PMID- 32853271
OWN - NLM
STAT- MEDLINE
DCOM- 20200924
LR  - 20200924
IS  - 1549-1676 (Electronic)
IS  - 1549-1277 (Print)
IS  - 1549-1277 (Linking)
VI  - 17
IP  - 8
DP  - 2020 Aug
TI  - 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.
PG  - e1003226
LID - 10.1371/journal.pmed.1003226 [doi]
LID - e1003226
AB  - 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 initiation. Initiation was higher in the 
      intervention (n = 296) versus standard arm (n = 297) by 7 days (91% versus 68%; 
      risk difference [RD] 23% [95% confidence interval (CI) 17%-29%]) and 28 days (94% 
      versus 82%; RD 12% [7%-17%]) after enrollment. In total, 87% of intervention and 
      38% of standard arm patients initiated on the same day. By 8 months after study 
      enrollment, 74% (220/296) of intervention and 59% (175/297) of standard arm 
      patients had both initiated ART in </=28 days and been retained in care (RD 15% 
      [7%-23%]). Among the 41% of participants with viral load results available, 
      suppression was 90% in the standard arm and 92% in the intervention arm among 
      patients initiated in </=28 days. No ART-associated adverse events were reported 
      after initiation; two intervention and four standard arm patients were reported 
      to have died during passive follow-up. Limitations of the study included limited 
      geographic generalizability, exclusion of patients too sick to consent, 
      fluctuations in procedures in the standard arm over the course of the study, high 
      fidelity to the trial protocol by study staff, and the possibility of 
      overestimating loss to follow-up due to data constraints. CONCLUSIONS: More than 
      85% of patients presenting for HIV testing or care, including those newly 
      diagnosed, were eligible and ready for same-day initiation under the SLATE II 
      algorithm. The algorithm increased initiation within 7 days without appearing to 
      compromise retention and viral suppression at 8 months, offering a practical and 
      acceptable approach that can be widely and immediately utilized by existing 
      providers. TRIAL REGISTRATION: Clinicaltrials.gov NCT03315013, registered 19 
      October 2017. First participant enrolled 14 March 2018.
FAU - Maskew, Mhairi
AU  - Maskew M
AUID- ORCID: 0000-0003-4238-0200
AD  - Health Economics and Epidemiology Research Office, Department of Internal 
      Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of 
      the Witwatersrand, Johannesburg, South Africa.
FAU - Brennan, Alana T
AU  - Brennan AT
AUID- ORCID: 0000-0002-7746-0668
AD  - Health Economics and Epidemiology Research Office, Department of Internal 
      Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of 
      the Witwatersrand, Johannesburg, South Africa.
AD  - Department of Global Health, Boston University School of Public Health, Boston, 
      Massachusetts, United States of America.
AD  - Department of Epidemiology, Boston University School of Public Health, Boston, 
      Massachusetts, United States of America.
FAU - Fox, Matthew P
AU  - Fox MP
AUID- ORCID: 0000-0001-9887-0634
AD  - Health Economics and Epidemiology Research Office, Department of Internal 
      Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of 
      the Witwatersrand, Johannesburg, South Africa.
AD  - Department of Global Health, Boston University School of Public Health, Boston, 
      Massachusetts, United States of America.
AD  - Department of Epidemiology, Boston University School of Public Health, Boston, 
      Massachusetts, United States of America.
FAU - Vezi, Lungisile
AU  - Vezi L
AUID- ORCID: 0000-0002-5282-8278
AD  - Health Economics and Epidemiology Research Office, Department of Internal 
      Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of 
      the Witwatersrand, Johannesburg, South Africa.
FAU - Venter, Willem D F
AU  - Venter WDF
AUID- ORCID: 0000-0002-4157-732X
AD  - Ezintsha, Wits Reproductive Health and HIV Institute, Department of Internal 
      Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of 
      the Witwatersrand, Johannesburg, South Africa.
FAU - Ehrenkranz, Peter
AU  - Ehrenkranz P
AUID- ORCID: 0000-0003-2028-4779
AD  - Bill & Melinda Gates Foundation, Seattle, Washington, United States of America.
FAU - Rosen, Sydney
AU  - Rosen S
AUID- ORCID: 0000-0002-6560-2964
AD  - Health Economics and Epidemiology Research Office, Department of Internal 
      Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of 
      the Witwatersrand, Johannesburg, South Africa.
AD  - Department of Global Health, Boston University School of Public Health, Boston, 
      Massachusetts, United States of America.
AD  - Department of Epidemiology, Boston University School of Public Health, Boston, 
      Massachusetts, United States of America.
LA  - eng
SI  - ClinicalTrials.gov/NCT03315013
PT  - Journal Article
PT  - Multicenter Study
PT  - Pragmatic Clinical Trial
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200827
PL  - United States
TA  - PLoS Med
JT  - PLoS medicine
JID - 101231360
RN  - 0 (Anti-HIV Agents)
SB  - IM
MH  - Adult
MH  - *Algorithms
MH  - Anti-HIV Agents/*administration & dosage
MH  - Female
MH  - Follow-Up Studies
MH  - HIV Infections/diagnosis/*drug therapy/*epidemiology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prevalence
MH  - South Africa/epidemiology
MH  - Tuberculosis/diagnosis/*epidemiology
MH  - Viral Load/drug effects/physiology
MH  - Young Adult
PMC - PMC7451542
COIS- All authors have completed the ICMJE uniform disclosure form at 
      www.icmje.org/coi_disclosure.pdf and declare: 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. PE is employed by the funding agency. SR is a 
      member of the Editorial Board of PLOS Medicine. The remaining authors declare 
      that they have no competing interests.
EDAT- 2020/08/28 06:00
MHDA- 2020/09/25 06:00
PMCR- 2020/08/27
CRDT- 2020/08/28 06:00
PHST- 2020/03/03 00:00 [received]
PHST- 2020/07/22 00:00 [accepted]
PHST- 2020/08/28 06:00 [entrez]
PHST- 2020/08/28 06:00 [pubmed]
PHST- 2020/09/25 06:00 [medline]
PHST- 2020/08/27 00:00 [pmc-release]
AID - PMEDICINE-D-20-00722 [pii]
AID - 10.1371/journal.pmed.1003226 [doi]
PST - epublish
SO  - PLoS Med. 2020 Aug 27;17(8):e1003226. doi: 10.1371/journal.pmed.1003226. 
      eCollection 2020 Aug.