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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

Author

Listed:
  • Mhairi Maskew
  • Alana T Brennan
  • Matthew P Fox
  • Lungisile Vezi
  • Willem D F Venter
  • Peter Ehrenkranz
  • Sydney Rosen
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 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. Mhairi Maskew and co-workers evaluate an algorithm for rapid HIV treatment initiation in settings with high tuberculosis symptom prevalence.Why was this study done?: What did the researchers do and find?: What do these findings mean?:

Suggested Citation

  • Mhairi Maskew & Alana T Brennan & Matthew P Fox & Lungisile Vezi & Willem D F Venter & Peter Ehrenkranz & Sydney Rosen, 2020. "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," PLOS Medicine, Public Library of Science, vol. 17(8), pages 1-20, August.
    • Handle: RePEc:plo:pmed00:1003226
    DOI: 10.1371/journal.pmed.1003226
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    References listed on IDEAS

    as
    1. Sydney Rosen & Mhairi Maskew & Bruce A Larson & Alana T Brennan & Isaac Tsikhutsu & Matthew P Fox & Lungisile Vezi & Margaret Bii & Willem D F Venter, 2019. "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," PLOS Medicine, Public Library of Science, vol. 16(9), pages 1-20, September.
    2. Ahmed, Shahira & Autrey, Jessica & Katz, Ingrid T. & Fox, Matthew P. & Rosen, Sydney & Onoya, Dorina & Bärnighausen, Till & Mayer, Kenneth H. & Bor, Jacob, 2018. "Why do people living with HIV not initiate treatment? A systematic review of qualitative evidence from low- and middle-income countries," Social Science & Medicine, Elsevier, vol. 213(C), pages 72-84.
    3. Sydney Rosen & Matthew P Fox & Bruce A Larson & Papa Salif Sow & Peter D Ehrenkranz & Francois Venter & Yukari C Manabe & Jonathan Kaplan & Models for Accelerating Treatment Initiation (MATI) Technica, 2016. "Accelerating the Uptake and Timing of Antiretroviral Therapy Initiation in Sub-Saharan Africa: An Operations Research Agenda," PLOS Medicine, Public Library of Science, vol. 13(8), pages 1-13, August.
    4. Jacob Bor & Matthew P Fox & Sydney Rosen & Atheendar Venkataramani & Frank Tanser & Deenan Pillay & Till Bärnighausen, 2017. "Treatment eligibility and retention in clinical HIV care: A regression discontinuity study in South Africa," PLOS Medicine, Public Library of Science, vol. 14(11), pages 1-20, November.
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