Cohort profile: improving treatment of HIV-infected Ethiopian children through better detection of treatment failure in southern Ethiopia.

PURPOSE: The Ethiopian Paediatric HIV Cohort (EPHIC) was established to identify clinical and laboratory predictors of virological treatment failure to ultimately develop a clinical-immunological prediction rule with area under the curve of >0.80 for detecting first-line antiretroviral therapy failure (ARTF). It will also assess the performance of the current WHO guidelines for detection of first-line ARTF in children.

PARTICIPANTS: Using a prospective cohort design, HIV-infected children and adolescents below the age of 18 years are followed every 6 months with a set of clinical and laboratory parameters at 6 hospitals in southern Ethiopia. For inclusion in the cohort, children should be on or are initiating first-line antiretroviral therapy (ART) and are not on second-line ART. Virological treatment failure is taken as the gold standard for the diagnosis of treatment failure.

FINDINGS TO DATE: From October 2015 through April 2016, 628 children have been enrolled from 6 different HIV treatment centres across southern Ethiopia. The mean age at enrolment was 11.1 years and 47.6% were girls. Many of the children (88.6%) were at WHO Clinical stage 1 at time of enrolment. At enrolment, the mean duration on first-line ART was 45 months. Substitution of ART drugs was performed to nearly half (42.6%) of the cohort. Adherence as assessed with the Visual Analogue Scale was high (mean, 94.4%; SD=11.9). The median CD4 count of the cohort at enrolment was 741 with 3.1% having a value consistent with ARTF.

FUTURE PLANS: Regular data uploads from the 6 hospitals in southern Ethiopia enable this cohort to be followed prospectively. The cohort will be completed in September 2017. The successful completion of this study will allow for better targeting of viral-load testing to those at highest risk in resource-poor settings and provide clinicians and policymakers with a practical prediction rule.

ETHICS APPROVAL: SNNPR Regional Health Bureau Institutional Review Board.