Table 1. ECHO trial operational metrics.
ECHO Performance Standard | Target |
---|---|
#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 reporting | up-to-date for each DSMB review * |
#8 Data quality | current for each DSMB meeting, QC≤5/100 CRFs, ** fax time ≤7d ** |
* = overall, at each site, in each arm
** QC = quality control, CRFs = case report forms