Clinical trial NCT03980119: Utilizing the HITSystem for Optimizing Paediatric ART Retention and Adherence in Western Nyanza Province, Kenya
Official title: Utilizing the HITSystem 3.0 for Optimizing Paediatric ART Retention and Adherence in Western Nyanza Province, Kenya
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric HIV Infection
Lead sponsor: Global Health Innovations
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
name: Kenya Medical Research Institute
First posted: 2019-06-10
Enrollment: 1160
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pediatric ART Retention
timeFrame: 12 months
measure: Pediatric Viral Load Suppression
timeFrame: 12 months
Secondary outcomes:
measure: Missed ART
timeFrame: 12 months
measure: Medication Ratio >90%
timeFrame: 12 months
measure: Viral Load Testing
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Brad Gautney, MPH
role: PRINCIPAL_INVESTIGATOR
References: