private commercial facilities

Sponsors & Collaborators

• Global Health Innovations: lead
• London School of Hygiene and Tropical Medicine: collaborator
• Kenya Medical Research Institute: collaborator

Study Officials

• Brad Gautney, MPH

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brad Gautney, MPH

CONTACT

913-706-3120; brad.gautney@gmail.com

May Maloba, RN

CONTACT

+254 720 254069; maymcurtis@gmail.com

Study Design

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

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 10, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will become available upon publication of results.
• Access Criteria: Only PI, appropriate research members and publication editor will have access.