Pediatric HIV Infection Clinical Trial
Official title:
Utilizing the HITSystem 3.0 for Optimizing Paediatric ART Retention and Adherence in Western Nyanza Province, Kenya
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.
n/a
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