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

Paul K Drain; Jienchi Dorward; Lauren R Violette; Justice Quame-Amaglo; Katherine K Thomas; Natasha Samsunder; Hope Ngobese; Koleka Mlisana; Pravikrishnen Moodley; Deborah Donnell; Ruanne V Barnabas; Kogieleum Naidoo; Salim S Abdool Karim; Connie Celum; Nigel Garrett

doi:10.1016/S2352-3018(19)30402-3

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

Lancet HIV. 2020 Apr;7(4):e229-e237. doi: 10.1016/S2352-3018(19)30402-3. Epub 2020 Feb 24.

Authors

Affiliations

¹ 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.
² 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.
³ Department of Medicine, School of Medicine, University of Washington, Seattle, WA, USA.
⁴ Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA.
⁵ Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.
⁶ Prince Cyril Zulu Communicable Disease Clinic, Durban Municipality, Durban, South Africa.
⁷ School of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, South Africa; National Health Laboratory Service, Durban, South Africa.
⁸ 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.
⁹ 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.
¹⁰ 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.
¹¹ 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.
¹² 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.

Abstract

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.

Publication types

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

MeSH terms

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

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

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