Utilizing the HITSystem 3.0 for Optimizing Paediatric ART Retention and Adherence in Western Nyanza Province, Kenya
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,160
- Primary Endpoint
- Pediatric Viral Load Suppression
Study Overview
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
- 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).
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 1 Day to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •Facilities that are classified as Level 1-
- •Facilities that are participating in other research involving paediatric ART programmes.
- •Private commercial facilities
Arms & Interventions
HITSystem 3.0 Intervention
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.
Intervention: HITSystem 3.0 (Other)
Control
All HIV-positive children and their caregivers attending health facilities randomized to the Control arm will receive HIV/AIDS standard of care.
Outcomes
Primary Outcomes
Pediatric Viral Load Suppression
Time Frame: 12 months
The proportion of HIV infected children who are virally suppressed (VL \<50) at the end of the 12-month follow-up period.
Pediatric ART Retention
Time Frame: 12 months
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.
Secondary Outcomes
- Viral Load Testing(Baseline, 6 months, 12 months)
- Missed ART(12 months)
- Medication Ratio >90%(12 months)