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Randomized Controlled Trial
. 2021 Oct;24(10):e25825.
doi: 10.1002/jia2.25825.

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

Mhairi Maskew  1 , Alana T Brennan  1   2   3 , Willem D F Venter  4 , Matthew P Fox  1   2   3 , Lungisile Vezi  1 , Sydney Rosen  1   2
Affiliations
Randomized Controlled Trial

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

Mhairi Maskew et al. J Int AIDS Soc. 2021 Oct.

Abstract

Introduction: Same-day initiation (SDI) of antiretroviral therapy (ART) for HIV consistently increases ART uptake, but concerns remain about higher attrition from care after initiation. We analysed 12-month retention in the SLATE SDI trials.

Methods: SLATE I (Simplified Algorithms for Treatment Eligibility I, enrolment 06 March-28 July 2017) and SLATE II (enrolment 14 March-18 September 2018) were individually randomized trials at public outpatient clinics in Johannesburg that enrolled patients not yet on ART and administered the SLATE I or II algorithm. This included a symptom self-report, medical history, brief physical examination and readiness questionnaire to assess the eligibility for SDI. The studies compared the offer of SDI using the SLATE algorithms to standard of care initiation procedures. ART uptake and early retention were previously reported. Using routine clinic records, we conducted a pooled analysis of retention in care and HIV viral suppression 14 months after study enrolment, a time point equivalent to 12 months potential on ART, with an additional month allowed on either end to initiate ART and to return for the 12-month visit.

Results and discussion: We enrolled 1193 study participants (standard arms, n = 599, 50%; intervention arms, n = 594, 50%) and analysed by originally assigned groups. By 14 months after enrolment, 50% of intervention arm patients and 46% of standard arm patients remained in care at the initiating site (crude risk difference 4% (95% confidence interval -1%-10%); crude relative risk 1.10 (0.97-1.23), with similar viral suppression between arms. Observed attrition from care at site by 14 months was high in both study arms, but we found no evidence that the offer of SDI led to greater overall attrition or lower rates of viral suppression 1 year after starting ART and may have generated small improvements. SDI may have shifted some attrition from before to after dispensing of the first dose of medication.

Conclusions: An offer of SDI of ART, following a carefully designed protocol to identify patients who are eligible and ready to start treatment, is not inherently associated with an overall increase in patient attrition from care and leads to similar rates of viral suppression.

Trial registration: Clinicaltrials.gov NCT02891135, registered 01 September 2016. First participant enrolled 06 March 2017 in South Africa. Clinicaltrials.gov NCT03315013, registered 19 October 2017. First participant enrolled 14 March 2018.

Keywords: South Africa; implementation science; randomized trial; retention; same-day ART; viral suppression.

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Conflict of interest statement

WDFV sits on antiretroviral initiation guideline committees both local and international, has accepted speaking honoraria from multiple manufacturers of antiretrovirals and is on several of their advisory boards. The remaining authors declare that they have no competing interests.

Figures

Figure 1
Figure 1
SLATE I and SLATE II algorithms. Abbreviations: ART, antiretroviral therapy; ARVs, antiretroviral medications; LAM, lipoaribomannan; SLATE, Simplified Algorithms for Treatment Eligibility; TB, tuberculosis
See this image and copyright information in PMC

References

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    1. Republic of South Africa ‐ National Department of Health . Same‐day antiretroviral therapy (ART) initiation for HIV positive patients. Pretoria; 2017.
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    1. Rosen S, Maskew M, Brennan AT, Fox MP, Vezi L, Ehrenkranz PD, et al. Improved simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE II): protocol for a randomized evaluation. Trials. 2018;19:548. 10.1186/s13063-018-2928-5 - DOI - PMC - PubMed
    1. Rosen S, Maskew M, Larson BA, Brennan AT, Tsikhutsu I, Fox MP, et al. Simplified clinical algorithm for identifying patients eligible for same‐day HIV treatment initiation (SLATE): results from an individually randomized trial in South Africa and Kenya Title. PLoS Med. 2019;16:e1002912. 10.1371/journal.pmed.1002912 - DOI - PMC - PubMed

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