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
Introduction In its 2017 revision of the global guidelines for HIV care and treatment, the World Health Organization (WHO) called for rapid or same-day initiation of antiretroviral therapy (ART) for eligible patients testing positive for HIV [1], with the goal of reducing losses of treatment-eligibl...
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| Published in | PLoS medicine Vol. 17; no. 8; p. e1003226 |
|---|---|
| Main Authors | , , , , , , |
| Format | Journal Article |
| Language | English |
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Public Library of Science
01.08.2020
Public Library of Science (PLoS) |
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| Online Access | Get full text |
| ISSN | 1549-1676 1549-1277 1549-1676 |
| DOI | 10.1371/journal.pmed.1003226 |
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| Abstract | Introduction In its 2017 revision of the global guidelines for HIV care and treatment, the World Health Organization (WHO) called for rapid or same-day initiation of antiretroviral therapy (ART) for eligible patients testing positive for HIV [1], with the goal of reducing losses of treatment-eligible patients from care before they receive their first dose of antiretroviral (ARV) medications [2–4]. The algorithm, previously reported in [15] and illustrated in Fig 1, consisted of four screening tools, each evaluating an area of eligibility required for same-day ART initiation: (1) symptom report, (2) medical history, (3) brief physical examination, and (4) patient readiness assessment. Patients were excluded if they were pregnant (pregnancy was an exclusion criterion because treatment guidelines for pregnant women differ from those for nonpregnant adults; most pregnant women are diagnosed with HIV and initiated on ART in antenatal clinics, not general adult HIV clinics); did not intend to return to this clinic for further HIV care in the coming year; refused to be traced by phone or in person for follow-up care if test results received after the enrollment visit indicated that further care was needed; were not physically, mentally, or emotionally able to participate in the study in the opinion of the investigators or study staff; were not willing or able to provide written informed consent to participate in the study; or had previously enrolled in the same study or the SLATE I study. After exclusion of pregnant women, all study participants completed an interviewer-administered questionnaire exploring patients’ demographic characteristics, HIV history, knowledge and treatment preferences, employment and primary activities, and visit costs. |
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| AbstractList | BackgroundMany 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 findingsSLATE 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.ConclusionsMore 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 registrationClinicaltrials.gov NCT03315013, registered 19 October 2017. First participant enrolled 14 March 2018. Introduction In its 2017 revision of the global guidelines for HIV care and treatment, the World Health Organization (WHO) called for rapid or same-day initiation of antiretroviral therapy (ART) for eligible patients testing positive for HIV [1], with the goal of reducing losses of treatment-eligible patients from care before they receive their first dose of antiretroviral (ARV) medications [2–4]. The algorithm, previously reported in [15] and illustrated in Fig 1, consisted of four screening tools, each evaluating an area of eligibility required for same-day ART initiation: (1) symptom report, (2) medical history, (3) brief physical examination, and (4) patient readiness assessment. Patients were excluded if they were pregnant (pregnancy was an exclusion criterion because treatment guidelines for pregnant women differ from those for nonpregnant adults; most pregnant women are diagnosed with HIV and initiated on ART in antenatal clinics, not general adult HIV clinics); did not intend to return to this clinic for further HIV care in the coming year; refused to be traced by phone or in person for follow-up care if test results received after the enrollment visit indicated that further care was needed; were not physically, mentally, or emotionally able to participate in the study in the opinion of the investigators or study staff; were not willing or able to provide written informed consent to participate in the study; or had previously enrolled in the same study or the SLATE I study. After exclusion of pregnant women, all study participants completed an interviewer-administered questionnaire exploring patients’ demographic characteristics, HIV history, knowledge and treatment preferences, employment and primary activities, and visit costs. Mhairi Maskew and co-workers evaluate an algorithm for rapid HIV treatment initiation in settings with high tuberculosis symptom prevalence. 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.BACKGROUNDMany 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.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.METHODS AND FINDINGSSLATE 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.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.CONCLUSIONSMore 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.Clinicaltrials.gov NCT03315013, registered 19 October 2017. First participant enrolled 14 March 2018.TRIAL REGISTRATIONClinicaltrials.gov NCT03315013, registered 19 October 2017. First participant enrolled 14 March 2018. Introduction In its 2017 revision of the global guidelines for HIV care and treatment, the World Health Organization (WHO) called for rapid or same-day initiation of antiretroviral therapy (ART) for eligible patients testing positive for HIV [1], with the goal of reducing losses of treatment-eligible patients from care before they receive their first dose of antiretroviral (ARV) medications [2–4]. The algorithm, previously reported in [15] and illustrated in Fig 1, consisted of four screening tools, each evaluating an area of eligibility required for same-day ART initiation: (1) symptom report, (2) medical history, (3) brief physical examination, and (4) patient readiness assessment. Patients were excluded if they were pregnant (pregnancy was an exclusion criterion because treatment guidelines for pregnant women differ from those for nonpregnant adults; most pregnant women are diagnosed with HIV and initiated on ART in antenatal clinics, not general adult HIV clinics); did not intend to return to this clinic for further HIV care in the coming year; refused to be traced by phone or in person for follow-up care if test results received after the enrollment visit indicated that further care was needed; were not physically, mentally, or emotionally able to participate in the study in the opinion of the investigators or study staff; were not willing or able to provide written informed consent to participate in the study; or had previously enrolled in the same study or the SLATE I study. After exclusion of pregnant women, all study participants completed an interviewer-administered questionnaire exploring patients’ demographic characteristics, HIV history, knowledge and treatment preferences, employment and primary activities, and visit costs. |
| Author | Maskew, Mhairi Rosen, Sydney Fox, Matthew P. Brennan, Alana T. Vezi, Lungisile Venter, Willem D. F. Ehrenkranz, Peter |
| AuthorAffiliation | 3 Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts, United States of America University of Southampton, UNITED KINGDOM 4 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 2 Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, United States of America 5 Bill & Melinda Gates Foundation, Seattle, Washington, United States of America 1 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 |
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| Copyright | 2020 Maskew et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. 2020 Maskew et al 2020 Maskew et al |
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| Notes | ObjectType-Article-2 SourceType-Scholarly Journals-1 content type line 14 ObjectType-Feature-3 ObjectType-Evidence Based Healthcare-1 ObjectType-Article-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 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. |
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| Snippet | Introduction In its 2017 revision of the global guidelines for HIV care and treatment, the World Health Organization (WHO) called for rapid or same-day... Many countries encourage same-day initiation of antiretroviral therapy (ART), but evidence on eligibility for same-day initiation, how best to implement it,... Mhairi Maskew and co-workers evaluate an algorithm for rapid HIV treatment initiation in settings with high tuberculosis symptom prevalence. BackgroundMany countries encourage same-day initiation of antiretroviral therapy (ART), but evidence on eligibility for same-day initiation, how best to... |
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| SubjectTerms | Algorithms Antigens Antiretroviral drugs Antiretroviral therapy Biology and Life Sciences Clinics Consent Drug therapy Enrollments HIV Human immunodeficiency virus Medicine and Health Sciences Patients People and places Physical Sciences Pregnancy Primary care Questionnaires Research and Analysis Methods Tuberculosis Womens health |
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| Title | 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 |
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