Table 2 Outcomes of the SLATE II study

 ART initiation within 7 days of study enrollment

WHO calls for initiation within 7 days for all patients

Intention-to-treat analysis; comparison of proportions between groups presented as a risk difference and 95% confidence intervals

 Initiated ART within 28 days of study enrollment and alive, in care, and retained on ART 8 months after study enrollment

Retention at 8 months captures early attrition on ART, in case the manner of ART initiation affects longer-term outcomes (8 months was selected to allow up to 1 month to initiate ART, 6 months of follow-up after treatment initiation, and up to 1 month to return for the 6 months routine clinic visit)

Intention-to-treat analysis; comparison of proportions between groups presented as a risk difference and 95% confidence intervals. Reasons for not achieving this outcome will also be described to the extent that routinely collected follow-up data allow

  ART initiation within 14 days of study enrollment for TB suspects

SLATE II aims to avoid delay of ART initiation in patients with mild TB symptoms

Intention-to-treat analysis; comparison of proportions between groups presented as a risk difference and 95% confidence intervals

  ART initiation within 1, 14, and 28 days of study enrollment

Both national and global guidelines recommend same-day initiation (1 day). Since other published studies have used 14 and 28 days, maintaining this secondary outcome will allow comparison with SLATE II results

Intention-to-treat analysis; comparison of proportions between groups presented as a risk difference and 95% confidence intervals

  Time to initiation, in days

Time to initiation captures any effect of SLATE II on accelerating initiation

Intention-to-treat analysis; comparison of time to initiation presented as survival curves with log rank test

  Viral suppression by 8 months after study enrollment, for all patients and for TB suspects

Allows ≤1 month (28 days) to initiate ART, 6 months of follow-up after treatment initiation, and ≤ 1 month to return for the 6 months routine clinic visit

Intention-totreat analysis; comparison of proportions between groups presented as a risk difference and 95% confidence intervals. 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 enrollment, for all patients and for TB suspects

Allows ≤1 month (28 days) to initiate ART, 12 months of follow-up after treatment initiation, and ≤ 1 month to return for the 12 months routine clinic visit; any visit 12–14 months after study enrollment will represent the 12 months visit

Intention-to-treat analysis; comparison of proportions between groups presented as a risk difference and 95% confidence intervals

  Proportions of study patients who screen in and screen out for immediate ART initiation using SLATE II algorithm criteria

Will provide guidance on proportions of patients who could be initiated under SLATE II if adopted as routine care

Intention-to-treat analysis; comparison of proportions between groups presented as a risk difference and 95% confidence intervals

  Reasons for ineligibility

Will provide guidance on types of referral services required from clinics

Descriptive analysis of proportions of patients screening out for each possible reason indicated on SLATE II screens

  Frequency and types of adverse events

Will indicate probability of adverse events related to the algorithm and guidance on what to expect

Descriptive analysis of adverse events reported in medical records after ART initiation for each follow-up period

  Patient preferences on the speed and timing of ART initiation

Baseline questionnaire data

Descriptive analysis of medians and interquartile ranges (IQRs) for continuous outcomes and proportions and corresponding 95% confidence intervals for categorical outcomes

  Proportion of symptomatic patients who test positive for TB using the LAM test

Will determine usefulness of using a point-of-care LAM test as part of ART initiation

Descriptive analysis of proportion of tests found positive

  Proportions of symptomatic and asymptomatic patients who test positive for TB using Xpert MTB/RIF

Will determine usefulness of testing asymptomatic patients with Xpert as part of ART initiation

Descriptive analysis of proportion of tests found positive

  Costs to patients of ART initiation under standard and intervention procedures

SLATE II is hypothesized to reduce the number of clinic visits required for ART initiation and thus costs to patients

Sum of clinic visit costs and time spent from enrollment 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 intervention

SLATE II is hypothesized to reduce the number of clinic visits required for ART initiation and thus costs to providers

Estimate of provider costs using previously described [33] bottom-up costing methods, with resource utilization extracted from medical records and case report forms (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 (standard deviations) and medians (IQRs) in local currencies and US dollars

  Comparison of SLATE I and SLATE II results

Assess changes between the original and revised algorithms and to look for secular changes in patient characteristics, clinic procedures, and patient outcomes over time

Direct comparison of findings between the two studies wherever possible (Note: If standard arm results change significantly between SLATE I and SLATE II, may conduct a difference-in-differences analysis, with SLATE I serving as the “pre” period and SLATE II as the “post” period)