A clinical algorithm for same-day HIV treatment initiation in settings with high TB symptom prevalence in South Africa: The SLATE II individually randomized clinical trial

Abstract

Background Many countries encourage same-day initiation of antiretroviral therapy (ART), but evidence on eligibility for same-day initiation, how best to implement it, and its impact on outcomes remains scarce. Building on the Simplified Algorithm for Treatment Eligibility (SLATE) I trial, in which nearly half of participants were ineligible for same-day initiation mainly because of TB symptoms, the study evaluated the revised SLATE II algorithm, which allowed same-day initiation for patients with mild TB symptoms and other less serious reasons for delay. Methods and findings SLATE II was a nonblinded, 1:1 individually randomized pragmatic trial at three primary healthcare clinics in Johannesburg, South Africa. It randomized adult patients presenting for an HIV test or any HIV care but not yet on ART. Intervention arm patients were assessed with a symptom screen, medical history, brief physical examination, and readiness questionnaire to distinguish between patients eligible for immediate ART dispensing and those requiring further care before initiation. Standard arm patients received usual care. Follow-up was by review of routine clinic records. Primary outcomes were (1) ART initiation in �7 days and (2) ART initiation in �28 days and retention in care at 8 months (composite outcome). From 14 March to 18 September 2018, 593 adult HIV+, nonpregnant patients were enrolled (median interquartile range [IQR] age 35 [29-43]; 63% (n = 373) female; median CD4 count 293 [133-487]). Half of study patients (n = 295) presented with TB symptoms, whereas only 13 (4%) standard arm and 7 (2%) intervention arm patients tested positive for TB disease. Among 140 intervention arm patients with TB symptoms, 72% were eligible for same-day

Retention in care and viral suppression after same-day ART initiation: One-year outcomes of the SLATE I and II individually randomized clinical trials in South Africa

“…The SLATE trials had a number of limitations which are addressed in our previous reports [6,16]. The limitation most likely to have affected these results was our reliance on routinely collected data and the absence of unique identification numbers in the South African health system.…”

“…SLATE I and SLATE II were individually randomised, non-blinded pragmatic evaluations to assess the effect of each SLATE algorithm on ART initiation and retention in care. Both studies have been described in detail elsewhere [3–6,11,12]. Both algorithms consisted of four screening tools (Figure 1), each evaluating specific criteria for same-day ART initiation: 1) symptom report, 2) medical history, 3) physical examination, and 4) patient readiness assessment.…”

“…While evidence from the SLATE trials [5,6] and others [7,8] demonstrate improved uptake of ART with SDI compared to standard care, concerns remain whether the benefits of SDI can be translated into improved retention once on treatment, or if instead attrition is simply shifted from before to soon after ART initiation, or even made worse by pressure that the expectation of same-day initiation is perceived to place on patients [9,10]. Overall attrition at 8 months was lower in the intervention arm in both trials [5,6], but its timing differed.…”

“…While evidence from the SLATE trials [5,6] and others [7,8] demonstrate improved uptake of ART with SDI compared to standard care, concerns remain whether the benefits of SDI can be translated into improved retention once on treatment, or if instead attrition is simply shifted from before to soon after ART initiation, or even made worse by pressure that the expectation of same-day initiation is perceived to place on patients [9,10]. Overall attrition at 8 months was lower in the intervention arm in both trials [5,6], but its timing differed. In SLATE I, roughly one third of the attrition observed in the standard arm but more than half in the intervention arm occurred after patients initiated ART; in SLATE II, half of the attrition observed in the standard arm but nearly three quarters of the attrition observed in the intervention arm occurred after initiation.…”

Retention in care and viral suppression after same‐day ART initiation: One‐year outcomes of the SLATE I and II individually randomized clinical trials in South Africa

“…SLATE I (Simplified Algorithms for Treatment Eligibility I) [3] and SLATE II [4] were designed as simple, clinical algorithms that require no point-of-care laboratory testing and can be used by existing healthcare personnel to distinguish patients who can start ART that day, even if they have mild symptoms of illness, from those who require additional care prior to initiation. While evidence from the SLATE trials [5,6] and others [7,8] demonstrates improved uptake of ART with SDI compared to standard care, concerns remain whether the benefits of SDI can be translated into improved retention once on treatment, or if instead attrition is simply shifted from before to soon after ART initiation, or even made worse by pressure that the expectation of SDI is perceived to place on patients [9,10]. Overall attrition at 8 months was lower in the intervention arm in both trials [5,6], but its timing differed.…”