EID LIFE
Trial question
What is the effect of point-of-care testing and antiretroviral treatment at birth in infants with HIV infection?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
55.0% female
45.0% male
N = 125
125 patients (69 female, 56 male).
Inclusion criteria: neonates born to HIV-infected mothers.
Key exclusion criteria: having delivered > 72 hours ago; incarceration; stillbirth; women presenting with an emergency requiring immediate medical assistance, if not resolved at study inclusion; infants requiring emergency care or born with severe malformation.
Interventions
N=69 point-of-care test-and-treat (point-of-care testing and antiretroviral treatment at birth and week 4-8, starting these at week 4-8).
N=56 standard of care (no immediate point-of-care-testing and antiretroviral treatment at birth).
Primary outcome
Death, loss of retention, medical event, virological failure, toxicity in human immunodeficiency virus-positive infants at month 18
76.8%
85.7%
85.7 %
64.3 %
42.9 %
21.4 %
0.0 %
Point-of-care
test-and-treat
Standard of
care
No significant
difference ↔
No significant difference in death, loss of retention, medical event, virological failure, toxicity in HIV-positive infants at month 18 (76.8% vs. 85.7%; IRR 0.857, 95% CI 0.51 to 1.49).
Secondary outcomes
No significant difference in death, loss of retention, medical event, virological failure, toxicity in HIV-positive infants at month 3 (58% vs. 55.4%; IRR 0.908, 95% CI 0.51 to 1.82).
No significant difference in death, loss of retention, medical event, virological failure, toxicity in HIV-positive infants at month 6 (75.4% vs. 82.1%; IRR 0.817, 95% CI 0.51 to 1.38).
No significant difference in death, loss of retention, medical event, virological failure, toxicity in HIV-positive infants at month 12 (72.5% vs. 80.4%; IRR 0.845, 95% CI 0.48 to 1.51).
Safety outcomes
Significant difference in viral suppression at month 18 (65.7% vs. 29.6%).
Conclusion
In neonates born to HIV-infected mothers, point-of-care test-and-treat was not superior to standard of care with respect to death, loss of retention, medical event, virological failure, toxicity in HIV-positive infants at month 18.
Reference
Ilesh V Jani, Issa Sabi, Kira Elsbernd et al. Impact of point-of-care birth test-and-treat on clinical outcomes among infants with HIV: A cluster randomized trial in Mozambique and Tanzania. Clin Infect Dis. 2024 Nov 8:ciae530. Online ahead of print.
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