Table 1. ECHO trial operational metrics.
ECHO Performance Standard | Target (*=overall, at each site, in each arm) |
---|---|
#1 Accrual | Achieve target sample within ~18 months |
#2 Method refusal | <5% of subjects* |
#3 Retention | Per-visit completion of ≥90% and ≤10% of expected person-years lost* |
#4 Method discontinuation | ≤10% of all person-time off assigned method* |
#5 HIV incidence | sufficient to meet the study objectives (≥3.5%/year) |
#6 Ineligible enrolments | <1–2% of total* |
#7 HIV endpoint enrolments | up-to-date for each DSMB review* |
#8 Data quality | current for each DSMB, QC≤5/100 CRFs, fax time ≤7d* |