Point-of-care HIV viral load testing combined with task shifting to improve treatment outcomes (STREAM): findings from an open-label, non-inferiority, randomised controlled trial.

Adult Anti-HIV Agents / therapeutic use Drug Monitoring Female HIV Infections / drug therapy HIV-1 / drug effects Humans Male Point-of-Care Testing South Africa Treatment Outcome Viral Load / drug effects

Journal

The lancet. HIV
ISSN: 2352-3018
Titre abrégé: Lancet HIV
Pays: Netherlands
ID NLM: 101645355

Informations de publication

Date de publication:
04 2020
Historique:
received: 17 09 2019
revised: 27 10 2019
accepted: 15 11 2019
pubmed: 28 2 2020
medline: 29 8 2020
entrez: 28 2 2020
Statut: ppublish

Résumé

Monitoring HIV treatment with laboratory testing introduces delays for providing appropriate care in resource-limited settings. The aim of our study was to determine whether point-of-care HIV viral load testing with task shifting changed treatment and care outcomes for adults on antiretroviral therapy (ART) when compared with standard laboratory viral load testing. We did an open-label, non-inferiority, randomised controlled trial in a public clinic in Durban, South Africa. We enrolled HIV-positive adults (aged ≥18 years) who presented for their first routine HIV viral load test 6 months after ART initiation. Individuals were randomly assigned by a random number allocation sequence to receive either point-of-care viral load testing at enrolment and after 6 months with task shifting to enrolled nurses (intervention group), or laboratory viral load testing (standard-of-care group). The primary outcome was combined viral suppression (<200 copies per mL) and retention at 12 months after enrolment. A non-inferiority margin of 10% was used. Analysis was done by intention to treat. This study was registered with ClinicalTrials.gov, NCT03066128. Between Feb 24, 2017, and Aug 23, 2017, we screened 657 participants, and 390 were enrolled and randomly assigned to either the intervention group (n=195) or standard-of-care group (n=195). 175 (90%) individuals in the intervention group and 148 (76%) individuals in the standard-of-care group had the primary outcome of retention with viral suppression, a difference of 13·9% (95% CI 6·4-21·2; p<0·00040). 182 participants (93%) in the intervention group had viral suppression compared with 162 (83%) in the standard-of-care group (difference 10·3%, 3·9-16·8; p=0·0025); 180 (92%) and 162 (85%) were retained in care (7·7%, 1·3-14·2; p=0·026). There were no adverse events related to point-of-care HIV viral load testing or task shifting. Point-of-care viral load testing combined with task shifting significantly improved viral suppression and retention in HIV care. Point-of-care testing can simplify treatment and improve outcomes for HIV-positive adults receiving ART in resource-limited settings. National Institute of Allergy and Infectious Diseases.

Sections du résumé

BACKGROUND
Monitoring HIV treatment with laboratory testing introduces delays for providing appropriate care in resource-limited settings. The aim of our study was to determine whether point-of-care HIV viral load testing with task shifting changed treatment and care outcomes for adults on antiretroviral therapy (ART) when compared with standard laboratory viral load testing.
METHODS
We did an open-label, non-inferiority, randomised controlled trial in a public clinic in Durban, South Africa. We enrolled HIV-positive adults (aged ≥18 years) who presented for their first routine HIV viral load test 6 months after ART initiation. Individuals were randomly assigned by a random number allocation sequence to receive either point-of-care viral load testing at enrolment and after 6 months with task shifting to enrolled nurses (intervention group), or laboratory viral load testing (standard-of-care group). The primary outcome was combined viral suppression (<200 copies per mL) and retention at 12 months after enrolment. A non-inferiority margin of 10% was used. Analysis was done by intention to treat. This study was registered with ClinicalTrials.gov, NCT03066128.
FINDINGS
Between Feb 24, 2017, and Aug 23, 2017, we screened 657 participants, and 390 were enrolled and randomly assigned to either the intervention group (n=195) or standard-of-care group (n=195). 175 (90%) individuals in the intervention group and 148 (76%) individuals in the standard-of-care group had the primary outcome of retention with viral suppression, a difference of 13·9% (95% CI 6·4-21·2; p<0·00040). 182 participants (93%) in the intervention group had viral suppression compared with 162 (83%) in the standard-of-care group (difference 10·3%, 3·9-16·8; p=0·0025); 180 (92%) and 162 (85%) were retained in care (7·7%, 1·3-14·2; p=0·026). There were no adverse events related to point-of-care HIV viral load testing or task shifting.
INTERPRETATION
Point-of-care viral load testing combined with task shifting significantly improved viral suppression and retention in HIV care. Point-of-care testing can simplify treatment and improve outcomes for HIV-positive adults receiving ART in resource-limited settings.
FUNDING
National Institute of Allergy and Infectious Diseases.

Identifiants

DOI: 10.1016/S2352-3018(19)30402-3 PMID: 32105625 PMC: PMC7183312
pubmed: 32105625
pii: S2352-3018(19)30402-3
doi: 10.1016/S2352-3018(19)30402-3
pmc: PMC7183312
mid: NIHMS1567480
pii:
doi:

Substances chimiques

Anti-HIV Agents 0

Banques de données

ClinicalTrials.gov
['NCT03066128']

Types de publication

Journal Article Randomized Controlled Trial Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e229-e237

Subventions

Organisme : NIAID NIH HHS
ID : P30 AI027757
Pays : United States
Organisme : NIAID NIH HHS
ID : R21 AI124719
Pays : United States

Commentaires et corrections

Type : CommentIn
Type : CommentIn

Informations de copyright

Copyright © 2020 Elsevier Ltd. All rights reserved.

Références

AIDS Res Hum Retroviruses. 2017 Dec;33(12):1181-1184
pubmed: 28793781
J Int AIDS Soc. 2017 Nov;20 Suppl 7:
pubmed: 29130601
J Acquir Immune Defic Syndr. 2016 Jun 1;72(2):e45-8
pubmed: 26959192
J Virol Methods. 2017 Jun;244:39-45
pubmed: 28274744
MMWR Morb Mortal Wkly Rep. 2015 Nov 27;64(46):1287-90
pubmed: 26605986
BMJ Open. 2016 Aug 16;6(8):e011999
pubmed: 27531735
BMJ Open. 2017 Sep 27;7(9):e017507
pubmed: 28963304
PLoS One. 2018 Sep 19;13(9):e0201341
pubmed: 30231022
J Clin Microbiol. 2016 Aug;54(8):2104-8
pubmed: 27252459
Implement Sci. 2012 Jul 16;7:66
pubmed: 22800379
J Clin Microbiol. 2018 Mar 26;56(4):
pubmed: 29386266
Clin Microbiol Rev. 2019 May 15;32(3):
pubmed: 31092508
BMC Psychiatry. 2015 May 23;15:118
pubmed: 26001915
Stat Med. 1998 Apr 30;17(8):873-90
pubmed: 9595617
J Int AIDS Soc. 2017 Jul 21;20(Suppl 4):22024
pubmed: 28770588
Lancet Infect Dis. 2014 Mar;14(3):239-49
pubmed: 24332389

Auteurs

Paul K Drain (PK)

Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA; Department of Medicine, School of Medicine, University of Washington, Seattle, WA, USA; Department of Epidemiology, School of Public Health, University of Washington, Seattle, WA, USA. Electronic address: pkdrain@uw.edu.

Jienchi Dorward (J)

Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.

Lauren R Violette (LR)

Department of Medicine, School of Medicine, University of Washington, Seattle, WA, USA.

Justice Quame-Amaglo (J)

Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA.

Katherine K Thomas (KK)

Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA.

Natasha Samsunder (N)

Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.

Hope Ngobese (H)

Prince Cyril Zulu Communicable Disease Clinic, Durban Municipality, Durban, South Africa.

Koleka Mlisana (K)

School of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, South Africa; National Health Laboratory Service, Durban, South Africa.

Pravikrishnen Moodley (P)

School of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, South Africa; National Health Laboratory Service, Durban, South Africa; Department of Virology, Inkosi Albert Luthuli Central Hospital, Cato Manor, South Africa.

Deborah Donnell (D)

Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA.

Ruanne V Barnabas (RV)

Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA; Department of Medicine, School of Medicine, University of Washington, Seattle, WA, USA.

Kogieleum Naidoo (K)

Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa; School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa; CAPRISA-MRC HIV-TB Pathogenesis and Treatment Research Unit, and Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, South Africa.

Salim S Abdool Karim (SS)

Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa; School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa; Department of Epidemiology, Columbia University, New York, NY, USA.

Connie Celum (C)

Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA; Department of Medicine, School of Medicine, University of Washington, Seattle, WA, USA.

Nigel Garrett (N)

Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa; School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female

Evaluation of Low-Value Services Across Major Medicare Advantage Insurers and Traditional Medicare.

Ciara Duggan, Adam L Beckman, Ishani Ganguli et al.
1.00
Humans United States Aged Cross-Sectional Studies Medicare Part C

Effectiveness of Virtual Yoga for Chronic Low Back Pain: A Randomized Clinical Trial.

Hallie Tankha, Devyn Gaskins, Amanda Shallcross et al.
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Point-of-care HIV viral load testing combined...
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Anti-infectieux › Antiviraux › Antirétroviraux › Agents antiVIH › Point-of-care HIV viral load testing combined...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Monitorage physiologique › Surveillance des médicaments › Point-of-care HIV viral load testing combined...
questionsmedicales.fr › Maladies du système immunitaire › Déficits immunitaires › Infections à VIH › Point-of-care HIV viral load testing combined...
questionsmedicales.fr › Virus › Virus à ARN › Retroviridae › Lentivirus › Lentivirus des primates › VIH (Virus de l'Immunodéficience Humaine) › VIH-1 (Virus de l'Immunodéficience Humaine de type 1) › Point-of-care HIV viral load testing combined...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Point-of-care HIV viral load testing combined...
questionsmedicales.fr › Administration des services de santé › Gestion des soins aux patients › Systèmes automatisés lit malade › Analyse sur le lieu d'intervention › Point-of-care HIV viral load testing combined...
questionsmedicales.fr › Régions géographiques › Afrique › Afrique subsaharienne › Afrique australe › République d'Afrique du Sud › Point-of-care HIV viral load testing combined...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Point-of-care HIV viral load testing combined...
questionsmedicales.fr › Phénomènes microbiologiques › Phénomènes physiologiques viraux › Charge virale › Point-of-care HIV viral load testing combined...