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The problem
Intervention: Dolutegravir-based antiretroviral therapy
Who it was tested with: Children and adolescents with HIV-1 initiating or switching to dolutegravir-based ART (238 total participants across two trials).
The same group is measured before the intervention and again afterwards, with a baseline and an endline and sometimes a midline. Change is visible, but other causes cannot be ruled out.
"We performed descriptive post hoc analyses of body mass index-for-age (BAZ), weight-for-age (WAZ), and length/height-for-age z scores (L/HAZ) for each trial through Week 48" - this describes a single-arm study measuring the same participants at baseline and follow-up without a comparison group, fitting the PRE_POST design tier.
Single-arm design without a comparison group means growth changes cannot be definitively attributed to dolutegravir versus other factors like general ART benefits or natural growth patterns.
Across countries and designs
1 study · 1 country