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

Pediatric HIV Infection Clinical Trial

— PARA  

Official title:

Utilizing the HITSystem 3.0 for Optimizing Paediatric ART Retention and Adherence in Western Nyanza Province, Kenya

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03980119
• Other study ID #: HITSystem Peds Retention Kenya
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2019
• Est. completion date: December 2021

Study information

• Verified date: June 2019
• Source: Global Health Innovations
• Contact: Brad Gautney, MPH
• Phone: 913-706-3120
• Email: brad.gautney[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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

The proposed trial design is an unblinded CRT with two arms: the HITSystem 3.0 Intervention vs. Standard of Care (SOC) as the control. The CRT will be implemented in 20 health facilities (10 intervention and 10 control) in Western Nyanza province in Kenya and will collect data from HIV-infected children aged ≤16 years. Outcomes will focus on ART retention, adherence and viral suppression.

Outcomes will be assessed among all HIV positive children aged ≤16 years attending the trial facilities for HIV care at the start of the trial, or who are diagnosed as HIV positive during the first 12 months of the trial. Follow-up data will be collected on each child for 12 months. Therefore, the total duration of the trial will be for 24 months.

All HIV-positive children and their caregivers attending health facilities randomised to the intervention arm will be monitored by the HITSystem 3.0.

The study will be conducted in Western Nyanza province, Kenya, which comprises six counties.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1160
• Est. completion date: December 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

Health facilities must meet the following criteria to be eligible for the trial:

1. Level 3-5 and located in the Western Nyanza Province.

2. Currently provide PMTCT, EID and paediatric ART programmes.

3. Either government or private not-for-profit

4. Agreement to participate, which will be granted by both Kisumu County minister of health, as well as the facility Director of Medical Operations (DMO).

Exclusion Criteria:

1. Facilities that are classified as Level 1-2.

2. Facilities that are participating in other research involving paediatric ART programmes.

3. Private commercial facilities

Related Conditions & MeSH terms

• HIV Infections
• Pediatric HIV Infection

Intervention

Other:
• HITSystem 3.0
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Global Health Innovations	Kenya Medical Research Institute, London School of Hygiene and Tropical Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Missed ART	The proportion of HIV infected children who ever experienced a gap of >30 days without ART medication during the 12-month follow-up period.	12 months
Secondary	Medication Ratio >90%	The proportion of HIV-infected children with an ART medication possession ratio of =90% during the 12-month follow-up period	12 months
Secondary	Viral Load Testing	he proportion of HIV infected children who received viral load testing (per Kenya guidelines) at baseline, 6 months and 12 months	Baseline, 6 months, 12 months