Table 2

Secondary outcomes

Secondary outcomeJustification and/or further descriptionData analysis
ART outcomes
ART initiation within 14 days of study enrolmentNational guidelines in both study countries19 20 recommend initiation ≤14 daysIntention-to-treat analysis; comparison of proportions between groups presented as a risk difference and 95% CIs
Time to initiation, in daysOne goal of SLATE algorithm is to accelerate initiation; time to initiation captures any effect on this.Intention-to-treat analysis; comparison of time to initiation presented as survival curves with log rank test
Viral suppression by 8 months after study enrolmentAllows ≤1 month (28 days) to initiate ART, 6 months of follow-up after treatment initiation and ≤1 month to return for the 6-month routine clinic visitIntention-to-treat analysis; comparison of proportions between groups presented as a risk difference and 95% CIs. Reasons for not achieving this outcome will also be described to the extent that routinely collected follow-up data allow.
Retention in care 14 months after study enrolmentAllows ≤1 month (28 days) to initiate ART, 12 months of follow-up after treatment initiation and ≤1 month to return for the 12-month routine clinic visit; any visit 12–14 months after study enrolment will represent the 12-month visitIntention-to-treat analysis; comparison of proportions between groups presented as a risk difference and 95% CIs
Retention in care at 16 months after study enrolmentAllows ≤1 month (28 days) to initiate ART, 12 months of follow-up after treatment initiation and ≤3 months to return for the 12-month routine clinic visit, to allow comparability with other studies of 12-month retention in care, which often define loss to follow-up as 90 days late for the last scheduled visit.Intention-to-treat analysis; comparison of proportions between groups presented as a risk difference and 95% CIs
SLATE evaluation
Proportions of study patients who screen in and screen out for immediate ART initiation using SLATE algorithm criteriaWill provide guidance on proportions of patients who could be initiated under SLATE if adopted as routine careIntention-to-treat analysis; comparison of proportions between groups presented as a risk difference and 95% CIs
Reasons for ineligibilityWill provide guidance on types of referral services required from clinicsDescriptive analysis of proportions of patients screening out for each possible reason indicated on SLATE screens
Patient preferences on the speed and timing of ART initiationBaseline questionnaire dataDescriptive analysis of medians and IQRs for continuous outcomes and proportions and corresponding 95% CIs for categorical outcomes
Health system outcomes
Costs to patients of ART initiation under standard and intervention proceduresSLATE is hypothesised to reduce the number of clinic visits required for ART initiation and thus costs to patientsSum of clinic visit costs and time spent from enrolment visit to visit at which ARVs are dispensed, calculated from questionnaire responses.
Costs to providers of ART initiation under standard and intervention procedures and cost-effectiveness of interventionSLATE is hypothesised to reduce the number of clinic visits required for ART initiation and thus costs to providersEstimate of provider costs using previously described21 bottom-up costing methods, with resource utilisation extracted from medical records and CRFs and unit costs obtained from study sites. The average cost to the provider per patient achieving each primary outcome will be compared between intervention and standard initiation groups to provide an estimate of the cost-effectiveness of the two strategies. Costs will be reported as means (SD) and medians (IQRs) in local currencies and US dollars.
  • ART, antiretroviral therapy; CRFs, case report forms; SLATE, Simplified Algorithm for Treatment Eligibility.